CMT-LBP: Cognitive Muscular Therapy for Low Back Pain

Sponsor

University of Salford (Other)

Overall Status

Recruiting

CT.gov ID

NCT05611476

Collaborator

(none)

Enrollment

Location

Arm

10.8

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain Chronic Pain Muscle Tightness	Behavioral: Cognitive Muscular Therapy for low back pain	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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 feedbackThe 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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cognitive Muscular Therapy for Low Back Pain

Actual Study Start Date :

Dec 8, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Rowland Morris Disability questionnaire [Change from baseline to 2 months]
Used to capture pain/disability associated with low back pain. Score 0-24 (0=no pain, 24=maximum pain)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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