Overview

This trial is active, not recruiting.

Condition chronic low back pain
Treatments balance exercise training, routine back exercise program
Phase phase 0
Sponsor Baskaran Chandrasekaran
Start date June 2014
End date December 2014
Trial size 48 participants
Trial identifier NCT02222935, PSG02

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Balance exercise training - thrice week, 2 weeks, 10 repetition Maximum/ set, 2 sets
balance exercise training
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 - 10 Repetition Maximum / set, 2 sets, three times weekly, 2 weeks
routine back exercise program
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 Outcomes

Measure
Starr Edward Balance Test
time frame: Baseline, 2 weeks

Secondary Outcomes

Measure
Berg Balance Scale
time frame: Baseline, 2 weeks
Visual Analogue score
time frame: Baseline, 2 weeks

Eligibility Criteria

Male or female participants from 25 years up to 45 years old.

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)

Additional Information

Official title Effectiveness of Balance Training Over Routine Back Exercise in Improving Functional Outcomes of Chronic Low Back Pain Patients
Principal investigator Pavita Devi, BPT
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by PSG Hospitals.