Clinical trial NCT05611476: Cognitive Muscular Therapy for Low Back Pain
Official title: Cognitive Muscular Therapy for Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Chronic Pain
Muscle Tightness
Keywords: Psychologically informed physiotherapy
Electromyography biofeedback
Cognitive Muscular Therapy
Lead sponsor: University of Salford
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 feedback
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Rowland Morris Disability questionnaire
timeFrame: Change from baseline to 2 months
Secondary outcomes:
measure: Change in Pain catastrophizing scale
timeFrame: Change from baseline to 2 months
measure: Change in Tampa scale of kinesiophobia
timeFrame: Change from baseline to 2 months
measure: Change in Oswestry disability scale
timeFrame: Change from baseline to 2 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University of Salford
state: Greater Manchester
Study officials:
References: