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

This study has been completed.
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Pierre Balthazard, University of Applied Sciences of Western Switzerland
ClinicalTrials.gov Identifier:
NCT01496144
First received: December 16, 2011
Last updated: December 20, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Back Pain Lower Back Chronic
Procedure: Manual therapy and active exercises
Procedure: Detuned ultrasound and active exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Applied Sciences of Western Switzerland:

Primary Outcome Measures:
  • Visual Analogue Scale - VAS-pain [ Time Frame: During treatment, over a period of 4 to 8 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire - FABQ) [ Time Frame: Before randomization and untill 6 months after the end of treatment ] [ Designated as safety issue: No ]
    measures level of fear and avoidance beliefs about work and physical activity in patients with low back pain


Enrollment: 42
Study Start Date: December 2005
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Spinal mobilisation
  • Manipulation
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 Name: Electrotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01496144

Locations
Switzerland
Département de l'appareil locomoteur (DAL), Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Vaud, Switzerland, 1005
Sponsors and Collaborators
University of Applied Sciences of Western Switzerland
Centre Hospitalier Universitaire Vaudois
Investigators
Study Director: Olivier Dériaz, MD, PhD Institut de Recherche en Réadaptation et Clinique Romande de Réadaptation SUVACare, Sion, Switzerland
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pierre Balthazard, Bachelor of sciences in physical therapy, University of Applied Sciences of Western Switzerland
ClinicalTrials.gov Identifier: NCT01496144     History of Changes
Other Study ID Numbers: FNS13DPD3-109903, FNS13DPD3-109903
Study First Received: December 16, 2011
Last Updated: December 20, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Applied Sciences of Western Switzerland:
Chronic non specific low back pain
Manual therapy
Active exercises
Pain
Disability

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014