Condition category
Musculoskeletal Diseases
Date applied
28/04/2006
Date assigned
28/04/2006
Last edited
12/09/2011
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 S. Bierma-Zeinstra

ORCID ID

Contact details

Erasmus Medical Center
Department of General Practice
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
s.bierma-zeinstra@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR640

Study information

Scientific title

Acronym

TIS (Trochanter Injection Study)

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

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 names

Triamcinolone acetate, lidocaine

Primary outcome measures

Experienced recovery (7 points Likert scale) and severity of pain (0-10 visual analogue scale [VAS]) at 3 months follow up.

Secondary outcome measures

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).

Overall trial start date

01/05/2006

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Patients who don’t 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

Recruitment start date

01/05/2006

Recruitment end date

01/05/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3000 DR
Netherlands

Sponsor information

Organisation

Erasmus Medical Center, Department of General Practice (The Netherlands)

Sponsor details

P.O. Box 1738
Rotterdam
3000 DR
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

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

1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17880718
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21555750

Publication citations

  1. Protocol

    Brinks A, van Rijn RM, Bohnen AM, Slee GL, Verhaar JA, Koes BW, Bierma-Zeinstra SM, Effect of corticosteroid injection for trochanter pain syndrome: design of a randomised clinical trial in general practice., BMC Musculoskelet Disord, 2007, 8, 95, doi: 10.1186/1471-2474-8-95.

  2. Results

    Brinks A, van Rijn RM, Willemsen SP, Bohnen AM, Verhaar JA, Koes BW, Bierma-Zeinstra SM, Corticosteroid injections for greater trochanteric pain syndrome: a randomized controlled trial in primary care., Ann Fam Med, 9, 3, 226-234, doi: 10.1370/afm.1232.

Additional files

Editorial Notes