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

NCT ID: NCT05021003

Last Updated: 2022-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-05

Study Completion Date

2022-03-30

Brief Summary

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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

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A

: Core stabilization training with pressure biofeedback unit

Group Type EXPERIMENTAL

pressure biofeedback

Intervention Type OTHER

: Core stabilization training with pressure biofeedback unit

Group B

: Core stabilization training without pressure biofeedback unit

Group Type ACTIVE_COMPARATOR

core stabilization exercises

Intervention Type OTHER

: Core stabilization training without pressure biofeedback unit

Interventions

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pressure biofeedback

: Core stabilization training with pressure biofeedback unit

Intervention Type OTHER

core stabilization exercises

: Core stabilization training without pressure biofeedback unit

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Muhammad Salman Bashir, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Riphah International University

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Burton AK, Balague F, Cardon G, Eriksen HR, Henrotin Y, Lahad A, Leclerc A, Muller G, van der Beek AJ; COST B13 Working Group on Guidelines for Prevention in Low Back Pain. Chapter 2. European guidelines for prevention in low back pain : November 2004. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S136-68. doi: 10.1007/s00586-006-1070-3. No abstract available.

Reference Type BACKGROUND
PMID: 16550446 (View on PubMed)

Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983 May;16(1):87-101. doi: 10.1016/0304-3959(83)90088-X.

Reference Type BACKGROUND
PMID: 6602967 (View on PubMed)

Bhadauria EA, Gurudut P. Comparative effectiveness of lumbar stabilization, dynamic strengthening, and Pilates on chronic low back pain: randomized clinical trial. J Exerc Rehabil. 2017 Aug 29;13(4):477-485. doi: 10.12965/jer.1734972.486. eCollection 2017 Aug.

Reference Type BACKGROUND
PMID: 29114516 (View on PubMed)

Other Identifiers

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REC/Lhr/21/0117 Hashim

Identifier Type: -

Identifier Source: org_study_id

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