Cognitive Muscular Therapy for Low Back Pain

NCT ID: NCT05611476

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-08
• Study Completion Date: 2023-08-01

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.

Detailed Description

There is evidence that people with chronic low back pain (LBP) demonstrate muscle overactivity during functional tasks when compared to healthy controls. Interestingly, this increased activity of the low back and trun, muscles has been associated with increased sensitivity to pain. It has also been shown that people with chronic LBP exhibit alterations in functional movement patterns and postures when compared to healthy people. Such alterations may be a direct result of increased stiffness in the spine which results from muscle overactivity. Psychosocial physiotherapy techniques for LBP are gaining widescale acceptance. However, these approaches are often combined with strengthening exercises, and not specifically aimed at reducing muscle overactivity. Therefore, there is a need for research into interventions for chronic LBP which integrate psychologically informed practice with training to reduce muscle overactivity.

The investigators have developed a new treatment for people with knee osteoarthritis, known as Cognitive Muscular Therapy (CMT). CMT is a form of psychologically informed physiotherapy which uses biofeedback training to reduce muscle overactivity and therefore lower the mechanical stress on the knee. CMT is delivered through five sequential intervention components and teaches patients to think and respond differently to pain, to improve postural control and to perform functional movements, such as walking, with less muscle tension. See the dedicated website for further details (https://hub.salford.ac.uk/cognitive-muscular-therapy/). Given the strong focus on postural control, the investigators are confident that CMT can be adapted and used to treat other chronic musculoskeletal conditions, such as LBP. In this project, the investigators will map changes to the five CMT intervention components. The intervention will then be delivered to patients with chronic low back pain, after which the investigators will seek to understand participant perceptions of the new treatment.

Conditions

Low Back Pain; Chronic Pain; Muscle Tightness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single group

This group will receive Cognitive Muscular Therapy for low back pain

Group Type: EXPERIMENTAL

Cognitive Muscular Therapy for low back pain

Intervention Type: BEHAVIORAL

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

Interventions

Cognitive Muscular Therapy for low back pain

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Above 18 years old

2. Speak and understand English sufficient to read the information sheet and sign the consent form

3. Ability to walk without an assistive device for at least 100m (to ensure patients have sufficient mobility to be able to complete the intervention)

4. Low back pain for at least three months' duration

5. Currently scoring 4 or more on the Roland disability scale

Exclusion Criteria

1. Dementia or other major cognitive impairment

2. Red flags (specific causes of LBP, such as acute disc prolapse with radicular pain, or other serious pathology)

3. Pregnancy

4. History of serious spinal injury (fractures, spinal cord injury)

5. BMI >33 (as EMG measurement is not possible in people with higher BMI)

6. Acute low back pain (Onset less than 3 months)

7. Any systemic inflammatory disorders, such as rheumatoid arthritis

8. Any balance disorders which may increase the risk of a fall

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Salford

OTHER

Sponsor Role: lead

Responsible Party

Stephen Preece

Professor of Biomechanics and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Salford

Manchester, Greater Manchester, United Kingdom

Countries

United Kingdom

References

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

Reference Type: DERIVED

PMID: 40972445 (View on PubMed)

Related Links

https://hub.salford.ac.uk/cognitive-muscular-therapy/

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

Other Identifiers

CMT-LBP-6581

Identifier Type: -

Identifier Source: org_study_id