COgNitive FuncTional Therapy+ for Chronic Low Back paIn

NCT04399772 | Completed

• 1 other identifier: 69712
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a patient-blinded 2-arm randomized controlled trial (RCT) assessing the effectiveness (in the short and long term) as well as total healthcare costs of a CFT+ (a combined physiotherapist/psychologist intervention) pathway compared with interdisciplinary pain management pathway (usual care) for patients with chronic low back pain referred to interdisciplinary pain treatment. The primary aim of this pragmatic randomized controlled trial (RCT) is to investigate if a physiotherapy-led CFT pathway that includes psychologist support (CFT+) with the option of additional usual care (if needed) is superior to the currently recommended interdisciplinary pain management pathway (usual care) in reducing disability at 12 months in patients with severe cLBP. In addition, an economic evaluation will investigate total health care costs of the two pathways at 12 months. In addition the study will explore changes in pain intensity, quality of life, thoughts and beliefs about back pain, and analgesic consumption in patients randomized to the CFT+ pathway compared with patients randomized to the interdisciplinary pain management pathway.

Conditions

Chronic Low-back Pain

Keywords

Low back pain; Cognitive Functional Therapy; Interdisciplinary pain management; RCT; Disability

Outcome Measures

Primary Outcomes (1)

• Pain-related disability during the last 7 days

  Proportion of patients who have an improvement of 8 points or more on the Oswestry Disability Index (ODI) at 12 months. The ODI assesses pain-related disability within the last 7 days, asking patients to reflect on their ability to manage their everyday life despite their back pain for these domains: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling. Each domain is scored on a 0-5 scale. The index is calculated by dividing the summed score by the total possible score multiplied by 100 and expressed as a percentage with 100 representing the greatest disability.

  Change from baseline to 12 months

Secondary Outcomes (9)

• Trajectory of Pain-related disability during the last 7 days

  Assessed after 0, 3, 6, 9, and 12 months

• Average pain intensity during the last 24 hours

  Assessed at 0, 3, 6, 9, and 12 months

• Health-related quality of life

  Assessed at 0, 3 and 12 months

• Level of pain catastrophization

  Assessed at 0, 3 and 12 months

• Level of patient enablement

  Assessed at 0, 3 and 12 months

Other Outcomes (4)

• Depression (for patient description)

  Baseline

• Anxiety (for patient description)

  Baseline

• Kinesiophobia (for patient description)

  Baseline

Study Arms (2)

Cognitive Functional Therapy+ pathway

EXPERIMENTAL

Treatment is performed by a CFT trained physiotherapists and a psychologist in the Pain Center. Patients receive max 10 consultations over 3 months. The first two sessions is combined with the physiotherapist and psychologist who investigates potential maintaining factors for pain and disability in the patient's everyday life. Remaining sessions are run by the physiotherapist, and the treatment is individually tailored to the needs of the individual patient, aiming to provide the patient with skills in dealing with his / her own situation via information, reflection, change of movement and training of functions and physical level. The psychologist provide extra support for 2-3 sessions to reinforce the physiotherapist work.The ethical committee made blinding conditional on a possibility of usual care after CFT+ if: the patient does not feel ready to stop treatment AND analgesic treatment is inappropriate OR the social situation is problematic OR significant psychological distress.

Behavioral: Cognitive Functional Therapy+ pathway

Interdisciplinary pain management pathway

ACTIVE COMPARATOR

Treatment at the Interdisciplinary University Pain Center are based on elements from cognitive-behavioral therapy, Acceptance and Commitment Therapy, and Mindfulness-Based Stress Reduction programs. Treatment can be diverse, but based on an individual assessment it consists of a combination of (1) medical treatment with a specialist pain consultant+specialist pain nurse (ie, individual adjustment of analgesics to improve effect and reduce side effects) AND (2) one or more of the following: individual consultations with a specialist pain psychologist, physiotherapist or social worker with cognitive-behavioral therapy training as well as participation in a group program with relaxation therapy, acceptance and commitment therapy or standardized mindfulness-based stress reduction programs. On average patients in the pain center receives 9-10 sessions.

Behavioral: Interdisciplinary pain management pathway

Interventions

Cognitive Functional Therapy+ pathway BEHAVIORAL

The CFT+ intervention comprises 4 main components: (1) making sense of pain: context-based patient education focusing on the multidimensional nature of pain and disability, while reducing the threat of structural damage and correcting unhelpful beliefs; (2) exposure with control: graded exposure to painful, feared, or avoided activities with body relaxation; (3) lifestyle changes: encouraged to perform physical activity based on preference and taught strategies to manage stress and poor sleep, (4) focus on coping strategies in life and how these strategies influence the current situation. After CFT+, patients can be offered the comparator pathway should that be clinically indicated from these criteria: the patient does not feel ready to stop treatment AND Analgesic treatment is inappropriate OR Social situation is problematic OR Significantly psychological distress that requires further treatment by psychologist. This decision is based on a multidisciplinary team conference.

Cognitive Functional Therapy+ pathway

Interdisciplinary pain management pathway BEHAVIORAL

Treatment at the Interdisciplinary University Pain Center are based on elements from cognitive-behavioral therapy, Acceptance and Commitment Therapy, and Mindfulness-Based Stress Reduction programs. Individualized combination of (1) medical treatment with a specialist pain consultant+specialist pain nurse (ie, individual adjustment of analgesics to improve effect and reduce side effects), (2) one or more of the following: individual consultations with a specialist pain psychologist, physiotherapist or social worker with cognitive-behavioral therapy training as well as participation in a group program with relaxation therapy, acceptance and commitment therapy or standardized mindfulness-based stress reduction programs.

Interdisciplinary pain management pathway

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-75 years referred to interdisciplinary pain management at the Pain Center
• Adequate Danish language skills
• Chronic low back pain (pain in the area between the 12th rib and buttock crease lasting more than 6 months)
• Low back pain self-reported as significant contributor to daily disability (Yes/No)
• Low back pain intensity \> 4 on 0-10 numerical rating scale
• Provide consent that data collected via questionnaires and registries can be used for research purposes

You may not qualify if:

• Previously attended an interdisciplinary pain management program
• Wheel chair bound
• Suicidal ideation - evaluated using Patient Health Questionnaire-9 (Item 9 has to be answered "never")
• Self-reported former/ present addictive drug or alcohol behavior
• Self-reported current pregnancy

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator
• Curtin University: collaborator
• Manchester Metropolitan University: collaborator

Study Sites (1)

Pain Center, University Hospital Odense

Odense, Funen, 5000, Denmark

Location

Related Publications (1)

• Vaegter HB, Johansen JV, Sopina L, Smith A, Kent P, Fuglsang KS, Pedersen JF, Schutze R, O'Sullivan P, Handberg G, Fatoye F, Ussing K, Stegemejer I, Thorlund JB. A Cognitive Functional Therapy+ Pathway Versus an Interdisciplinary Pain Management Pathway for Patients With Severe Chronic Low Back Pain (CONFeTTI Trial): Protocol for a Pragmatic Randomized Controlled Trial. Phys Ther. 2021 Sep 1;101(9):pzab132. doi: 10.1093/ptj/pzab132.

  PMID: 34003285 DERIVED

Related Links

• CFT pilot study in the Pain Center

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Henrik B Vægter, PhD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study has ethical approval that the patients involved are not aware that there is a difference between the two treatment strategies in the study. Patient masking in this study is done to ensure that included patients are as representative as possible. The randomization sequence is distributed and stored in sealed opaque envelopes handled only by an independent study secretary who has no other involvement in the trial. All outcome measurements are completed via an electronic questionnaire system sent via personal links to the patients' official digital inbox, e-Boks (used by public hospitals, municipalities and other institutions to send official documents to citizens of Denmark). The researcher responsible for the statistical analyzes are blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Physiotherapy

Model Details: This study is a patient-blinded 2-arm randomized controlled trial with a parallel group design and 1:1 group allocation.

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: September 27, 2020
• Primary Completion: March 1, 2023
• Study Completion: February 29, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)