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

NCT06759675 | Not Yet Recruiting

• 1 other identifier: GBE and CFT in chronic LBP
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain, Chronic

Keywords

Cognitive Functional therapy; group based exercise; chronic low back

Outcome Measures

Primary Outcomes (1)

• NPRS

  Numerical pain rating scale used to assess pain level

  Baseline

Secondary Outcomes (1)

• ODI

  Baseline

Study Arms (2)

Group 1

EXPERIMENTAL

group based exercises with Cognitive functional therapy

Other: group based exercise with Cognitive functional therapy

Group 2

ACTIVE COMPARATOR

group based exercise only

Other: Group based exercise

Interventions

group based exercise with Cognitive functional therapy OTHER

1. Cognitive functional therapy CFT A cognitive functional therapy is the behavioral approach which is used to treat low back pain. This approach has 3 components Making sense of pain Exposure with control Lifestyle changes 2. Group exercises Group exercises will be the exercises that perform on all individuals. It is performed in a group session having 3 components Pain education Exercises Relaxation

Group 1

Group based exercise OTHER

Group exercises Group exercises will be the exercises that perform on all individuals. It is performed in a group session having 3 components Pain education Exercises Relaxation

Group 2

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Faisalabad: lead

Related Publications (3)

• 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.

  PMID: 33744183 BACKGROUND

• 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.

  PMID: 37548608 BACKGROUND

• 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.

  PMID: 31630089 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Central Study Contacts

Kashaf Zahra, Orthopedic Physiotherapy

CONTACT

+92 300 6688412; zahrakashaf931@gmail.com

Fahad Tanveer, Orthopedic Physiotherapy

CONTACT

+92 331 4193741; zahrakashaf24@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Comparative effects of Group based exercises with and without Cognitive Functional Therapy on clinical outcomes in patients with chronic Low Back Pain

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 6, 2025
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share