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OpenTrials
Completed

NCT Number: NCT05611476

Cognitive Muscular Therapy for Low Back Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Salford

Manchester, Greater Manchester, M6 6PU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Muscular Therapy for low back pain

Behavioral

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

Primary outcomes

  1. Change in Rowland Morris Disability questionnaire

    Time frame: 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 outcomes

  1. Change in Pain catastrophizing scale

    Time frame: Change from baseline to 2 months

    Used to capture pain catastrophizing behaviours. Score 0-52 (0=no pain catastrophizing, 52=maximum pain catastrophizing)

  2. Change in Tampa scale of kinesiophobia

    Time frame: Change from baseline to 2 months

    Used to capture kinesiophobia behaviours. Score 17-68 (0=no kinesiophobia, 52=maximum kinesiophobia)

  3. Change in Oswestry disability scale

    Time frame: Change from baseline to 2 months

    Used to capture intensity of low back pain. Score 0-100 (0=no pain)

Sponsors and collaborators

Lead sponsor

University of Salford

Other

Registry information

Acronym: CMT-LBP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 10, 2022
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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