Trial document





This trial has been registered retrospectively.
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  DRKS00009249

Trial Description

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Title

Immediate pain reduction in adhesive capsulitis by acupuncture

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Trial Acronym

AC-Aku

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Adhesive capsulitis (frozen shoulder) is one main reason for shoulder pain which progresses in 3 stages, self-limiting in 1 to 4 years. This study investigated the effect of acupuncture performed with press-tack needles on shoulder pain due to adhesive capsulitis as well as the effect of classical acupuncture needling on the course of disease. Sixty volunteers with diagnosed adhesive capsulitis were randomly allocated to press-tack acupuncture treatment or optically identical placebo press-tacks. Neither the patient nor the caregiver was aware of the type of press-tack. Acupuncture treatment was performed at reflex areas on arms and legs, avoiding local shoulder needling. There was an immediate average improvement of 3.33 points on Constant Murley Shoulder Score (CMSS) pain sub score in the treatment group and of 1.6 in the placebo group. The superiority of acupuncture treatment over placebo was statistically significant. The participants were then offered to receive 10 follow-up treatments with classical acupuncture needles. Patients who received acupuncture additionally to physiotherapy got relevant improvement within an average of 14.94 weeks while patients who received physiotherapy alone got relevant improvement within an average of 30.92 weeks. These results give evidence that acupuncture can influence the intensity of pain as well as the long term time course of adhesive capsulitis but further studies are necessary for the affirmation of these results.




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Brief Summary in Scientific Language

Adhesive capsulitis (frozen shoulder) is one main reason for pain of the shoulder joint. Adhesive capsulitis is self limiting in a period of one to four years presenting three distinct stages. The first stage is characterized by an acute synovitis of the glenohumeral joint. Most patients progress to the second stage with restriction of the range of motion and usually lasting pain. The third stage begins when the range of motion begins to improve. Treatment is usually symptomatical by long term intake of oral analgesic or antiphlogistic drugs beside manual therapy and physiotherapy. This study investigated the short term effect of acupuncture performed with press-tack needles on pain perception as well as the long term effect of classical acupuncture needling on the course of the disease. Sixty volunteers with adhesive capsulitis stage 1 or 2 where randomly assigned to press-tack acupuncture needles compared to optically identical placebo press-tacks in a patient and observer blinded randomized study, using acupuncture treatment on distant reflex areas avoiding local treatment. There was an immediate improvement of 3.33± 3.2 points on Constant Murley Shoulder Score (CMSS) pain sub score in the treatment group and of 1.6 ± 2.80 in the placebo group (p <0.02). The study confirmed that acupuncture can influence short term pain perception and that press-tack needles together with press-tack placebo are a functioning option for double blind studies in acupuncture.
The participants were subsequently offered to receive 10 treatments with classical acupuncture needles over 10 weeks in an open follow up clinical application observation. Evaluation after one year showed that patients that took acupuncture additionally to physiotherapy got relevant improvement within 14.94 ±15.89 weeks compared to 30.92 ±15.81 weeks with physiotherapy alone (p< 0.005). These results give evidence that acupuncture can also influence the time course of adhesive capsulitis but further controlled studies are necessary for the affirmation of these results.

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Organizational Data

  •   DRKS00009249
  •   2015/11/18
  •   [---]*
  •   yes
  •   Approved
  •   PV4255, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  •   U1111-1176-6382 
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Health Condition or Problem studied

  •   M75.0 -  Adhesive capsulitis of shoulder
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Interventions/Observational Groups

  •   Singular acupuncture treatment with verum press-tack needles using balanced acupuncture method by Schroeder, and 10 treatments with classical acupuncture needles as open follow-up clinical application observation
  •   Singular acupuncture treatment with placebo press-tack needles, using balanced acupuncture method by Schroeder, and 10 treatments with classical acupuncture needles as open follow up clinical application observation
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

CMSS pain subscore immediately before and after treatment

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Secondary Outcome

CMSS activity of daliy living subscore; CMSS mobility subscore; CMSS power subscore; and CMSS total score immediately before and after treatment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2013/06/12
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Stage 1 or 2 of primary adhesive capsulitis with symptoms of >= 10 on the Constant Murley shoulder score (CMSS) pain sub-score lasting over 2 month and under 12 months.

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Exclusion Criteria

Prior treatment with press-tack needles, history of major shoulder injury or surgery, patients with other disorders which could account for the presenting shoulder symptoms; patients with cervical neuropathy, paralysis, or neurological changes of the affected upper limb; patients with fractures, open wounds at the acupuncture application sides, mental disorders which may affect the diagnosis or progression of the disorder, degenerative, inflammatory, or infectious arthritis; patients with past intra-articular injection treatment regarding the presenting shoulder pain within the past 4 weeks before the first visit; pregnant or breastfeeding patients, patients deemed by the researcher as unable to normally adhere to the research protocol, and lack of written informed consent.

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Addresses

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    • HanseMerkur Versicherungsgesellschaft
    • Siegfried-Wedells-Platz 1
    • 20354  Hamburg
    • Germany
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    • Klinik für Unfall-, Hand- u. WiederherstellungschirurgieUniversitätsklinikum Hamburg-Eppendorf
    • Mr.  Prof. Dr. med  Daniel  Briem 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • HanseMerkur Zentrum für Traditionelle Chinesische Medizin am Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Dr. med.  Sven  Schroeder 
    • Martinistraße 52, Haus 55
    • 20246  Hamburg
    • Germany
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    • HanseMerkur Zentrum für Traditionelle Chinesische Medizin am Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Dr. med.  Sven  Schroeder 
    • Martinistraße 52, Haus 55
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • HanseMerkur Versicherungsgesellschaft
    • Siegfried-Wedells-Platz 1
    • 20354  Hamburg
    • Germany
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    • HanseMerkur Zentrum für Traditionelle Chinesische Medizin am Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Dr. med.  Sven  Schroeder 
    • Martinistraße 52, Haus 55
    • 20246  Hamburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/09/01
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Trial Publications, Results and other Documents

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