Pelvic PainNCT05429957
Effects of Muscle Energy Technique Versus Aerobic Exercises on Pain and Disability in Patients With Chronic Pelvic Pain
A study testing Muscle Energy Technique and Aerobic Exercises in people with Pelvic Pain and Chronic Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of study is to find out the effects of muscle energy technique versus aerobic exercises on pain and disability in patients with chronic pelvic pain. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Pelvic Pain, Chronic Pain
- What is being tested?
- Muscle Energy Technique and Aerobic Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jan 2022to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with chronic pelvic pain of >6 months' duration and the cause of their pain is unknown
- CPP was located within the true pelvis (between and below the anterior iliac crests)
- Average score of at least 4 out of 10 (0-10) on a numeric rating scale
- moderate to severe pain on pelvic pain impact questionnaire
Who cannot join
- History of cancer
- Pregnancy at the time of inclusion
- Known pelvic pathology (eg, endometriosis, ovarian cyst, fibroid >3cm)
- Intraabdominal and pelvic surgery within the last six months
- chronic or recurrent gastro-intestinal disease including irritable bowel syndrome
- Received any physiotherapy treatment within the previous month
Trial locations and contacts
1 site in 1 country.
About this study
The aim of study is to find out the effects of muscle energy technique versus aerobic exercises on pain and disability in patients with chronic pelvic pain.
- Conditions
- Pelvic Pain, Chronic Pain
- Being tested
- Muscle Energy Technique, Aerobic Exercises
- Keywords
- Pelvic Pain, Female, Exercise
- Medical subject headings
- Pelvic Pain, Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Energy TechniqueOther
Muscle energy technique (Post Isometric relaxation) three times per week for 8 weeks.
- MET of the Iliopsoas
- MET of Piriformis muscle
- MET of Quadratus Lumborum muscle
- MET of Erector Spinae muscle
Aerobic ExercisesOther
Aerobic exercise (treadmill walking) three times per week for 8 weeks
- Warm-up phase: in which each patient alternately steps their legs forward, backward, and sideways in each direction for 5 min
- Active phase: Treadmill speed was 3km/hour for 5 weeks and progress to 4km/hour after 5 weeks for 20 min.
- Cool down phase: During a cool down period take a deep breath with both arms overhead and exhale while bringing the arms down, shaking out the legs and arms for 5 min.
| Study group | Role | What they receive |
|---|---|---|
| Muscle Energy Technique | Experimental | Muscle Energy Technique of Iliopsoas, Piriformis, Quadratus Lumborum and Erector Spinae muscle Receives: Other: Muscle Energy Technique |
| Aerobic Exercises | Experimental | aerobic exercises (walking on the treadmill) Receives: Other: Aerobic Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic pain impact questionnaire
The Pelvic Pain Impact Questionnaire evaluates the pelvic pain impact on life. It has patient generated language, is easily managed and scored, has psychometric properties and it is appropriate for clinical settings and research across primary, secondary and tertiary care. The ten-item questionnaire consist of 8 Likert questions and 2 additional, non-scored questions
Measured: 8th week
Numerical Pain Rating Scale
The Numerical Pain Rating Scale (NPRS) is a particular measure in which people rate their pain on an 11-point numerical scale. The scale is comprised of 0 (no pain at all) to 10, 0 show no pain at all and 10 indicate worst imaginable pain
Measured: 8th week
Secondary outcomes (1)
Pain disability index
The Pain Disability Index is a seven-item survey to investigate functional disability. Every question utilizes an ordinal scale going from 0 to 10, 0 indicates no disability and 10 means worst disability. Scores can be added to represent a combined score of worldwide disability ranging from 0 to 70 ,where higher scores indicate greater disability
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start20 Jan 2022
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Neelam, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429957
- Sponsor's protocol ID
- REC/RCR & AHS/22/0516
- Status last verified
- Dec 2022
- First submitted
- 20 Jun 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fuentes-Marquez P, Cabrera-Martos I, Valenza MC. Physiotherapy interventions for patients with chronic pelvic pain: A systematic review of the literature. Physiother Theory Pract. 2019 Dec;35(12):1131-1138. doi: 10.1080/09593985.2018.1472687. Epub 2018 May 14.
PubMed 29757068Chong OT, Critchley HO, Williams LJ, Haraldsdottir E, Horne AW, Fallon M. The impact of meridian balance method electro-acupuncture treatment on chronic pelvic pain in women: a three-armed randomised controlled feasibility study using a mixed-methods approach. Br J Pain. 2018 Nov;12(4):238-249. doi: 10.1177/2049463718776044. Epub 2018 May 14.
PubMed 30349698Horne AW, Vincent K, Hewitt CA, Middleton LJ, Koscielniak M, Szubert W, Doust AM, Daniels JP; GaPP2 collaborative. Gabapentin for chronic pelvic pain in women (GaPP2): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2020 Sep 26;396(10255):909-917. doi: 10.1016/S0140-6736(20)31693-7.
PubMed 32979978Ghai V, Subramanian V, Jan H, Pergialiotis V, Thakar R, Doumouchtsis SK; CHORUS: An International Collaboration for Harmonising Outcomes, Research, Standards in Urogynaecology, Women's Health. A systematic review on reported outcomes and outcome measures in female idiopathic chronic pelvic pain for the development of a core outcome set. BJOG. 2021 Mar;128(4):628-634. doi: 10.1111/1471-0528.16412. Epub 2020 Sep 1.
PubMed 32654406Lamvu G, Carrillo J, Ouyang C, Rapkin A. Chronic Pelvic Pain in Women: A Review. JAMA. 2021 Jun 15;325(23):2381-2391. doi: 10.1001/jama.2021.2631.
PubMed 34128995Nygaard AS, Stedenfeldt M, Oian P, Haugstad GK. Characteristics of women with chronic pelvic pain referred to physiotherapy treatment after multidisciplinary assessment: a cross-sectional study. Scand J Pain. 2019 Apr 24;19(2):355-364. doi: 10.1515/sjpain-2018-0308.
PubMed 30703061
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Muscle Energy Technique Versus Aerobic Exercises on Pain and Disability in Patients With Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT05429957
- Acronym / sponsor ID
- REC/RCR & AHS/22/0516
- Conditions
- Pelvic Pain, Chronic Pain
- Keywords
- Pelvic Pain, Female, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 23 Jun 2022 (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 aim of study is to find out the effects of muscle energy technique versus aerobic exercises on pain and disability in patients with chronic pelvic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle Energy Technique | Experimental | Other: Muscle Energy TechniqueMuscle Energy Technique of Iliopsoas, Piriformis, Quadratus Lumborum and Erector Spinae muscle |
| Aerobic Exercises | Experimental | Other: Aerobic Exercisesaerobic exercises (walking on the treadmill) |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women with chronic pelvic pain of >6 months' duration and the cause of their pain is unknown
- CPP was located within the true pelvis (between and below the anterior iliac crests)
- Average score of at least 4 out of 10 (0-10) on a numeric rating scale
- moderate to severe pain on pelvic pain impact questionnaire
Key exclusion criteria (6 listed)
- History of cancer
- Pregnancy at the time of inclusion
- Known pelvic pathology (eg, endometriosis, ovarian cyst, fibroid >3cm)
- Intraabdominal and pelvic surgery within the last six months
- chronic or recurrent gastro-intestinal disease including irritable bowel syndrome
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 |
|---|---|---|
| Muscle Energy TechniqueMuscle energy technique (Post Isometric relaxation) three times per week for 8 weeks. * MET of the Iliopsoas * MET of Piriformis muscle * MET of Quadratus Lumborum muscle * MET of Erector Spinae muscle | Other | Muscle Energy Technique |
| Aerobic ExercisesAerobic exercise (treadmill walking) three times per week for 8 weeks * Warm-up phase: in which each patient alternately steps their legs forward, backward, and sideways in each direction for 5 min * Active phase: Treadmill speed was 3km/hour for 5 weeks and progress to 4km/hour after 5 weeks for 20 min. * Cool down phase: During a cool down period take a deep breath with both arms overhead and exhale while bringing the arms down, shaking out the legs and arms for 5 min. | Other | Aerobic Exercises |
Primary outcome
Pelvic pain impact questionnaire
Time frame: 8th week
The Pelvic Pain Impact Questionnaire evaluates the pelvic pain impact on life. It has patient generated language, is easily managed and scored, has psychometric properties and it is appropriate for clinical settings and research across primary, secondary and tertiary care. The ten-item questionnaire consist of 8 Likert questions and 2 additional, non-scored questions
Numerical Pain Rating Scale
Time frame: 8th week
The Numerical Pain Rating Scale (NPRS) is a particular measure in which people rate their pain on an 11-point numerical scale. The scale is comprised of 0 (no pain at all) to 10, 0 show no pain at all and 10 indicate worst imaginable pain
1 secondary outcome
Pain disability index
Time frame: 8th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Background: PubMed 29757068Fuentes-Marquez P, Cabrera-Martos I, Valenza MC. Physiotherapy interventions for patients with chronic pelvic pain: A systematic review of the literature. Physiother Theory Pract. 2019 Dec;35(12):1131-1138. doi: 10.1080/09593985.2018.1472687. Epub 2018 May 14.
- Background: PubMed 30349698Chong OT, Critchley HO, Williams LJ, Haraldsdottir E, Horne AW, Fallon M. The impact of meridian balance method electro-acupuncture treatment on chronic pelvic pain in women: a three-armed randomised controlled feasibility study using a mixed-methods approach. Br J Pain. 2018 Nov;12(4):238-249. doi: 10.1177/2049463718776044. Epub 2018 May 14.
- Background: PubMed 32979978Horne AW, Vincent K, Hewitt CA, Middleton LJ, Koscielniak M, Szubert W, Doust AM, Daniels JP; GaPP2 collaborative. Gabapentin for chronic pelvic pain in women (GaPP2): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2020 Sep 26;396(10255):909-917. doi: 10.1016/S0140-6736(20)31693-7.
- Background: PubMed 32654406Ghai V, Subramanian V, Jan H, Pergialiotis V, Thakar R, Doumouchtsis SK; CHORUS: An International Collaboration for Harmonising Outcomes, Research, Standards in Urogynaecology, Women's Health. A systematic review on reported outcomes and outcome measures in female idiopathic chronic pelvic pain for the development of a core outcome set. BJOG. 2021 Mar;128(4):628-634. doi: 10.1111/1471-0528.16412. Epub 2020 Sep 1.
- Background: PubMed 34128995Lamvu G, Carrillo J, Ouyang C, Rapkin A. Chronic Pelvic Pain in Women: A Review. JAMA. 2021 Jun 15;325(23):2381-2391. doi: 10.1001/jama.2021.2631.
- Background: PubMed 30703061Nygaard AS, Stedenfeldt M, Oian P, Haugstad GK. Characteristics of women with chronic pelvic pain referred to physiotherapy treatment after multidisciplinary assessment: a cross-sectional study. Scand J Pain. 2019 Apr 24;19(2):355-364. doi: 10.1515/sjpain-2018-0308.
- Individual participant dataSharing planned: No
Related trials for Pelvic Pain
Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Active, not recruiting
Hypopressive-Core Stabilization With and Without Whole-Body Vibration in Postpartum Pelvic Girdle Pain
Postpartum Pelvic Girdle Pain
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
Hafiza Neelam, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Energy Technique and Aerobic Exercises in people with Pelvic Pain and Chronic Pain, run by Riphah International University 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 4 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: finished, as of the sponsor's last update on 9 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pelvic pain impact questionnaire (time frame: 8th week). The study lists 2 primary outcomes in all. 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 NCT05429957, which also lists 6 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 9 Dec 2022.