Cognitive Muscular Therapy for Low Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cognitive Muscular Therapy for Low Back Pain

Conditions
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Chronic Pain, Low Back Pain, Muscle Tightness

Intervention / Treatment
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* Behavioral: Cognitive Muscular Therapy for low back pain


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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 feedback
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Muscular Therapy, Psychologically informed physiotherapy, Electromyography biofeedback