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

Primary Purpose

Back Pain Lower Back Chronic

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Manual therapy and active exercises
Detuned ultrasound and active exercises
Sponsored by
University of Applied Sciences of Western Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain Lower Back Chronic focused on measuring Chronic non specific low back pain, Manual therapy, Active exercises, Pain, Disability

Eligibility Criteria

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

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Manual therapy and active exercises

Detuned ultrasound and active exercises

Arm Description

Spinal manipulation /mobilisation

Outcomes

Primary Outcome Measures

Visual Analogue Scale - VAS-pain
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)
measures level of fear and avoidance beliefs about work and physical activity in patients with low back pain

Full Information

First Posted
December 16, 2011
Last Updated
December 20, 2011
Sponsor
University of Applied Sciences of Western Switzerland
Collaborators
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT01496144
Brief Title
Manual Therapy on the Improvement of Functional Disability in Patients With Chronic Non Specific Low Back Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Applied Sciences of Western Switzerland
Collaborators
Centre Hospitalier Universitaire Vaudois

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain Lower Back Chronic
Keywords
Chronic non specific low back pain, Manual therapy, Active exercises, Pain, Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual therapy and active exercises
Arm Type
Experimental
Arm Description
Spinal manipulation /mobilisation
Arm Title
Detuned ultrasound and active exercises
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Manual therapy and active exercises
Other Intervention Name(s)
Spinal mobilisation, Manipulation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Detuned ultrasound and active exercises
Other Intervention Name(s)
Electrotherapy
Intervention Description
Electrotherapy device inactivated and ineffective. Active exercises, consisting of mobility, stretching, strengthening and motor control exercises
Primary Outcome Measure Information:
Title
Visual Analogue Scale - VAS-pain
Description
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
Time Frame
During treatment, over a period of 4 to 8 weeks
Secondary Outcome Measure Information:
Title
Fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire - FABQ)
Description
measures level of fear and avoidance beliefs about work and physical activity in patients with low back pain
Time Frame
Before randomization and untill 6 months after the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Dériaz, MD, PhD
Organizational Affiliation
Institut de Recherche en Réadaptation et Clinique Romande de Réadaptation SUVACare, Sion, Switzerland
Official's Role
Study Director
Facility Information:
Facility Name
Département de l'appareil locomoteur (DAL), Centre Hospitalier Universitaire Vaudois (CHUV)
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1005
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
17250965
Citation
Ferreira ML, Ferreira PH, Latimer J, Herbert RD, Hodges PW, Jennings MD, Maher CG, Refshauge KM. Comparison of general exercise, motor control exercise and spinal manipulative therapy for chronic low back pain: A randomized trial. Pain. 2007 Sep;131(1-2):31-7. doi: 10.1016/j.pain.2006.12.008. Epub 2007 Jan 23.
Results Reference
background
PubMed Identifier
12642755
Citation
Aure OF, Nilsen JH, Vasseljen O. Manual therapy and exercise therapy in patients with chronic low back pain: a randomized, controlled trial with 1-year follow-up. Spine (Phila Pa 1976). 2003 Mar 15;28(6):525-31; discussion 531-2. doi: 10.1097/01.BRS.0000049921.04200.A6.
Results Reference
background
PubMed Identifier
11896377
Citation
Hemmila HM, Keinanen-Kiukaanniemi SM, Levoska S, Puska P. Long-term effectiveness of bone-setting, light exercise therapy, and physiotherapy for prolonged back pain: a randomized controlled trial. J Manipulative Physiol Ther. 2002 Feb;25(2):99-104. doi: 10.1067/mmt.2002.122329.
Results Reference
background
PubMed Identifier
14520029
Citation
Niemisto L, Lahtinen-Suopanki T, Rissanen P, Lindgren KA, Sarna S, Hurri H. A randomized trial of combined manipulation, stabilizing exercises, and physician consultation compared to physician consultation alone for chronic low back pain. Spine (Phila Pa 1976). 2003 Oct 1;28(19):2185-91. doi: 10.1097/01.BRS.0000085096.62603.61.
Results Reference
background
PubMed Identifier
12779297
Citation
Assendelft WJ, Morton SC, Yu EI, Suttorp MJ, Shekelle PG. Spinal manipulative therapy for low back pain. A meta-analysis of effectiveness relative to other therapies. Ann Intern Med. 2003 Jun 3;138(11):871-81. doi: 10.7326/0003-4819-138-11-200306030-00008.
Results Reference
background
PubMed Identifier
22925609
Citation
Balthazard P, de Goumoens P, Rivier G, Demeulenaere P, Ballabeni P, Deriaz O. 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. BMC Musculoskelet Disord. 2012 Aug 28;13:162. doi: 10.1186/1471-2474-13-162.
Results Reference
derived

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

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