SIJ - Sprain of Sacroiliac JointNCT04757415
Gluteal Activation With or Without Traction Straight Leg Raise Technique
A study testing Traction straight leg raise technique for hamstring and Gluteal activation exercises,Hotpack in people with SIJ - Sprain of Sacroiliac Joint and Weakness, Muscle, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study was a Randomized clinical trial conducted to determine the Effects of gluteal activation with or without traction straight leg raise technique among patients of sacroiliac joint syndrome so that in future this study will be helpful for other clinician to determine that how much gluteal activation is… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- SIJ - Sprain of Sacroiliac Joint, Weakness, Muscle, Tightness of Back Muscles
- What is being tested?
- Traction straight leg raise technique for hamstring and Gluteal activation exercises,Hotpack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2021to 31 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects with LBP below the level of L5,
- With pain over the posterior aspect of SI joint around posterior superior iliac spine and buttock with or without above knee leg pain.
- Females only
Who cannot join
- Had radicular pain with neurological (sensory or motor) deficits,
- Had a history of spinal surgery, spinal, pelvic, or lower extremity fracture; hospitalization for trauma or motor vehicle accident;
- Hip or knee dysfunctions;
- Pregnancy;
- Any systemic disease such as arthritis, tuberculosis, liver, or kidney failure
- Subjects with leg length discrepancies, because of its potential effect on hamstring muscle length were also excluded. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Gluteal Activation With or Without Traction Straight Leg Raise Technique Among Patients of Sacroiliac Joint Syndrome
This study was a Randomized clinical trial conducted to determine the Effects of gluteal activation with or without traction straight leg raise technique among patients of sacroiliac joint syndrome so that in future this study will be helpful for other clinician to determine that how much gluteal activation is important in low back pain or sacroiliac joint syndrome, and how it affects our sling system.
Read the detailed description
Non Probability Convenient sampling was done . Patients following eligibility criteria from Sports and Spine Professionals ,Lahore were considered. Sample size was calculated with Epi tool calculator. 38 Participants were randomly allocated in two groups equally via convenient sampling method. Baseline assessment was done initially. Group A was given gluteal activation exercises with traction straight leg raise technique for hamstring and Group B was gluteal activation exercises without traction straight leg raise technique for hamstring. Duration of research was almost 6 months. Patient will undergo 10 treatments in five weeks. Each session will take 30 minutes. Pre and Post treatment readings were taken in 1st and 10th session over a 5 week period respectively. Assessment was done via sphygmomanometer and numeric pain rating scale for assessing muscle strength of gluteus maximum and pain levels respectively. All participants were provided written informed consent prior to commencement of the procedures. They were free to quit the treatment at any stage of research. Data was analyzed by using SPSS version 23.
- Being tested
- Traction straight leg raise technique for hamstring, Gluteal activation exercises,Hotpack
- Keywords
- Gluteal activation, Straight leg raise hamstring technique, Sacroiliac joint pain
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traction straight leg raise technique for hamstringOther
traction straight leg raise technique is used along with gluteal exercises
Gluteal activation exercises,HotpackOther
only gluteal activation exercises were performed without traction straight leg raise technique
| Study group | Role | What they receive |
|---|---|---|
| Traction straight leg raise technique for hamstring. | Experimental | Experimental group underwent conventional physiotherapy treatment (hot pack) followed by five main gluteal activation exercises three in first five sessions and rest two in remaining five sessions along with traction straight leg raise technique. Each session took 30 minutes . Participants were treated 10 times over a 5 week period with 2 treatment sessions per week. Pre and Post treatment readings were taken in 1st and 10th session over a 5 week period respectively. Assessment was done via Numeric pain rating scale and sphygmomanometer for assessing pain intensity and muscle strength of gluteus maximus. Receives: Other: Traction straight leg raise technique for hamstring |
| Gluteal activation exercises | Experimental | Experimental group underwent conventional physiotherapy treatment (hot pack) followed by five main gluteal activation exercises three in first five sessions and rest two in remaining five sessions. Each session took 30 minutes . Participants were treated 10 times over a 5 week period with 2 treatment sessions per week. Pre and Post treatment readings were taken in 1st and 10th session over a 5 week period respectively. Assessment was done via Numeric pain rating scale and sphygmomanometer for assessing pain intensity and muscle strength of gluteus maximus. Receives: Other: Gluteal activation exercises,Hotpack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of muscle strength of gluteus maximum by "Sphygmomanometer"
change in strength of gluteal muscle was checked at 1st session and then follow up at end of 10th session
Measured: Baseline at 1st session on 1st week,at 10th sessions on 5th week
Secondary outcomes (1)
change in pain by "Numeric Pain rating Scale"
change in pain intensity was checked at 1st session and then follow up at end of 10th session
Measured: Baseline at 1st session on 1st week , at 10th session on 5th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start15 Oct 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SIJ - Sprain of Sacroiliac JointStudies 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757415
- Sponsor's protocol ID
- REC/LHR/20/0103 Farzana Saqib
- Status last verified
- Dec 2022
- First submitted
- 5 Feb 2021
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Massoud Arab A, Reza Nourbakhsh M, Mohammadifar A. The relationship between hamstring length and gluteal muscle strength in individuals with sacroiliac joint dysfunction. J Man Manip Ther. 2011 Feb;19(1):5-10. doi: 10.1179/106698110X12804993426848.
PubMed 22294848Added MAN, de Freitas DG, Kasawara KT, Martin RL, Fukuda TY. STRENGTHENING THE GLUTEUS MAXIMUS IN SUBJECTS WITH SACROILIAC DYSFUNCTION. Int J Sports Phys Ther. 2018 Feb;13(1):114-120.
PubMed 29484248Feeney DF, Capobianco RA, Montgomery JR, Morreale J, Grabowski AM, Enoka RM. Individuals with sacroiliac joint dysfunction display asymmetrical gait and a depressed synergy between muscles providing sacroiliac joint force closure when walking. J Electromyogr Kinesiol. 2018 Dec;43:95-103. doi: 10.1016/j.jelekin.2018.09.009. Epub 2018 Sep 22.
PubMed 30267967Chance-Larsen K, Littlewood C, Garth A. Prone hip extension with lower abdominal hollowing improves the relative timing of gluteus maximus activation in relation to biceps femoris. Man Ther. 2010 Feb;15(1):61-5. doi: 10.1016/j.math.2009.07.001. Epub 2009 Aug 12.
PubMed 19679506
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gluteal Activation With or Without Traction Straight Leg Raise Technique Among Patients of Sacroiliac Joint Syndrome
- ClinicalTrials.gov ID
- NCT04757415
- Acronym / sponsor ID
- REC/LHR/20/0103 Farzana Saqib
- Keywords
- Gluteal activation, Straight leg raise hamstring technique, Sacroiliac joint pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 17 Feb 2021 (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.
This study was a Randomized clinical trial conducted to determine the Effects of gluteal activation with or without traction straight leg raise technique among patients of sacroiliac joint syndrome so that in future this study will be helpful for other clinician to determine that how much gluteal activation is important in low back pain or sacroiliac joint syndrome, and how it affects our sling system.
Detailed description
Non Probability Convenient sampling was done . Patients following eligibility criteria from Sports and Spine Professionals ,Lahore were considered. Sample size was calculated with Epi tool calculator. 38 Participants were randomly allocated in two groups equally via convenient sampling method. Baseline assessment was done initially. Group A was given gluteal activation exercises with traction straight leg raise technique for hamstring and Group B was gluteal activation exercises without traction straight leg raise technique for hamstring. Duration of research was almost 6 months. Patient will undergo 10 treatments in five weeks. Each session will take 30 minutes. Pre and Post treatment readings were taken in 1st and 10th session over a 5 week period respectively. Assessment was done via sphygmomanometer and numeric pain rating scale for assessing muscle strength of gluteus maximum and pain levels respectively. All participants were provided written informed consent prior to commencement of the procedures. They were free to quit the treatment at any stage of research. Data was analyzed by using SPSS version 23.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traction straight leg raise technique for hamstring. | Experimental | Other: Traction straight leg raise technique for hamstringExperimental group underwent conventional physiotherapy treatment (hot pack) followed by five main gluteal activation exercises three in first five sessions and rest two in remaining five sessions along with traction straight leg raise technique. Each session took 30 minutes . Participants were treated 10 times over a 5 week period with 2 treatment sessions per week. Pre and Post treatment readings were taken in 1st and 10th session over a 5 week period respectively. Assessment was done via Numeric pain rating scale and sphygmomanometer for assessing pain intensity and muscle strength of gluteus maximus. |
| Gluteal activation exercises | Experimental | Other: Gluteal activation exercises,HotpackExperimental group underwent conventional physiotherapy treatment (hot pack) followed by five main gluteal activation exercises three in first five sessions and rest two in remaining five sessions. Each session took 30 minutes . Participants were treated 10 times over a 5 week period with 2 treatment sessions per week. Pre and Post treatment readings were taken in 1st and 10th session over a 5 week period respectively. Assessment was done via Numeric pain rating scale and sphygmomanometer for assessing pain intensity and muscle strength of gluteus maximus. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects with LBP below the level of L5,
- With pain over the posterior aspect of SI joint around posterior superior iliac spine and buttock with or without above knee leg pain.
- Females only
Key exclusion criteria (6 listed)
- Had radicular pain with neurological (sensory or motor) deficits,
- Had a history of spinal surgery, spinal, pelvic, or lower extremity fracture; hospitalization for trauma or motor vehicle accident;
- Hip or knee dysfunctions;
- Pregnancy;
- Any systemic disease such as arthritis, tuberculosis, liver, or kidney failure
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 |
|---|---|---|
| Traction straight leg raise technique for hamstringtraction straight leg raise technique is used along with gluteal exercises | Other | Traction straight leg raise technique for hamstring. |
| Gluteal activation exercises,Hotpackonly gluteal activation exercises were performed without traction straight leg raise technique | Other | Gluteal activation exercises |
Primary outcome
Change of muscle strength of gluteus maximum by "Sphygmomanometer"
Time frame: Baseline at 1st session on 1st week,at 10th sessions on 5th week
change in strength of gluteal muscle was checked at 1st session and then follow up at end of 10th session
1 secondary outcome
change in pain by "Numeric Pain rating Scale"
Time frame: Baseline at 1st session on 1st week , at 10th session on 5th 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 8 Dec 2022.
- Background: PubMed 22294848Massoud Arab A, Reza Nourbakhsh M, Mohammadifar A. The relationship between hamstring length and gluteal muscle strength in individuals with sacroiliac joint dysfunction. J Man Manip Ther. 2011 Feb;19(1):5-10. doi: 10.1179/106698110X12804993426848.
- Background: PubMed 29484248Added MAN, de Freitas DG, Kasawara KT, Martin RL, Fukuda TY. STRENGTHENING THE GLUTEUS MAXIMUS IN SUBJECTS WITH SACROILIAC DYSFUNCTION. Int J Sports Phys Ther. 2018 Feb;13(1):114-120.
- Background: PubMed 30267967Feeney DF, Capobianco RA, Montgomery JR, Morreale J, Grabowski AM, Enoka RM. Individuals with sacroiliac joint dysfunction display asymmetrical gait and a depressed synergy between muscles providing sacroiliac joint force closure when walking. J Electromyogr Kinesiol. 2018 Dec;43:95-103. doi: 10.1016/j.jelekin.2018.09.009. Epub 2018 Sep 22.
- Background: PubMed 19679506Chance-Larsen K, Littlewood C, Garth A. Prone hip extension with lower abdominal hollowing improves the relative timing of gluteus maximus activation in relation to biceps femoris. Man Ther. 2010 Feb;15(1):61-5. doi: 10.1016/j.math.2009.07.001. Epub 2009 Aug 12.
- Individual participant dataSharing planned: No
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.
Rabiya Noor, 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 Traction straight leg raise technique for hamstring and Gluteal activation exercises,Hotpack in people with SIJ - Sprain of Sacroiliac Joint and Weakness, Muscle, 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 3 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 8 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?
Change of muscle strength of gluteus maximum by "Sphygmomanometer" (time frame: Baseline at 1st session on 1st week,at 10th sessions on 5th 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 NCT04757415, which also lists 4 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 8 Dec 2022.