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

Primary Purpose

Low Back Pain, Chronic Pain, Muscle Tightness

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive Muscular Therapy for low back pain
Sponsored by
University of Salford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Psychologically informed physiotherapy, Electromyography biofeedback, Cognitive Muscular Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of SalfordRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single group

Arm Description

This group will receive Cognitive Muscular Therapy for low back pain

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
November 1, 2022
Last Updated
December 9, 2022
Sponsor
University of Salford
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1. Study Identification

Unique Protocol Identification Number
NCT05611476
Brief Title
Cognitive Muscular Therapy for Low Back Pain
Acronym
CMT-LBP
Official Title
Cognitive Muscular Therapy for Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Chronic Pain, Muscle Tightness
Keywords
Psychologically informed physiotherapy, Electromyography biofeedback, Cognitive Muscular Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single group
Arm Type
Experimental
Arm Description
This group will receive Cognitive Muscular Therapy for low back pain
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Muscular Therapy for low back pain
Intervention Description
Psychologically informed physiotherapy which used biofeedback training to reduce muscle overactivity and improve postural control
Primary Outcome Measure Information:
Title
Change in Rowland Morris Disability questionnaire
Description
Used to capture pain/disability associated with low back pain. Score 0-24 (0=no pain, 24=maximum pain)
Time Frame
Change from baseline to 2 months
Secondary Outcome Measure Information:
Title
Change in Pain catastrophizing scale
Description
Used to capture pain catastrophizing behaviours. Score 0-52 (0=no pain catastrophizing, 52=maximum pain catastrophizing)
Time Frame
Change from baseline to 2 months
Title
Change in Tampa scale of kinesiophobia
Description
Used to capture kinesiophobia behaviours. Score 17-68 (0=no kinesiophobia, 52=maximum kinesiophobia)
Time Frame
Change from baseline to 2 months
Title
Change in Oswestry disability scale
Description
Used to capture intensity of low back pain. Score 0-100 (0=no pain)
Time Frame
Change from baseline to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen J Preece, PhD
Phone
+44 161 295 2273
Ext
52273
Email
s.preece@salford.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Smith, BSc
Phone
+44 161 295 2273
Email
J.Smith72@salford.ac.uk
Facility Information:
Facility Name
University of Salford
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M6 6PU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Parker, PhD
Email
J.Parker17@salford.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We may make the clinical data available through a document which will be linked to the journal paper we publish
Links:
URL
https://hub.salford.ac.uk/cognitive-muscular-therapy/
Description
Description of CMT for knee pain. This will be adapted for low back pain.

Learn more about this trial

Cognitive Muscular Therapy for Low Back Pain

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