Classical Massage and Acupuncture for chronic back pain - a randomized non-inferiority study
- Conditions
- M47M51M54SpondylosisOther intervertebral disc disordersDorsalgia
- Registration Number
- DRKS00013180
- Lead Sponsor
- Klinik Blankenstein
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 132
Inclusion criteria
- Female inpatients of the department of naturopathy clinic Blankenstein
- Age between 18 and 75 years
- Signed informed consent
- Anamnesis of chronic back pain for more than 6 months
- Score in the Hannover Functional Ability Questionnaire: 0-16 points
- Low back pain defined as pain in the lumbar spine with or without segmental radiance
- At least one of the following ICD-10 diagnoses in the main or secondary diagnosis:
-- spondylosis with radiculopathy in the thoracolumbar region, lumbar region, lumbosacral region, sacral or sacro-zygeal region (M 47.20, 47.25, 47.26, 47.27, 47.28)
-- Chronic degenerative lumbar syndrome (M 47.26)
-- Chronic facet syndrome (M 47.2)
-- Lumbar and other disc damage with radiculopathy (M 51.1); Lumbago with disc displacement (M 51.2)
-- Panniculitis in the thoracolumbar area, sacral and sacrococcygeal area (M 54.1, 54.4, 54.5, 54.8).
Exclusion criteria
- Chronic pain conditions due to other diseases that make the back pain disappear into the background.
- Osteoporotic or traumatic vertebral fractures or severe malformations of the spine, spondylolisthesis
- Inflammatory rheumatic diseases of the spine
- Skin diseases that do not allow a cupping massage
- Participation in this study at an earlier date
- Current participation in another clinical trial in the treatment of back pain
- Patients who are unable to understand the meaning of the study (language, dementia, etc.)
- Opioid or drug addiction, alcoholism, compliance not guaranteed
- Preliminary spine surgery in the last 3 months before the start of the study
- Ankylosing spondylitis
- cachexia
- Pain catheters / CT-guided intra-articular injections in the last 10 days in the lumbar region
- Acupuncture or cupping therapy up to one month before the start of therapy
- Progressive systemic diseases such as tuberculosis, leukoses, carcinomas (except for long-term full remission), collagenosis, multiple sclerosis, AIDS, HIV infection
- severe depression (according to psychiatric diagnosis)
- Severe cardiopathies
- Fever
- pregnancy
- severe coagulation disorders
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome was the non-inferiority of the classical massage compared to the acupuncture treatment in terms of functional limitation in everyday life using the Hannover Functional Questionnaire (HFAQ) and the reduction of pain intensity (Von Korff questionnaire) in the period from admission to one month after inpatient stay.
- Secondary Outcome Measures
Name Time Method A secondary outcome is the change in health status and quality of life after five treatments of classical massage compared to the control group. This is operationalized using the SF-12 questionnaire.<br>The change in the sensation of pain at the time of discharge of the above-mentioned therapy compared to the change in the control group is also examined. This is operationalized by the Visual Analogue Scale (VAS).<br>In addition, patient satisfaction was assessed on the basis of a 5-point Likert scale (very satisfied, satisfied, undecided, dissatisfied, very dissatisfied) after discharge, and the desire for further treatment was documented.