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

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:

MedlinePlus related topics: Back Pain Exercise and Physical Fitness

U.S. FDA Resources

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

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:

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. 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.

Hemmilä HM, Keinänen-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.

Niemistö 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.

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. Review. Summary for patients in: Ann Intern Med. 2003 Jun 3;138(11):I33.

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

Balthazard P, de Goumoens P, Rivier G, Demeulenaere P, Ballabeni P, Dériaz 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.

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
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013