Manual Therapy on the Improvement of Functional Disability in Patients With Chronic Non Specific Low Back Pain

December 20, 2011 updated by: Pierre Balthazard, University of Applied Sciences of Western Switzerland

Manual Therapy Followed by Specific Active Exercises Versus a Placebo Followed by Specific Active Exercises on the Improvement of Functional Disability in Patients With Chronic Non Specific Low Back Pain: a Randomized Controlled Trial

Background: Models have tried to explain the driving mechanisms behind chronic non specific low back pain (CNSLBP) in order to propose better appropriate conservative treatment. Altered responses at spinal and/or supraspinal level may affect the perception of pain and degree of disability of CNSLBP patients. Recent clinical recommendations still propose active exercises (AE) for CNSLBP. However, acceptance of exercises by patients may be limited by pain-related manifestations. Current evidences suggest manual therapy (MT) induces a short-term analgesic effect through neurophysiological mechanisms at peripheral, spinal and cortical levels. The aim of this study was first, to assess whether MT has an instant analgesic effect, and second, to compare the long-lasting effect on functional disability of MT followed by AE to sham therapy (ST) followed by AE. Methods: Forty-two CNSLBP patients without co-morbidities, randomly distributed into 2 treatment groups, received either spinal manipulation/mobilization (first intervention) plus AE (MT group; n = 22), or detuned ultrasound (first intervention) plus AE (ST group; n = 20). Eight therapeutic sessions were delivered over 4 to 8 weeks. Instant analgesic effect was obtained by measuring pain intensity (Visual Analogue Scale) before and immediately after the first intervention of each therapeutic session. Pain intensity, disability (Oswestry Disability Index) and fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire) were determined before treatment, after the 8th therapeutic session, and at 3- and 6-month follow-ups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1005
        • Département de l'appareil locomoteur (DAL), Centre Hospitalier Universitaire Vaudois (CHUV)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • suffering from non specific low back pain with or without symptoms in the lower extremity for a period between 12 and 26 weeks
  • can maintain the usual medication

Exclusion Criteria:

  • spinal fracture or surgery within the previous 6 months
  • pregnancy
  • neoplasia
  • spinal infection
  • spinal inflammatory arthritis
  • low back pain of visceral origin
  • severe sensitive and/or motor radicular deficit from nerve root origin of less than 6 months
  • score of 3/5 or more on the Waddell Score
  • on sick leaves from work for 6 months or more
  • psychiatric disorders
  • opioid medication
  • patient unable to collaborate (linguistic barrier; cognitive impairments)
  • radiologic abnormalities other than degenerative disease
  • clinical neurogenic claudication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manual therapy and active exercises
Spinal manipulation /mobilisation
Procedure: Manual therapy and active exercises

Spinal manipulation/mobilisation (5-10 minutes), consisting of passive accessory intervertebral movements, muscle-energy techniques and high velocity, low amplitude dynamic thrust.

Active exercises (20 minutes), consisting of mobility, stretching, strengthening and motor control exercises

Other Names:
  • Manipulation
  • Spinal mobilisation
Placebo Comparator: Detuned ultrasound and active exercises
Procedure: Detuned ultrasound and active exercises
Electrotherapy device inactivated and ineffective. Active exercises, consisting of mobility, stretching, strengthening and motor control exercises
Other Names:
  • Electrotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale - VAS-pain
Time Frame: During treatment, over a period of 4 to 8 weeks
self-report of clinical pain intensity, consisting of a 10 cm horizontal line scale on which is added the statements "no pain" on the left and "maximum intensity of pain" on the right
During treatment, over a period of 4 to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire - FABQ)
Time Frame: Before randomization and untill 6 months after the end of treatment
measures level of fear and avoidance beliefs about work and physical activity in patients with low back pain
Before randomization and untill 6 months after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Applied Sciences of Western Switzerland

Collaborators

Centre Hospitalier Universitaire Vaudois

Investigators

  • Study Director: Olivier Dériaz, MD, PhD, Institut de Recherche en Réadaptation et Clinique Romande de Réadaptation SUVACare, Sion, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

December 16, 2011

First Submitted That Met QC Criteria

December 20, 2011

First Posted (Estimate)

December 21, 2011

Study Record Updates

Last Update Posted (Estimate)

December 21, 2011

Last Update Submitted That Met QC Criteria

December 20, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNS13DPD3-109903 (Other Grant/Funding Number: Swiss National Fund DORE)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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