- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02222935
Effectiveness of Balance Training in Chronic Low Back Pain Patients (CLB)
Effectiveness of Balance Training Over Routine Back Exercise in Improving Functional Outcomes of Chronic Low Back Pain Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Balance deficits are common in low back pain. Current literature fail to prove the effectiveness of routine back exercises in improving balance of back pain patients. No study has concentrated on balance training in back pain patients.
Objective: Compare balance exercises and routine back exercises in improving balance and other functional outcomes.
Procedure: Back pain patients attending physiotherapy department of tertiary care teaching hospitals will be recruited voluntarily. Randomised to either balance and routine program based on simple lottery method. Balance training comprises of 5 exercises - single leg squats, dead lift, single leg raises, lateral step-ups and forward reach outs. Routine back exercises includes 5 sets - pelvic bridges, dynamic dead bug, prone planks, situps, lateral planks. 10Repetition Maximum, 2 Sets/ day, five days a week, 2 weeks. Baseline balance (star Edward, berg balance) and functional test (sit to stand) and pain (Visual analogue score) and post 2 weeks outcome scores will be analysed through paired and unpaired for between and within groups.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Tamilnadu
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Coimbatore, Tamilnadu, India, 641004
- PSG Hospitals, Department of Physical Medicine Rehabilitation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- non specific low back pain diagnosed by orthopedical surgeon or physiatrist
- Both genders
- Age 25 - 45 years (to avoid age related balance deficit)
- Should have balance deficit percentage (> 20%) through balance assessment scale
Exclusion Criteria:
- H/O Benign Paroxysmal Positional Vertigo
- Neuromuscular disorders(Stroke, Polio, Potts spine, spinal stenosis) affecting balance
- any form of ear infection
- Recent ear, nose, throat surgery
- Recent surgery in abdomen, thorax, head (< 2 years)
- Recent lower limb surgeries, injuries (< 6 months)
- Any form of walking aids (cane, walker)
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: Balance exercise training
Balance exercise training - thrice week, 2 weeks, 10 repetition Maximum/ set, 2 sets
|
Balance exercise - 5 type (single leg squat, dead lift, step ups, forward reaches), 10 Repetition Maximum, 2 sets, five times a week and 2 weeks
|
Active Comparator: Routine Back exercise Program
Routine Back exercise Program - 10 Repetition Maximum / set, 2 sets, three times weekly, 2 weeks
|
Back strengthening 5 exercises - pelvic bridges, prone plank, side plank, dead bug and prone lift ups, 10 Repetition Maximum, 2 sets, five times a week, 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Starr Edward Balance Test
Time Frame: Baseline, 2 weeks
|
Baseline, 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Berg Balance Scale
Time Frame: Baseline, 2 weeks
|
Baseline, 2 weeks
|
Visual Analogue score
Time Frame: Baseline, 2 weeks
|
Baseline, 2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pavita Devi, BPT, Senior Physiotherapist
- Study Chair: Baskaran Chandrasekaran, MPT, Senior Physiotherapist
- Study Chair: Sumathi Muraleetharan, BPT, Senior Physiotherpist
- Study Director: Ramamoorthy V Dr, MD PMR, Head of The Department, PMR
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSG02
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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