Low Back PainCMT-LBPNCT05611476
Cognitive Muscular Therapy for Low Back Pain
A study testing Cognitive Muscular Therapy for low back pain in people with Low Back Pain and Chronic Pain, run by University of Salford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Chronic Pain, Muscle Tightness
- What is being tested?
- Cognitive Muscular Therapy for low back pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Dec 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Salford
Manchester, Greater Manchester, M6 6PU
About this study
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.
Read the 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.
- Conditions
- Low Back Pain, Chronic Pain, Muscle Tightness
- Being tested
- Cognitive Muscular Therapy for low back pain
- Keywords
- Psychologically informed physiotherapy, Electromyography biofeedback, Cognitive Muscular Therapy
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Muscular Therapy for low back painBehavioural
Psychologically informed physiotherapy which used biofeedback training to reduce muscle overactivity and improve postural control
| Study group | Role | What they receive |
|---|---|---|
| Single group | Experimental | This group will receive Cognitive Muscular Therapy for low back pain Receives: Behavioral: Cognitive Muscular Therapy for low back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from baseline to 2 months
Secondary outcomes (3)
Change in Pain catastrophizing scale
Used to capture pain catastrophizing behaviours. Score 0-52 (0=no pain catastrophizing, 52=maximum pain catastrophizing)
Measured: 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)
Measured: 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)
Measured: Change from baseline to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start8 Dec 2022
- Primary completion1 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Preece, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611476
- Sponsor's protocol ID
- CMT-LBP-6581
- Acronym
- CMT-LBP
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We may make the clinical data available through a document which will be linked to the journal paper we publish
Publications
Preece SJ, Smith J, Brookes N, Gates S, Ghio D. Cognitive Muscular Therapy for low back pain: a pilot study. Musculoskelet Sci Pract. 2025 Nov;80:103415. doi: 10.1016/j.msksp.2025.103415. Epub 2025 Sep 13.
PubMed 40972445
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Muscular Therapy for Low Back Pain
- ClinicalTrials.gov ID
- NCT05611476
- Acronym / sponsor ID
- CMT-LBP / CMT-LBP-6581
- Conditions
- Low Back Pain, Chronic Pain, Muscle Tightness
- Keywords
- Psychologically informed physiotherapy, Electromyography biofeedback, Cognitive Muscular Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Behavioral: Cognitive Muscular Therapy for low back painThis group will receive Cognitive Muscular Therapy for low back pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Muscular Therapy for low back painPsychologically informed physiotherapy which used biofeedback training to reduce muscle overactivity and improve postural control | Behavioural | Single group |
Primary outcome
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)
3 secondary outcomes
Change in Pain catastrophizing scale
Time frame: Change from baseline to 2 months
Change in Tampa scale of kinesiophobia
Time frame: Change from baseline to 2 months
Change in Oswestry disability scale
Time frame: Change from baseline to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 40972445Preece SJ, Smith J, Brookes N, Gates S, Ghio D. Cognitive Muscular Therapy for low back pain: a pilot study. Musculoskelet Sci Pract. 2025 Nov;80:103415. doi: 10.1016/j.msksp.2025.103415. Epub 2025 Sep 13.
- Description of CMT for knee pain. This will be adapted for low back pain.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We may make the clinical data available through a document which will be linked to the journal paper we publish
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Muscular Therapy for low back pain in people with Low Back Pain and Chronic Pain, run by University of Salford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Rowland Morris Disability questionnaire (time frame: Change from baseline to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05611476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.