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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01496144
First Posted: December 21, 2011
Last Update Posted: December 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Pierre Balthazard, University of Applied Sciences of Western Switzerland
December 16, 2011
December 21, 2011
December 21, 2011
December 2005
December 2010   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
Manual Therapy on the Improvement of Functional Disability in Patients With Chronic Non Specific Low Back Pain
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Back Pain Lower Back Chronic
  • 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
  • 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
  • Experimental: Manual therapy and active exercises
    Spinal manipulation /mobilisation
    Intervention: Procedure: Manual therapy and active exercises
  • Placebo Comparator: Detuned ultrasound and active exercises
    Intervention: Procedure: Detuned ultrasound and active exercises

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
January 2011
December 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01496144
FNS13DPD3-109903
FNS13DPD3-109903 ( Other Grant/Funding Number: Swiss National Fund DORE )
No
Not Provided
Not Provided
Pierre Balthazard, University of Applied Sciences of Western Switzerland
University of Applied Sciences of Western Switzerland
Centre Hospitalier Universitaire Vaudois
Study Director: Olivier Dériaz, MD, PhD Institut de Recherche en Réadaptation et Clinique Romande de Réadaptation SUVACare, Sion, Switzerland
University of Applied Sciences of Western Switzerland
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP