Therapeutic ultrasound will be more effective than placebo ultrasound at reducing pain and improving function in chronic low back pain patients.
ID
Bron
Aandoening
chronic low back pain; rugklachten
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Functional disability due to low back pain, measured by the Roland Morris Disability Questionnaire;<br>
2. Pain intensity measured by the visual analog scale (VAS);<br>
3. Functional rating index (FRI).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Therapeutic ultrasound will be more effective than placebo ultrasound at reducing pain and improving function in chronic low back pain patients.
Onderzoeksopzet
Baseline (randomization), 4 weeks (post-treatment), 3 months.
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients with NSLBP who have pain for more than 3 months will be eligible.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Register | ID |
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NTR-new | NL2127 |
NTR-old | NTR2251 |
Ander register | METC Tehran University of Medical Sciences : 01032010 |
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