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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05021003
• Other study ID #: REC/Lhr/21/0117 Hashim
• Status: Completed
• Phase: N/A
• Start date: August 5, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: April 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• pressure biofeedback
: Core stabilization training with pressure biofeedback unit
• core stabilization exercises
: Core stabilization training without pressure biofeedback unit

Locations

Country	Name	City	State
Pakistan	Riphah International University	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View Citation

Burton AK, Balagué F, Cardon G, Eriksen HR, Henrotin Y, Lahad A, Leclerc A, Müller 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:S136-68. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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