"Cognitive Functional Therapy" vs. Manual Therapy for Non-specific Low Back Pain

NCT ID: NCT01794962

Last Updated: 2018-03-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2018-03-31

Brief Summary

This is a pilot study. Chronic LBP is a major health care problem in Denmark. Few patients receive a specific diagnosis, leaving the majority of patients diagnosed with non specific low back pain(NSLBP). Classification systems can help to guide the treatment of NSLBP. This pilot study will compare manual therapy (manipulation and soft tissue treatment)and exercises to a classification based biopsychosocial intervention (a cognitive/functional approach) as described by Peter O'Sullivan, on a subgroup called "flexion pattern"

This pilot study has three specific aims:

(i) To determine the mean and standard deviation on the numerical rating scale of participants in this setting who have a motor control flexion pattern, so that sample size calculations for a fully powered randomized controlled trial could be performed.

(ii) To test the logistical and practical procedures that will be required to perform a fully powered randomized controlled trial using these two treatments.

(iii) To gain a preliminary estimate of any difference in the effect of these two treatments, so as to determine if the results of a fully powered randomized controlled trial might be clinically important and therefore worthwhile undertaking

Detailed Description

This is a pilot study. Chronic LBP is a major health care problem in Denmark. Few patients receive a specific diagnosis, leaving the majority of patients diagnosed with non specific low back pain(NSLBP). Classification systems can help to guide the treatment of NSLBP.This project will recruit patients , classified with a "flexion pattern" according to the classification system proposed by Peter O´Sullivan. When classified with a flexion pattern the patients will be randomized into either of two treatment arms. Manual therapy (manipulation and soft tissue treatment)and exercises by a chiropractor or to a classification based biopsychosocial intervention done by a physiotherapist, (a cognitive/functional approach) as described by Peter O'Sullivan

This pilot study has three specific aims:

(i) To determine the mean and standard deviation on the numerical rating scale of participants in this setting who have a motor control flexion pattern, so that sample size calculations for a fully powered randomized controlled trial could be performed.

(ii) To test the logistical and practical procedures that will be required to perform a fully powered randomized controlled trial using these two treatments.

(iii) To gain a preliminary estimate of any difference in the effect of these two treatments, so as to determine if the results of a fully powered randomized controlled trial might be clinically important and therefore worthwhile undertaking

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manual therapy and exercises

Manual therapy treatment: spinal manipulation, Soft tissue treatment, muscle energy techniques. Exercises: stabilisation exercises, Mckenzie exercises and general muscle exercises.

Group Type: EXPERIMENTAL

manual therapy and exercises

Intervention Type: OTHER

Patients in this group will be treated with joint mobilization or manipulation techniques applied to the spine or pelvis primarily and is designed to be consistent with best current manual therapy practice.

Cognitive Functional Therapy

An in depth interview, including investigating the patients beliefs on back pain, fear towards movement, anxiety and distress, using reflecting questions. The physical part consists of specific and functional exercises related to the patients functional complaints.And general physical activity for 30 mins 3-4 times weekly.

Group Type: EXPERIMENTAL

Cognitive functional therapy

Intervention Type: OTHER

The intervention is directed at the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder.

Interventions

Cognitive functional therapy

The intervention is directed at the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder.

Intervention Type: OTHER

manual therapy and exercises

Patients in this group will be treated with joint mobilization or manipulation techniques applied to the spine or pelvis primarily and is designed to be consistent with best current manual therapy practice.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Participants must be between 18 - 65 years old and have, with a history of low back pain more than three months.

The primary pain area from T12- to the gluteal folds. Low back pain must be provoked by movements and/or physical activities. Average pain intensity in the last two weeks must be al least: 4/10 on Pain numerical rating scale Participants must have adequate comprehension and expressing the Danish language.

Participants must be classified as having a "flexion pattern".

Exclusion Criteria

Participants must not have been sick listed for more than 4 months; have an acute exacerbation of LBP, surgery of low limb within last 4 months or hip or knee osteoarthritis limiting loading of knee and hip flexion.

Follow medical conditions are also excluding participants:

A history of spinal surgery Radicular pain (disc prolapse or foraminal stenosis): non painful symptoms in leg, clinical signs of altered nerve conduction) Spinal stenosis A previous history psychiatric disease Current pregnancy Widespread non-specific pain (for filling criteria for fibromyalgia) Imaging confirming spondylolisthesis

Other diseases:

Rheumatoid arthritis ankylosing spondylitis neurologic disease infection cancer previous history of osteoporosis The patient can´t be classified as having a flexion pattern Lack of compliance during the intervention: if a patient fails to turn up for more than one appointment with out prior notice.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spine Centre of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kasper Ussing, Msc

Role: PRINCIPAL_INVESTIGATOR

Spine Centre of Southern Denmark

Locations

Kasper Ussing

Middelfart, Fyn, Denmark

Countries

Denmark

Other Identifiers

KU2012

Identifier Type: -

Identifier Source: org_study_id