Chronic Low Back PainNCT02145728

The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain

A study testing Individual Cognitive Functional Therapy and Group Exercise Classes in people with Chronic Low Back Pain, run by University of Limerick at 3 sites in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate whether individual cognitive functional therapy (CFT), when compared to group exercise classes is effective in reducing pain and disability in patients with non-specific chronic low back pain. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Chronic Low Back Pain
What is being tested?: Individual Cognitive Functional Therapy and Group Exercise Classes
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 208 participants
Where: 3 sitesIreland
Study dates: May 2014to Dec 2018
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged between 18 and 75
Chronic low back pain greater than 6 months duration
Score greater than 14% for disability on Oswestry Disability Index (ODI)
Independently mobile (with or without aids), to be capable of participating in a rehabilitation programme

Who cannot join

Primary pain area is not the lumbar spine (from T12-buttocks)
Leg pain as the primary problem (nerve root compression or disc prolapse with true radicular pain/radiculopathy, lateral recess/central or spinal stenosis with primary leg pain)
<6 months post lumbar spine or lower limb or abdominal surgery
Pain relieving procedures such as injection based therapy (e.g epidurals) and day case procedures (e.g rhizotomy) in the last 3 months
Pregnancy
Rheumatologic/inflammatory disease (e.g. rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, lupus, scheuermann's disease)

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Progressive neurological disease (e.g. multiple sclerosis (MS), parkinson's disease (PD), motor neuron disease (MND)
Unstable cardiac conditions
Red flag disorders like malignancy/cancer, acute traumas like fracture (<6 months ago) or infection, spinal cord compression/cauda equina

Trial locations and contacts

3 sites in 1 country.

Ireland3 sites

Ballina Primary Care Centre
Mayo, Connacht, 0000
Claremorris Primary Care Centre
Mayo, Connacht, 0000
Mayo General Hospital
Mayo, Connacht, 0000

Other trials in Ireland

About this study

Official title: The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain: a Multi-centre Randomized Trial

Read the detailed description

A multi-centre randomised study with 6 month, 12 month and 36 month follow up will be used. Patient with non- specific chronic low back pain will be assessed for eligibility. The patients fitting the inclusion criteria will be randomised to receive either the individual CFT or the group classes consisting of education and exercise. Participants' pain, disability, socio-economic status, beliefs, fear, catastrophizing, self-efficacy, general health, stress levels, as well as number and cost of treatments will be evaluated using a range of outcome measures at the start and on completion of the treatment. Patients will receive another copy of the questionnaires in the post at 6 month, 12 months and 36 months after treatment to reassess clinical outcomes. If a participant does not respond to follow-up, they will be telephoned to ask if they wish to complete the questionnaires.

Conditions: Chronic Low Back Pain
Being tested: Individual Cognitive Functional Therapy, Group Exercise Classes
Keywords: Non-specific chronic low back pain, Cognitive functional therapy, Exercise classes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Individual Cognitive Functional TherapyBehavioural
Cognitive functional therapy (CFT) is a novel, patient centred behavioural intervention which addresses multiple dimensions in non-specific chronic low back pain (NSCLBP). It combines a functional behavioural approach of normalising provocative postures and movements while discouraging pain behaviours, with cognitive restructuring of the NSCLBP problem.
Group Exercise ClassesBehavioural
Each class involves a combination of education, exercise and relaxation/mindfulness. The education topics include pain and the nervous system, posture and ergonomics, exercise and relaxation and sleep. The exercise component includes 10 stations of a combination of aerobic, strength and flexibility exercises. These will be walking/jogging on the spot, mini-squats, sit to stands, wall push ups, bridging, step-ups and a combination of leg and low back stretches. The relaxation/mindfulness component will take place at the end of each class and will involve breathing and relaxation of the body.

Study groups in NCT02145728
Study group	Role	What they receive
Individual Cognitive Functional Therapy	Experimental	The intervention being tested has four main components: (1) a cognitive component, for each patient, their vicious cycle of pain will outlined in a diagram based on their findings from the examination and the Orebro Musculoskeletal Pain Screening Questionnaire; (2) specific movement exercises designed to normalize maladaptive movement behaviours; (3) targeted functional integration of activities in their daily life previously, reported to be avoided or provocative by the patient; and (4) a physical activity and lifestyle programme. Receives: Behavioral: Individual Cognitive Functional Therapy
Group Exercise Classes	Active comparator	6 classes will take place in total. The class has 3 components each week. First, a 30 minute talk and discussion on chronic pain, and some tips for participants. Second, a 40 minute exercise circuit, involving aerobic exercise, and gentle stretching and strengthening exercises. Finally, a 5 minute relaxation/mindfulness session will take place at the end. The total time involved is approximately 1 hour and 15 minutes. Receives: Behavioral: Group Exercise Classes

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Oswestry Disability Index (ODI)
Used to assess change in disability levels over the course of the trial and follow-up
Measured: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months

Secondary outcomes (14)

Numerical rating scale (NRS)
Measures pain intensity
Measured: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Socio-economic Conditions Index
Measures socio-economic status
Measured: Baseline
Back Pain Beliefs Questionnaire
Assess a person's beliefs about their back pain
Measured: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Physical activity subscale of the Fear-Avoidance Beliefs Questionnaire (FABQ)
Assesses a person's level of fear-avoidance beliefs regarding physical activities.
Measured: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
The catastrophising subscale of the Coping Strategies Questionnaire (CSQ)
Assesses level of pain catastrophizing.
Measured: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Pain Self- Efficacy Questionnaire (PSEQ)
Assesses level of pain self-efficacy
Measured: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Subjective Health Complaints Inventory (SHC)
Assess level of subjective health complaints
Measured: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Nordic Musculoskeletal Screening Questionnaire
Assesses areas of bodily pain
Measured: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Stress subscale of the Depression, Anxiety and Stress scale (DASS 21)
Assesses patient's stress levels.
Measured: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Patient Satisfaction Questionnaire
Assesses patient satisfaction
Measured: At 8-14 weeks
Short-Form Orebro Musculoskeletal Screening Questionnaire (OMSQ)
Stratifies patients into low, medium or high risk of delayed pain recovery and chronicity.
Measured: Measured at baseline
Medication usage
To assess changes in levels of medication used.
Measured: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Economic evaluation
Assesses direct and indirect costs of both treatment arms to see which is more cost-effective.
Measured: 6, 12 and 36 months
Level of co-interventions
Assesses the number/type of healthcare services availed of throughout the intervention period.
Measured: Baseline, post-intervention (at 8-14 weeks), 6, 12 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Dec 2018

First posted23 May 2014 (estimated)
Study startMay 2014
Primary completionSep 2016
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Chronic 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 208 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02145728
Sponsor's protocol ID: MGH-14-UL
Status last verified: Dec 2018
First submitted: 30 Apr 2014
Last updated: 12 Dec 2018
Results posted: No
Data monitoring committee: Yes

Publications

O'Sullivan P. It's time for change with the management of non-specific chronic low back pain. Br J Sports Med. 2012 Mar;46(4):224-7. doi: 10.1136/bjsm.2010.081638. Epub 2011 Aug 4. No abstract available.
PubMed 21821612
Vibe Fersum K, O'Sullivan P, Skouen JS, Smith A, Kvale A. Efficacy of classification-based cognitive functional therapy in patients with non-specific chronic low back pain: a randomized controlled trial. Eur J Pain. 2013 Jul;17(6):916-28. doi: 10.1002/j.1532-2149.2012.00252.x. Epub 2012 Dec 4.
PubMed 23208945
O'Keeffe M, O'Sullivan P, Purtill H, Bargary N, O'Sullivan K. Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT). Br J Sports Med. 2020 Jul;54(13):782-789. doi: 10.1136/bjsports-2019-100780. Epub 2019 Oct 19.
PubMed 31630089
O'Keeffe M, Purtill H, Kennedy N, O'Sullivan P, Dankaerts W, Tighe A, Allworthy L, Dolan L, Bargary N, O'Sullivan K. Individualised cognitive functional therapy compared with a combined exercise and pain education class for patients with non-specific chronic low back pain: study protocol for a multicentre randomised controlled trial. BMJ Open. 2015 Jun 1;5(6):e007156. doi: 10.1136/bmjopen-2014-007156.
PubMed 26033941

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Comparing Non-Medicine Strategies for Improving Low Back Pain
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain: a Multi-centre Randomized Trial
ClinicalTrials.gov ID: NCT02145728
Acronym / sponsor ID: MGH-14-UL
Conditions: Chronic Low Back Pain
Keywords: Non-specific chronic low back pain, Cognitive functional therapy, Exercise classes
Study type: Interventional
Recruitment status: Completed
Enrolment: 208 participants (actual)
Lead sponsor: University of LimerickUniversity, hospital or other
Collaborators: Curtin University, KU Leuven, Mayo General Hospital, Ireland, Health Service Executive, Ireland
Study start: May 2014 (actual)
Primary completion: Sep 2016 (actual)
Study completion: Dec 2018 (actual)
First posted: 23 May 2014 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Individual Cognitive Functional Therapy	Experimental	Behavioral: Individual Cognitive Functional TherapyThe intervention being tested has four main components: (1) a cognitive component, for each patient, their vicious cycle of pain will outlined in a diagram based on their findings from the examination and the Orebro Musculoskeletal Pain Screening Questionnaire; (2) specific movement exercises designed to normalize maladaptive movement behaviours; (3) targeted functional integration of activities in their daily life previously, reported to be avoided or provocative by the patient; and (4) a physical activity and lifestyle programme.
Group Exercise Classes	Active comparator	Behavioral: Group Exercise Classes6 classes will take place in total. The class has 3 components each week. First, a 30 minute talk and discussion on chronic pain, and some tips for participants. Second, a 40 minute exercise circuit, involving aerobic exercise, and gentle stretching and strengthening exercises. Finally, a 5 minute relaxation/mindfulness session will take place at the end. The total time involved is approximately 1 hour and 15 minutes.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Aged between 18 and 75
Chronic low back pain greater than 6 months duration
Score greater than 14% for disability on Oswestry Disability Index (ODI)
Independently mobile (with or without aids), to be capable of participating in a rehabilitation programme

Key exclusion criteria (9 listed)

Primary pain area is not the lumbar spine (from T12-buttocks)
Leg pain as the primary problem (nerve root compression or disc prolapse with true radicular pain/radiculopathy, lateral recess/central or spinal stenosis with primary leg pain)
<6 months post lumbar spine or lower limb or abdominal surgery
Pain relieving procedures such as injection based therapy (e.g epidurals) and day case procedures (e.g rhizotomy) in the last 3 months
Pregnancy

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
Individual Cognitive Functional TherapyCognitive functional therapy (CFT) is a novel, patient centred behavioural intervention which addresses multiple dimensions in non-specific chronic low back pain (NSCLBP). It combines a functional behavioural approach of normalising provocative postures and movements while discouraging pain behaviours, with cognitive restructuring of the NSCLBP problem.	Behavioural	Individual Cognitive Functional Therapy
Group Exercise ClassesEach class involves a combination of education, exercise and relaxation/mindfulness. The education topics include pain and the nervous system, posture and ergonomics, exercise and relaxation and sleep. The exercise component includes 10 stations of a combination of aerobic, strength and flexibility exercises. These will be walking/jogging on the spot, mini-squats, sit to stands, wall push ups, bridging, step-ups and a combination of leg and low back stretches. The relaxation/mindfulness component will take place at the end of each class and will involve breathing and relaxation of the body.	Behavioural	Group Exercise Classes

Primary outcome

Change in Oswestry Disability Index (ODI)
Time frame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Used to assess change in disability levels over the course of the trial and follow-up

14 secondary outcomes

Numerical rating scale (NRS)
Time frame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Socio-economic Conditions Index
Time frame: Baseline
Back Pain Beliefs Questionnaire
Time frame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Physical activity subscale of the Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
The catastrophising subscale of the Coping Strategies Questionnaire (CSQ)
Time frame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Pain Self- Efficacy Questionnaire (PSEQ)
Time frame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Subjective Health Complaints Inventory (SHC)
Time frame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Nordic Musculoskeletal Screening Questionnaire
Time frame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Stress subscale of the Depression, Anxiety and Stress scale (DASS 21)
Time frame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Patient Satisfaction Questionnaire
Time frame: At 8-14 weeks
Short-Form Orebro Musculoskeletal Screening Questionnaire (OMSQ)
Time frame: Measured at baseline
Medication usage
Time frame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Economic evaluation
Time frame: 6, 12 and 36 months
Level of co-interventions
Time frame: Baseline, post-intervention (at 8-14 weeks), 6, 12 and 36 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 12 Dec 2018.
Background: PubMed 21821612O'Sullivan P. It's time for change with the management of non-specific chronic low back pain. Br J Sports Med. 2012 Mar;46(4):224-7. doi: 10.1136/bjsm.2010.081638. Epub 2011 Aug 4. No abstract available.
Results publication: PubMed 23208945Vibe Fersum K, O'Sullivan P, Skouen JS, Smith A, Kvale A. Efficacy of classification-based cognitive functional therapy in patients with non-specific chronic low back pain: a randomized controlled trial. Eur J Pain. 2013 Jul;17(6):916-28. doi: 10.1002/j.1532-2149.2012.00252.x. Epub 2012 Dec 4.
Derived from this study: PubMed 31630089O'Keeffe M, O'Sullivan P, Purtill H, Bargary N, O'Sullivan K. Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT). Br J Sports Med. 2020 Jul;54(13):782-789. doi: 10.1136/bjsports-2019-100780. Epub 2019 Oct 19.
Derived from this study: PubMed 26033941O'Keeffe M, Purtill H, Kennedy N, O'Sullivan P, Dankaerts W, Tighe A, Allworthy L, Dolan L, Bargary N, O'Sullivan K. Individualised cognitive functional therapy compared with a combined exercise and pain education class for patients with non-specific chronic low back pain: study protocol for a multicentre randomised controlled trial. BMJ Open. 2015 Jun 1;5(6):e007156. doi: 10.1136/bmjopen-2014-007156.

Related trials for Chronic Low Back Pain

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
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RecruitingPhase 2
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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.

Dr Kieran O' Sullivan, PhD study director

University of Limerick

Mary O'Keeffe, BSc Physio principal investigator

University of Limerick

Prof. Peter O'Sullivan, Professor principal investigator

Curtin University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Individual Cognitive Functional Therapy and Group Exercise Classes in people with Chronic Low Back Pain, run by University of Limerick at 3 sites in Ireland.

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 4 inclusion and 9 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 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Ireland. 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 Oswestry Disability Index (ODI) (time frame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 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 NCT02145728, which also lists 4 linked publications.

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 12 Dec 2018.