Multicentric, prospective, controlled, randomized study on the effectiveness of lumbar supports in the treatment of acute or sub-acute, non-specific back pai
- Conditions
- Acute or sub-acute, non-specific back pain
- Registration Number
- DRKS00032192
- Lead Sponsor
- niversität Osnabrück
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 146
Presence of acute or sub-acute, non-specific low back pain, new (acute) or for < 3 months, but not more than 2 times in the last year; sufficient psychological stability, assessed by the doctor; sufficient mental and linguistic abilities to fill in the questionnaires and to take part in the examinations, assessed by the doctor; assumed reliability with regard to the ability to meet the requirements of the study (i.e., to comply with the wearing time with the bandage and/or to be able to handle the bandage correctly), assessed by the doctor; presence of a signed declaration of consent
Chronic back pain (pain at the time of medical consultations longer than 3 months); Osteoporosis, if treated with osteoporosis-specific drugs (e.g. bisphosphonates, parathormones); osteoporosis is not considered an exclusion criterion if the treatment is simply supplemented with vitamin D and calcium; Presence of a depression requiring therapy that is being treated with antidepressants; Previous operations on the spine / in the back area; Specific back/spine diseases, such as: Activated facet joint arthrosis (= spondylarthrosis), inflammatory diseases with back involvement, acute radicular symptoms with radiating pain (radicular character) or segmental, sensory or motor paresis, fractures, tumor diseases; Disorders/disorders of the lower extremities that severely impair gait and standing with trunk alterations; paralysis of the lower extremities; High mental stress and psychosocial abnormalities, assessed by the doctor; Psychosocial stress, assessed by the doctor: exclusion with a score of = 9 points (= upper third of the scale; 'strong or very strong psychosocial stress') when using the psychosocial screening questionnaire: UKS dr D. Kuch; Interventional therapies carried out (e.g. injections near the spine; endoscopic or surgical interventions on the spine) in the last year; Abdominal circumference of more than 145 cm (obesity per magna), as there is no sufficiently large lumbar bandage for these people
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain reduction and reduction in the consumption of painkillers due to the worn back bandage after 7 days, after 3 weeks, after 6 weeks and after 12 weeks, recorded using a questionnaire and medication prescription plan.
- Secondary Outcome Measures
Name Time Method Sick days (reduction in periods of incapacity to work), improvement in mobility, health-related quality of life, reduction in treatment costs (socio-economic parameters).