Clinical trial NCT02222935: Effectiveness of Balance Training in Chronic Low Back Pain Patients
Official title: Effectiveness of Balance Training Over Routine Back Exercise in Improving Functional Outcomes of Chronic Low Back Pain Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Chronic Low Back Pain
Keywords: Balance training
low back pain
balance test
routine back exercise
Lead sponsor: PSG Hospitals
Sponsor class: OTHER
First posted: 2014-08-22
Enrollment: 48
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Starr Edward Balance Test
timeFrame: Baseline, 2 weeks
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: Baseline, 2 weeks
measure: Visual Analogue score
timeFrame: Baseline, 2 weeks
Other outcomes:
Locations:
city: Coimbatore
country: India
facility: PSG Hospitals, Department of Physical Medicine Rehabilitation
state: Tamilnadu
Study officials:
affiliation: Senior Physiotherapist
name: Pavita Devi, BPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Senior Physiotherapist
name: Baskaran Chandrasekaran, MPT
role: STUDY_CHAIR
affiliation: Senior Physiotherpist
name: Sumathi Muraleetharan, BPT
role: STUDY_CHAIR
affiliation: Head of The Department, PMR
name: Ramamoorthy V Dr, MD PMR
role: STUDY_DIRECTOR
References: