"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"

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

Study Overview

• Status: Terminated
• Conditions: Low Back Pain
• Intervention / Treatment: Other: manual therapy and exercises; Other: Cognitive functional therapy

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Fyn
    • Middelfart, Fyn, Denmark, 5500
      • Kasper Ussing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual therapy and exercises; Manual therapy treatment: spinal manipulation, Soft tissue treatment, muscle energy techniques. Exercises: stabilisation exercises, Mckenzie exercises and general muscle exercises.	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.
Experimental: 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.	Other: Cognitive functional therapy; The intervention is directed at the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity(numerical rating scale)	Pain intensity Numerical Rating Scale, as pain is the primary reason for patients to seek care. Numerical Rating Scales have shown to have reliability, validity and responsiveness to change at a best practise standard.	12 months FU

Secondary Outcome Measures

Outcome Measure	Time Frame
Ronald Morris Questionaire	12 months follow up

Other Outcome Measures

Outcome Measure	Time Frame
Fear/Avoidance Beliefs Questionaire	12 months follow up

Collaborators and Investigators

• Sponsor: Spine Centre of Southern Denmark
• Investigators: Principal Investigator: Kasper Ussing, Msc, Spine Centre of Southern Denmark

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: January 27, 2013
• First Submitted That Met QC Criteria: February 16, 2013
• First Posted (Estimate): February 20, 2013

Study Record Updates

• Last Update Posted (Actual): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 7, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: LBP; Classification; Manual Therapy; Cognitive functional therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: KU2012