- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07332390
Comparison of Moderate Load Eccentric Core Exercises and Pilates in Patients With Non-Specific Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Low back pain (LBP) is the most prevalent musculoskeletal condition worldwide, affecting an estimated 619 million people and ranking among the leading causes of disability across all ages. It reduces quality of life, productivity, and mental well-being, creating a major socioeconomic burden. The biopsychosocial model describes LBP as a multifactorial disorder influenced by biological, psychological, and social factors, emphasizing the need for interdisciplinary management. According to the WHO, LBP is defined as pain occurring between the 12th rib and inferior gluteal folds, with or without referred pain, and is classified as acute (<6 weeks), subacute (6-12 weeks), or chronic (>12 weeks).
Most LBP is nonspecific (≈90%), with no structural cause, and influenced by inactivity, obesity, smoking, and psychosocial stress. In 2019, LBP ranked 6th in DALYs for females, highlighting a greater burden among women. Impaired trunk muscle activation and proprioception contribute to motor control deficits, abnormal recruitment patterns, and recurrent pain. Core musculature plays a central role: Bergmark classified spinal muscles into deep stabilizers (e.g., multifidus, transversus abdominis) and superficial movers (e.g., extensors), both essential for spinal stability. Weakness of extensors predisposes to initial episodes of LBP, while dysfunction of deep stabilizers is associated with chronicity. Exercise therapy is a key intervention. Eccentric training has gained attention for superior neuromuscular adaptations, increasing strength, muscle fiber size, and coordination, with evidence from athletic populations showing functional benefits beyond concentric training. Pilates provides a holistic approach emphasizing controlled movement, breathing, and core activation, improving alignment, flexibility, proprioception, and quality of life. Core stabilization exercises (CSE) specifically target proprioception and motor control, reducing lumbar joint position error, pain, and disability.
Several randomized controlled trials support these interventions. Puntumetakul et al. reported that CSE significantly reduced lumbar JPE, pain, and disability compared to thermal therapy. Zirek et al. found that six weeks of Pilates decreased pain and disability and improved quality of life in chronic LBP. Su Su Hlaing et al. showed that core stabilization and strengthening improved proprioception and muscular thickness of TrA and multifidi. Antonelli et al. demonstrated that Pilates improved pelvic alignment, trunk stability, and reduced pain. Moradi et al. confirmed that modified Pilates led to greater improvements in motor control, pain, and functional recovery compared to traditional exercises.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ruqia Begum, MS-OMPT
- Phone Number: 03115532544
- Email: ruqia@fui.edu.pk
Study Contact Backup
- Name: Tehreem Zahra, DPT
- Phone Number: 0334-9709725
- Email: tehreemzahra2310@gmail.com
Study Locations
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Punjab Province
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Islamabad, Punjab Province, Pakistan, 46000
- Recruiting
- Foundation University Islamabad
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Contact:
- Tehreem Zahra, DPT
- Phone Number: 0334-9709725
- Email: tehreemzahra2310@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Adults 18 to 45 years
- Both genders
- Low back (from T12 to buttock line) pain for more than 3 months
- Non-specific low back pain i.e. signs or symptoms not attributable to any specific structure
- Low back pain on 3-8 NPRS
Exclusion Criteria:
• Acute flare Low Back Pain
- Low back pain on NPRS (>8)
- Thoracic pain
- Centralization and peripheralization of pain
- Leg symptoms when walking, eased in flexion (Signs of stenosis)
- Pain due to repetitive movement
- Paresthesia/numbness
- Structural deformity (scoliosis, spondylosis, spondylolisthesis)
- Curve reversal
- Pregnancy
- Post-surgery (within 6 months of abdominal, spinal, or lower limb surgery)
- Degenerative or inflammatory spinal diseases
- Malignancy
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 |
|---|---|
|
Experimental: Moderate load eccentric core exercises
Participants will perform moderate load eccentric core exercises targeting trunk stabilizer and global core muscles, including eccentric back extensions, abdominal rollouts etc. Exercises will emphasize slow eccentric contractions (3-5 sec) at 50-70% 1RM or equivalent resistance, performed for 8-12 reps, 2-3 sets, three times per week.
The protocol aims to enhance core strength, proprioception, neuromuscular control, and spinal stability, thereby reducing pain, disability, and recurrence in nonspecific low back pain.
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MODERATE LOAD ECCENTRIC CORE EXERCISES: Eccentric training protocol will be incorporated in core strengthening regime .
This will be conducted in two phases.
Phase 1 will be the familiarization phase and phase 2 will be the acclimatization phase .
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|
Experimental: Pilates
Participants will undergo a Pilates-based exercise program focusing on core activation, controlled breathing, postural alignment, and trunk stability.
The program will include mat-based Pilates movements such as pelvic tilts, bridging, hundred, leg stretch, and spine mobility exercises.
Sessions will emphasize slow, controlled movements with deep stabilizer activation (transversus abdominis, multifidus), performed for 8-12 reps, 2-3 sets, three times per week.
The aim is to improve core strength, posture, proprioception, flexibility, and overall functional control, leading to reduced pain and disability in nonspecific low back pain.
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Pilates description: participants will be enrolled in group B of the study and will follow a Pilates program designed to ensure progressive overload. The protocol will begin with foundational exercises focused on motor learning and core activation, progressing gradually to more advanced functional and load-bearing stability exercises. The primary focus will be on deep core recruitment, utilizing a beginner-level approach to avoid generalized movements and ensure targeted muscle activation. This structured progression will ensure that core stability remains the central focus, with each phase building upon the previous one. Warm up: Before starting the session, participants will perform warm up exercises for 10 minutes that include the following exercises:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain intensity
Time Frame: baseline , 4th week and 8th week.
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it will be assessed by Numeric Pain Rating Scale NPRS.
0 means no pain and 10 means worst pain.
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baseline , 4th week and 8th week.
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Lumber range of motion
Time Frame: Baseline , 4th week and 8th week.
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Lumber range of motion will be measured through dual inclinometer.
Ranges include lumber flexion, lumber extension, right lateral flexion and left lateral flexion.
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Baseline , 4th week and 8th week.
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Core endurance
Time Frame: baseline , 4th week and 8th week
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It will be assessed through McGill core endurance battery. Core endurance will be assessed by measuring the time to hold a certain position. Time will be recorded. Core endurance include: Flexor trunk endurance Extensor trunk endurance Right side plank Left side plank |
baseline , 4th week and 8th week
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Inclinometer For Lumbar Joint Position Error
Time Frame: BASELINE, 4th and 8th week
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Two inclinometers will be used for measuring JPE, one will be positioned at T12 spinous process and other will be placed at S1 spinous process.
Participants will be blindfolded to eliminate visual cues and will memorize a target position by holding it for 5 seconds before returning to neutral.
They will then attempt to reposition their spine into the target position in lumber flexion without visual feedback.
The difference between the achieved and target positions will be recorded as the joint position error, measuring proprioceptive accuracy.
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BASELINE, 4th and 8th week
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2025/26
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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