Effectiveness of Balance Training in Chronic Low Back Pain Patients (CLB)

August 21, 2014 updated by: Baskaran Chandrasekaran

Effectiveness of Balance Training Over Routine Back Exercise in Improving Functional Outcomes of Chronic Low Back Pain Patients

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

Study Overview

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

Interventional

Enrollment (Actual)

48

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tamilnadu
      • Coimbatore, Tamilnadu, India, 641004
        • PSG Hospitals, Department of Physical Medicine Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (Estimate)

August 22, 2014

Study Record Updates

Last Update Posted (Estimate)

August 22, 2014

Last Update Submitted That Met QC Criteria

August 21, 2014

Last Verified

August 1, 2014

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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