|- candidate number||7835|
|- NTR Number||NTR2251|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-mrt-2010|
|- Secondary IDs||01032010 METC Tehran University of Medical Sciences|
|- Public Title||The effect of ultrasound as a treatment for long lasting low back pain.|
|- Scientific Title||The Effect of Continuous Ultrasound on Chronic Non Specific Low Back Pain: a Randomized Controlled Trial.|
|- hypothesis||Therapeutic ultrasound will be more effective than placebo ultrasound at reducing pain and improving function in chronic low back pain patients.|
|- Healt Condition(s) or Problem(s) studied||Back pain, Chronic|
|- Inclusion criteria||Patients with NSLBP who have pain for more than 3 months will be eligible. |
|- Exclusion criteria||Patients with underling systematic or visceral disease and specific conditions such as neoplasm, fractures, spondylolysthesis, spondylolysis, spinal stenosis, ankylosing spondylitis, previous low back surgery, and pregnancy will be excluded.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2010|
|- planned closingdate||1-mei-2011|
|- Target number of participants||50|
|- Interventions||Continuous therapeutic ultrasound therapy plus semi-supervised exercise program versus placebo ultrasound plus semi-supervised exercise program. |
Subjects in each group will receive 10 sessions of treatment, each around 20 minutes, during a period of 4 weeks.
Semi-supervised exercies program involves a series of exercies taught to the patient, who will be expected to continue them at home. When patients present for the experimental treatment, their exercies will be checked and progressed. Exercises involve lower limb stretching and abdominal/trunk muscle strengthening.
|- Primary outcome||1. Functional disability due to low back pain, measured by the Roland Morris Disability Questionnaire;|
2. Pain intensity measured by the visual analog scale (VAS);
3. Functional rating index (FRI).
|- Secondary outcome||1. Paravertebral muscle fatigue during a Beiring-Sorensen test;|
2. Lumbar flexion and extension range of motion using modified modified Schober method.
|- Timepoints||Baseline (randomization), 4 weeks (post-treatment), 3 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Nicholas Henschke|
|- CONTACT for SCIENTIFIC QUERIES|| Nicholas Henschke|
|- Sponsor/Initiator ||Tehran University of Medical Sciences|
(Source(s) of Monetary or Material Support)
|Tehran University of Medical Sciences, Iran|
|- Brief summary||Chronic non-specific low-back pain (NSLBP) is one of the most common and expensive musculoskeletal disorders in industrialized countries. One of the most widely used modalities in the field of physiotherapy for treating LBP is therapeutic ultrasound. Despite its common use, there is still inconclusive evidence to support its effectiveness in this group of patients. This trial will evaluate the effectiveness of continuous ultrasound in addition to exercise therapy in patients with chronic NSLBP.
A total of 50 patients, between the ages 18 and 65 years old who have had NSLBP for more than three months will be recruited from university hospitals. Participants will be randomized to receive continuous ultrasound plus exercise therapy or placebo ultrasound plus exercise therapy. These groups will be treated for 10 sessions during a period of 4 weeks. Primary outcome measures will be functional disability and pain intensity. Lumbar flexion and extension range of motion (ROM) as well as changes in electromyography muscle fatigue indices during the Sorensen test will be measured as secondary outcomes. All outcome measures will be measured at baseline, after completion of the treatment sessions, and after three months.|
The results of this trial will help to provide some evidence regarding the use of continuous ultrasound in chronic NSLBP patients. This should lead to a more evidence-based approach to clinical decision making regarding the use of ultrasound for NSLBP.
|- Main changes (audit trail)|
|- RECORD||15-mrt-2010 - 15-apr-2010|