Condition category
Musculoskeletal Diseases
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
26/02/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr B J Berkhout

ORCID ID

Contact details

Vrieseweg 157
Dordrecht
3311 NV
Netherlands
+31 (0)78 614 4000
berkh994@planet.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The aim of the present study is whether a simultaneus intervention with (maximal five) corticosteroid/lidocaine injections and exercises for the cuff muscles (both according a standard protocol), have better results than a sequential intervention of first (maximal five) corticosteroid/lidocaine injections followed after six weeks by exercises (usual care, according to Dutch College of Family Physicians [NHG] standard) in a group of patients with shoulder complaints.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group, single blinded, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Triamcinolon injections, Dutch College of Family Physician (NHG) standard, complaints of shoulder, exercises, efficacy

Intervention

Group A: the patients will be injected with a combination of lidocaine and 1 ml kenacort A40 and at the same time exercises
Group B: 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

Intervention type

Drug

Phase

Not Specified

Drug names

Lidocaine, kenacort

Primary outcome measures

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.

Secondary outcome measures

Change compared to the baseline assessments of:
1. Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
2. Short Form health survey (SF-36) questionnaire
3. Analgesic use
4. Participant rated improvement
5. Range of motion maesurements
6. Painful-arc
7. Complications of injections

Overall trial start date

01/06/2007

Overall trial end date

31/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with shoulder complaints consulting their General Practitioner (GP)
2. Presence of painful-arc and restricted range of motion

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

205

Participant exclusion criteria

1. Not signed informed consent form
2. Age under 18 or above 70 years
3. Treatment (exercises or corticosteroid injections) of shoulder complaints during the last six months
4. Insufficient command of the Dutch language, spoken and/or written

Recruitment start date

01/06/2007

Recruitment end date

31/05/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Vrieseweg 157
Dordrecht
3311 NV
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Department of Orthopaedics
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 5088
d.meuffels@erasmusmc.nl

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes