Post Partum Lumbopelvic PainNCT05921747
The Impact of Innovative Technology Strategies on Implementing Exercise Programs Using Fully Immersive Virtual Reality for Postpartum Women
A study testing VR Intervention Group Protocol in people with Post Partum Lumbopelvic Pain, run by Shalamar Institute of Health Sciences at 1 site in Pakistan.
Trial summary
The study aims to determine the effect of traditional exercise through using fully immersive virtual reality in postpartum female with lumbopelvic pain. This study will be single-blind randomized clinical -trial and will be conducted at Shalamar Institute of health sciences in 1 year after the approval by… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Post Partum Lumbopelvic Pain
- What is being tested?
- VR Intervention Group Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Aug 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postpartum women with acute and chronic lumbopelvic pain.
- Primary parous \& multiparous women.
Who cannot join
- Postpartum women with nausea, dizziness and blurred vision, high risk pregnancies.
- Structural disorder of spinal alignment (Scoliosis, kyphosis, lordosis)
- Traumatic/ Inflammatory / Infectious Conditions
- Diagnosed stress / depression
- History of spinal, pelvic, or femur surgery or previous fracture, neoplasm
- Any Previous history of backache
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shalamar School of Allied Health Sciences
Lahore, Punjab Province, 54840
About this study
The study aims to determine the effect of traditional exercise through using fully immersive virtual reality in postpartum female with lumbopelvic pain.
This study will be single-blind randomized clinical -trial and will be conducted at Shalamar Institute of health sciences in 1 year after the approval by institutional review board. Sixty female participants with a history of lumbopelvic pain will be recruited on the basis of inclusion and exclusion criteria. Data will be collected after taking written Informed Consent from each patient. The included participants will be randomized by gold fish randomization method and allocated to two groups (A \& B) each with 30 participants.
Read the detailed description
Lumbopelvic pain refers to self-reported pain in the lower back, sacroiliac joints, or a combination of these locations, among pregnant and postnatal women. Approximately 50% of pregnant women report lumbopelvic pain to some degree. Recent studies indicate the importance of hip extensors, pelvic floor muscle (PFM) and transverse abdominal muscle (TrAM) in the development of lumbopelvic pain.Moreover, pelvic instability, asymmetry and insufficient compression of the sacroiliac joints contribute to continuous lumbopelvic pain after delivery. In Europe every tenth women shortly postpartum and every sixth has reported similar symptoms 6 weeks later. Age, PGP during pregnancy and abdominal midline doming were associated with experiencing PGP shortly postpartum.
Studies have demonstrated the importance of choosing an optimal treatment strategy in clinical practice, and 5 subgroups of self-rated pain locations have been identified in the pelvic area. The study focused on pelvic girdle pain (PGP), or PGP in combination with lumbar pain, since these groups have been shown to have the highest impact on activity levels and health-related quality of life.
Traditional exercises that include dynamically controlling the lumbar segments and pelvic joints have been shown to result in functional improvement in patients with lumbopelvic pain. The term "core stability" is commonly used to refer to the ability of these "core" muscles to stabilize the lumbar spine and pelvic girdle during static postures and dynamic movements. A host of theories and "stabilization exercise" programs have been developed to train these muscles as a means of treating and/or preventing lower back pain (LBP). However, there is still much inconsistency and debate both in the clinical and research communities with regards to what constitutes "core stability" and a "stabilization exercise". Chronic pain is a global healthcare burden with as much as of 11% of the US population suffering from pain lasting six months or longer, and upwards of 20% in Europe. Chronic pain can lead to depression, anxiety, sleep disturbances, and impairment in cognitive tasks.
Established research supports VR(virtual relaity) as a treatment strategy for burn pain, acute pain, and experimentally induced pain. Two primary approaches afford analgesic benefits of VR: distraction therapy and immersive-ness. Distraction therapy temporarily takes attention away from pain while patients are engaged in the VR experience. In immersive VR, the user can interact with an artificial environment to treat chronic pain. In immersive VR, the user can interact with an artificial environment to treat chronic pain. One form of immersive VR is virtual embodiment. Virtual embodiment refers to the sense of owning a virtual body, from a first-person perspective, feeling the agent of the sensory feedback related to the actions of the virtual body. Through activation of somatosensory and premotor circuitry associated with the body parts that are embodied, the use of virtual embodiment as an immersive VR technique has been shown to influence pain-free range of motion in patients with unilateral chronic shoulder pain.
A case series was conducted in 2020, in which they describe two case studies that use embodiment in virtual reality as a treatment for chronic low back pain. The purpose of this case series was to determine the feasibility of a novel virtual reality-based digital therapeutic for the treatment of chronic pain. Two patients with chronic low back pain received seven sessions, two sessions per week, of a novel digital therapeutic that combines virtual embodiment with graded motor imagery to deliver functional rehabilitation exercises using an off-the-shelf virtual reality system. Pain catastrophizing scale was assessed before the first session and after the seventh session to determine the extent to which virtual embodiment training can improve psychological symptoms of chronic low back pain. In both patients, pain intensity was improved after individual sessions of virtual embodiment training. They concluded that embodiment in virtual reality improves symptoms of persistent chronic low back pain.
A study (RCT) was conducted in 2022 and their study have measured the Effects of a motor control exercise program on lumbopelvic pain recurrences and intensity in pregnant women with a history of lumbopelvic pain. Forty pregnant women with a history of lower back pelvic pain (LBPP) were recruited and randomly allocated to a control (20 participants) or intervention (20 participants) group. The control group have received standard prenatal care, including basic information on what to do when suffering from LBPP. The intervention group have participated in three 40-min exercise sessions per week from < 20 weeks until 34-36 weeks of gestation: one supervised group session via the Zoom platform (once a month) and two unsupervised sessions at home. A motor control exercise program was developed to target strengthening of the lumbo-pelvic-hip core muscles and to improve spinal and pelvic stabilization. Participants of this group have also received standard prenatal care. They concluded that motor control exercise program have allowed pregnant women to progress at their own pace through different levels of exercises. In addition, the use of technology in the follow-up of the women will make the approach flexible and adapted to their daily routines.
The purpose of the study is to reduce the potential abuse, dependency of painkillers and manual therapy intervention for treating chronic lumbopelvic pain. In order to promote an advance and noninvasive method for treating lumbopelvic pain in postpartum female this study will help to design better rehabilitative program including core stability exercise using the analgesic and distracting effects of Immersive Virtual reality. This study will help physiotherapist as well as other health care professionals to treat other factors contributing to lumbopelvic pain other than weak muscles and posture alignment in postpartum female through virtual reality.
- Conditions
- Post Partum Lumbopelvic Pain
- Being tested
- Traditional exercise as control group, VR Intervention Group Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional exercise as control groupOther
Standard Traditional exercise program:
The traditional exercises will include Kegel pelvic floor exercise, dead weight lifts, wide back rows, lunges with rotation, good morning (hip hinge), and lateral side bends. .
Pre and post measurement will be taken before and after the session.
VR Intervention Group ProtocolDevice
Also called VR Intervention Group Protocol as experimental group
Participants in the intervention group will undergo a virtual reality (VR)-based exercise program using Meta Quest 2 head-mounted displays (Meta Platforms Inc., USA) and the Lumbar Pain Rehab software provided by DynamicsVR (Dynamics VR S.L., Cadiz, Spain). The virtual reality (VR) intervention will consist of eight structured sessions designed to address postpartum lumbo-pelvic pain through the immersive, interactive training.
Each session incorporating pelvic floor muscle training using VR, consisting of three sets of 12 repetitions, with each contraction and relaxation phase lasting three seconds. In addition, patients engaged in two five-minute blocks of immersive VR activities with a two-minute rest interval, resulting in total session duration of 18 minutes.
A familiarization session will be conducted prior to the intervention to acclimate participants to the VR environment. This will include modified pelvic floor training (3 sets of 8 repetitions; 3 seconds of contraction.
| Study group | Role | What they receive |
|---|---|---|
| traditional exercises as control group | Other | Traditional exercise as control group
Postpartum women in this group will receive an 18-minute training session that will start with pelvic floor muscle training with 3 sets of 12 repetitions of 3 seconds of contraction and 3 seconds of relaxation in a lying position. The second part will be performed with 2 sets of 5-minute training modules with 1-minute rest between modules. A five-exercise circuit will be performed with one minute per exercise where the aim is to achieve the maximum number of repetitions possible, and then move on to the next exercise. For the exercises 2 dumbbells of 1 kilogram will be required. The exercises will include Kegel pelvic floor exercise, dead weight lifts, wide back rows, lunges with rotation, good morning (hip hinge), and lateral side bends. These traditional exercises were designed to build strength and improve pelvic floor function, lumbo-pelvic pain mirroring under the supervision of physiotherapist. Receives: Other: Traditional exercise as control group |
| VR Intervention Group Protocol | Experimental | Experimental: Participants in the intervention group will undergo a virtual reality (VR)-based exercise program using Meta Quest 2 head-mounted displays (Meta Platforms Inc., USA) and the Lumbar Pain Rehab software provided by DynamicsVR (Dynamics VR S.L., Cadiz, Spain). The virtual reality (VR) intervention will consist of eight structured sessions designed to address postpartum lumbo-pelvic pain through the immersive, interactive training.
Each session incorporating pelvic floor muscle training using VR, consisting of three sets of 12 repetitions, with each contraction and relaxation phase lasting three seconds. In addition, patients engaged in two five-minute blocks of immersive VR activities with a two-minute rest interval, resulting in total session duration of 18 minutes. Receives: Other: Traditional exercise as control group; Device: VR Intervention Group Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To access intensity of Pain
Visual analog scale (VAS) will be used to determine the intensity of pain. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Measured: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Secondary outcomes (14)
Level of Urinary incontinence
Urinary Distress Index will be used to access distress caused by urinary incontinence.UDI-6 scores more than 33.33 indicate higher distress caused by urinary incontinence symptoms.
Measured: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Effect on lumbopelvic pain
During pregnancy, women go through several hormonal and biomechanical changes as well as neuromuscular adaptations which could explain the development of lumbopelvic pain. Pregnancy-related hormonal changes, characterized by an increase in relaxin, estrogen and progesterone levels, are potentially linked to hyperlaxity of ligament and joint instability, thus contributing to lumbopelvic pain. In addition, biomechanical changes induced by the growing fetus, can modify posture, load sharing and mechanical stress in the lumbar and pelvic structures. Finally, neuromuscular adaptations during pregnancy include an increase in the activation of lumbopelvic muscles and a decrease in endurance of the pelvic floor muscles. Short Form McGill Pain Questionnaire(SF-MPQ) will be used to determine the intensity of pain.
The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Measured: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Presence of Simulator Sickness
Simulator Sickness Questionnaire (SSQ) will be used for assessment .The overall support score (SSQN) is calculated by taking an average of the individual scores across the 27 items. A high score on the SSQ indicates more optimism about life than a low score. Respondents with low SSQ scores have a higher prevalence of negative life events and illness.
Measured: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
condition-specific measure for women with pelvic girdle pain
Pelvic Girdle Questionnaire (PGQ) will be used .To calculate the total PGQ score, all scores are summarized and divided by the total possible score of 75 (maximum possible scores of 60 for activity and 15 for symptoms), subsequently recalculated to a percentage, resulting in percentage scores ranging from 0 (no disability) to 100 (severe disability).
Measured: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
To access fear of movement
Tampa scale of kinesiophobia (TSK). TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia
Measured: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Effect on disability due to pelvic pain
Pelvic Floor Disability Index ( PFDI) will be used to assesses the distress of pelvic organ prolapse (POP), anorectal and urinary symptoms in three subscales, respectively, Pelvic Organ Prolapse Distress Inventory (POPDI-6), Colorectal-Anal Distress Inventory (CRADI-8) and Urinary Distress Inventory (UDI-6) .The PFDI-20 has 20 items and 3 scales of your symptoms. All items use the following format with a response scale from 0 to 4. Scale Scores
Measured: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Effect on disability due to lumbopelvic pain
Due to physiological changes the pregnant female experience lumber pain. to determine lumber pain Oswestry Disability Index (ODI) will be used.
ODI scale will include following levels for assessment 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled
Measured: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Level of Depression, anxiety & stress
DASS (Depression anxiety stress scale)questionnaire will be used for assessment. The total score represents overall distress (0 to 30), with higher scores indicating more severe distress or a greater number of symptoms. Two subscales are presented: Anxiety-Stress: Items 1, 4, 6, 7, 8, 9 (raw score range = 0 to 18) Depression: Items 2, 3, 5, 10 (raw score range = 0 to 12)
Measured: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Effect on functioning
Patient Specific Functional Scale(PSFS) will be used. This scale will nominate 3 to 5 activities that they are unable to do or having difficulty doing because of their injury or problem. These activities are rated on an 11-point scale, where 0 is unable to perform the activity and 10 is able to perform the activity at preinjury level.
Measured: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Psychological assessment (Rumination, Magnification &Helplessness)
Pain Catastrophizing Scale will be used for measurement. Patients are asked to rate the degree to which they have any of the thoughts described in the questionnaire using a 5-point Likert scale ranging from 0 (never) to 4 (always). The total score is the sum of the scores for the individual items, and ranges from 0 to 52.
Measured: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
coping strategy of pain
Pain coping strategies were measured using the Coping Strategies Questionnaire (CSQ), which assesses three domains: cognitive, emotional, and behavioral responses to pain. Items are recorded on a 0-6 scale, with higher values shows more frequent use of each coping strategy.
Measured: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
To access fatigue
Fatigue severity was evaluated using the fatigue severity scale (FSS), a 9-item self-report measure designed to capture the impact of fatigue on daily functioning. Although the original scale does not include categorical thresholds, the scale is sometimes interpreted as low (scores 1-4), medium or borderline (4-5), and high or severe (5-7). In the present study, scores between 1 and 4 were operationally defined as indicative of low fatigue.
Measured: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
To acess breathlessness
Breathlessness intensity was measured with the modified Borg dyspnoea scale(24) (0-10), a numerical rating tool used to quantify perceived breathlessness during or following physical activity, where 0 represents no breathlessness, and 10 denotes maximal breathlessness. A score of <5 was used as an operational definition of moderate breathlessness.
Measured: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
To acess sleep quality and disturbance
Sleep quality and disturbances were assessed using the MOS Sleep Scale, a 12-item self-report questionnaire that evaluates sleep patterns over the previous four weeks. The scale generates six domain scores and two composite indices, each transformed to a 0-100 metric.
Measured: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start2 Aug 2023
- Primary completion31 Mar 2026
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Post Partum Lumbopelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After selecting the desired sample size (tentative 17) the subjects will be randomly allocated to the both treatment groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalamar Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javeria Dr Aslam, Ph.D, Principal investigator, Shalamar Institute of Health SciencesCarlos R. Morales, Ph.D, Study director, Universided Europea Madrid, SpainRAQUEL DIAZ-MECO, Ph.D, Study director, Universided Europea Madrid, SpainAlba P. Alemany, Ph.D, Principal investigator, Department of Radiology & Physical Medicine, Complutense University of Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921747
- Sponsor's protocol ID
- SSAHS 2023/01
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vesentini G, Prior J, Ferreira PH, Hodges PW, Rudge M, Ferreira ML. Pelvic floor muscle training for women with lumbopelvic pain: A systematic review and meta-analysis. Eur J Pain. 2020 Nov;24(10):1865-1879. doi: 10.1002/ejp.1636. Epub 2020 Sep 6.
PubMed 32735717Daneau C, Abboud J, Marchand AA, Houle M, Pasquier M, Ruchat SM, Descarreaux M. Mechanisms Underlying Lumbopelvic Pain During Pregnancy: A Proposed Model. Front Pain Res (Lausanne). 2021 Dec 2;2:773988. doi: 10.3389/fpain.2021.773988. eCollection 2021.
PubMed 35295430Catena RD, Wolcott WC. Self-selection of gestational lumbopelvic posture and bipedal evolution. Gait Posture. 2021 Sep;89:7-13. doi: 10.1016/j.gaitpost.2021.06.022. Epub 2021 Jun 26.
PubMed 34217002Starzec-Proserpio M, Wegrzynowska M, Sys D, Kajdy A, Rongies W, Baranowska B. Prevalence and factors associated with postpartum pelvic girdle pain among women in Poland: a prospective, observational study. BMC Musculoskelet Disord. 2022 Oct 20;23(1):928. doi: 10.1186/s12891-022-05864-y.
PubMed 36266709Trujillo MS, Alvarez AF, Nguyen L, Petros J. Embodiment in Virtual Reality for the Treatment of Chronic Low Back Pain: A Case Series. J Pain Res. 2020 Nov 25;13:3131-3137. doi: 10.2147/JPR.S275312. eCollection 2020.
PubMed 33269003Luo Y, He L, Li Y, Xie J, Gong S, Zhang Q, Yin E, Gu M, Yi C. Sacral osteotomy combined with triangular osteosynthesis in the treatment of malunion and nonunion of vertically displaced pelvic fractures. J Orthop Surg Res. 2022 Sep 5;17(1):409. doi: 10.1186/s13018-022-03296-x.
PubMed 36064584Beales D, Lutz A, Thompson J, Wand BM, O'Sullivan P. Disturbed body perception, reduced sleep, and kinesiophobia in subjects with pregnancy-related persistent lumbopelvic pain and moderate levels of disability: An exploratory study. Man Ther. 2016 Feb;21:69-75. doi: 10.1016/j.math.2015.04.016. Epub 2015 May 1.
PubMed 25997987Saleh MSM, Botla AMM, Elbehary NAM. Effect of core stability exercises on postpartum lumbopelvic pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(2):205-213. doi: 10.3233/BMR-181259.
PubMed 30282349Ehsani F, Sahebi N, Shanbehzadeh S, Arab AM, ShahAli S. Stabilization exercise affects function of transverse abdominis and pelvic floor muscles in women with postpartum lumbo-pelvic pain: a double-blinded randomized clinical trial study. Int Urogynecol J. 2020 Jan;31(1):197-204. doi: 10.1007/s00192-019-03877-1. Epub 2019 Apr 23.
PubMed 31016337Sonmezer E, Ozkoslu MA, Yosmaoglu HB. The effects of clinical pilates exercises on functional disability, pain, quality of life and lumbopelvic stabilization in pregnant women with low back pain: A randomized controlled study. J Back Musculoskelet Rehabil. 2021;34(1):69-76. doi: 10.3233/BMR-191810.
PubMed 32986655Matamala-Gomez M, Slater M, Sanchez-Vives MV. Impact of virtual embodiment and exercises on functional ability and range of motion in orthopedic rehabilitation. Sci Rep. 2022 Mar 23;12(1):5046. doi: 10.1038/s41598-022-08917-3.
PubMed 35322080Daneau C, Marchand AA, Bussieres A, O'Shaughnessy J, Ruchat SM, Descarreaux M. Effects of a motor control exercise program on lumbopelvic pain recurrences and intensity in pregnant women with a history of lumbopelvic pain: a study protocol for a randomized controlled feasibility trial. Pilot Feasibility Stud. 2022 Mar 21;8(1):65. doi: 10.1186/s40814-022-01024-0.
PubMed 35313988Kale, A.A. and Pathan, N.M., 2019. Effect of Core Stabilisation Exercises in Postnatal Women with Lumbo-Pelvic Instability. Indian Journal of Physiotherapy and Occupational Therapy, 13(2), p.19.
Aslam J, Paris-Alemany A, Romero-Morales C, Conde RD. Psychological and emotional benefits of virtual reality-based exercise for postpartum women with lumbopelvic pain: A randomized controlled trial. PLOS Glob Public Health. 2026 Sep 2;6(9):e0006354. doi: 10.1371/journal.pgph.0006354. eCollection 2026.
PubMed 42685098Aslam J, Paris-Alemany A, Diaz-Meco-Conde R, Romero-Morales C. The impact of virtual reality exercise programs on postpartum pelvic pain and disability among women with lumbopelvic pain. PeerJ. 2026 Jul 1;14:e21202. doi: 10.7717/peerj.21202. eCollection 2026.
PubMed 42405262
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Innovative Technology Strategies on Implementing Exercise Programs Using Fully Immersive Virtual Reality for Postpartum Women
- ClinicalTrials.gov ID
- NCT05921747
- Acronym / sponsor ID
- SSAHS 2023/01
- Conditions
- Post Partum Lumbopelvic Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Shalamar Institute of Health SciencesUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to determine the effect of traditional exercise through using fully immersive virtual reality in postpartum female with lumbopelvic pain.
This study will be single-blind randomized clinical -trial and will be conducted at Shalamar Institute of health sciences in 1 year after the approval by institutional review board. Sixty female participants with a history of lumbopelvic pain will be recruited on the basis of inclusion and exclusion criteria. Data will be collected after taking written Informed Consent from each patient. The included participants will be randomized by gold fish randomization method and allocated to two groups (A \& B) each with 30 participants.
Detailed description
Lumbopelvic pain refers to self-reported pain in the lower back, sacroiliac joints, or a combination of these locations, among pregnant and postnatal women. Approximately 50% of pregnant women report lumbopelvic pain to some degree. Recent studies indicate the importance of hip extensors, pelvic floor muscle (PFM) and transverse abdominal muscle (TrAM) in the development of lumbopelvic pain.Moreover, pelvic instability, asymmetry and insufficient compression of the sacroiliac joints contribute to continuous lumbopelvic pain after delivery. In Europe every tenth women shortly postpartum and every sixth has reported similar symptoms 6 weeks later. Age, PGP during pregnancy and abdominal midline doming were associated with experiencing PGP shortly postpartum.
Studies have demonstrated the importance of choosing an optimal treatment strategy in clinical practice, and 5 subgroups of self-rated pain locations have been identified in the pelvic area. The study focused on pelvic girdle pain (PGP), or PGP in combination with lumbar pain, since these groups have been shown to have the highest impact on activity levels and health-related quality of life.
Traditional exercises that include dynamically controlling the lumbar segments and pelvic joints have been shown to result in functional improvement in patients with lumbopelvic pain. The term "core stability" is commonly used to refer to the ability of these "core" muscles to stabilize the lumbar spine and pelvic girdle during static postures and dynamic movements. A host of theories and "stabilization exercise" programs have been developed to train these muscles as a means of treating and/or preventing lower back pain (LBP). However, there is still much inconsistency and debate both in the clinical and research communities with regards to what constitutes "core stability" and a "stabilization exercise". Chronic pain is a global healthcare burden with as much as of 11% of the US population suffering from pain lasting six months or longer, and upwards of 20% in Europe. Chronic pain can lead to depression, anxiety, sleep disturbances, and impairment in cognitive tasks.
Established research supports VR(virtual relaity) as a treatment strategy for burn pain, acute pain, and experimentally induced pain. Two primary approaches afford analgesic benefits of VR: distraction therapy and immersive-ness. Distraction therapy temporarily takes attention away from pain while patients are engaged in the VR experience. In immersive VR, the user can interact with an artificial environment to treat chronic pain. In immersive VR, the user can interact with an artificial environment to treat chronic pain. One form of immersive VR is virtual embodiment. Virtual embodiment refers to the sense of owning a virtual body, from a first-person perspective, feeling the agent of the sensory feedback related to the actions of the virtual body. Through activation of somatosensory and premotor circuitry associated with the body parts that are embodied, the use of virtual embodiment as an immersive VR technique has been shown to influence pain-free range of motion in patients with unilateral chronic shoulder pain.
A case series was conducted in 2020, in which they describe two case studies that use embodiment in virtual reality as a treatment for chronic low back pain. The purpose of this case series was to determine the feasibility of a novel virtual reality-based digital therapeutic for the treatment of chronic pain. Two patients with chronic low back pain received seven sessions, two sessions per week, of a novel digital therapeutic that combines virtual embodiment with graded motor imagery to deliver functional rehabilitation exercises using an off-the-shelf virtual reality system. Pain catastrophizing scale was assessed before the first session and after the seventh session to determine the extent to which virtual embodiment training can improve psychological symptoms of chronic low back pain. In both patients, pain intensity was improved after individual sessions of virtual embodiment training. They concluded that embodiment in virtual reality improves symptoms of persistent chronic low back pain.
A study (RCT) was conducted in 2022 and their study have measured the Effects of a motor control exercise program on lumbopelvic pain recurrences and intensity in pregnant women with a history of lumbopelvic pain. Forty pregnant women with a history of lower back pelvic pain (LBPP) were recruited and randomly allocated to a control (20 participants) or intervention (20 participants) group. The control group have received standard prenatal care, including basic information on what to do when suffering from LBPP. The intervention group have participated in three 40-min exercise sessions per week from < 20 weeks until 34-36 weeks of gestation: one supervised group session via the Zoom platform (once a month) and two unsupervised sessions at home. A motor control exercise program was developed to target strengthening of the lumbo-pelvic-hip core muscles and to improve spinal and pelvic stabilization. Participants of this group have also received standard prenatal care. They concluded that motor control exercise program have allowed pregnant women to progress at their own pace through different levels of exercises. In addition, the use of technology in the follow-up of the women will make the approach flexible and adapted to their daily routines.
The purpose of the study is to reduce the potential abuse, dependency of painkillers and manual therapy intervention for treating chronic lumbopelvic pain. In order to promote an advance and noninvasive method for treating lumbopelvic pain in postpartum female this study will help to design better rehabilitative program including core stability exercise using the analgesic and distracting effects of Immersive Virtual reality. This study will help physiotherapist as well as other health care professionals to treat other factors contributing to lumbopelvic pain other than weak muscles and posture alignment in postpartum female through virtual reality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- After selecting the desired sample size (tentative 17) the subjects will be randomly allocated to the both treatment groups
| Arm | Type | Receives |
|---|---|---|
| traditional exercises as control group | Other | Other: Traditional exercise as control groupTraditional exercise as control group Postpartum women in this group will receive an 18-minute training session that will start with pelvic floor muscle training with 3 sets of 12 repetitions of 3 seconds of contraction and 3 seconds of relaxation in a lying position. The second part will be performed with 2 sets of 5-minute training modules with 1-minute rest between modules. A five-exercise circuit will be performed with one minute per exercise where the aim is to achieve the maximum number of repetitions possible, and then move on to the next exercise. For the exercises 2 dumbbells of 1 kilogram will be required. The exercises will include Kegel pelvic floor exercise, dead weight lifts, wide back rows, lunges with rotation, good morning (hip hinge), and lateral side bends. These traditional exercises were designed to build strength and improve pelvic floor function, lumbo-pelvic pain mirroring under the supervision of physiotherapist. |
| VR Intervention Group Protocol | Experimental | Other: Traditional exercise as control group, Device: VR Intervention Group ProtocolExperimental: Participants in the intervention group will undergo a virtual reality (VR)-based exercise program using Meta Quest 2 head-mounted displays (Meta Platforms Inc., USA) and the Lumbar Pain Rehab software provided by DynamicsVR (Dynamics VR S.L., Cadiz, Spain). The virtual reality (VR) intervention will consist of eight structured sessions designed to address postpartum lumbo-pelvic pain through the immersive, interactive training. Each session incorporating pelvic floor muscle training using VR, consisting of three sets of 12 repetitions, with each contraction and relaxation phase lasting three seconds. In addition, patients engaged in two five-minute blocks of immersive VR activities with a two-minute rest interval, resulting in total session duration of 18 minutes. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Postpartum women with acute and chronic lumbopelvic pain.
- Primary parous \& multiparous women.
Key exclusion criteria (6 listed)
- Postpartum women with nausea, dizziness and blurred vision, high risk pregnancies.
- Structural disorder of spinal alignment (Scoliosis, kyphosis, lordosis)
- Traumatic/ Inflammatory / Infectious Conditions
- Diagnosed stress / depression
- History of spinal, pelvic, or femur surgery or previous fracture, neoplasm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional exercise as control groupStandard Traditional exercise program: The traditional exercises will include Kegel pelvic floor exercise, dead weight lifts, wide back rows, lunges with rotation, good morning (hip hinge), and lateral side bends. . Pre and post measurement will be taken before and after the session. | Other | VR Intervention Group Protocol, traditional exercises as control group |
| VR Intervention Group ProtocolAlso: VR Intervention Group Protocol as experimental groupParticipants in the intervention group will undergo a virtual reality (VR)-based exercise program using Meta Quest 2 head-mounted displays (Meta Platforms Inc., USA) and the Lumbar Pain Rehab software provided by DynamicsVR (Dynamics VR S.L., Cadiz, Spain). The virtual reality (VR) intervention will consist of eight structured sessions designed to address postpartum lumbo-pelvic pain through the immersive, interactive training. Each session incorporating pelvic floor muscle training using VR, consisting of three sets of 12 repetitions, with each contraction and relaxation phase lasting three seconds. In addition, patients engaged in two five-minute blocks of immersive VR activities with a two-minute rest interval, resulting in total session duration of 18 minutes. A familiarization session will be conducted prior to the intervention to acclimate participants to the VR environment. This will include modified pelvic floor training (3 sets of 8 repetitions; 3 seconds of contraction. | Device | VR Intervention Group Protocol |
Primary outcome
To access intensity of Pain
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Visual analog scale (VAS) will be used to determine the intensity of pain. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
14 secondary outcomes
Level of Urinary incontinence
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Effect on lumbopelvic pain
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Presence of Simulator Sickness
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
condition-specific measure for women with pelvic girdle pain
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
To access fear of movement
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Effect on disability due to pelvic pain
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Effect on disability due to lumbopelvic pain
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Level of Depression, anxiety & stress
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Effect on functioning
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Psychological assessment (Rumination, Magnification &Helplessness)
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
coping strategy of pain
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
To access fatigue
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
To acess breathlessness
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
To acess sleep quality and disturbance
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 32735717Vesentini G, Prior J, Ferreira PH, Hodges PW, Rudge M, Ferreira ML. Pelvic floor muscle training for women with lumbopelvic pain: A systematic review and meta-analysis. Eur J Pain. 2020 Nov;24(10):1865-1879. doi: 10.1002/ejp.1636. Epub 2020 Sep 6.
- Background: PubMed 35295430Daneau C, Abboud J, Marchand AA, Houle M, Pasquier M, Ruchat SM, Descarreaux M. Mechanisms Underlying Lumbopelvic Pain During Pregnancy: A Proposed Model. Front Pain Res (Lausanne). 2021 Dec 2;2:773988. doi: 10.3389/fpain.2021.773988. eCollection 2021.
- Background: PubMed 34217002Catena RD, Wolcott WC. Self-selection of gestational lumbopelvic posture and bipedal evolution. Gait Posture. 2021 Sep;89:7-13. doi: 10.1016/j.gaitpost.2021.06.022. Epub 2021 Jun 26.
- Background: PubMed 36266709Starzec-Proserpio M, Wegrzynowska M, Sys D, Kajdy A, Rongies W, Baranowska B. Prevalence and factors associated with postpartum pelvic girdle pain among women in Poland: a prospective, observational study. BMC Musculoskelet Disord. 2022 Oct 20;23(1):928. doi: 10.1186/s12891-022-05864-y.
- Background: PubMed 33269003Trujillo MS, Alvarez AF, Nguyen L, Petros J. Embodiment in Virtual Reality for the Treatment of Chronic Low Back Pain: A Case Series. J Pain Res. 2020 Nov 25;13:3131-3137. doi: 10.2147/JPR.S275312. eCollection 2020.
- Background: PubMed 36064584Luo Y, He L, Li Y, Xie J, Gong S, Zhang Q, Yin E, Gu M, Yi C. Sacral osteotomy combined with triangular osteosynthesis in the treatment of malunion and nonunion of vertically displaced pelvic fractures. J Orthop Surg Res. 2022 Sep 5;17(1):409. doi: 10.1186/s13018-022-03296-x.
- Background: PubMed 25997987Beales D, Lutz A, Thompson J, Wand BM, O'Sullivan P. Disturbed body perception, reduced sleep, and kinesiophobia in subjects with pregnancy-related persistent lumbopelvic pain and moderate levels of disability: An exploratory study. Man Ther. 2016 Feb;21:69-75. doi: 10.1016/j.math.2015.04.016. Epub 2015 May 1.
- Results publication: PubMed 30282349Saleh MSM, Botla AMM, Elbehary NAM. Effect of core stability exercises on postpartum lumbopelvic pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(2):205-213. doi: 10.3233/BMR-181259.
- Results publication: PubMed 31016337Ehsani F, Sahebi N, Shanbehzadeh S, Arab AM, ShahAli S. Stabilization exercise affects function of transverse abdominis and pelvic floor muscles in women with postpartum lumbo-pelvic pain: a double-blinded randomized clinical trial study. Int Urogynecol J. 2020 Jan;31(1):197-204. doi: 10.1007/s00192-019-03877-1. Epub 2019 Apr 23.
- Results publication: PubMed 32986655Sonmezer E, Ozkoslu MA, Yosmaoglu HB. The effects of clinical pilates exercises on functional disability, pain, quality of life and lumbopelvic stabilization in pregnant women with low back pain: A randomized controlled study. J Back Musculoskelet Rehabil. 2021;34(1):69-76. doi: 10.3233/BMR-191810.
- Results publication: PubMed 35322080Matamala-Gomez M, Slater M, Sanchez-Vives MV. Impact of virtual embodiment and exercises on functional ability and range of motion in orthopedic rehabilitation. Sci Rep. 2022 Mar 23;12(1):5046. doi: 10.1038/s41598-022-08917-3.
- Results publication: PubMed 35313988Daneau C, Marchand AA, Bussieres A, O'Shaughnessy J, Ruchat SM, Descarreaux M. Effects of a motor control exercise program on lumbopelvic pain recurrences and intensity in pregnant women with a history of lumbopelvic pain: a study protocol for a randomized controlled feasibility trial. Pilot Feasibility Stud. 2022 Mar 21;8(1):65. doi: 10.1186/s40814-022-01024-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javeria Dr Aslam, Ph.D principal investigator
Shalamar Institute of Health Sciences
Carlos R. Morales, Ph.D study director
Universided Europea Madrid, Spain
RAQUEL DIAZ-MECO, Ph.D study director
Universided Europea Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Intervention Group Protocol in people with Post Partum Lumbopelvic Pain, run by Shalamar Institute of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To access intensity of Pain (time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05921747, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.