Is a simultaneous intervention of triamcinolon injections with standardised exercises more effective compared to the usual care according to the Dutch College of Family Physicians standard in patients with shoulder complaints? A prospective, single blind, randomised clinical trial

ISRCTN	ISRCTN75642432
DOI	https://doi.org/10.1186/ISRCTN75642432
Protocol serial number	N/A
Sponsor	Erasmus Medical Centre (The Netherlands)
Funder	Erasmus Medical Centre (The Netherlands)

Submission date: 26/02/2007
Registration date: 26/02/2007
Last edited: 26/02/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr B J Berkhout
Scientific

Vrieseweg 157
Dordrecht
3311 NV
Netherlands

Phone	+31 (0)78 614 4000
Email	berkh994@planet.nl

Study information

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group, single blinded, multicentre trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Lidocaine, kenacort
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/05/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	205
Key inclusion criteria	1. Patients with shoulder complaints consulting their General Practitioner (GP) 2. Presence of painful-arc and restricted range of motion
Key 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
Date of first enrolment	01/06/2007
Date of final enrolment	31/05/2010

Locations

Countries of recruitment

Netherlands

Study participating centre

Vrieseweg 157

Dordrecht
3311 NV
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan