- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07370272
CMCT Versus CSE in Treatment of SIJ Pain
Lumbopelvic Cognitive Movement Control Training Versus Core Stability Exercises in Treatment of Sacroiliac Joint Pain
This study aims to investigate the difference between integrating lumbopelvic cognitive movement control training versus core stabilization exercises to the conventional physiotherapy program on pain, function, lumbopelvic stability, functional load transfer, and postural control in patients suffering from SIJ pain. The main question it aims to answer is:
What are the effects of adding lumbopelvic movement control training versus core stabilization exercises to the conventional physiotherapy program in treating patients with SIJ pain?
Researchers will compare adding lumbopelvic movement control training versus core stabilization exercises to the conventional physiotherapy program to investigate its effectiveness in treatment of SIJ pain
Participants will:
receive the intervention as follows:
- Group (A) - Control Group: will receive conventional physiotherapy program (US and MET)
- Group (B) - Core Stability Exercises Group: will receive conventional US, MET, and core stability ex's
- Group (C) - Lumbopelvic cognitive movement control training Group: will receive conventional US, MET, and cognitive movement control training.
- receive the training protocol 3 times a week for 8 weeks according to the set schedules.
- perform a home exercise program in the same dose of repetitions and time as in the session.
- be assessed before and after the intervention and training period to address the outcome measures.
Study Overview
Status
Conditions
Detailed Description
The sacroiliac joint (SIJ) pain is a significant contributor to LBP at any age, but it affects the elderly and young active people more frequently. Based on estimates from several studies, the SIJ causes pain in 10-38% of LBP patients. Altered lumbopelvic stability causes faulty movement of the spine during limb movement, and the faulty movement may cause mechanical irritation to the adjacent joint which when repeated and accumulated may cause LBP or SIJP. Additionally, it was revealed that patients with LBP have altered movement strategies in the form of uncontrolled movements which cause symptoms. This uncontrolled movement can be defined as 'an inability to cognitively control movement at a specific site and direction, while moving elsewhere to benchmark standards'.
Despite the need to identify the most effective treatment options for SIJ pain, controversy still remains with unclear definite conclusion regarding the use of physiotherapy interventions in those patients. Clinically, the diagnosis pathway has become more definite, but the treatment algorithm is less well-defined with conflicting evidence of the standard treatment either invasively or conservatively. For the management of SIJP, the conventional approach which includes ultrasound (US) application combined with muscle energy technique (MET) for the lumbopelvic region can be successfully used. Moreover, core stabilization exercises are considered a fundamental component of physiotherapy with the goal to improve the strength and coordination of deep core stabilizers such as the transversus abdominis, multifidus, and pelvic floor muscles, which are critical for maintaining lumbopelvic stability, reducing pain and disability and also, lowing the risk of recurrent injury. Among the conservative interventions, cognitive movement control training has begun to emerge as a promising management approach and garnered attention in recent years because it involves active cognitive participation and focuses on improving stability and neuromuscular control of the lumbosacral region.
Despite that stabilization and motor control exercises, in the context of the physiotherapy literature, are a well-established management method for LBP and SIJ region pain, there is still limited evidence on which stabilization or motor control training approach is more effective and leads to better outcomes in patients with LBP of sacroiliac origin. Unfortunately, within the available literature, various treatment plans for SIJ pain have been described but there are few published studies regarding postural lumbopelvic stability and SIJ and as a result, the assessment and management of SIJP subjects with potential balance or postural control deficits are valuable and needed.
Although the effectiveness of motor control training in reducing pain in the lumbar spine was confirmed, the need for the selection of exercises due to the occurrence of various forms of movement pattern disorders is still critical. This underlies the need to recognize individual differences in clinical presentation and/or which activities and functions are painful and difficult to do. Therefore, here is the importance of cognitive movement control training in targeting the patient's own complaint and also tailoring interventions based on assessment.
So, CMCT can be an effective form of treatment for lumbopelvic pain because this type of exercises restores normal muscle activation, proprioceptive reeducation, and retraining of movement patterns with a positive effect of on disability and pain severity in the short-term and long-term.
Despite it has been shown to have great clinical utility at the hip and groin and also, on the non-specific low back pain with positive effects on disability and pain severity in the short and long terms, there are no clear results about the effect of cognitive movement control retraining on patients with SIJP. Therefore, here is the significance of this study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mina M Morkos, Assistant Lecturer, PT. MSc.
- Phone Number: +20 1285061286
- Email: mina.maher.morkos@gmail.com
Study Locations
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-
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Giza, Egypt
- Faculty of physical therapy, Cairo University
-
Contact:
- Marihan Z Aziz
- Phone Number: +20 1201227971
- Email: marihan_aziz@cu.edu.eg
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Principal Investigator:
- Mina M Morkos, Assistant Lecturer, PT. MSc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age of the subjects will range between 18 - 45 years for young middle-aged adults.
- Unilateral SIJ pain lasting for at least 3 months, in lower back, buttock, groin, posterior superior iliac spine (PSIS) and with or without referral pain to the lower extremities.
- SIJ pain below L5 region.
- Non-centralized LBP i.e. has no directional preference.
- Score positive on 3 out of 5 SIJP provocation tests: compression, distraction, sacral thrust, thigh thrust, Gaenslen's.
Exclusion Criteria:
- Limb-length discrepancy,
- Clear signs of nerve root compression (radiating pain, motor and/or sensory deficits,
- Previous major back surgery or injury, fracture or arthritis of spine, pelvis, hip, knee or ankle joint,
- Seronegative spondyloarthropathies,
- Visual or vestibular deficit,
- Unable to follow command/ cognitive deficits,
- Postpartum women less than six months,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group (A): Control Group
The subjects will receive therapeutic ultrasound (for 5 mins, intensity of 1W/cm2).
In addition, MET will be applied in prone position for anterior and posterior innominate rotation around the pelvis.
|
The conventional approach includes ultrasound (US) application combined with muscle energy technique (MET) for the lumbopelvic region.
The subjects will receive therapeutic ultrasound (for 5 mins, intensity of 1W/cm2).
In addition, MET will be applied in prone for anterior and posterior innominate rotation around the pelvis.
The subject will then be asked to apply 20% force against that applied by the therapist and hold that contraction for 10 seconds over 5 to 10 repetitions.
Other Names:
|
|
Experimental: Group (B): Core Stability Exercises Group
In addition to the traditional protocol delivered in group (A) including US and stretching by MET, subjects in this group will perform core stabilization exercises (CSE) to improve the activation and coordination of deep core stabilizers: transversus abdominis, multifidus, and pelvic floor muscles. The core stabilization exercises consist of 5 exercises: pelvic tilt, double knee to chest, bridging, bird-dog, and cat-camel to be performed in the same order. |
The conventional approach includes ultrasound (US) application combined with muscle energy technique (MET) for the lumbopelvic region.
The subjects will receive therapeutic ultrasound (for 5 mins, intensity of 1W/cm2).
In addition, MET will be applied in prone for anterior and posterior innominate rotation around the pelvis.
The subject will then be asked to apply 20% force against that applied by the therapist and hold that contraction for 10 seconds over 5 to 10 repetitions.
Other Names:
In addition to the conventional protocol including US and MET stretching, subjects in this group will perform core stabilization exercises (CSE) to improve the activation and coordination of deep core stabilizers: transversus abdominis, multifidus, and pelvic floor muscles, which are essential for maintaining lumbopelvic stability and neuromuscular control. The core stabilization exercises consist of 5 exercises: pelvic tilt, double knee to chest, bridging, bird-dog, and cat-camel, to be performed in the same order. Also, before each exercise, the physical therapist will give detailed verbal explanation and visual instructions (pictures) regarding the start and end positions. Each exercise will be done for two sets of 10 repetitions, 3 sessions per week (day after day), for 8 weeks. |
|
Experimental: Group (C): Lumbopelvic cognitive movement control training Group
In addition to the traditional protocol delivered in group (A) including US and stretching by MET, subjects in this group will undergo lumbopelvic cognitive movement control training (CMCT) that requires the lumbopelvic region to be positioned neutrally and the subject will be asked to consciously maintain the desired alignment and keep a pre-determined value of PBU whilst the lower limbs are actively moved to achieve a pre-determined benchmark. This training will be in multi-directions to address the lumbopelvic uncontrolled movements into flexion, extension and rotation as follows:
|
The conventional approach includes ultrasound (US) application combined with muscle energy technique (MET) for the lumbopelvic region.
The subjects will receive therapeutic ultrasound (for 5 mins, intensity of 1W/cm2).
In addition, MET will be applied in prone for anterior and posterior innominate rotation around the pelvis.
The subject will then be asked to apply 20% force against that applied by the therapist and hold that contraction for 10 seconds over 5 to 10 repetitions.
Other Names:
In addition to the traditional protocol including US and MET stretching, subjects in this group will undergo lumbopelvic cognitive movement control training (CMCT) that requires the lumbopelvic region to be positioned in a neutral alignment and the subject will be asked to consciously maintain the desired alignment and keep a pre-determined value of PBU whilst the lower limbs are actively moved to achieve a pre-determined benchmark. This training will be in multi-directions to address the lumbopelvic uncontrolled movements into flexion, extension and rotation as follows:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain: using Numerical Pain Rating Scale (NPRS)
Time Frame: Baseline (pre-treatment) and after 8 weeks (post-treatment)
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The Arabic Numeric Pain Rating Scale (ANPRS) measures pain intensity in Arabic-speaking patients.
The patients will be asked to rate their pain on a 10-point pain scale with a 0 score means no pain and 10 score means maximum pain.
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Baseline (pre-treatment) and after 8 weeks (post-treatment)
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Functional disability: using Oswestry Disability Index (ODI)
Time Frame: Baseline (pre-treatment) and after 8 weeks (post-treatment)
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The Arabic ODI is appropriate for use as a patient reported outcome measure with Arabic speaking individuals with low back pain and /or SIJ pain.
The patients will be instructed to fill the ODI which is a self-report pencil and paper survey, where subjects indicate how their pain affects their abilities in 10 questions on domains such as pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, travel, and sexual life.
|
Baseline (pre-treatment) and after 8 weeks (post-treatment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lumbopelvic motor control function: by Pressure Biofeedback Unit (PBU)
Time Frame: Baseline (pre-treatment) and after 8 weeks (post-treatment)
|
It will be used to indirectly monitor muscle activity by the change of pressure as a mean to estimate the muscle activation of the multifidus (MF) and transversus abdominis (TA) muscles that, in turn, helps patients undertake motor control exercise interventions. While the subjects will be trying to keep the PBU value constant as possible (40 mm Hg in supine and 70 mm Hg in prone), they will be instructed to breathe normally to avoid a Valsalva maneuver and to consciously do certain lower limb movements (double bent leg lift and lowering in crook-lying, double knee bend in prone). |
Baseline (pre-treatment) and after 8 weeks (post-treatment)
|
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Functional Load transfer: by Active straight leg raise test (ASLR)
Time Frame: Baseline (pre-treatment) and after 8 weeks (post-treatment)
|
The ASLR test will be performed to detect failed load transfer across the lumbopelvic region in supine position with straight legs and feet apart.
Patients will be asked to raise his/her lower limb above the bench for 20 cm or 20° hip flexion without bending the knee and return it to back after a 1-2 second hold.
The test then will be repeated while a manual compressive force is applied through the ilia, or with a belt tightened around the pelvis or SIJ.
A positive test is denoted by improved ability to raise the leg.
|
Baseline (pre-treatment) and after 8 weeks (post-treatment)
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Balance and Postural control: by Single leg stance balance test with eyes closed (SLSBT-EC)
Time Frame: Baseline (pre-treatment) and after 8 weeks (post-treatment)
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This test will be used for detecting balance impairments and postural control deficits in SIJP patients.
While standing bare-footed on the weightbearing lower extremity on the floor with the contralateral hip flexed to 45° and the knee flexed to 90° so that the knee is in front of the standing leg and the foot behind the standing leg, the patients will be asked to balance for up to 30 s with eyes closed (EC).
|
Baseline (pre-treatment) and after 8 weeks (post-treatment)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Salwa F Abdelmajeed, Professor, PT. PhD., Cairo University
- Study Director: Marihan Z Aziz, Lecturer, PT. PhD, Cairo University
- Study Chair: Ihab M Emran, Assistant Professor, MD. PhD, Faculty of Medicine (Kasr Al-Aini), Cairo University
Publications and helpful links
General Publications
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- Hungerford B, Gilleard W, Hodges P. Evidence of altered lumbopelvic muscle recruitment in the presence of sacroiliac joint pain. Spine (Phila Pa 1976). 2003 Jul 15;28(14):1593-600.
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMCT in SIJ Pain
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
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