NCT01794962

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

Classification Based "Cognitive Functional Therapy" vs. Manual Therapy for a Subgroup of Patients With Chronic NSLBP, Classified as Having a "Flexion Pattern"

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Spine Centre of Southern Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Cognitive functional therapy	The intervention is directed at the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder.
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.

Timeline

• Start date: 2012-10-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2013-02-20
• Last updated: 2018-03-08

Locations

1 site across 1 country: Denmark