Trial document




This trial has been registered retrospectively.
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  DRKS00007491

Trial Description

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Title

Cupping Glass Massage and Acupuncture in the treatment of female patients with chronic non-specific low back pain – a non-inferiority randomized trial

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Trial Acronym

CGM Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study compares the efficacy of Cupping Glass Massage (CGM) with acupuncture therapy (ACU) in the treatment of non-specific low back pain. We assume that CGM is not inferior to ACU.

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Brief Summary in Scientific Language

Background: Up to now, only one study exists in the literature of Cupping Glass Massage (CGM) in patients with non-specific low back pain [9]. Given the increasing incidence and high prevalence of this disease, the research of therapy options is of high importance.
In the Clinic for True Naturopathy in Hattingen, Germany, the Cupping Glass Massage is subjectively employed successfully in patients with low back pain. To verify the treatment outcome a non-inferiority randomized controlled study was conducted.
Methods: The efficacy of CGM was compared with acupuncture therapy (ACU) in a total number of 136 in-patients with chronic non-specific low back pain. Primary objective was the non-inferiority of CGM compared to ACU as related to functional ability in everyday life, operationalized by the hannover functional ability questionnaire (HFAQ).
Results: In the Per-Protocol-Analysis the treatment outcome of CGM was statistically, significantly better (65,3 % CGM vs. 42,2 % ACU; p=0,025). The Intention-to-Treat analysis showed no significant differences between the therapy groups.
Conclusions: Results show that CGM is not inferior to ACU. In the Per-Protocol-Analysis CGM is superior to ACU. Differences are dumbed down in the analysis of Intention-to-Treat Population because of relatively high rate of dropouts.

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Organizational Data

  •   DRKS00007491
  •   2015/04/16
  •   [---]*
  •   yes
  •   Approved
  •   3004-07, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

  •   U1111-1164-1820 
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Health Condition or Problem studied

  •   M54.5 -  Low back pain
  •   M47 -  Spondylosis
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Interventions/Observational Groups

  •   Cupping Glass Massage (CGM), five times within two weeks
  •   Acupuncture therapy (ACU), five times within two weeks
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Non-inferiority of CGM compared to acupuncture therapy as related to functional disability operationalized by Hannover Functional Ability Questionnaire (HFAQ), after 3 months

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Secondary Outcome

Change in functional disability operationalized by Hannover Functional Ability Questionnaire (HFAQ) at discharge from hospital. Reduction of pain intensity and the reduction of impairments in everyday life due to pain measured by ‘von Korff’ Questionnaire at discharge from hospital and after 3 months. Further secondary outcomes were the improvement of Quality of Life (measured by SF-12 Questionnaire at the beginning and after 3 months) und the reduction of pain (measured by a visual analog scale [VAS] at the beginning, at discharge from hospital and after 3 months). Additionally the reduction of need of analgesics (at discharge from hospital and after 3 months) and the patients’ evaluation of therapy was measured by a five step graded scale
(at discharge from hospital and after 3 months).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2008/05/08
  •   130
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- Inpatients of the clinic for Naturopathy of the clinic of Blankenstein.
- Informed consent
- Anamnesis of chronic non-specific low back pain more than 6 month
- Point value in the Hannover Functional Ability Questionaire: 0-16 Points
- Low back pain defined as pain in the area of lumbar spine with and without segmental spread
- At least one of the following diagnoses (ICD 10) in the principal or secondary diagnosis:
1. M 47.20, 47.25, 47.26, 47.27, 47.28:
2. M 51.1, 51.2
3. M 54.1, 54.4, 54.5, 54.8, 54.10

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Exclusion Criteria

- Chronic pain due to other diseases taking low back pain in the backseat
- Osteoporotic and traumatic vertebral fractures or severe abnormalities in the spine, spondylolisthesis
- Inflammatory rheumatic illness of the spine
- Dermatosis that does not allow Cupping Glass Massage
- Participation in this study at another point of time
- Actual participation in another clinical study concerning the treatment of low back pain
- Patrient, who are not able to understand the meaning of the study (e.g. language, dementia)
- Opioid or drug dependency, alcoholism, compliance not guaranteed
- Antecedent operations at the spine in the last 3 month before recruitment
- Bechterew´s syndrome
- Cachexia
- Pain catheder/ CT-controlled Intra-articular injections in the last 10 days in the lumbar spine
- Cupping Glass Massage (CGM) or acupuncture therapy (ACU) up to one month before treatment onset
- Progressive systemic diseases like tuberculosis, leukosis, carcinoma (except for long-therm complete remission), collagenoses, multiple sclerosis, AIDS, HIV - Infection
- Severe depression (psychiatric diagnosis)
- Severe cardiopathies
- fever
- known pregnancy
- severe coagulopathy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik f. Naturheilkunde, Klinik Blankenstein
    • Mr.  Prof. Dr. med.  André-Michael  Beer 
    • Im Vogelsang 5
    • 45527  Hattingen
    • Germany
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    • Abt. f. Naturheilkunde, Klinik Blankenstein, ,
    • Mr.  Prof. Dr. med.  André-Michael  Beer 
    • Im Vogelsang 5
    • 45527  Hattingen
    • Germany
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    • Abt. f. Naturheilkunde, Klinik Blankenstein, ,
    • Mr.  Prof. Dr. med.  André-Michael  Beer 
    • Im Vogelsang 5
    • 45527  Hattingen
    • Germany
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Sources of Monetary or Material Support

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    • Abt. f. Naturheilkunde, Klinik Blankenstein, ,
    • Mr.  Prof. Dr. med.  André-Michael  Beer 
    • Im Vogelsang 5
    • 45527  Hattingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/03/05
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.