Trial document




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  DRKS00000691

Trial Description

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Title

Strain-counterstrain to treat restrictions of the mobility of the cervical spine - a randomized trial

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

In this study we will investigate whether a single osteopathic intervention (strain-counterstrain) improves the mobility of the cervical spine in patients with limited mobility and pain in the neck region. A total of 60 adult patients will be included. All patients will allocated randomly to a single strain-counterstain treatment or a sham intervention. Before and after treatment the range of motion of the cervical spine will be measured and patients will be asked to rate pain intesnity and to assess the effects of the treatment globally.

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Brief Summary in Scientific Language

Objective: To investigate whether a single strain-counterstrain intervention is more effective than a sham intervention in improving mobility in patients with restricted cervical range of motion and neck pain.
Design: Randomized, patient- and observer-blinded clinical trial.
Participants: 60 adult patients with acute or recurrent neck complaints (pain and/or restricted mobility).
Setting: A general practice with additional qualifications for manual therapies and sports medicine.
Interventions: All patients are randomloy allocated to receive either a single strain-counterstrain intervention or a sham treatment.
Outcome measures: Before and after treatment mobility of the cervical spine (flexion, extension, lateral flexion, rotation) will be measuerd by a blinded observer using the validated measurement tool CROM (Cervical Range of Motion). In addition patients will rate the intensity of complaints on a numerical rating scale and assess the treatment effect. Main outcome measure is the sum of changes (in %) in mobility restriction after treatment compared to normal mobility.

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Organizational Data

  •   DRKS00000691
  •   2011/02/02
  •   [---]*
  •   yes
  •   Approved
  •   3037/10, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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

  •   M54.2 -  Cervicalgia
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   A single strain-counterstrain intervention (duration about 15 min.)
  •   A single sham intervention (duration about 15 min.)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Single blind
  •   patient/subject, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Main outcome measure is the sum of changes (in %) in mobility restriction (measured with the CROM) after treatment compared to normal mobility.

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Secondary Outcome

Flexion, extension, lateral flexion, rotation (all measured with the CROM), pain intensity (numerical rating scale), and global treatment assessment (verbal rating scale) after intervention

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/02/06
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Age 18 to 65 years, acute or recurrent neck pain, according to manual testing blockage in the the cervical spine, signed informed consent

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Exclusion Criteria

Indivduals with contraindications against manual therapy, patients in which the use of the magnetic measurement device could be associated with a relevant risk (e.g. patients with a pacemaker), pregnant women

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Allgemeinmedizin Klinikum rechts der Isar der TU München
    • Mr.  Prof. Dr.  Reinhold  Klein 
    • Orleansstr. 47
    • 81667  München
    • Germany
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    •   089-614658916
    •   [---]*
    •   [---]*
    •   [---]*
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    • Institut für Allgemeinmedizin Klinikum rechts der Isar der TU München
    • Mr.  PD Dr.  Klaus  Linde 
    • Orleasstr. 47
    • 81667  München
    • Germany
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    • Institut für Allgemeinmedizin Klinikum rechts der Isar der TU München
    • Mr.  Prof. Dr.  Reinhold  Klein 
    • Orleansstr. 47
    • 81667  München
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Allgemeinmedizin
    • Mr.  Prof. Dr.  Reinhold  Klein 
    • Orleansstr. 47
    • 81667  München
    • Germany
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    •   089-614658916
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2011/08/03
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Trial Publications, Results and other Documents

  •   Klein R, Bareis A, Schneider A, Linde K. Strain–counterstrain to treat restrictions of the mobility of the cervical spine in patients with neck pain—A sham-controlled randomized trial. Complement Ther Med 2013;21:1-7.
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* This entry means the parameter is not applicable or has not been set.