Clinical trial NCT05021003: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Pain
Back
Core stabilization
Pressure biofeedback
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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).

Primary outcomes:
measure: NPRS
timeFrame: 4 weeks
measure: oswestry disability index
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Salman Bashir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.