Local Injection Under US Control in GTPS.

NCT01807962 | Terminated Phase 3 DMC

• 1 other identifier: CE 10-213
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periarthritis; Bursitis

Keywords

Injections, Subcutaneous; Cortisone; Anesthetics, Local

Outcome Measures

Primary Outcomes (1)

• The efficacy of ultrasound-guided injection with corticosteroid and local anaesthetic for GTPS.

  Difference in pain intensity in the lateral hip region at 4 weeks between the 2 treatment groups, as measured by a NRS. Because the timing of the response to an infiltration is not well established we plan to examine pain both at 4 weeks, as well as longitudinally over 4 weeks(evolution of pain over time).

  4 weeks

Secondary Outcomes (8)

• Number of "responders"

  4 weeks

• Number of patients with "low residual disease activity"

  4 weeks

• PGI patient

  4 weeks

• Lumbar spine function

  4 weeks

• Hip joint function

  4 weeks

Study Arms (2)

rapidocain and bethametsaone

ACTIVE COMPARATOR

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)

Drug: rapidocain and bethametsaone

sterile saline

PLACEBO COMPARATOR

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

Drug: sterile saline

Interventions

rapidocain and bethametsaone 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)

Also known as: diprophos, lidocaine

rapidocain and bethametsaone

sterile saline DRUG

Placebo = 5ml of sterile saline solution

Also known as: NaCl

sterile saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stephane Genevay: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

University Hospital, Geneva

Geneva, Switzerland

Location

MeSH Terms

Conditions

Periarthritis; Bursitis

Interventions

betamethasone dipropionate, betamethasone sodium phosphate drug combination; Lidocaine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Stephane Genevay, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Médecin adjoint

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 8, 2013
• Study Start: November 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 8, 2017

Record last verified: 2017-06

Locations

CH (1)