Trial document




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  DRKS00000567

Trial Description

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Title

Manual therapy intervention for carpal tunnel syndrom - a pilot study

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Trial Acronym

Man-CTS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Does a manual therapy interventionof the wrist improve clinical symptoms and electrophysiological results in patients with carpal tunnel syndrom?
Patients with clinical and elektrophysiological diagnosed carpal tunnel syndrom receive either manual therapy interventionof the wrist or care as usual in randomized order.
Follow up over 6 month consists of standardized questionnaire (Boston Carpal Tunnel Questionnaire) and electrophysiologic conduction studies.

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Brief Summary in Scientific Language

Randomized controlled study comparing manual chiropractic with usual care in patients with clinical and electrophysiologic confirmed carpal tunnel syndrom (CTS):
40 consecutively recruited patients with confirmed CTS (electric conduction study). Patients will be recruited in a specialist practice

Intervention:
Chiropractic manipulation of the wrist
Control: No intervention (care as usual)

Inclusion criteria:
Clinical and electophysiologic confirmed CTS

Exclusion criteria:
Patient not willing or able to participate.
Wrist fracture, acute infection/wound of the wrist/hand.
Indication for surgery

Outcome:
o Severity and functional status(severity symptom score, functional status score) according to Boston Carpal Tunnel Questionnaire (primary outcome)
o Comparison of further therapies used between control and intervention group (secondary outcome)
o Feasability of an intervention study with chiropractic manipulation

Follow up:
T1: after 2 weeks (Questionnaire)
T2: after 3 month(Questionnaire, elctrophysiologic conduction studies)
T3: after 6 month (Questionnaire)

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Organizational Data

  •   DRKS00000567
  •   2010/10/05
  •   [---]*
  •   yes
  •   Approved
  •   5517, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G56.0 -  Carpal tunnel syndrome
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   manual therapy intervention of the wrist
  •   Care as usual
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Characteristics

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

Symptom severity and functional status according to the scores from Boston Carpal Tunnel Questionnaire were assessed after 2 weeks, 3 and 6 month by postal questionnaire

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Secondary Outcome

Outcome:
- Descriptive comparison of further therapies used between control and intervention group (secondary outcome) will be assessed after 2 weeks, 3 and 6 month using standardized questionnaires
- Feasability of an intervention study with chiropractic manipulation (response rate, drop out,lost to follow up)
-Clinical status and nerve conduction studies will be repeated after 3 month

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/11/16
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

Patients with clinically suspected diagnosis of carpal tunnel syndrom confirmed by nerve conduction studies

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Exclusion Criteria

Exclusion criteria:
Patient not willing or able to participate.
Wrist fracture, acute infection/wound of the wrist/hand.
Indication for surgery

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Medizinische Hochschule Hannover
    • Mr.  Dr  Guido  Schmiemann 
    • Carl Neuberg Straße 1
    • 30625   Hannover
    • Germany
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    • Karl und Veronika Carstens Stiftung
    • Mr.  Rainer  Lüdtke 
    • Am Deimelsberg 36
    • 45276   Essen
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Dr  Guido  Schmiemann 
    • Carl Neuberg Straße 1
    • 30625   Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Dr  Guido  Schmiemann 
    • Carl Neuberg Straße 1
    • 30625   Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Allgemeinmedizin Medizinische Hochschule Hannover
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Carl und Veronika Carstens Stiftung
    • Am Deimelsberg 36
    • 45276   Essen
    • Germany
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    •   +49-201-5630516
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2011/11/02
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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.