NCT02222935

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jun 2014

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

6 months

First QC Date

August 20, 2014

Last Update Submit

August 21, 2014

Conditions

Keywords

Balance traininglow back painbalance testroutine back exercise

Outcome Measures

Primary Outcomes (1)

  • Starr Edward Balance Test

    Baseline, 2 weeks

Secondary Outcomes (2)

  • Berg Balance Scale

    Baseline, 2 weeks

  • Visual Analogue score

    Baseline, 2 weeks

Study Arms (2)

Balance exercise training

EXPERIMENTAL

Balance exercise training - thrice week, 2 weeks, 10 repetition Maximum/ set, 2 sets

Behavioral: Balance Exercise Training

Routine Back exercise Program

ACTIVE COMPARATOR

Routine Back exercise Program - 10 Repetition Maximum / set, 2 sets, three times weekly, 2 weeks

Behavioral: Routine Back exercise program

Interventions

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

Balance exercise training

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

Routine Back exercise Program

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PSG Hospitals, Department of Physical Medicine Rehabilitation

Coimbatore, Tamil Nadu, 641004, India

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pavita Devi, BPT

    Senior Physiotherapist

    PRINCIPAL INVESTIGATOR
  • Baskaran Chandrasekaran, MPT

    Senior Physiotherapist

    STUDY CHAIR
  • Sumathi Muraleetharan, BPT

    Senior Physiotherpist

    STUDY CHAIR
  • Ramamoorthy V Dr, MD PMR

    Head of The Department, PMR

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Physiotherapist

Study Record Dates

First Submitted

August 20, 2014

First Posted

August 22, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 22, 2014

Record last verified: 2014-08

Locations