- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07477717
COMBINATION OF LATISSIMUS DORSI AND GLUTEAL STRENGTHENING IN SACROILIAC DYSFUNCTION
COMBINATION OF LATISSIMUS DORSI AND GLUTEAL STRENGTHENING ON CLINICAL SYMPTOMS AND PELVIC ALIGNMENT IN SACROILIAC DYSFUNCTION
The current study will try to answer the following research question:
In adults with sacroiliac joint dysfunction, what is the effect of combination LD strengthening exercises with gluteal strengthening exercises compared with gluteal strengthening exercises alone on the primary outcomes of this study (pain intensity during pressure on posterior superior iliac spine [PSIS] and neuropathic pain severity) and the secondary outcomes (disability, pelvic inclination, pelvic torsion, sacral inclination, GMax and LD strength)?
Participants will be devided equally into two groups:
- Group A (Control group): will receive a gluteal strengthening exercise program.
- Group B (Intervention group): will receive the same gluteal strengthening exercise program as group A, in addition to the LD strengthening exercise program.
Study Overview
Status
Conditions
Detailed Description
Sacroiliac joint dysfunction (SIJD) is an underappreciated source of low back or buttock pain. It accounts for up to 40% of nonspecific low back pain cases. The prevalence of SIJD was 30% in students with LBP. The impact of SIJD on quality of life is comparable to that observed with osteoarthritis and spinal stenosis and is higher than many cardiovascular-related medical conditions.
One of the main risk factors associated with SIJD is inadequate force closure needed to stabilize the joint during movement, altered muscle coordination, and reduced muscle strength. The primary muscles responsible for force closure are the gluteus maximus (GMax) and latissimus dorsi (LD), as tension is transmitted from one side of the trunk to the other through their connection into the superficial layer of the thoracolumbar fascia (TLF).
GMax muscles showed a trend of reduced resting thickness of the muscles on the side of SJD when compared with the contralateral joint, as well as against the matched healthy individuals, while muscle thickness of LD reduced on the contralateral side as compared to the ipsilateral as well as against the matched healthy controls. On the other hand, the amplitude values of LD of the LBP group were significantly higher than those of the control group on both sides. But GMax amplitude was significantly lower than that of the control group on both sides.
To the best of the authors' knowledge, although both the latissimus dorsi (LD) and gluteal muscles play a crucial role in maintaining sacroiliac joint (SIJ) stability, limited studies compared the effect of incorporating LD activation exercises into gluteal strengthening programs for patients with sacroiliac joint dysfunction (SIJD).
This study will evaluate and compare between effect of adding LD activation exercises to the gluteal strengthening exercises and gluteal strengthening alone on neuropathic pain severity, pain intensity during pressure on PSIS, disability, pelvic inclination, pelvic torsion, and sacral inclination, GMax and LD strength.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shefaa AA Shuaib, MSc
- Phone Number: Egypt: 002 01065891770
- Email: sshh70535@gmail.com
Study Contact Backup
- Name: Enas F Youssef, PHD
- Phone Number: Egypt: 002 01127867507
- Email: Enas.fawzy@pt.cu.edu.eg
Study Locations
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-
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Cairo, Egypt
- Outpatient clinic of faculty of physical therapy, Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria :
- Patient with clinical diagnosis of low back pain because of SIJD.
- Age between 35-55 years old.
- Numeric pain rating scale (NPRS) score of less than 8
- moderate disability score ranging from 5-14 on the Arabic version of Roland-Arabic Disability Questionnaire (ArRMDQ).
- Patients with unilateral chronic pain for more than 3 months below L5 overlap the posterior aspect of the SIJ around PSIS.
- Patients with gluteal pain with or without groin pain, with or without lower extremity pain that are not compatible with the lumbar nerve roots dermatome.
- ≥4 in the diagnostic scoring system.
- Two out of 4 positive tests in a cluster of Laslett.
Exclusion Criteria:
- Patients with any previous fractures or surgery in the lumbosacral or pelvic region before the study.
- Pregnancy and lactation during study.
- Radicular pain or radiculopathy.
- Spinal pathology.
- Participation in physiotherapy sessions within 6 months before enrollment in the study.
- Injection of corticosteroids or anaesthetics in the SIJ during the previous month.
- Sacroiliac infection or sacroiliitis.
- Neurological signs of spinal stenosis.
- Uncontrolled hyper-tension.
- Treatment, including non-steroidal anti-inflammatories and painkillers, during the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Gluteal strengthening exercise program
Retro Step-Up Unilateral Wall Squat Wall Press Exercise Prone Hip Extension
|
Retro Step-Up Unilateral Wall Squat Wall Press Exercise Prone Hip Extension The treatment duration will be 6 weeks at a frequency of 3 supervised sessions/week (18 sessions total).
|
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Experimental: Gluteal strengthening combined with LD strengthening exercise program
Retro Step-Up Unilateral Wall Squat Wall Press Exercise Prone Hip Extension Conventional shoulder extension in the prone position Downward bar pulling in the seated position (LPD) following expert instruction Pull-down exercises from standing position Inverted row body weight exercises with a supinated grip and double-leg WB Modified curl-up Ipsilateral upper trunk bending
|
Retro Step-Up Unilateral Wall Squat Wall Press Exercise Prone Hip Extension Conventional shoulder extension in the prone position Downward bar pulling in the seated position (LPD) following expert instruction Pull-down exercises from standing position Inverted row body weight exercises with a supinated grip and double-leg WB Modified curl-up Ipsilateral upper trunk bending The treatment duration will be 6 weeks at a frequency of 3 supervised sessions/week (18 sessions total).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity using the Arabic version of the numeric pain rating scale (Ar-NPRS) during PSIS pressure
Time Frame: week 7
|
Ar- NPRS comprises an 11-point -horizontal scale‖ of 0-10 in Arabic numerals anchored by the two ends, the left (0 indicating no pain at all) and right (10) indicating the worst pain ever.
Mild pain ranges from 1-3, moderate pain 4-6 and severe pain 7-10.
The patients can indicate the number that describes their pain level closely.
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week 7
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Disability using the Arabic Roland-Morris disability questionnaire (ArRMDQ)
Time Frame: week 7
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The Arabic version of Roland-Morris Disability Questionnaire (ArRMDQ) consists of 24 items ranging from 0 to 24.
Statements were chosen to cover multiple aspects of daily living, and the phrase -because of my back‖ was added to each statement to specify that the limitation described was due to back problems
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week 7
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shefaa AA Shuaib, MSc, Cairo University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LD strengthening in SID
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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