Lower Back PainNCT05529602
Post Isometric Relaxation and Core Stability Exercises in Sacroiliac Joint Dysfunction
A study testing conventional physical therapy and relaxation exercise in people with Lower Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
There is growing evidence on the effects of post isometric relaxation exercises and core stability exercises on pain and disability secondary to various disorders. However, very few studies have explored their effects in postpartum Sacroiliac joint dysfunction. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- conventional physical therapy and relaxation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2021to 30 Aug 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postpartum females with sacroiliac joint dysfunction
- Diagnosed Patients with SIJ dysfunction
- Females who will be physically active
- Age between 20 to 35 years
- Females having a post-partum period
Who cannot join
- Post Spinal surgery/instrumentation
- prolonged steroid use and bone tissue infection or malignancy)
- Radiculopathy
- Acute Traumatic injury of spine/lower extremity
- Patient under anticoagulant therapy
- Delivery with any complication
Show all 9Show fewer
- Females have any history of diabetes, hypertension, or any chronic illness
- Any Pelvic or abdominal surgery in past
- Disc herniation or spine fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Post Isometric Relaxation and Core Stability Exercises on Pain and Disability in Postpartum Females With Sacroiliac Joint Dysfunction
There is growing evidence on the effects of post isometric relaxation exercises and core stability exercises on pain and disability secondary to various disorders. However, very few studies have explored their effects in postpartum Sacroiliac joint dysfunction. The aim of this study will be to compare the effects of post isometric relaxation exercises and core stability exercises on pain in postpartum Sacroiliac joint dysfunction.
Read the detailed description
A previous study conducted by Farhadi et al. assessed that the prevalence of sacroiliac joint pain has been reported between 13-30% in postpartum females aged between 40-and 45 years. Specifically, 13% of the individuals with low back pain have the origin of their pain from the sacroiliac joint. It has been found that 33.6% of pregnant women have pelvic girdle pain, and 18.9% of post-partum women have "serious" pelvic girdle pain. In most women with pregnancy-related sacroiliac, joint pain resolves with time after pregnancy, but in some females, the pain lingers on. Patients with Sacroiliac dysfunction generally complain of pain in their back, and buttock or may radiate to the knee. On examination, there is pain and local tenderness. The symptoms increase on position change such as getting up from a sitting or lying position or while ascending and descending stairs. Sacroiliac pain is localized to the posterior pelvis and is described as stabbing pain deep.
Terzi and Clinton et al., (2019) found thirty women diagnosed with post-partum SIJ pain, their age ranged from (25-35)years, their BMI ranged from (25-to 30)kg/m², and their number of parity ranged(from 2-to 4)times were selected randomly from the outpatient clinic of Al-Ahrar teaching hospital. Women were divided randomly into two equal groups, Group A (Control group): 15 patients, they were treated by TENS for 4 weeks 30 min\session, 3 sessions \week. Group B(Study group):15 patient, were treated with core stability exercises for 4 weeks, 30 min\session, 5 sessions \week plus TENS as for group A. All participant was evaluated by VAS, Oswestry disability index (ODI), serum cortisol levels before and after treatment. The results revealed that there was a statistically significant decrease in the mean value of VAS in the group (B) when compared with its corresponding value in group (A). In spite of there being no statistically significant difference in plasma cortisol level, there was a clinical difference and high percent of improvement in favor of group B (8.83%) over group A (2.66%). Also, there was a statistically significant decrease in the mean value of ODI in the group (B) when compared with its corresponding value in group (A). It was concluded that core stability exercises could be used as a complementary treatment in reducing post-partum SIJ pain. Also, it could be considered a useful treatment to increase flexibility and range of motion.
Shamsi et al., in 2014, found that reduced pain and increased function are outcomes when core stability exercises are used in the early stages of interventions. Also, Huxel et al., found that core exercises resulted in better outcomes measures than general exercise in the first 3 months of interventions for LBP, as they found clinical improvements in pain perception and functional disability levels when the patients with LBP engaged in core-specific exercise.
One study was done by Noelle M.Selkow et al., (2017) supports the findings of our study by concluding that MET is effective in decreasing pain in patients with acute low back pain. Another study was done by Roberts BL where he described two techniques of soft tissue manipulation viz neuromuscular technique and MET and found that MET can reduce Pain, muscle rigidity, and lengthen muscle fibers. The effect of MET on disability is supported by Fenech et al., (2015) determined that LBP is one of the most common musculoskeletal problems that affects about 60-80% of the population throughout their life expectancy. The lifetime prevalence of low back pain is reported to be 84% with 11-12% of the population being disabled by this condition. In 2010 Global Burden of Disease conducted a study on low back pain and estimated the global age-standardized point prevalence to be 9.4%. Low back pain is a self-limiting condition that can commonly be found in middle age ranging from 35 to 65 years and 90% of the people can be cured within 3-4 months without any treatment protocol.
- Conditions
- Lower Back Pain
- Being tested
- conventional physical therapy, relaxation exercise
- Keywords
- core stability, Core strengthening, chronic low back pain, therapeutic exercises
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physical therapyOther
core stability exercises
A total of 3 sessions per week were given for 15-20 minutes
relaxation exerciseOther
the experimental group was given Post-isometric relaxation exercise along with core stability
A total of 3 sessions per week were given for 15-20 minutes
| Study group | Role | What they receive |
|---|---|---|
| post isometric relaxation exercises and core stability | Experimental | for pain and disability secondary to SIJ dysfunction in postpartum females Receives: Other: conventional physical therapy |
| conventional physical therapy | Other | for management of lower back pain Receives: Other: relaxation exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
MODIFIED OSWESTRY DISABILITY INDEX (MODI)
ODI is a reliable and valid to assess the functional disability related to low back pain,
it has 10 questions, each question is answered via six choices, the first statement takes 0 and the sixth statement take 5, the patient was asked to selected the best chouce that prescribe her disability, then all scores collected and taken as a percentage from the total score the higher score indicate great disability, scores from 0-20% denote minimal disability, scores 40-60% denote moderate disability, while scores from 60-80% denote crippled disability , finally scores from 80-100% represent patient who are confined to bed. Changes from the baseline and 3rd week.
Measured: 3rd week
Secondary outcomes (1)
Numeric Pain Rating Scale (NPRS)
Changes from baseline the Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). Changes from the baseline and 3rd week.
Measured: 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Dec 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 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 Lower Back 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Afifa Safdar, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529602
- Sponsor's protocol ID
- REC/RCR & AHS/22/0508
- Status last verified
- Sep 2023
- First submitted
- 24 Jul 2022
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ostgaard HC, Andersson GB, Wennergren M. The impact of low back and pelvic pain in pregnancy on the pregnancy outcome. Acta Obstet Gynecol Scand. 1991;70(1):21-4. doi: 10.3109/00016349109006172.
PubMed 1830444To WW, Wong MW. Factors associated with back pain symptoms in pregnancy and the persistence of pain 2 years after pregnancy. Acta Obstet Gynecol Scand. 2003 Dec;82(12):1086-91. doi: 10.1046/j.1600-0412.2003.00235.x.
PubMed 14616251Berg G, Hammar M, Moller-Nielsen J, Linden U, Thorblad J. Low back pain during pregnancy. Obstet Gynecol. 1988 Jan;71(1):71-5.
PubMed 2962023Hayden JA, Ellis J, Ogilvie R, Malmivaara A, van Tulder MW. Exercise therapy for chronic low back pain. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD009790. doi: 10.1002/14651858.CD009790.pub2.
PubMed 34580864Puntumetakul R, Saiklang P, Tapanya W, Chatprem T, Kanpittaya J, Arayawichanon P, Boucaut R. The Effects of Core Stabilization Exercise with the Abdominal Drawing-in Maneuver Technique versus General Strengthening Exercise on Lumbar Segmental Motion in Patients with Clinical Lumbar Instability: A Randomized Controlled Trial with 12-Month Follow-Up. Int J Environ Res Public Health. 2021 Jul 23;18(15):7811. doi: 10.3390/ijerph18157811.
PubMed 34360103Javadov A, Ketenci A, Aksoy C. The Efficiency of Manual Therapy and Sacroiliac and Lumbar Exercises in Patients with Sacroiliac Joint Dysfunction Syndrome. Pain Physician. 2021 May;24(3):223-233.
PubMed 33988941
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post Isometric Relaxation and Core Stability Exercises on Pain and Disability in Postpartum Females With Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT05529602
- Acronym / sponsor ID
- REC/RCR & AHS/22/0508
- Conditions
- Lower Back Pain
- Keywords
- core stability, Core strengthening, chronic low back pain, therapeutic exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 7 Sep 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.
There is growing evidence on the effects of post isometric relaxation exercises and core stability exercises on pain and disability secondary to various disorders. However, very few studies have explored their effects in postpartum Sacroiliac joint dysfunction. The aim of this study will be to compare the effects of post isometric relaxation exercises and core stability exercises on pain in postpartum Sacroiliac joint dysfunction.
Detailed description
A previous study conducted by Farhadi et al. assessed that the prevalence of sacroiliac joint pain has been reported between 13-30% in postpartum females aged between 40-and 45 years. Specifically, 13% of the individuals with low back pain have the origin of their pain from the sacroiliac joint. It has been found that 33.6% of pregnant women have pelvic girdle pain, and 18.9% of post-partum women have "serious" pelvic girdle pain. In most women with pregnancy-related sacroiliac, joint pain resolves with time after pregnancy, but in some females, the pain lingers on. Patients with Sacroiliac dysfunction generally complain of pain in their back, and buttock or may radiate to the knee. On examination, there is pain and local tenderness. The symptoms increase on position change such as getting up from a sitting or lying position or while ascending and descending stairs. Sacroiliac pain is localized to the posterior pelvis and is described as stabbing pain deep.
Terzi and Clinton et al., (2019) found thirty women diagnosed with post-partum SIJ pain, their age ranged from (25-35)years, their BMI ranged from (25-to 30)kg/m², and their number of parity ranged(from 2-to 4)times were selected randomly from the outpatient clinic of Al-Ahrar teaching hospital. Women were divided randomly into two equal groups, Group A (Control group): 15 patients, they were treated by TENS for 4 weeks 30 min\session, 3 sessions \week. Group B(Study group):15 patient, were treated with core stability exercises for 4 weeks, 30 min\session, 5 sessions \week plus TENS as for group A. All participant was evaluated by VAS, Oswestry disability index (ODI), serum cortisol levels before and after treatment. The results revealed that there was a statistically significant decrease in the mean value of VAS in the group (B) when compared with its corresponding value in group (A). In spite of there being no statistically significant difference in plasma cortisol level, there was a clinical difference and high percent of improvement in favor of group B (8.83%) over group A (2.66%). Also, there was a statistically significant decrease in the mean value of ODI in the group (B) when compared with its corresponding value in group (A). It was concluded that core stability exercises could be used as a complementary treatment in reducing post-partum SIJ pain. Also, it could be considered a useful treatment to increase flexibility and range of motion.
Shamsi et al., in 2014, found that reduced pain and increased function are outcomes when core stability exercises are used in the early stages of interventions. Also, Huxel et al., found that core exercises resulted in better outcomes measures than general exercise in the first 3 months of interventions for LBP, as they found clinical improvements in pain perception and functional disability levels when the patients with LBP engaged in core-specific exercise.
One study was done by Noelle M.Selkow et al., (2017) supports the findings of our study by concluding that MET is effective in decreasing pain in patients with acute low back pain. Another study was done by Roberts BL where he described two techniques of soft tissue manipulation viz neuromuscular technique and MET and found that MET can reduce Pain, muscle rigidity, and lengthen muscle fibers. The effect of MET on disability is supported by Fenech et al., (2015) determined that LBP is one of the most common musculoskeletal problems that affects about 60-80% of the population throughout their life expectancy. The lifetime prevalence of low back pain is reported to be 84% with 11-12% of the population being disabled by this condition. In 2010 Global Burden of Disease conducted a study on low back pain and estimated the global age-standardized point prevalence to be 9.4%. Low back pain is a self-limiting condition that can commonly be found in middle age ranging from 35 to 65 years and 90% of the people can be cured within 3-4 months without any treatment protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post isometric relaxation exercises and core stability | Experimental | Other: conventional physical therapyfor pain and disability secondary to SIJ dysfunction in postpartum females |
| conventional physical therapy | Other | Other: relaxation exercisefor management of lower back pain |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Postpartum females with sacroiliac joint dysfunction
- Diagnosed Patients with SIJ dysfunction
- Females who will be physically active
- Age between 20 to 35 years
- Females having a post-partum period
Key exclusion criteria (9 listed)
- Post Spinal surgery/instrumentation
- prolonged steroid use and bone tissue infection or malignancy)
- Radiculopathy
- Acute Traumatic injury of spine/lower extremity
- Patient under anticoagulant therapy
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 |
|---|---|---|
| conventional physical therapycore stability exercises A total of 3 sessions per week were given for 15-20 minutes | Other | post isometric relaxation exercises and core stability |
| relaxation exercisethe experimental group was given Post-isometric relaxation exercise along with core stability A total of 3 sessions per week were given for 15-20 minutes | Other | conventional physical therapy |
Primary outcome
MODIFIED OSWESTRY DISABILITY INDEX (MODI)
Time frame: 3rd week
ODI is a reliable and valid to assess the functional disability related to low back pain, it has 10 questions, each question is answered via six choices, the first statement takes 0 and the sixth statement take 5, the patient was asked to selected the best chouce that prescribe her disability, then all scores collected and taken as a percentage from the total score the higher score indicate great disability, scores from 0-20% denote minimal disability, scores 40-60% denote moderate disability, while scores from 60-80% denote crippled disability , finally scores from 80-100% represent patient who are confined to bed. Changes from the baseline and 3rd week.
1 secondary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 3rd 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 18 Sep 2023.
- Background: PubMed 1830444Ostgaard HC, Andersson GB, Wennergren M. The impact of low back and pelvic pain in pregnancy on the pregnancy outcome. Acta Obstet Gynecol Scand. 1991;70(1):21-4. doi: 10.3109/00016349109006172.
- Background: PubMed 14616251To WW, Wong MW. Factors associated with back pain symptoms in pregnancy and the persistence of pain 2 years after pregnancy. Acta Obstet Gynecol Scand. 2003 Dec;82(12):1086-91. doi: 10.1046/j.1600-0412.2003.00235.x.
- Background: PubMed 2962023Berg G, Hammar M, Moller-Nielsen J, Linden U, Thorblad J. Low back pain during pregnancy. Obstet Gynecol. 1988 Jan;71(1):71-5.
- Background: PubMed 34580864Hayden JA, Ellis J, Ogilvie R, Malmivaara A, van Tulder MW. Exercise therapy for chronic low back pain. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD009790. doi: 10.1002/14651858.CD009790.pub2.
- Background: PubMed 34360103Puntumetakul R, Saiklang P, Tapanya W, Chatprem T, Kanpittaya J, Arayawichanon P, Boucaut R. The Effects of Core Stabilization Exercise with the Abdominal Drawing-in Maneuver Technique versus General Strengthening Exercise on Lumbar Segmental Motion in Patients with Clinical Lumbar Instability: A Randomized Controlled Trial with 12-Month Follow-Up. Int J Environ Res Public Health. 2021 Jul 23;18(15):7811. doi: 10.3390/ijerph18157811.
- Background: PubMed 33988941Javadov A, Ketenci A, Aksoy C. The Efficiency of Manual Therapy and Sacroiliac and Lumbar Exercises in Patients with Sacroiliac Joint Dysfunction Syndrome. Pain Physician. 2021 May;24(3):223-233.
- 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.
Afifa Safdar, PhD* 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 conventional physical therapy and relaxation exercise in people with Lower Back 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 5 inclusion and 9 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 18 Sep 2023. 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?
MODIFIED OSWESTRY DISABILITY INDEX (MODI) (time frame: 3rd week). 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 NCT05529602, 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 18 Sep 2023.