Sacroiliac DisorderNCT04161443
Effect of Quadratus Lumborum Muscle Energy Technique in Sacroilliac Joint Dysfunction.
A study testing physiotherapy in people with Sacroiliac Disorder, run by University of Lahore at 1 site in Pakistan.
Trial summary
Sacroiliac joint as a potential source of low back pain is an overlooked problem. Yet, in the existing years there has been an increasing interest in sacroiliac joint as a pain originator and more attention is being paid into its assessment and treatment in the current literature. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Sacroiliac Disorder
- What is being tested?
- physiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2018to 10 Dec 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Subjects with unilateral non-specific LBP
- The Subjects having at least 3 pain provocative tests of SIJ positive out of 5.
- Age 30-50 years. Both male and female.
- Pain history greater than six weeks.
- SIJ diagnostic scoring cut off point 4.
- VAS cut off point mild to moderate.
Who cannot join
- Radiating pain with sensory or motor deficits.
- History of fracture or any spinal surgery
- Trauma
- Any dysfunction of hip or knee
- Any systemic disease.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Institute of physical medicine and rehabilitation, Dow University of health sciences
Karachi, Sindh, 74200
About this study
Official title: Effect of Quadratus Lumborum Muscle Energy Technique Along With Gluteus Medius Strengthening Verus Gluteus Medius Strengthening Alone in the Management of Sacroilliac Joint Dysfunction.; A Randomized Controlled Trial.
Sacroiliac joint as a potential source of low back pain is an overlooked problem. Yet, in the existing years there has been an increasing interest in sacroiliac joint as a pain originator and more attention is being paid into its assessment and treatment in the current literature. Muscle imbalance due to postural dysfunction involves mainly gluteus medius and hamstring; however the role of quadratus lumborum working on compensatory mechanism and its treatment effect in the management of sacroiliac joint dysfunction is yet not discovered.
Read the detailed description
Going through current literature, it is evident that sacroiliac joint dysfunction as a postural dysfunction is highly prevalent among adult population. This dysfunction due to major muscle imbalances if not treated timely can result in serious consequences later in life where it becomes the permanent dysfunction involving the major changes in the joint itself. Muscle imbalance due to postural dysfunction involves mainly gluteus medius and hamstring; however the role of quadratus lumborum working on compensatory mechanism and its treatment effect in the management of sacroiliac joint dysfunction is yet not discovered. All patients will be assessed and screened by consultants as indicated and will refer to physiotherapy with diagnosed non- specific chronic back pain.Patients will further be screened for SIJ dysfunction by physiotherapist.Only those patients who fulfill the criteria of Quadratus lumborum tightness \& Gulteus medius weakness will randomly be selected and the sample of 70 will finally be selected for intervention.Written consent form will be taken from all study participants.Simple randomization technique will be used through "Randomization Main" software and randomization sheet will be generated. Patients will be further be assigned equally into two groups as per randomization sheet.Treatment will be performed three sessions per week for 4 weeks with postural advice and home exercise program with daily record of home diary. The selected outcome measures will be taken on initial visit (pre intervention), session 6 and final session 12 (post intervention).
- Conditions
- Sacroiliac Disorder
- Being tested
- physiotherapy
- Keywords
- MET, Quadratus lumborum, Sacroilliac joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyOther
- Treatment will be performed three sessions per week for 4 weeks with postural advice and home exercise program with daily record of home diary.
- The selected outcome measures will be taken on initial visit (pre intervention), session 6 and final session 12 (post intervention).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Following physiotherapy treatment will be given to the participants in this group for 4 weeks and each session last for 30 minutes.
i. MET Quadratus lumborum ii. Ultrasound iii. Gluteus medius exercises iv. Hamstring stretch Posture advice and home exercise program Receives: Other: physiotherapy |
| Comparator | Active comparator | Following physiotherapy treatment will be given to the participants in this group for 4 weeks and each session last for 30 minutes.
i. Ultrasound ii.Gluteus medius exercises iii.Hamstring stretch Receives: Other: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale to measure the change in level of Pain intensity
A Visual Analogue ScalE is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end ranging from no pain to severe pain.
Measured: Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline, at 6th session at the end of 2nd week and 12th session at the end of 4th week.
Oswestry Disability Index to measure change in level of disability
Change in level of disability as evaluated by means of Oswestry Disability Index 2.0 (ODI)
Measured: Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline, at 6th session at the end of 2nd week and 12th session at the end of 4th week.
SF-36 QUALITY OF LIFE to measure change in general health
SF-36 measure 8 different health concepts including general health, physical functioning, role functioning, bodily pain, mental health, emotional functioning, vitality, and social functioning.
Measured: Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline and 12th session at the end of 4th week.
Secondary outcomes (1)
Hand Held Dynamometer to check gluteus medius muscle strength
The strength of the gluteus medius muscle was assessed on the dominant side using the Microfet2 hand-held dynamometer (MicroFET 2, Hoogan Health Industries, West Jordan, UT, USA).
Measured: Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline, at 6th session at the end of 2nd week and 12th session at the end of 4th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start15 Oct 2018
- Primary completion10 Dec 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac DisorderStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabail Soomro, University of Lahore
- Investigators
- Rabail Soomro, Principal investigator, University of LahoreHussain Kari mi, Study chair, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161443
- Sponsor's protocol ID
- 019
- Status last verified
- Aug 2023
- First submitted
- 30 Oct 2019
- Last updated
- 21 Aug 2023
- 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 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Quadratus Lumborum Muscle Energy Technique Along With Gluteus Medius Strengthening Verus Gluteus Medius Strengthening Alone in the Management of Sacroilliac Joint Dysfunction.; A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04161443
- Acronym / sponsor ID
- 019
- Conditions
- Sacroiliac Disorder
- Keywords
- MET, Quadratus lumborum, Sacroilliac joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 13 Nov 2019 (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.
Sacroiliac joint as a potential source of low back pain is an overlooked problem. Yet, in the existing years there has been an increasing interest in sacroiliac joint as a pain originator and more attention is being paid into its assessment and treatment in the current literature. Muscle imbalance due to postural dysfunction involves mainly gluteus medius and hamstring; however the role of quadratus lumborum working on compensatory mechanism and its treatment effect in the management of sacroiliac joint dysfunction is yet not discovered.
Detailed description
Going through current literature, it is evident that sacroiliac joint dysfunction as a postural dysfunction is highly prevalent among adult population. This dysfunction due to major muscle imbalances if not treated timely can result in serious consequences later in life where it becomes the permanent dysfunction involving the major changes in the joint itself. Muscle imbalance due to postural dysfunction involves mainly gluteus medius and hamstring; however the role of quadratus lumborum working on compensatory mechanism and its treatment effect in the management of sacroiliac joint dysfunction is yet not discovered. All patients will be assessed and screened by consultants as indicated and will refer to physiotherapy with diagnosed non- specific chronic back pain.Patients will further be screened for SIJ dysfunction by physiotherapist.Only those patients who fulfill the criteria of Quadratus lumborum tightness \& Gulteus medius weakness will randomly be selected and the sample of 70 will finally be selected for intervention.Written consent form will be taken from all study participants.Simple randomization technique will be used through "Randomization Main" software and randomization sheet will be generated. Patients will be further be assigned equally into two groups as per randomization sheet.Treatment will be performed three sessions per week for 4 weeks with postural advice and home exercise program with daily record of home diary. The selected outcome measures will be taken on initial visit (pre intervention), session 6 and final session 12 (post intervention).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: physiotherapyFollowing physiotherapy treatment will be given to the participants in this group for 4 weeks and each session last for 30 minutes. i. MET Quadratus lumborum ii. Ultrasound iii. Gluteus medius exercises iv. Hamstring stretch Posture advice and home exercise program |
| Comparator | Active comparator | Other: physiotherapyFollowing physiotherapy treatment will be given to the participants in this group for 4 weeks and each session last for 30 minutes. i. Ultrasound ii.Gluteus medius exercises iii.Hamstring stretch |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Subjects with unilateral non-specific LBP
Key exclusion criteria (6 listed)
- Radiating pain with sensory or motor deficits.
- History of fracture or any spinal surgery
- Trauma
- Any dysfunction of hip or knee
- Any systemic 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 |
|---|---|---|
| physiotherapy* Treatment will be performed three sessions per week for 4 weeks with postural advice and home exercise program with daily record of home diary. * The selected outcome measures will be taken on initial visit (pre intervention), session 6 and final session 12 (post intervention). | Other | Comparator, Experimental |
Primary outcome
visual analog scale to measure the change in level of Pain intensity
Time frame: Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline, at 6th session at the end of 2nd week and 12th session at the end of 4th week.
A Visual Analogue ScalE is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end ranging from no pain to severe pain.
Oswestry Disability Index to measure change in level of disability
Time frame: Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline, at 6th session at the end of 2nd week and 12th session at the end of 4th week.
Change in level of disability as evaluated by means of Oswestry Disability Index 2.0 (ODI)
SF-36 QUALITY OF LIFE to measure change in general health
Time frame: Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline and 12th session at the end of 4th week.
SF-36 measure 8 different health concepts including general health, physical functioning, role functioning, bodily pain, mental health, emotional functioning, vitality, and social functioning.
1 secondary outcome
Hand Held Dynamometer to check gluteus medius muscle strength
Time frame: Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline, at 6th session at the end of 2nd week and 12th session at the end of 4th 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 21 Aug 2023.
- 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.
Rabail Soomro principal investigator
University of Lahore
Hussain Kari mi study chair
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy in people with Sacroiliac Disorder, run by University of Lahore 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 6 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 21 Aug 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?
visual analog scale to measure the change in level of Pain intensity (time frame: Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline, at 6th session at the end of 2nd week and 12th session at the end of 4th week.). The study lists 3 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 21 Aug 2023.