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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR898 |
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Date of registration:
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09/02/2007 |
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Primary sponsor: |
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Public title:
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Is a simultaneaus intervention of triamcinolon injections with standardized exercises more effective compared to the usual care according to the NHG standard in patients with shoulder complaints.
A prospective, singel blind, randomized clinical trial.
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Scientific title:
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Is a simultaneaus intervention of triamcinolon injections with standardized exercises more effective compared to the usual care according to the NHG standard in patients with shoulder complaints.
A prospective, singel blind, randomized clinical trial.
- Investigation of the efficacy of shoulder injections |
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Date of first enrolment:
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1/6/2007 |
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Target sample size:
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205 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=898 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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B.J
Berkhout |
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Address:
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Vrieseweg 157
3311 NV
Dordrecht
The Netherlands |
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Telephone:
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+31 78-6144000 |
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Email:
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email: berkh994@planet.nl |
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Affiliation:
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Name:
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B.J
Berkhout |
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Address:
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Vrieseweg 157
3311 NV
Dordrecht
The Netherlands |
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Telephone:
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+31 78-6144000 |
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Email:
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email: berkh994@planet.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with shoulder complaints consulting their GP;
2. Presence of painfull-arc and restricted range of motion.
Exclusion criteria: 1. Not signed informed consent form;
2. Age under 18 or above 70 year;
3. Treatment (exercises or corticosteroid injections) of shoulder complaints during the last 6 months;
4. Insufficient command of the Dutch language, spoken and/or written.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Complaints of shoulder, Triamcinolone injections, NHG standard, Exercises, Efficacy
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Intervention(s)
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Group A: a simultaneus intervention in which the patients will be injected with a combination of lidocaine and 1 ml Kenacort A40 and at the same time exercises; and group B in which the patient will be injected with a combination of lidocaine and 1 ml Kenacort A40 and after six weeks according to the NHG-standard with exercises.
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Primary Outcome(s)
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The primary outcome is the change in pain in rest, during activities or during the night of the last 24 hours, between baseline and 78 weeks.
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Secondary Outcome(s)
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Change compared to the baseline assessments of:
1. DASH questionnaire;
2. SF36 questionnaire;
3. Analgetica use;
4. Participant rated improvement;
5. Range of Motion maesurements;
6. Painful-Arc;
7. Complications of injections.
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Secondary ID(s)
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ISRCTN75642432
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N/A
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Source(s) of Monetary Support
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Erasmus Medical Center, Department of Orthopaedics
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