Local Injection Under US Control in GTPS.

NCT ID: NCT01807962

Last Updated: 2017-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-12-31

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 and it is classically defined as pain and tenderness in the region of the greater trochanter that may radiate down to the postero-lateral aspect of the thigh and may mimic nerve root compression.

The prevalence of GTPS amongst adult patients referred to a spine clinic for chronic low back pain (LBP) has been reported to be 20-35%. In addition to pain, GTPS induces functional disability which at times may profoundly interfere with patients' daily activities. The diagnosis of GTPS is suspected in a patient complaining of lateral hip pain. The reproduction of typical pain on palpation of the posterior part of the greater trochanter is the only well recognised clinical sign, although other clinical signs have been described. As is frequently the case with these type of syndromes, the physiopathology of GTPS is probably a mixture of several musculoskeletal problems, among which trochanteric bursitis and gluteus medius (GMe) tendinosis are the most frequently cited.

MRI studies have demonstrated GMe tendinosis or tears in patients with GTPS and MRI is used as the gold standard for the diagnosis of GTPS in many studies. Musculoskeletal ultrasound (US) is of increasing interest among rheumatologists. It readily demonstrates soft tissue lesions, fluid collections, allows dynamic examination and the undertaking of ultrasound guided procedures. GMe and gluteus minus (GMi) tendinopathy or tears as well as bursitis can be clearly demonstrated by ultrasound and US may guide steroid injection for the treatment of GMe tendinopathy. However, to date no study has compared the utility of MRI compared to US.

There are very few well-performed studies regarding the treatment of GTPS. Although poorly studied, analgesics and non steroidal anti-inflammatory drugs (NSAIDs) are often used as first line therapy. The duration of therapy required with these oral agents is unknown and there are significant potential side-effects from these treatments. The vast majority of patients referred to secondary or tertiary centres have failed these oral therapies. Some authors advocate physiotherapy (massage or stretching) but once again, there is no strong evidence to support this approach. Thus, most patients are treated with an injection of a combination of steroids and local anaesthetic. However, there is no convincing evidence in the literature that this practice is effective.

The use of musculoskeletal ultrasound (US) has been shown to improve the accuracy of corticosteroid injections for many joints and extra-articular structures such as bursa and tendon sheaths. Although small observational studies have suggested that local corticosteroid injection may be effective in the short term, no prospective controlled study has been carried out to establish the efficacy of this common intervention.

Conditions

Periarthritis; Bursitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

rapidocain and bethametsaone

Rapidocain and Bethametsaone :

Lidocaine (Rapidocain(R)): 4ml of 1% Lidocaine Bethametasone (Diprophos): 1ml ampoule (containing 5mg/ml dipropionate de bétaméthasone and 2mg/ml phosphate disodique de bétaméthasone)

Group Type: ACTIVE_COMPARATOR

rapidocain and bethametsaone

Intervention Type: DRUG

lidocaine (Rapidocain(R)): 4ml of 1% Lidocaine

bethametasone (Diprophos): 1ml ampoule (containing 5mg/ml dipropionate de betamethasone and 2mg/ml phosphate disodique de betamethasone)

sterile saline

Placebo arm with 5ml of sterile saline (NaCl) solution

Group Type: PLACEBO_COMPARATOR

sterile saline

Intervention Type: DRUG

Placebo = 5ml of sterile saline solution

Interventions

rapidocain and bethametsaone

lidocaine (Rapidocain(R)): 4ml of 1% Lidocaine

bethametasone (Diprophos): 1ml ampoule (containing 5mg/ml dipropionate de betamethasone and 2mg/ml phosphate disodique de betamethasone)

Intervention Type: DRUG

sterile saline

Placebo = 5ml of sterile saline solution

Intervention Type: DRUG

Other Intervention Names

diprophos; lidocaine; NaCl

Eligibility Criteria

Inclusion Criteria

1. Patients complaining of lateral hip pain for more than 1 month.

2. NRS lateral hip pain score ≥ 4 in the preceding week.

3. 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).

4. Typical lateral hip pain reproduced by palpation of the greater trochanter

Exclusion Criteria

1. Age younger than 18 years old

2. Concomitant local surgical intervention for tumours, infection or fracture, based on clinical history and physical examination

3. Previous ipsilateral prosthetic hip surgery

4. Scheduled ipsilateral hip surgery within 3 months

5. Fibromyalgia (diagnosis established by a rheumatologist)

6. Flair of chronic inflammatory joint disease (as defined by a rheumatologist)

7. Skin lesions at the injection site

8. Allergy to one of the studied drugs

9. Anticoagulation with internal normalized ration (INR) >3

10. Blood coagulation disorder, such as haemophilia.

11. Serious and uncontrolled psychiatric disease (as assessed by the clinician as a contraindication for steroid)

12. 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.

13. 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.

14. Presence of a pacemaker or other metallic object that constitutes a CI to MRI, or severe claustrophobia

15. Pregnant women (according to a pregnancy test) or nursing (breastfeeding) mothers.

16. Unwillingness or inability to give informed consent.

17. Unavailability for follow-up

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

Stephane Genevay

OTHER

Sponsor Role: lead

Responsible Party

Stephane Genevay

Médecin adjoint

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephane Genevay, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

University Hospital, Geneva

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

CE 10-213

Identifier Type: -

Identifier Source: org_study_id