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

NCT01496144 | Completed

• 1 other identifier: FNS13DPD3-109903
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain Lower Back Chronic

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  During treatment, over a period of 4 to 8 weeks

Secondary Outcomes (1)

• Fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire - FABQ)

  Before randomization and untill 6 months after the end of treatment

Study Arms (2)

Manual therapy and active exercises

EXPERIMENTAL

Spinal manipulation /mobilisation

Procedure: Manual therapy and active exercises

Detuned ultrasound and active exercises

PLACEBO COMPARATOR

Procedure: Detuned ultrasound and active exercises

Interventions

Manual therapy and active exercises 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

Also known as: Spinal mobilisation, Manipulation

Manual therapy and active exercises

Detuned ultrasound and active exercises PROCEDURE

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

Also known as: Electrotherapy

Detuned ultrasound and active exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Applied Sciences of Western Switzerland: lead
• Centre Hospitalier Universitaire Vaudois: collaborator

Study Sites (1)

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

Lausanne, Canton of Vaud, 1005, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 17250965 BACKGROUND

• 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.

  PMID: 12642755 BACKGROUND

• 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.

  PMID: 11896377 BACKGROUND

• 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.

  PMID: 14520029 BACKGROUND

• 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.

  PMID: 12779297 BACKGROUND

• 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.

  PMID: 22925609 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Musculoskeletal Manipulations; Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Olivier Dériaz, MD, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor of sciences in physical therapy

Study Record Dates

• First Submitted: December 16, 2011
• First Posted: December 21, 2011
• Study Start: December 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: December 21, 2011

Record last verified: 2011-12

Locations

CH (1)