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

Sponsor

University of Applied Sciences of Western Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT01496144

Collaborator

Centre Hospitalier Universitaire Vaudois (Other)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Back Pain Lower Back Chronic	Procedure: Manual therapy and active exercises Procedure: Detuned ultrasound and active exercises	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (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

Study Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Electrotherapy

Arm

Intervention/Treatment

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 Names:

Electrotherapy

Outcome Measures

Primary Outcome Measures

Visual Analogue Scale - VAS-pain [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.