Manual Therapy on the Improvement of Functional Disability in Patients With Chronic Non Specific Low Back Pain
CompletedNot applicableNCT01496144
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Procedure: Manual therapy and active exercises
- Procedure: Detuned ultrasound and active exercises
- Sponsor
- University of Applied Sciences of Western Switzerland
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Start date
- 2005-12
- Primary completion
- 2010-12
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Switzerland
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01496144