Sacroiliac Joint DysfunctionNCT05479266
Comparison of Muscle Energy Techniques and Myofascial Release on Low Back Pain Due to Sacroiliac Joint Dysfunction
A study testing Muscle Energy Technique and Myofascial release in people with Sacroiliac Joint Dysfunction and Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to compare the effects of Muscle Energy Techniques and Myofascial Release on Lumbar Range of motion, pain and disability in patients of low back pain due to Sacroiliac Joint Dysfunction, Randomized controlled trials were done at a private clinic, The Health Professionals Bahria Town Phase… Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Sacroiliac Joint Dysfunction, Low Back Pain
- What is being tested?
- Muscle Energy Technique and Myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2021to 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 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- history of systemic illness
- acute injury or fracture in the lower limbs
- any hip joint pathology/infection/malignancy
- previous hip surgery or recently received intra-articular injections
- spinal stenosis/spondylolisthesis/disc disease
- congenital spinal deformity
- hypermobility of sacroiliac joint
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this research is to compare the effects of Muscle Energy Techniques and Myofascial Release on Lumbar Range of motion, pain and disability in patients of low back pain due to Sacroiliac Joint Dysfunction, Randomized controlled trials were done at a private clinic, The Health Professionals Bahria Town Phase 6, Islamabad. The Sample Size was 30. The subjects were divided into two groups, 15 subjects in Interventional group A receiving conventional physical therapy treatment alongside METs for hamstrings, iliopsoas and piriformis muscle while the other 15 subjects in Interventional group B receiving conventional physical therapy treatment with direct myofascial release of hamstrings, iliopsoas and piriformis muscle. study duration was of 6 months. Samling technique applied was non.probability sampling. Only females of age group 40-55 yrs having sacroiliac joint pain with limited lumbar range of motion were reduced. Tools used in the study were Numeric Pain Rating Scale(NPRS), Modified Oswestry Disability Index(MODI), Pelvic and bubble Inclinometer. Data was analyzed through SPSS 21.
Read the detailed description
Sacroiliac joint is the most common source of low back pain affecting 70-85% of adults. Accordingly, 13-30% of patients with lower back pain have Sacroiliac joint dysfunction. The main mechanism for developing sacroiliac joint dysfunction includes different unidirectional pelvic shear force along with repetitive torsional force and inflammation which produces not only the lower back pain but also groin and gluteal pain. Muscle imbalances has also been sighted as possible cause of pain. This theory states that the sacroiliac joint itself is unaffected, but the musculature surrounding the sacroiliac joint is in form of dysfunction. This muscular imbalance could limit the flexibility of muscle of low back pain and ultimately begin a syndrome of chronic disuse culminating in decreased function and heightened pain. The use of a combination of tests showed a high sensitivity and specificity to indicate the presence of sacroiliac joint dysfunction that includes FABER, posterior shear and resisted abduction pain provocation tests.
Treatment of sacroiliac joint pain is variable and no set method or protocol of treatment has been found to be efficacious and reliable. Interventions to treat pain of SIJ dysfunction includes Non-steroidal Anti-Inflammatory drugs(NSAIDs), physical therapy, corticosteroid injections, osteopathic manipulations(manual medicine), radiofrequency denervation, sacroiliac joint belts and surgery. Muscle Energy Techniques is the most commonly used manual medicine techniques that depends on method of using low amplitude muscle contractions against resistance thinking that it would improve vascular circulation and have a positive influence on static and dynamic posture. this techniques was further modified by having patients use their muscles in a controlled position against a counterforce. Muscle energy techniques have several uses that can help increase muscle strength, increase range of motion(ROM) and decrease edema.
Myofascial release techniques(MFR) are another manual medicine technique that is described as 'designed to stretch and reflexively release patterned soft tissue( particularly the muscles and fascia) and joint related restrictions'. myofascial abnormalities may lead to connective tissue fibrosis, increased tissue stiffness and further movement impairment which may lead to low back pain chronicity.
In a study conducted by D. Sharma et al in 2014 on comparing the effects of muscle energy techniques and mobilizations in treating sacroiliac joint dysfunction focusing on piriformis, quadratus lumborum and erector spinae muscles, concluded that METs and mobilizations are both effective in treating chronic low back pain due to sacroiliac joint dysfunction. Outcomes were measured on first day and then after 1st and 2nd week from each subject, pain and disability by Visual Analogue Scale and Modified Oswestry Disability Index Questionnaire(MODI) In a randomized controlled trial conducted by Arguisuelas et al in 2017 for studying the effects of Myofascial release (MFR) for quadratus lumborum, psoas muscle, thoracolumbar fascia and lumbar paravertebral muscles in Non-specific chronic low back pain , it was concluded that myofascial release therapy produced a significant improvement in both pain and disability. Pain was measured by means of Short Form Mc Gill Pain Questionnaire (SF-MPQ) and Visual Analogue scale and disability measured with Roland Morris Questionnaire.
In another study conducted by Sabah et al in 2019 concluded that muscle energy techniques for iliopsoas, hamstrings, erector spinae and quadratus lumborum is an effective treatment for decreasing anterior pelvic tilting angle and reducing pain in patients with chronic SIJ dysfunction. The study findings revealed a statistical significant decrease of anterior pelvic tilting angle in group A(p<0.001), also a significant decrease in pain in the 2 groups compared with the pre-intervention values(p<0.001) In 2020, Faryal et al conducted a study in peshawar, concluded that muscle energy technique targeting quadratus lumborum, iliopsoas and piriformis muscle and maitland mobilizations are both effective in treating the chronic sacroiliac joint dysfunction in terms of decreasing pain and disability when using lumbopelvic stabilization exercises as an adjunct therapy with them.
In previous studies both muscle energy techniques and myofascial release therapy has been proven to be effective in treating chronic low back pain due to sacroiliac joint dysfunction. Currently to our knowledge there exists very weak evidence to which one technique can be proved to be more effective than the other. The purpose of this study is to compare the effects of both these therapies on pain and functional status in patients with sacroiliac joint dysfunction in addition to conventional physical therapy treatment protocols.
- Conditions
- Sacroiliac Joint Dysfunction, Low Back Pain
- Being tested
- Muscle Energy Technique, Myofascial release
- Keywords
- sacroiliac Joint Dysfunction, Muscle Energy Techniques, Myofascial Release, Pain, Disability, Range of Motion
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Energy TechniqueOther
Also called Transcutaneous Electrical Nerve Stimulations and Hot pack
METS-Post isometric relaxation will be applied for piriformis, iliopsoas and hamstrings muscle. There will be three repetitions for each muscle, once per day and thrice a week for three weeks
Myofascial releaseOther
Also called Transcutaneous Electrical Nerve Stimulations and Hot pack
Myofascial Release will be done for piriformis, iliopsoas and hamstrings muscle. There will be three repetitions for each muscle, once per day and thrice a week for three weeks
| Study group | Role | What they receive |
|---|---|---|
| Muscle Energy Techniques | Experimental | Muscle Energy Techniques and Conventional Physical Therapy Receives: Other: Muscle Energy Technique |
| Myofascial Release | Experimental | Myofascial Release and Conventional Physical Therapy Receives: Other: Myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
NPRS is an 11- point numeric scale with 0 representing one pain extreme (e.g no pain) amd 10 representing the other extreme (e.g worst pain imaginable), scores range from 1-10. the highest the score the greater the intensity of pain
Measured: 3rd week
Modified Oswestry Disability Index
this questionnaire consists of 10 items addressing different aspects of function. Each itemis scored from 0-5, with higher values representing greater disability. The total score is multiplied by 2 and expressed as percentage. Fore each section the total possible score is 5.
Measured: 3rd week
Range of Motion(lumbar spine)
Lumbar spine flexion, extension and sidebending will be measured with bubble inclinometer
Measured: 3rd week
pelvic tilting
pelvic tilting will be measured with pelvic inclinometer
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 posted29 Jul 2022
- Study start1 Nov 2021
- Primary completion15 Mar 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DysfunctionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Affan Iqbal, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479266
- Sponsor's protocol ID
- RIPHAH/FR&AHS/Letter-0976
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Muscle Energy Techniques and Myofascial Release on Low Back Pain Due to Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT05479266
- Acronym / sponsor ID
- RIPHAH/FR&AHS/Letter-0976
- Conditions
- Sacroiliac Joint Dysfunction, Low Back Pain
- Keywords
- sacroiliac Joint Dysfunction, Muscle Energy Techniques, Myofascial Release, Pain, Disability, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 29 Jul 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 this research is to compare the effects of Muscle Energy Techniques and Myofascial Release on Lumbar Range of motion, pain and disability in patients of low back pain due to Sacroiliac Joint Dysfunction, Randomized controlled trials were done at a private clinic, The Health Professionals Bahria Town Phase 6, Islamabad. The Sample Size was 30. The subjects were divided into two groups, 15 subjects in Interventional group A receiving conventional physical therapy treatment alongside METs for hamstrings, iliopsoas and piriformis muscle while the other 15 subjects in Interventional group B receiving conventional physical therapy treatment with direct myofascial release of hamstrings, iliopsoas and piriformis muscle. study duration was of 6 months. Samling technique applied was non.probability sampling. Only females of age group 40-55 yrs having sacroiliac joint pain with limited lumbar range of motion were reduced. Tools used in the study were Numeric Pain Rating Scale(NPRS), Modified Oswestry Disability Index(MODI), Pelvic and bubble Inclinometer. Data was analyzed through SPSS 21.
Detailed description
Sacroiliac joint is the most common source of low back pain affecting 70-85% of adults. Accordingly, 13-30% of patients with lower back pain have Sacroiliac joint dysfunction. The main mechanism for developing sacroiliac joint dysfunction includes different unidirectional pelvic shear force along with repetitive torsional force and inflammation which produces not only the lower back pain but also groin and gluteal pain. Muscle imbalances has also been sighted as possible cause of pain. This theory states that the sacroiliac joint itself is unaffected, but the musculature surrounding the sacroiliac joint is in form of dysfunction. This muscular imbalance could limit the flexibility of muscle of low back pain and ultimately begin a syndrome of chronic disuse culminating in decreased function and heightened pain. The use of a combination of tests showed a high sensitivity and specificity to indicate the presence of sacroiliac joint dysfunction that includes FABER, posterior shear and resisted abduction pain provocation tests.
Treatment of sacroiliac joint pain is variable and no set method or protocol of treatment has been found to be efficacious and reliable. Interventions to treat pain of SIJ dysfunction includes Non-steroidal Anti-Inflammatory drugs(NSAIDs), physical therapy, corticosteroid injections, osteopathic manipulations(manual medicine), radiofrequency denervation, sacroiliac joint belts and surgery. Muscle Energy Techniques is the most commonly used manual medicine techniques that depends on method of using low amplitude muscle contractions against resistance thinking that it would improve vascular circulation and have a positive influence on static and dynamic posture. this techniques was further modified by having patients use their muscles in a controlled position against a counterforce. Muscle energy techniques have several uses that can help increase muscle strength, increase range of motion(ROM) and decrease edema.
Myofascial release techniques(MFR) are another manual medicine technique that is described as 'designed to stretch and reflexively release patterned soft tissue( particularly the muscles and fascia) and joint related restrictions'. myofascial abnormalities may lead to connective tissue fibrosis, increased tissue stiffness and further movement impairment which may lead to low back pain chronicity.
In a study conducted by D. Sharma et al in 2014 on comparing the effects of muscle energy techniques and mobilizations in treating sacroiliac joint dysfunction focusing on piriformis, quadratus lumborum and erector spinae muscles, concluded that METs and mobilizations are both effective in treating chronic low back pain due to sacroiliac joint dysfunction. Outcomes were measured on first day and then after 1st and 2nd week from each subject, pain and disability by Visual Analogue Scale and Modified Oswestry Disability Index Questionnaire(MODI) In a randomized controlled trial conducted by Arguisuelas et al in 2017 for studying the effects of Myofascial release (MFR) for quadratus lumborum, psoas muscle, thoracolumbar fascia and lumbar paravertebral muscles in Non-specific chronic low back pain , it was concluded that myofascial release therapy produced a significant improvement in both pain and disability. Pain was measured by means of Short Form Mc Gill Pain Questionnaire (SF-MPQ) and Visual Analogue scale and disability measured with Roland Morris Questionnaire.
In another study conducted by Sabah et al in 2019 concluded that muscle energy techniques for iliopsoas, hamstrings, erector spinae and quadratus lumborum is an effective treatment for decreasing anterior pelvic tilting angle and reducing pain in patients with chronic SIJ dysfunction. The study findings revealed a statistical significant decrease of anterior pelvic tilting angle in group A(p<0.001), also a significant decrease in pain in the 2 groups compared with the pre-intervention values(p<0.001) In 2020, Faryal et al conducted a study in peshawar, concluded that muscle energy technique targeting quadratus lumborum, iliopsoas and piriformis muscle and maitland mobilizations are both effective in treating the chronic sacroiliac joint dysfunction in terms of decreasing pain and disability when using lumbopelvic stabilization exercises as an adjunct therapy with them.
In previous studies both muscle energy techniques and myofascial release therapy has been proven to be effective in treating chronic low back pain due to sacroiliac joint dysfunction. Currently to our knowledge there exists very weak evidence to which one technique can be proved to be more effective than the other. The purpose of this study is to compare the effects of both these therapies on pain and functional status in patients with sacroiliac joint dysfunction in addition to conventional physical therapy treatment protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle Energy Techniques | Experimental | Other: Muscle Energy TechniqueMuscle Energy Techniques and Conventional Physical Therapy |
| Myofascial Release | Experimental | Other: Myofascial releaseMyofascial Release and Conventional Physical Therapy |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- history of systemic illness
- acute injury or fracture in the lower limbs
- any hip joint pathology/infection/malignancy
- previous hip surgery or recently received intra-articular injections
- spinal stenosis/spondylolisthesis/disc disease
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 TechniqueAlso: Transcutaneous Electrical Nerve Stimulations and Hot packMETS-Post isometric relaxation will be applied for piriformis, iliopsoas and hamstrings muscle. There will be three repetitions for each muscle, once per day and thrice a week for three weeks | Other | Muscle Energy Techniques |
| Myofascial releaseAlso: Transcutaneous Electrical Nerve Stimulations and Hot packMyofascial Release will be done for piriformis, iliopsoas and hamstrings muscle. There will be three repetitions for each muscle, once per day and thrice a week for three weeks | Other | Myofascial Release |
Primary outcome
Numeric Pain Rating Scale
Time frame: 3rd week
NPRS is an 11- point numeric scale with 0 representing one pain extreme (e.g no pain) amd 10 representing the other extreme (e.g worst pain imaginable), scores range from 1-10. the highest the score the greater the intensity of pain
Modified Oswestry Disability Index
Time frame: 3rd week
this questionnaire consists of 10 items addressing different aspects of function. Each itemis scored from 0-5, with higher values representing greater disability. The total score is multiplied by 2 and expressed as percentage. Fore each section the total possible score is 5.
Range of Motion(lumbar spine)
Time frame: 3rd week
Lumbar spine flexion, extension and sidebending will be measured with bubble inclinometer
pelvic tilting
Time frame: 3rd week
pelvic tilting will be measured with pelvic inclinometer
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 29 Jul 2022.
- 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.
Muhammad Affan Iqbal, 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 Muscle Energy Technique and Myofascial release in people with Sacroiliac Joint Dysfunction and Low 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 0 inclusion and 7 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 29 Jul 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?
Numeric Pain Rating Scale (time frame: 3rd week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2022.