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

• ClinicalTrials.gov Identifier: NCT01496144
• Recruitment Status: Completed
• First Posted: December 21, 2011
• Last Update Posted: December 21, 2011
• Sponsor: University of Applied Sciences of Western Switzerland
• Collaborator: Centre Hospitalier Universitaire Vaudois
• Information provided by (Responsible Party): Pierre Balthazard, University of Applied Sciences of Western Switzerland

Tracking Information

• First Submitted Date: December 16, 2011
• First Posted Date: December 21, 2011
• Last Update Posted Date: December 21, 2011
• Study Start Date: December 2005
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 20, 2011)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: December 20, 2011)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Back Pain Lower Back Chronic

Intervention

• 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
• 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

Study Arms

• Experimental: Manual therapy and active exercises
  Spinal manipulation /mobilisation
  Intervention: Procedure: Manual therapy and active exercises
• Placebo Comparator: Detuned ultrasound and active exercises
  Intervention: Procedure: Detuned ultrasound and active exercises

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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 20, 2011): 42
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2011
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT01496144
• Other Study ID Numbers: FNS13DPD3-109903; FNS13DPD3-109903 ( Other Grant/Funding Number: Swiss National Fund DORE )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pierre Balthazard, University of Applied Sciences of Western Switzerland
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Applied Sciences of Western Switzerland
• Original Study Sponsor: Same as current
• Collaborators: Centre Hospitalier Universitaire Vaudois

Investigators

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

• PRS Account: University of Applied Sciences of Western Switzerland
• Verification Date: December 2011