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

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ClinicalTrials.gov Identifier: NCT01496144

Recruitment Status : Completed

First Posted : December 21, 2011

Last Update Posted : December 21, 2011

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Sponsor:

Collaborator:

Centre Hospitalier Universitaire Vaudois

Information provided by (Responsible Party):

Pierre Balthazard, University of Applied Sciences of Western Switzerland

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.

Condition or disease	Intervention/treatment	Phase
Back Pain Lower Back Chronic	Procedure: Manual therapy and active exercises Procedure: Detuned ultrasound and active exercises	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	42 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (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
Study Start Date :	December 2005
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain Exercise for Older Adults

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

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: 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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496144

Locations

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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

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

More Information

Publications:

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Pierre Balthazard, Bachelor of sciences in physical therapy, University of Applied Sciences of Western Switzerland
ClinicalTrials.gov Identifier:	NCT01496144
Other Study ID Numbers:	FNS13DPD3-109903 FNS13DPD3-109903 ( Other Grant/Funding Number: Swiss National Fund DORE )
First Posted:	December 21, 2011 Key Record Dates
Last Update Posted:	December 21, 2011
Last Verified:	December 2011

Keywords provided by Pierre Balthazard, University of Applied Sciences of Western Switzerland:


Chronic non specific low back pain Manual therapy Active exercises Pain Disability

Additional relevant MeSH terms:

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Back Pain Low Back Pain Pain Neurologic Manifestations

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