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Clinical Trials/DRKS00013180
DRKS00013180Completed未知

Classical Massage and Acupuncture for chronic back pain - a randomized non-inferiority study - KMM and AKU in chronic back pain

Klinik Blankenstein0 sites132 target enrollmentStarted: February 14, 2019Last updated:
Conditions

Trial Snapshot

Phase
未知
Status
Completed
Sponsor
Enrollment
132

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized controlled study
Masking
Open (masking not used)

Eligibility Criteria

Ages
18 Years to 75 Years (—)
Sex
Female

Inclusion Criteria

  • •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

  • •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
  • •- pregnancy
  • •- severe coagulation disorders

Investigators

Sponsor
Klinik Blankenstein

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