Clinical trial NCT06759675: Comparative Effects of Group Based Exercises with and Without Cognitive Functional Therapy on Clinical Outcomes in Patients with Chronic Low Back Pain
Official title: Comparative Effects of Group Based Exercises with and Without Cognitive Functional Therapy on Clinical Outcomes in Patients with Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain, Chronic
Keywords: Cognitive Functional therapy
group based exercise
chronic low back
Lead sponsor: University of Faisalabad
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: NPRS
timeFrame: Baseline
Secondary outcomes:
measure: ODI
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
citation: Oiestad BE. Critically appraised paper: Cognitive functional therapy reduced disability compared with group-based exercise and education for chronic low back pain [synopsis]. J Physiother. 2021 Apr;67(2):141. doi: 10.1016/j.jphys.2021.01.004. Epub 2021 Mar 17. No abstract available.
citation: Avila L, da Silva MD, Neves ML, Abreu AR, Fiuza CR, Fukusawa L, de Sa Ferreira A, Meziat-Filho N. Effectiveness of Cognitive Functional Therapy Versus Core Exercises and Manual Therapy in Patients With Chronic Low Back Pain After Spinal Surgery: Randomized Controlled Trial. Phys Ther. 2024 Jan 1;104(1):pzad105. doi: 10.1093/ptj/pzad105.
citation: O'Keeffe M, O'Sullivan P, Purtill H, Bargary N, O'Sullivan K. Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT). Br J Sports Med. 2020 Jul;54(13):782-789. doi: 10.1136/bjsports-2019-100780. Epub 2019 Oct 19.