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Multicentric, prospective, controlled, randomized study on the effectiveness of lumbar supports in the treatment of acute or sub-acute, non-specific back pain

Multicentric, prospective, controlled, randomized study on the effectiveness of lumbar supports in the treatment of acute or sub-acute, non-specific back pain - LumboTrain

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00032192
Enrollment
146
Registered
2023-07-03
Start date
2023-07-03
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute or sub-acute, non-specific back pain

Interventions

Group 1: Intervention group: Patients treated using the conventional treatment regimen (care as usual) plus additional lumbar bandage Group 2: Control group: Patients treated using the conventional tr

Sponsors

Universität Osnabrück
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Sick days (reduction in periods of incapacity to work), improvement in mobility, health-related quality of life, reduction in treatment costs (socio-economic parameters).

Countries

Germany

Contacts

Public ContactSwen Malte John

Universität Osnabrück

johnderm@uni-osnabrueck.de+49 541 9692357

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026