Cognitive Muscular Therapy for Low Back Pain (CMT-LBP)

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Chronic Pain; Muscle Tightness
• Intervention / Treatment: Behavioral: Cognitive Muscular Therapy for low back pain

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M6 6PU
      • University of Salford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single group; This group will receive Cognitive Muscular Therapy for low back pain	Behavioral: Cognitive Muscular Therapy for low back pain; Psychologically informed physiotherapy which used biofeedback training to reduce muscle overactivity and improve postural control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain catastrophizing scale	Used to capture pain catastrophizing behaviours. Score 0-52 (0=no pain catastrophizing, 52=maximum pain catastrophizing)	Change from baseline to 2 months
Change in Tampa scale of kinesiophobia	Used to capture kinesiophobia behaviours. Score 17-68 (0=no kinesiophobia, 52=maximum kinesiophobia)	Change from baseline to 2 months
Change in Oswestry disability scale	Used to capture intensity of low back pain. Score 0-100 (0=no pain)	Change from baseline to 2 months

Collaborators and Investigators

• Sponsor: University of Salford

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Psychologically informed physiotherapy; Electromyography biofeedback; Cognitive Muscular Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain
• Other Study ID Numbers: CMT-LBP-6581

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We may make the clinical data available through a document which will be linked to the journal paper we publish

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No