Comparative Effects of Group Based Exercises with and Without Cognitive Functional Therapy on Clinical Outcomes in Patients with Chronic Low Back Pain

Not Applicable

Not yet recruiting

• Conditions: Low Back Pain, Chronic

• Registration Number: NCT06759675
• Lead Sponsor: University of Faisalabad

Brief Summary

1.1Research objective The objective of the study is to find the comparative effects of group based exercises with and without cognitive functional therapy on clinical outcomes in patients with chronic low back? 1.2 Hypothesis Null Hypothesis H0= There is no significant difference of clinical outcomes between the cognitive functional therapy with group exercises and group based exercises only in patients with chronic low back pain.

Alternative Hypothesis H1= There is a significant difference of clinical outcomes between the cognitive functional therapy with group exercises and group based exercises only in patients with chronic low back pain.

Detailed Description

Background: Low back pain is the problem gradually increasing in both young and older adults. It can be specific and non-specific, the specific low back pain is the pain which arises due to any structural or functional disease like due to any mechanical factors, poor posture, improper way of lifting and bending while non-specific low back pain is the pain which have no any known causes. Cognitive functional therapy and group based exercises both have beneficial effects to reduce LBP. Aims and objectives: The aim of the study will be to find the comparative effects of group based exercises with and without cognitive functional therapy on clinical outcome in patients with chronic low back pain. Methodology: This study will be Randomized controlled trial. The subjects will be selected through Probability Purposive Sampling.Sample will be 40 calculated by the rao-soft with 20 percent chances of drop out. The participants will be taken from Mujahid hospital, Faisal Hospital and Madina teaching hospital. Participants will be assessed by using Oswestry Disability index and Numerical Pain Rating Scale NPRS for low back pain. Participants will be randomly allocated into two groups.One group will be treated with CFT and group based exercises and one with only group exercises. And at the end, data will be analyzed by using Statistical Package for the Social Sciences (SPSS).

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-28
• Study First Submitted QC: 2024-12-28
• Last Update Submitted: 2024-12-28
• Study Start: 2025-01
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-03
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Pain level equal or more than 3 on NPRS A score of fourteen percent 14% or more on the Oswestry Disability Index (ODI) Low back pain for at least 6months duration

Exclusion Criteria

• Red flags (neoplastic diseases or cancer in the spine, inflammatory diseases, infections, and fractures) Neurological symptoms and psychiatric, rheumatologic, and cardiac diseases Radiculopathy with symptoms Lumbar stenosis Spondylolisthesis History of spinal surgeries Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
NPRS	Baseline	Numerical pain rating scale used to assess pain level

Secondary Outcome Measures

Name	Time	Method
ODI	Baseline	Oswestry Disability Index gives information about functional limitation and level of disability due to pain