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

Back Pain Lower Back Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496144
• Other study ID #: FNS13DPD3-109903
• Secondary ID: FNS13DPD3-109903
• Status: Completed
• Phase: N/A
• First received: December 16, 2011
• Last updated: December 20, 2011
• Start date: December 2005
• Est. completion date: January 2011

Study information

• Verified date: December 2011
• Source: University of Applied Sciences of Western Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic
• Low Back Pain

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

Locations

Country	Name	City	State
Switzerland	Département de l'appareil locomoteur (DAL), Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
University of Applied Sciences of Western Switzerland	Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire - FABQ)	measures level of fear and avoidance beliefs about work and physical activity in patients with low back pain	Before randomization and untill 6 months after the end of treatment	No