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

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ClinicalTrials.gov Identifier: NCT02222935
Recruitment Status : Unknown
Verified August 2014 by Baskaran Chandrasekaran, PSG Hospitals.
Recruitment status was:  Active, not recruiting
First Posted : August 22, 2014
Last Update Posted : August 22, 2014
Sponsor:
Information provided by (Responsible Party):
Baskaran Chandrasekaran, PSG Hospitals

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

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Behavioral: Balance Exercise Training Behavioral: Routine Back exercise program Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Balance Training Over Routine Back Exercise in Improving Functional Outcomes of Chronic Low Back Pain Patients
Study Start Date : June 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Balance exercise training
Balance exercise training - thrice week, 2 weeks, 10 repetition Maximum/ set, 2 sets
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

Active Comparator: Routine Back exercise Program
Routine Back exercise Program - 10 Repetition Maximum / set, 2 sets, three times weekly, 2 weeks
Behavioral: 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 Outcome Measures :
  1. Starr Edward Balance Test [ Time Frame: Baseline, 2 weeks ]

Secondary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: Baseline, 2 weeks ]
  2. Visual Analogue score [ Time Frame: Baseline, 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222935


Locations
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India
PSG Hospitals, Department of Physical Medicine Rehabilitation
Coimbatore, Tamilnadu, India, 641004
Sponsors and Collaborators
Baskaran Chandrasekaran
Investigators
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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

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Responsible Party: Baskaran Chandrasekaran, Senior Physiotherapist, PSG Hospitals
ClinicalTrials.gov Identifier: NCT02222935     History of Changes
Other Study ID Numbers: PSG02
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: August 22, 2014
Last Verified: August 2014
Keywords provided by Baskaran Chandrasekaran, PSG Hospitals:
Balance training
low back pain
balance test
routine back exercise
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms