Effectiveness of Balance Training in Chronic Low Back Pain Patients (CLB)
Primary Purpose
Chronic Low Back Pain
Status
Unknown status
Phase
Early Phase 1
Locations
India
Study Type
Interventional
Intervention
Balance Exercise Training
Routine Back exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Balance training, low back pain, balance test, routine back exercise
Eligibility Criteria
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)
Sites / Locations
- PSG Hospitals, Department of Physical Medicine Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Balance exercise training
Routine Back exercise Program
Arm Description
Balance exercise training - thrice week, 2 weeks, 10 repetition Maximum/ set, 2 sets
Routine Back exercise Program - 10 Repetition Maximum / set, 2 sets, three times weekly, 2 weeks
Outcomes
Primary Outcome Measures
Starr Edward Balance Test
Secondary Outcome Measures
Berg Balance Scale
Visual Analogue score
Full Information
NCT ID
NCT02222935
First Posted
August 20, 2014
Last Updated
August 21, 2014
Sponsor
Baskaran Chandrasekaran
1. Study Identification
Unique Protocol Identification Number
NCT02222935
Brief Title
Effectiveness of Balance Training in Chronic Low Back Pain Patients
Acronym
CLB
Official Title
Effectiveness of Balance Training Over Routine Back Exercise in Improving Functional Outcomes of Chronic Low Back Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Baskaran Chandrasekaran
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Balance problems are addressed in low back pain patients. Dearth of literature available to prove core strengthening or any form of back exercises improving functional outcomes or balance in chronic back pain patients. No studies focus on balance training in improving balance of low back pain patients. The authors are conducting a randomised trial comparing balance exercises and routine back exercise program in improving pain, functional outcomes and balance of the patients
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Balance training, low back pain, balance test, routine back exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Balance exercise training
Arm Type
Experimental
Arm Description
Balance exercise training - thrice week, 2 weeks, 10 repetition Maximum/ set, 2 sets
Arm Title
Routine Back exercise Program
Arm Type
Active Comparator
Arm Description
Routine Back exercise Program - 10 Repetition Maximum / set, 2 sets, three times weekly, 2 weeks
Intervention Type
Behavioral
Intervention Name(s)
Balance Exercise Training
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Routine Back exercise program
Intervention Description
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
Primary Outcome Measure Information:
Title
Starr Edward Balance Test
Time Frame
Baseline, 2 weeks
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Time Frame
Baseline, 2 weeks
Title
Visual Analogue score
Time Frame
Baseline, 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavita Devi, BPT
Organizational Affiliation
Senior Physiotherapist
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Baskaran Chandrasekaran, MPT
Organizational Affiliation
Senior Physiotherapist
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sumathi Muraleetharan, BPT
Organizational Affiliation
Senior Physiotherpist
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ramamoorthy V Dr, MD PMR
Organizational Affiliation
Head of The Department, PMR
Official's Role
Study Director
Facility Information:
Facility Name
PSG Hospitals, Department of Physical Medicine Rehabilitation
City
Coimbatore
State/Province
Tamilnadu
ZIP/Postal Code
641004
Country
India
12. IPD Sharing Statement
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Effectiveness of Balance Training in Chronic Low Back Pain Patients
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