Status:

TERMINATED

Local Injection Under US Control in GTPS.

Lead Sponsor:

Stephane Genevay

Collaborating Sponsors:

University Hospital, Geneva

Conditions:

Periarthritis

Bursitis

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

We hypothesize that local ultrasound guided injection with corticosteroid and local anaesthetic are effective on the symptoms of GTPS.

Detailed Description

The greater trochanteric pain syndrome (GTPS) is a frequent soft tissue syndrome which is often not recognised by medical practitioners. Currently, there is no validated definition of this syndrome an...

Eligibility Criteria

Inclusion

  • Patients complaining of lateral hip pain for more than 1 month.
  • NRS lateral hip pain score ≥ 4 in the preceding week.
  • Failure of another "standard" treatment:
  • Physiotherapy: local therapy or a stretching program, or
  • Analgesic treatment (minimum of 5 days of consecutive therapy, including, but not limited to, NSAIDs).
  • Typical lateral hip pain reproduced by palpation of the greater trochanter

Exclusion

  • Age younger than 18 years old
  • Concomitant local surgical intervention for tumours, infection or fracture, based on clinical history and physical examination
  • Previous ipsilateral prosthetic hip surgery
  • Scheduled ipsilateral hip surgery within 3 months
  • Fibromyalgia (diagnosis established by a rheumatologist)
  • Flair of chronic inflammatory joint disease (as defined by a rheumatologist)
  • Skin lesions at the injection site
  • Allergy to one of the studied drugs
  • Anticoagulation with internal normalized ration (INR) \>3
  • Blood coagulation disorder, such as haemophilia.
  • Serious and uncontrolled psychiatric disease (as assessed by the clinician as a contraindication for steroid)
  • Other contraindications to steroid use, such as:
  • uncontrolled diabetes (non-fasting blood glucose \> 10 mmol/L)
  • unstable hypertension (systolic pressure \> 160mmHg or diastolic pressure \> 100mmHg), or
  • open or closed angle glaucoma.
  • Requirement for systemic steroids (including steroid injections) or dose modification of disease modifying anti-rheumatic drugs during the preceding three months. Oral corticosteroids (\< 10mg / day of Prednisone or equivalent) will be permitted providing that the dose has been stable for 4 weeks prior to inclusion and that the patient is expected to remain on the baseline dose for the duration of the study.
  • Presence of a pacemaker or other metallic object that constitutes a CI to MRI, or severe claustrophobia
  • Pregnant women (according to a pregnancy test) or nursing (breastfeeding) mothers.
  • Unwillingness or inability to give informed consent.
  • Unavailability for follow-up

Key Trial Info

Start Date :

November 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2015

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT01807962

Start Date

November 1 2011

End Date

December 1 2015

Last Update

June 8 2017

Active Locations (1)

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1

University Hospital, Geneva

Geneva, Switzerland