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

Primary Purpose

Low Back Pain

Status

Terminated

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Cognitive functional therapy

manual therapy and exercises

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Classification, LBP, Cognitive functional therapy, Manual Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Kasper Ussing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Manual therapy and exercises

Cognitive Functional Therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Ronald Morris Questionaire

Full Information

NCT ID

NCT01794962

First Posted

January 27, 2013

Last Updated

March 7, 2018

Sponsor

Spine Centre of Southern Denmark

1. Study Identification

Unique Protocol Identification Number

NCT01794962

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Terminated

Study Start Date

October 2012 (undefined)

Primary Completion Date

March 2018 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Spine Centre of Southern Denmark

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

Classification, LBP, Cognitive functional therapy, Manual Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Manual therapy and exercises

Arm Type

Experimental

Arm Description

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

Arm Title

Cognitive Functional Therapy

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Cognitive functional therapy

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

manual therapy and exercises

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain Intensity(numerical rating scale)

Description

Time Frame

12 months FU

Secondary Outcome Measure Information:

Title

Ronald Morris Questionaire

Time Frame

12 months follow up

Other Pre-specified Outcome Measures:

Title

Fear/Avoidance Beliefs Questionaire

Time Frame

12 months follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kasper Ussing, Msc

Organizational Affiliation

Spine Centre of Southern Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kasper Ussing

City

Middelfart

State/Province

Fyn

ZIP/Postal Code

5500

Country

Denmark

12. IPD Sharing Statement

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

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