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Glucocorticoid injections for greater trochanteric pain syndrome: a randomised double-blind placebo-controlled (GLUTEAL) trial

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Abstract

Small observational studies suggest that local glucocorticoid (GC) injection may be effective in the management of the greater trochanteric pain syndrome (GTPS). The objective was to perform the first randomised double-blind placebo-controlled trial to investigate the efficacy of local GC injection in the management of GTPS. The trial was conducted between November 2011 and May 2015. Inclusion criteria included lateral hip pain (LHP) for greater than 1 month, a LHP score of ≥ 4/10 and typical LHP reproduced by palpation of the greater trochanter. Participants were randomised in a 1:1 ratio to injection with a combination of local anaesthetic and GC (intervention) or injection with normal saline solution (placebo). The primary outcome of interest was the difference in pain intensity at 4 weeks post-injection between the two groups. Patients were followed for 6 months. A total of 46 patients were included. There were no significant differences between the two groups in terms of pain reduction at 1 month (p = 0.23). When including all measures in the first 4 weeks and using multilevel regression, there was a trend towards improvement in pain scores in favour of the intervention group (p = 0.08). There were no significant differences in pain scores between groups at 3 and 6 months. In the management of GTPS, local glucocorticoid injections are of no greater efficacy than injection of normal saline solution. Given the lack of long-term improvement and the potential for cortisone-related side effects, this intervention is of limited benefit.

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Abbreviations

AE :

adverse events

GC :

glucocorticoid

GTPS :

greater trochanteric pain syndrome

LA :

local anaesthetic

LHP :

lateral hip pain

MCS :

mental component score of the SF-12

NRS :

numerical rating scale

NSAIDs :

nonsteroidal anti-inflammatory drugs

PCT :

placebo-controlled trial

PCS :

physical component score of the SF-12

RCT :

randomised controlled trials

SAE :

serious adverse event

SF-12 :

12-Item Short Form Health Survey

VAS :

visual analogue score

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Acknowledgements

We sincerely thank our research nurse, Mrs. Danielle Gascon, for her indispensable contribution to the organisation of this trial and to all the patients who kindly participated.

Funding

This study was supported by a grant from the Geneva University Hospital Foundation.

Author information

Authors and Affiliations

  1. Department of Rheumatology, Geneva University Hospital, 26 Avenue Beau-Séjour, 1211, Geneva 14, Switzerland

    Michael John Nissen, Axel Finckh, Delphine Sophie Courvoisier & Stéphane Genevay

  2. Department of Rheumatology, Neuchâtel Hospital, Neuchâtel, Switzerland

    Laure Brulhart

  3. Department of Orthopaedics, Geneva University Hospital, Geneva, Switzerland

    Antonio Faundez

Authors
  1. Michael John Nissen
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  2. Laure Brulhart
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  3. Antonio Faundez
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  4. Axel Finckh
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  5. Delphine Sophie Courvoisier
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  6. Stéphane Genevay
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Contributions

MN designed the trial, performed the patient visits, involved in data collection, monitored data collection, cleaned and analysed the data, statistical analysis and drafted and revised the paper. He is guarantor.

LB designed the trial, performed the patient visits, involved in data collection, monitored data collection and drafted and revised the paper.

AFa designed the trial, monitored data collection and drafted and revised the paper.

AFi designed the trial, monitored data collection, analysed the data, statistical analysis and drafted and revised the paper.

DC monitored data collection, cleaned and analysed the data, statistical analysis and drafted and revised the paper.

SG designed the trial, performed the patient visits, involved in data collection, monitored data collection, analysed the data and drafted and revised the paper. He was the sponsor and principal investigator.

Corresponding author

Correspondence to Michael John Nissen.

Ethics declarations

Ethics approval

The local ethics committee at the Geneva University Hospital approved the trial (number 10-213).

Consent to participate

All participants provided informed written consent.

Disclosures

None.

Electronic supplementary material

Supplementary file 1

Detailed description of exclusion criteria. (DOCX 12.1 kb)

Supplementary file 2

NRS pain scores prior to the injection and 30 minutes post-injection. (DOCX 27.8 kb)

Supplementary file 3

Adverse effect outcomes at 6 months based on the number of glucocorticoid (GC) injections received (0, 1 or 2 injections). (DOCX 28.2 kb)

Supplementary file 4

Detailed description of the serious adverse events. (DOCX 27.8 kb)

Supplementary file 5

Changes in NRS (numeric rating scale) pain scores over 6 months in patients with a single normal saline injection (PBO_0), a single glucocorticoid injection (GC_0), a normal saline injection followed by a glucocorticoid injection 4 weeks later (PBO_GC) and in patients with 2 glucocorticoid injections 4 weeks apart (GC_GC). 1 = first injection in all patients. 2 = second injection in patients with a NRS pain >2/10 at 4 weeks. (PNG 263 kb)

High Resolution Image (TIF 132 kb)

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Nissen, M.J., Brulhart, L., Faundez, A. et al. Glucocorticoid injections for greater trochanteric pain syndrome: a randomised double-blind placebo-controlled (GLUTEAL) trial. Clin Rheumatol 38, 647–655 (2019). https://doi.org/10.1007/s10067-018-4309-6

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  • DOI: https://doi.org/10.1007/s10067-018-4309-6

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