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

December 11, 2018 updated by: University of Limerick

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
208

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Individual Cognitive Functional Therapy
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.
Behavioral: Individual Cognitive Functional Therapy
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.
Active Comparator: Group Exercise Classes
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.
Behavioral: Group Exercise Classes
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Numerical rating scale (NRS)
Time Frame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Measures pain intensity
Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Socio-economic Conditions Index
Time Frame: Baseline
Measures socio-economic status
Baseline
Back Pain Beliefs Questionnaire
Time Frame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Assess a person's beliefs about their back pain
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
Assesses a person's level of fear-avoidance beliefs regarding physical activities.
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
Assesses level of pain catastrophizing.
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
Assesses level of pain self-efficacy
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
Assess level of subjective health complaints
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
Assesses areas of bodily pain
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
Assesses patient's stress levels.
Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Patient Satisfaction Questionnaire
Time Frame: At 8-14 weeks
Assesses patient satisfaction
At 8-14 weeks
Short-Form Orebro Musculoskeletal Screening Questionnaire (OMSQ)
Time Frame: Measured at baseline
Stratifies patients into low, medium or high risk of delayed pain recovery and chronicity.
Measured at baseline
Medication usage
Time Frame: Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
To assess changes in levels of medication used.
Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months
Economic evaluation
Time Frame: 6, 12 and 36 months
Assesses direct and indirect costs of both treatment arms to see which is more cost-effective.
6, 12 and 36 months
Level of co-interventions
Time Frame: Baseline, post-intervention (at 8-14 weeks), 6, 12 and 36 months
Assesses the number/type of healthcare services availed of throughout the intervention period.
Baseline, post-intervention (at 8-14 weeks), 6, 12 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Limerick

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KU Leuven
Curtin University
Health Service Executive, Ireland
Mayo General Hospital, Ireland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dr Kieran O' Sullivan, PhD, University of Limerick
  • Principal Investigator: Mary O'Keeffe, BSc Physio, University of Limerick
  • Principal Investigator: Prof. Peter O'Sullivan, Professor, Curtin University
  • Principal Investigator: Dr Norelee Kennedy, PhD, University of Limerick
  • Principal Investigator: Prof. Wim Dankaerts, Professor, KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MGH-14-UL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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