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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Individual Cognitive Functional Therapy
Group Exercise Classes
Sponsored by
University of Limerick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Non-specific chronic low back pain, Cognitive functional therapy, Exercise classes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Sites / Locations

  • Ballina Primary Care Centre
  • Claremorris Primary Care Centre
  • Mayo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individual Cognitive Functional Therapy

Group Exercise Classes

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Oswestry Disability Index (ODI)
Used to assess change in disability levels over the course of the trial and follow-up

Secondary Outcome Measures

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

Full Information

First Posted
April 30, 2014
Last Updated
December 11, 2018
Sponsor
University of Limerick
Collaborators
Curtin University, KU Leuven, Mayo General Hospital, Ireland, Health Service Executive, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT02145728
Brief Title
The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain
Official Title
The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain: a Multi-centre Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Limerick
Collaborators
Curtin University, KU Leuven, Mayo General Hospital, Ireland, Health Service Executive, Ireland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Non-specific chronic low back pain, Cognitive functional therapy, Exercise classes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Kieran O' Sullivan, PhD
Organizational Affiliation
University of Limerick
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mary O'Keeffe, BSc Physio
Organizational Affiliation
University of Limerick
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof. Peter O'Sullivan, Professor
Organizational Affiliation
Curtin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Norelee Kennedy, PhD
Organizational Affiliation
University of Limerick
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof. Wim Dankaerts, Professor
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ballina Primary Care Centre
City
Mayo
State/Province
Connacht
ZIP/Postal Code
0000
Country
Ireland
Facility Name
Claremorris Primary Care Centre
City
Mayo
State/Province
Connacht
ZIP/Postal Code
0000
Country
Ireland
Facility Name
Mayo General Hospital
City
Mayo
State/Province
Connacht
ZIP/Postal Code
0000
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21821612
Citation
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.
Results Reference
background
PubMed Identifier
23208945
Citation
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.
Results Reference
result
PubMed Identifier
31630089
Citation
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.
Results Reference
derived
PubMed Identifier
26033941
Citation
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.
Results Reference
derived

Learn more about this trial

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

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