Effectiveness of Balance Training in Chronic Low Back Pain Patients

Chronic Low Back Pain Clinical Trial

— CLB  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02222935
• Other study ID #: PSG02
• Status: Active, not recruiting
• Phase: Phase 0
• First received: August 20, 2014
• Last updated: August 21, 2014
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2014
• Source: PSG Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Behavioral:
• 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
• 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

Locations

Country	Name	City	State
India	PSG Hospitals, Department of Physical Medicine Rehabilitation	Coimbatore	Tamilnadu

Sponsors (1)

Lead Sponsor	Collaborator
Baskaran Chandrasekaran

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Starr Edward Balance Test		Baseline, 2 weeks	No
Secondary	Berg Balance Scale		Baseline, 2 weeks	No
Secondary	Visual Analogue score		Baseline, 2 weeks	No