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Completed

NCT Number: NCT05021003

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

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

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Key information

Conditions

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

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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  • 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).

Treatment and study plan

pressure biofeedback

Other

: Core stabilization training with pressure biofeedback unit

core stabilization exercises

Other

: Core stabilization training without pressure biofeedback unit

Primary outcomes

  1. NPRS

    Time frame: 4 weeks

    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

  2. oswestry disability index

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2021
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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