Cognitive Muscular Therapy for Low Back Pain

NCT05611476 | Completed

• 1 other identifier: CMT-LBP-6581
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to adapt Cognitive Muscular Therapy so that it can be used to manage chronic low back pain. A secondary aim is to understand the potential therapeutic benefit of this intervention.

Conditions

Low Back Pain; Chronic Pain; Muscle Tightness

Keywords

Psychologically informed physiotherapy; Electromyography biofeedback; Cognitive Muscular Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Rowland Morris Disability questionnaire

  Used to capture pain/disability associated with low back pain. Score 0-24 (0=no pain, 24=maximum pain)

  Change from baseline to 2 months

Secondary Outcomes (3)

• Change in Pain catastrophizing scale

  Change from baseline to 2 months

• Change in Tampa scale of kinesiophobia

  Change from baseline to 2 months

• Change in Oswestry disability scale

  Change from baseline to 2 months

Study Arms (1)

Single group

EXPERIMENTAL

This group will receive Cognitive Muscular Therapy for low back pain

Behavioral: Cognitive Muscular Therapy for low back pain

Interventions

Cognitive Muscular Therapy for low back pain BEHAVIORAL

Psychologically informed physiotherapy which used biofeedback training to reduce muscle overactivity and improve postural control

Single group

Eligibility Criteria

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

You may qualify if:

• Above 18 years old
• Speak and understand English sufficient to read the information sheet and sign the consent form
• Ability to walk without an assistive device for at least 100m (to ensure patients have sufficient mobility to be able to complete the intervention)
• Low back pain for at least three months' duration
• Currently scoring 4 or more on the Roland disability scale

You may not qualify if:

• Dementia or other major cognitive impairment
• Red flags (specific causes of LBP, such as acute disc prolapse with radicular pain, or other serious pathology)
• Pregnancy
• History of serious spinal injury (fractures, spinal cord injury)
• BMI \>33 (as EMG measurement is not possible in people with higher BMI)
• Acute low back pain (Onset less than 3 months)
• Any systemic inflammatory disorders, such as rheumatoid arthritis
• Any balance disorders which may increase the risk of a fall

Sponsors & Collaborators

• University of Salford: lead

Study Sites (1)

University of Salford

Manchester, Greater Manchester, M6 6PU, United Kingdom

Location

Related Publications (1)

• Preece SJ, Smith J, Brookes N, Gates S, Ghio D. Cognitive Muscular Therapy for low back pain: a pilot study. Musculoskelet Sci Pract. 2025 Nov;80:103415. doi: 10.1016/j.msksp.2025.103415. Epub 2025 Sep 13.

  PMID: 40972445 DERIVED

Related Links

• Description of CMT for knee pain. This will be adapted for low back pain.

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biomechanics and Rehabilitation

Model Details: The primary aim is to develop the intervention. We will do this through delivery of the intervention to three waves of patients. After each of the first two waves, the intervention will be adapted based on participant feedback

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 10, 2022
• Study Start: December 8, 2022
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

GB (1)