- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07425197
Comparative Effects of Two Rehabilitation Approaches on Lumbopelvic Function in Sacroiliac Joint Dysfunction (DNS CSE SIJD)
Effects of Dynamic Neuromuscular Stabilization Verses Core Stability Exercises on Pain and Lumbopelvic Stability Among Patients With Sacroiliac Joint Dysfunction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sacroiliac joint dysfunction (SIJD) is an increasingly recognized source of chronic low back and lumbopelvic pain, with significant implications for functional mobility and quality of life. The sacroiliac joint functions as a key biomechanical link between the spine and lower limbs, transmitting forces and maintaining postural stability during movement. Dysfunction in this joint can lead to abnormal motion, impaired neuromuscular coordination, asymmetrical pelvic alignment, and altered load transfer, which together contribute to persistent pain and disability. Individuals with SIJD commonly experience localized pain in the lower back, buttocks, groin, or posterior thigh, often exacerbated by prolonged standing, walking, transitional movements, or activities requiring unilateral weight-bearing. The condition is frequently misdiagnosed or overlooked due to symptom overlap with lumbar spine disorders. Consequently, clinical diagnosis relies on a combination of a cluster of sacroiliac joint provocation tests and the careful exclusion of other musculoskeletal or neurological causes.
Exercise-based rehabilitation is widely recommended as a primary conservative strategy for managing SIJD. Core Stability Exercises (CSE) are a conventional physiotherapy approach that emphasizes the activation, coordination, and strengthening of deep trunk stabilizers, particularly the transversus abdominis and lumbar multifidus. These exercises aim to restore segmental spinal control, improve lumbopelvic stability, and enhance the efficiency of force transmission across the pelvis and lower back during dynamic tasks. Dynamic Neuromuscular Stabilization (DNS), in contrast, is a motor control-oriented rehabilitation approach derived from developmental kinesiology principles. DNS focuses on restoring optimal breathing patterns, regulating intra-abdominal pressure, and facilitating coordinated activation of the diaphragm, pelvic floor, abdominal wall, and spinal stabilizers. Exercises are based on developmental movement patterns observed in early infancy and progress gradually from supported to more challenging functional postures. Both interventions are widely applied clinically; however, direct comparative evidence for their effectiveness in SIJD remains limited, particularly in structured, supervised outpatient settings.
This single-blinded, parallel-group randomized controlled trial was conducted to evaluate and compare the effects of DNS and CSE on pain intensity and lumbopelvic stability in adults with chronic SIJD. Participants aged 20-50 years with sacroiliac region pain persisting for at least three months were recruited. Inclusion required a clinical diagnosis confirmed by at least three positive provocation tests and the ability to participate in structured exercise sessions. Exclusion criteria included previous spinal or pelvic surgery, inflammatory joint disorders, pregnancy, neurological conditions, cardiopulmonary limitations, or other serious musculoskeletal pathologies. Participants with poor attendance or inability to complete the prescribed sessions were also excluded.
Eligible participants were randomly allocated to either the DNS group (Group 1) or the CSE group (Group 2) using a computer-generated randomization sequence, with allocation concealment maintained to reduce selection bias. Outcome assessment was conducted by a physiotherapist blinded to group assignment. Ethical approval was obtained prior to commencement, and all participants provided written informed consent. Participant confidentiality and standard ethical safeguards were strictly maintained throughout the study.
All participants received a standardized baseline physiotherapy program during each session to ensure uniform adjunct care. This included the application of superficial heat, transcutaneous electrical nerve stimulation, and stretching exercises targeting relevant muscle groups. After baseline treatment, participants received their respective exercise interventions. The DNS group engaged in a structured program three times per week over four weeks, focusing on diaphragmatic breathing, postural stabilization, and coordinated activation of deep trunk and pelvic muscles. Exercises progressed according to motor control proficiency, from supported positions to functional postures, with continuous verbal and tactile feedback to ensure proper execution. The CSE group performed a progressive core stabilization program with the same frequency and duration, emphasizing controlled activation of the transversus abdominis and lumbar multifidus, progressing to incorporate limb movements, balance challenges, and functional tasks. Biofeedback and therapist guidance were provided to promote correct recruitment patterns and postural alignment.
Primary outcomes included pain intensity, measured with the Numeric Pain Rating Scale, and lumbopelvic stability, assessed using a pressure biofeedback unit. Baseline measurements were obtained prior to intervention, and follow-up assessments were performed at the end of the four-week program.
All data were systematically entered, coded, and analyzed using the Statistical Package for the Social Sciences (SPSS). The dataset was screened for completeness, missing values, and entry errors. Descriptive statistics summarized demographic characteristics and baseline variables. Inferential analyses examined within-group and between-group changes using paired and independent statistical tests. Analysis of covariance was applied where baseline differences required adjustment. A significance threshold of p ≤ 0.05 was applied, and effect sizes with confidence intervals were calculated to assess clinical relevance alongside statistical significance.
A total of 40 participants completed the study, with 57.5% female and 42.5% male. Pain distribution was bilateral in 37.5%, predominantly right-sided in 37.5%, and left-sided in 25%. The mean age was 32.95 ± 7.57 years, and mean BMI was 26.83 ± 4.93 kg/m². Baseline comparison confirmed no significant differences between groups in pain intensity (p = 0.745) or lumbopelvic stability (p = 0.991), ensuring comparability for evaluating treatment effects.
Within-group analysis demonstrated substantial reductions in pain and improvements in lumbopelvic stability. Mean pain decreased from 6.58 ± 1.35 to 3.03 ± 1.29 (t = 13.375, p < 0.001), and lumbopelvic stability scores improved from 13.33 ± 3.72 to 6.35 ± 2.85 (t = 13.395, p < 0.001). Between-group comparison revealed a trend toward greater pain reduction in the DNS group (p = 0.052) and a statistically significant improvement in lumbopelvic stability compared to the CSE group (p = 0.011), indicating enhanced postural control outcomes with DNS.
Overall, both DNS and CSE were effective in reducing pain and improving lumbopelvic stability in individuals with chronic SIJD. DNS showed superior enhancement of neuromuscular control, suggesting it may provide additional benefits for improving coordinated trunk and pelvic muscle function. These findings contribute to the evidence base for physiotherapy interventions in SIJD and support the integration of motor control-based strategies alongside conventional core stabilization exercises in clinical practice
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr. Muhammad Zohaib, DPT
- Phone Number: 03204417377
- Email: muhammad.zohaib@ubas.edu.pk
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Ghurki Trust Teaching Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion criteria
- Age between 30 and 45 years
Confirmed diagnosis by at least three positive provocation tests
- FABER
- Gaenslen's, Thigh Thrust
- Compression
- Distraction
- Pain lasting three months or longer
- NPRS score between 4 and 7
Exclusion criteria:
- Other spinal conditions such as, spinal stenosis or tumors
- Prior history of spinal or pelvic surgery
- Patients with neurological disorders or systemic diseases such as rheumatoid arthritis
- Pregnant women
- Patients with cardiopulmonary conditions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dynamic Neuromuscular Stabilization
The intervention focuses on restoring motor control through developmental movement patterns, emphasizing coordinated activation of the diaphragm, pelvic floor, deep trunk, and spinal stabilizers.
Exercises progress from supported positions, such as supine or quadruped, to more functional postures like sitting, standing, and weight-shifting tasks.
Verbal and tactile feedback is provided throughout to ensure correct breathing, intra-abdominal pressure, and postural alignment, aiming to improve lumbopelvic stability, neuromuscular coordination, and reduce sacroiliac joint pain.
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Dynamic Neuromuscular Stabilization (DNS) is a motor control-based rehabilitation approach using human developmental movement patterns to restore optimal motor programs and improve lumbopelvic stability.
In this study, participants receive supervised DNS sessions three times per week for four weeks, 45 minutes per session, including conventional physiotherapy followed by DNS exercises.
Exercises progress from supine diaphragmatic breathing, abdominal bracing, quadruped rocking, and side-lying reaches to half-kneel, standing weight shifts, step-ups, split-squats and get-ups.
Emphasis is on coordinated activation of diaphragm, pelvic floor, deep trunk, and spinal stabilizers, intra-abdominal pressure regulation, postural alignment, and sensorimotor control, with continuous verbal and tactile feedback.
Unlike conventional core programs, DNS targets motor control, functional integration, and neuromuscular coordination rather than only strength or endurance.
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Active Comparator: Core stability Exercise
The intervention targets activation and strengthening of deep trunk muscles, mainly the transversus abdominis and lumbar multifidus, to enhance segmental spinal stability.
Exercises begin with low-load, isolated contractions of these muscles in supine or prone positions and progress to include limb movements, balance challenges, and functional tasks.
Biofeedback and therapist guidance are used to ensure proper recruitment, postural control, and trunk endurance, aiming to reduce pain and improve lumbopelvic stability without integrating developmental movement patterns or specialized breathing techniques.
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Core Stability Exercises (CSE) focus on improving segmental spinal and lumbopelvic stability by targeting the transversus abdominis (TrA) and lumbar multifidus (LM).
In this study, participants receive supervised CSE sessions three times per week for four weeks, 45 minutes per session, beginning with low-load activation in supine, prone, and seated positions using abdominal drawing-in maneuver (ADIM), LM activation with contralateral arm raise, and TrA-LM co-contraction with bridging.
Progression includes endurance training with controlled extremity movements, quadruped bird-dog, bridge marching, mini-squats, step-ups, wall push-ups, and self-palpation for awareness.
Exercises emphasize isolated muscle activation, segmental control, and functional strength, guided by therapist supervision and biofeedback
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lumbopelvic stability
Time Frame: 4 weeks
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Lumbopelvic Stability was measured with two validated instruments: Pressure Biofeedback Unit (PBU).
The PBU is an inflatable pressure cuff that is attached to a pressure gauge that was positioned under the lumbar spine.
Test was performed in hook lying abdominal drawing-in test by inflating the cuff approximately 40 mmHg.
The patient was instructed to contract the TrA by draw-in maneuver.
Normal functioning involves sustaining pressure within ±5-10 mmHg of the baseline value.
A decrease or rise above this level signifies compromised stability
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4 weeks
|
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Pain Intensity
Time Frame: 4 weeks
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Pain Intensity was measured with the Numeric Pain Rating Scale (NPRS), an 11-point self-report scale from 0 (no pain) to 10 (worst pain possible).
Participants were asked to indicate their average pain during the past 24 hours.
The NPRS is a reliable and valid instrument to quantify musculoskeletal pain and can detect clinically significant change in pain.
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4 weeks
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Collaborators and Investigators
Investigators
- Study Chair: Dr. Muhammad Zohaib, Lahore University of Biological and Applied Sciences
- Principal Investigator: Saffa Shahid, DPT, Lahore College of Physical therapy
- Principal Investigator: Seher Mushtaq, DPT, Lahore College of Physical therapy
- Principal Investigator: Syed Muhammad Moiz, DPT, Lahore College of Physical therapy
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
Keywords
Other Study ID Numbers
- DPT/ERB/43
- U1111-1334-7752 (Registry Identifier: WHO- Universal Trial number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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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