Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00005338

Trial Description

start of 1:1-Block title

Title

Testing the effectiveness of an add-on treatment for impingement syndrome stage I and II - Marnitz therapy as a combination partner for standardized physiotherapy - Pilot Study

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://-

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The aim of this study was to evalute the subjective and objective outcomes patients with diagnosed impingement syndrome stage I and II after treatment with physiotherapy (PT) in conjunction with Marnitz therapy and solitary PT through research and interviews, and compared with the starting position.
By randomization patients were assigned in the intervention or the control group .
The intervention group received six times physiotherapy and additionally six times Marnitz therapy in the head, shoulder girdle and the thoracic spine. The Marnitz therapy was performed before PT and lasted 20 minutes. The control group received six times PT.
All patients received the same six standardized treatment units PT. The duration was 30 minutes. The measures of PT directed on the current state of research and notably including exercises motility, strength and posture improvement. To reduce the risk of performance bias all six treatment sequences were determined in advance. The course of treatment has been documented, ie it was noted that all planned exercises were carried out or why not.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

This was an exploratory, randomized pilot study. The aim of this pilot study was to evaluate the subjective and objective results of a physiotherapy treatment to evaluate (Marnitz therapy and treatment vs. only treatment) in patients with impingement syndrome through research and interviews, and compared with the starting position.
The primary outcome measures were the functional improvement of the shoulder joint and a subjective pain relief for the patient.
Secondary outcomes were other effects of the intervention but changing the level of suffering and change the position of the scapula as well as the study of the relationship between handedness and the affected side. In order to compare the progress and outcome of the treatments between the two groups at different time points corresponding test results were evaluated using the Constant score. The data were analyzed descriptively using Microsoft® Excel®. The effect measure was the mean difference. The statistical test was the t-test for comparison of two means metric populations in independent samples.
Before and after the intervention no significant differences existed between the groups in terms of primary and secondary outcome measures . The comparative studies over a three week period showed both in the intervention group as in the control group therapy success. The intervention group improved statistically highly significant (p <0.01) in the criteria of mobility and the reduction of the positive Impingementtests and skapula position. The control group improved statistically highly significant in the criteria pain, activities of daily living, impingementtests and statistically significant (p <0.05) in reducing the level of suffering. The low post-hoc power of 9% relatives the test result. In this pilot study, there was no evidence that the Marnitz therapy was superior to supplement standardized treatment alone.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005338
  •   2014/05/19
  •   [---]*
  •   yes
  •   Approved
  •   2013-111, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M75.4 -  Impingement syndrome of shoulder
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Marnitz therapy and standardized physiotherapy
  •   standardized physiotherapy
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

n this pilot study, a patient questionnaire is modified according to Constant and Murley used to compare changes in shoulder function before and after the intervention.
This patient questionnaire has been validated and allows a reproducible self survey of the shoulder function. Patients filled out independently, but under the supervision of the researcher, the patient questionnaire for Constant score (CS).
The questionnaire is completed before the first and after the sixth treatment.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

The investigation by the researcher took place in the side comparison and focused the scapula position of the patient. The following points were palpated to determine whether or not was a tenderness on palpation: the greater tuberosity, lesser tuberosity of the humeral head tendon of the long head of the biceps and the coracoid process.
The tenderness palpation and the scapula position were evaluated before the first and after the sixth treatment.
Further, the relationship between handedness and the affected side was examined.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/02/11
  •   24
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Impingement syndrome diagnosis and at least two positive Impingementtests from Hawkins test, Painful arc, Neer test

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

complete or severe partial Rotatorenmanschettendefekte or lesions, osteoarthritis or isolated AC osteoarthritis, significant movement restriction (frozen shoulder), acute bursitis subakromialis, calcific tendinitis, running bond or insurance method, pregnant women, patients under 18 years, patients with diseases that do not physical or physical strain caused

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Gesundheits- und PflegewissenschaftMedizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg
    • Ms.  Prof. Dr.  Gabriele   Meyer 
    • Magdeburger Straße 8
    • 06112  Halle (Saale)
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   03455574135
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Institut für Gesundheits- und PflegewissenschaftMedizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg
    • Ms.  Diplom  Katrin  Beutner 
    • Magdeburger Straße 8
    • 06112  Halle (Saale)
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Institut für Gesundheits- und PflegewissenschaftMedizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg
    • Ms.  Diplom  Katrin  Beutner 
    • Magdeburger Straße 8
    • 06112  Halle (Saale)
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Institut für Gesundheits- und PflegewissenschaftenMedizinische Fakultät der MLU Halle-Wittenberg
    • Ms.  Prof. Dr.  Gabriele  Meyer 
    • Magdeburger Straße 8
    • 06112  Halle (Saale)
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   03455574135
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/07/14
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.