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

NCT05021003 | Completed DMC

• 1 other identifier: REC/Lhr/21/0117 Hashim
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Low Back Pain

Keywords

Pain; Back; Core stabilization; Pressure biofeedback

Outcome Measures

Primary Outcomes (2)

• 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

  4 weeks

• 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.

  4 weeks

Study Arms (2)

Group A

EXPERIMENTAL

: Core stabilization training with pressure biofeedback unit

Other: pressure biofeedback

Group B

ACTIVE COMPARATOR

: Core stabilization training without pressure biofeedback unit

Other: core stabilization exercises

Interventions

pressure biofeedback OTHER

: Core stabilization training with pressure biofeedback unit

Group A

core stabilization exercises OTHER

: Core stabilization training without pressure biofeedback unit

Group B

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

• 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.

  PMID: 16550446 BACKGROUND

• 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.

  PMID: 6602967 BACKGROUND

• 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.

  PMID: 29114516 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Pain

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhammad Salman Bashir, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 25, 2021
• Study Start: August 5, 2021
• Primary Completion: January 30, 2022
• Study Completion: March 30, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)