Cognitive Functional Therapy Compared to Cognitive Patient Education and Physiotherapy for Patients With Low Back Pain

NCT03952741 | Completed

• 1 other identifier: 250.05
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Background: There is a need for projects that link work closer to the rehabilitation chain to further understand risk factors for sick-leave. The new aspect of this project is that it combines work place intervention with individualized physiotherapy, based on validated standardized tests and a classification based treatment system. Aim: The aim is to expand the knowledge and understanding of complex causes of musculoskeletal pain, particularly low back pain (LBP). The main aim is to examine if cognitive functional therapy (CFT) can further reduce sick-leave and pain, and increase function and well-being. Material and methods: To ensure good recruitment we have collaboration with the Department for Health and social services in the county of Bergen, which has a sickness absence above average among their health workers. We will invite those with LBP problems to be included in an RCT and receive CFT in a physiotherapy clinic (usually offered 5 to 12 visits). The comparison group will receive a series with cognitive patient education and physiotherapy (COPE-PT) given by a physiotherapist. All participants will be followed by their workplace leaders. All patients who enter the RCT will be re-examined at 3 and 12 months and the predictors for sick-leave, function and coping in different sub-groups of patients with NSLBP will be studied.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Sick listing - self reported

  Measure if there is a change in self reported sick listing from baseline to after treatment and 12 months follow up

  Baseline, after 3 months and after 12 months

Secondary Outcomes (3)

• Roland Morris

  Baseline, 3 months and 12 months

• Numerical Pain Rating Scale (NPRS)

  Baseline, 3 months and 12 months

• Hopkins Symptoms Checklist

  Baseline, 3 months and 12 months

Study Arms (2)

Cognitive Functional Therapy

EXPERIMENTAL

The intervention is a targeted cognitive functional therapy and will be based on examination findings. It is behaviorally directed with a focus on normalizing mal-adaptive pain, cognitive and movement behaviors in a graduated manner. In the evaluation process it is considered whether the patient has adjusted to the back complaints in a positive way (confrontation, active coping, minimal avoidance behavior) or in a negative way (passive coping, fear and avoidance behavior). Work related issues will be a particular focus, with the aim of achieving close co-operation between the worker, the workplace and the worker's responsible health care provider.

Behavioral: Physical Therapy

Cognitive Patient Education and PT

ACTIVE COMPARATOR

The intervention in the second group will receive much training in cognitive coping techniques after the COPE LBP trial principles (Werner et al. 2010). The educational part of the COPE for new instructors with a PT background takes 2 days supervised by Werner and his group, with regular follow-up meeting with the project leaders, together with a psychologist trained in cognitive therapy

Behavioral: Physical Therapy

Interventions

Physical Therapy BEHAVIORAL

Also known as: Cognitive functional therapy and Cognitive patient education

Cognitive Functional Therapy; Cognitive Patient Education and PT

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NSLBP for \> 3 months, and reported that their pain was provoked by postures, movement and daily activities.
• Pain intensity measured with a numerical rating scale (NPRS) over the last 14 days \>3/10
• Roland Morris Disability Questionnaire (RMDQ) ≥ 7 was necessary to be admitted to the study.
• Ørebro Musculoskeletal Pain Questionnaire-short form (ØMPQ-SF) was used to examine the participants risk profile pre-treatment, and had to be ≥ 30, on a scale from 0-100.

You may not qualify if:

• Continuous sick-leave duration ≥ 4 months
• Acute exacerbation of LBP a
• Specific LBP diagnosis - radicular pain, disc herniation, spondylolisthesis, stenosis, Modic changes
• Any low limb surgery in the last 3 months; surgery involving the lumbar spine;
• Pregnancy
• Diagnosed psychiatric disorder
• Active rheumatologic disease, progressive neurological disease
• Serious cardiac or other internal medical condition
• Malignant diseases, acute traumas, infections, or acute vascular catastrophes.

Sponsors & Collaborators

• University of Bergen: lead

Study Sites (1)

University of Bergen

Bergen, Hordaland, 5018, Norway

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: RCT

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: May 16, 2019
• Study Start: March 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: November 1, 2017
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

NO (1)