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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
pressure biofeedback
core stabilization exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Pain, Back, Core stabilization, Pressure biofeedback

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesDoes not accept 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).

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

: Core stabilization training with pressure biofeedback unit

: Core stabilization training without pressure biofeedback unit

Outcomes

Primary Outcome Measures

NPRS
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
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.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2021
Last Updated
April 21, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05021003
Brief Title
Effects of Core Stabilization Training With and Without Pressure Biofeedback in Patients With Low Back Pain
Official Title
Effects of Core Stabilization Training With and Without Pressure Biofeedback in Patients With Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 5, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Pain, Back, Core stabilization, Pressure biofeedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
: Core stabilization training with pressure biofeedback unit
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
: Core stabilization training without pressure biofeedback unit
Intervention Type
Other
Intervention Name(s)
pressure biofeedback
Intervention Description
: Core stabilization training with pressure biofeedback unit
Intervention Type
Other
Intervention Name(s)
core stabilization exercises
Intervention Description
: Core stabilization training without pressure biofeedback unit
Primary Outcome Measure Information:
Title
NPRS
Description
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
Time Frame
4 weeks
Title
oswestry disability index
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Salman Bashir, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16550446
Citation
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.
Results Reference
background
PubMed Identifier
6602967
Citation
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.
Results Reference
background
PubMed Identifier
29114516
Citation
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.
Results Reference
background

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

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