Effects of Core Stabilization Training With and Without Pressure Biofeedback in Patients With Low Back Pain

Sponsor

Riphah International University (Other)

Overall Status

Completed

CT.gov ID

NCT05021003

Collaborator

(none)

Enrollment

Location

Arms

7.8

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Mechanical low back pain is an impairment of musculoskeletal system. Lifetime prevalence of low back pain is 60-85%. Frequent micro-trauma to the structures of the spine, poor control and stabilization leads to LBP and eventually causes functional limitation. The objective of the study to find whether Core Stabilization Training with Pressure Biofeedback could reduce pain and improves functional activity in patients with mechanical low back pain. To study the effectiveness of Core Stabilization Training with Pressure Biofeedback in reducing pain and improving functional activity in subjects with mechanical low backpain between the age group of 25-40 years. To find out the effect of core stabilization training with pressure biofeedback in reducing pain and improving functional activity in subjects with mechanical low back pain between the age group of 25-40 years. The study will be conducted on 30 subjects between the age group of 25-40 years with mechanical low back pain and according to the inclusion criteria were recruited in the study. NPRS at rest and activity, Modified ODI will assess PRE and POST treatment. P value: less than 0.05 using SPSS (Statistical package for social sciences) for NPRS(pain at rest and activity) and modified ODI i.e. core stabilization training with pressure biofeedback had statistical improvement in NPRS (Pain at rest and activity) and modified ODI score. Core stabilization training with pressure biofeedback is effective inreducing pain (at rest and activity) and functional disability in subjects between the age group of 25-40 years with mechanical low back pain

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Other: pressure biofeedback Other: core stabilization exercises	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Core Stabilization Training With and Without Pressure Biofeedback in Patients With Low Back Pain

Actual Study Start Date :

Aug 5, 2021

Actual Primary Completion Date :

Jan 30, 2022

Actual Study Completion Date :

Mar 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A : Core stabilization training with pressure biofeedback unit	Other: pressure biofeedback : Core stabilization training with pressure biofeedback unit
Active Comparator: Group B : Core stabilization training without pressure biofeedback unit	Other: core stabilization exercises : Core stabilization training without pressure biofeedback unit

Arm

Intervention/Treatment

Experimental: Group A

: Core stabilization training with pressure biofeedback unit

Other: pressure biofeedback

: Core stabilization training with pressure biofeedback unit

Active Comparator: Group B

: Core stabilization training without pressure biofeedback unit

Other: core stabilization exercises

: Core stabilization training without pressure biofeedback unit

Outcome Measures

Primary Outcome Measures

NPRS [4 weeks]
In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity [1]. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible
oswestry disability index [4 weeks]
Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:\

Male and female patients between the age group 25-40 years having mechanical low back pain persisting for at least 6 months upto1 year.
Patients complaining Pain when sitting or standing for a long period or Pain when driving long distance, getting in and out of the car or lifting activities.
Patients with minimum and moderate disability based on Modified Oswestry Disability Index (ODI).
Patients with greater than and equal to 7 score on NPRS.

Exclusion Criteria:

Structural deformity (scoliosis, lordosis).
Systematic inflammatory disease (vasculitis, connective tissue disease and granulomatous disease).
Nerve root compression (Disc bulge and Lumbar radiculopathy).
History of spinal surgery or fractures (laminectomy).