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

NCT ID: NCT01496144

Last Updated: 2011-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Back Pain Lower Back Chronic

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Manual therapy and active exercises

Spinal manipulation /mobilisation

Group Type EXPERIMENTAL

Manual therapy and active exercises

Intervention Type PROCEDURE

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

Detuned ultrasound and active exercises

Group Type PLACEBO_COMPARATOR

Detuned ultrasound and active exercises

Intervention Type PROCEDURE

Electrotherapy device inactivated and ineffective. Active exercises, consisting of mobility, stretching, strengthening and motor control exercises

Interventions

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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

Intervention Type PROCEDURE

Detuned ultrasound and active exercises

Electrotherapy device inactivated and ineffective. Active exercises, consisting of mobility, stretching, strengthening and motor control exercises

Intervention Type PROCEDURE

Other Intervention Names

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Spinal mobilisation Manipulation Electrotherapy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role collaborator

University of Applied Sciences of Western Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Pierre Balthazard

Bachelor of sciences in physical therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olivier Dériaz, MD, PhD

Role: STUDY_DIRECTOR

Institut de Recherche en Réadaptation et Clinique Romande de Réadaptation SUVACare, Sion, Switzerland

Locations

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

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 17250965 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12642755 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11896377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14520029 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12779297 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22925609 (View on PubMed)

Other Identifiers

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FNS13DPD3-109903

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FNS13DPD3-109903

Identifier Type: -

Identifier Source: org_study_id