Corticosteroid injections in patients with trochanteric pain syndrome: open label randomized clinical trial in general practice

ISRCTN	ISRCTN16994576
DOI	https://doi.org/10.1186/ISRCTN16994576
Protocol serial number	NTR640
Sponsor	Erasmus Medical Center, Department of General Practice (The Netherlands)
Funder	Netherlands Organisation for Health Research and Development (ZonMw)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr S. Bierma-Zeinstra
Scientific

Erasmus Medical Center
Department of General Practice
P.O. Box 1738
Rotterdam
3000 DR
Netherlands

Email	s.bierma-zeinstra@erasmusmc.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	TIS (Trochanter Injection Study)
Study objectives	Local corticosteroid injections combined with usual care will have a positive effect on experienced recovery and will reduce pain at 3 and 12 months follow up compared to usual care alone.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Trochanteric pain (trochanteric bursitis, pseudotrochanteric bursitis)
Intervention	1. Intervention group: Usual care combined with corticosteroid injections (triamcinolone acetate 40 mg, lidocaine 1%) 2. Control group: Usual care
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Triamcinolone acetate, lidocaine
Primary outcome measure(s)	Experienced recovery (7 points Likert scale) and severity of pain (0-10 visual analogue scale [VAS]) at 3 months follow up.
Key secondary outcome measure(s)	1. Disease specific outcomes of pain and function (WOMAC/HOOS), at 3 and 12 months follow up 2. Primary outcomes at 6 weeks and at 6, 9 and 12 months follow-up 3. Cost-effectiveness over 12 months of follow-up. Costs will be estimated by medical consumption, and productivity loss (PRODISC).
Completion date	01/05/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	150
Key inclusion criteria	Patients aged 18-80 consulting the general practitioner with trochanteric hip pain existing longer then one week, with the following signs: 1. Severe local pain by pressure at the trochanter major, but unsure whether the patient recognizes this as the pain he/she consulted for 2. Local pain by pressure at the trochanter major, which the patient recognizes as the pain he/she consulted for
Key exclusion criteria	1. Patients who dont understand the questionnaires because of inadequate mastering of Dutch language or cognitive disorders 2. Patients who presented themselves in the previous year to the GP with the same complaints 3. Patients with sensibility disorders due to meralgia paresthetica, patients who previously have undergone hip surgery at the same side and patients with systematic rheumatologic or neurologic disorders
Date of first enrolment	01/05/2006
Date of final enrolment	01/05/2007

Erasmus Medical Center

Rotterdam
3000 DR
Netherlands

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2011		Yes	No
Protocol article	protocol	19/09/2007		Yes	No