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Local Injection Under US Control in GTPS.

Primary Purpose

Periarthritis, Bursitis

Status
Terminated
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
rapidocain and bethametsaone
sterile saline
Sponsored by
Stephane Genevay
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periarthritis focused on measuring Injections, Subcutaneous, Cortisone, Anesthetics, Local

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, Geneva

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

rapidocain and bethametsaone

sterile saline

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Number of "responders"
Number of "responders" (defined as a reduction in NRS ≥ 1.5)at 4 weeks and at 6 months.
Number of patients with "low residual disease activity"
Number of patients with "low residual disease activity" (defined as NRS ≤ 2.0)at 4 weeks and at 6 months.
PGI patient
Patient Global Assessment
Lumbar spine function
Lumbar spine function measured with the Oswestry questionnaire at 4 weeks and at 6 months
Hip joint function
Hip joint function (Womac questionnaire)at 4 weeks and 6 months
QoL
Quality of life (SF-12)at 4 weeks and 6 months
Requirement for oral analgesics
Recording patient requirements for analgesics at weekly intervals following the intervention
Side effects of the intervention
Clinical side effects - patients will be questioned specifically with respect to certain side-effects potentially linked to the injection technique and /or the injected substances. Any other side-effects cited by the patient will be recorded appropriately. Ultrasound-measured side-effects: hematoma, GMe or GMi tear, tendinosis or calcification post-intervention that had not been visualised on the initial US prior to the first injection. Measured at 4 weeks and at 6 months

Full Information

First Posted
March 7, 2013
Last Updated
June 7, 2017
Sponsor
Stephane Genevay
Collaborators
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT01807962
Brief Title
Local Injection Under US Control in GTPS.
Official Title
A Randomised Double Blind Controlled Trial of Injection of Local Anaesthetic and Corticosteroid Under Ultrasound Control in the Greater Trochanteric Pain Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Slower than planned recruitement
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephane Genevay
Collaborators
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periarthritis, Bursitis
Keywords
Injections, Subcutaneous, Cortisone, Anesthetics, Local

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rapidocain and bethametsaone
Arm Type
Active Comparator
Arm Description
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)
Arm Title
sterile saline
Arm Type
Placebo Comparator
Arm Description
Placebo arm with 5ml of sterile saline (NaCl) solution
Intervention Type
Drug
Intervention Name(s)
rapidocain and bethametsaone
Other Intervention Name(s)
diprophos, lidocaine
Intervention Description
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
Intervention Name(s)
sterile saline
Other Intervention Name(s)
NaCl
Intervention Description
Placebo = 5ml of sterile saline solution
Primary Outcome Measure Information:
Title
The efficacy of ultrasound-guided injection with corticosteroid and local anaesthetic for GTPS.
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of "responders"
Description
Number of "responders" (defined as a reduction in NRS ≥ 1.5)at 4 weeks and at 6 months.
Time Frame
4 weeks
Title
Number of patients with "low residual disease activity"
Description
Number of patients with "low residual disease activity" (defined as NRS ≤ 2.0)at 4 weeks and at 6 months.
Time Frame
4 weeks
Title
PGI patient
Description
Patient Global Assessment
Time Frame
4 weeks
Title
Lumbar spine function
Description
Lumbar spine function measured with the Oswestry questionnaire at 4 weeks and at 6 months
Time Frame
4 weeks
Title
Hip joint function
Description
Hip joint function (Womac questionnaire)at 4 weeks and 6 months
Time Frame
4 weeks
Title
QoL
Description
Quality of life (SF-12)at 4 weeks and 6 months
Time Frame
4 weeks
Title
Requirement for oral analgesics
Description
Recording patient requirements for analgesics at weekly intervals following the intervention
Time Frame
4 weeks
Title
Side effects of the intervention
Description
Clinical side effects - patients will be questioned specifically with respect to certain side-effects potentially linked to the injection technique and /or the injected substances. Any other side-effects cited by the patient will be recorded appropriately. Ultrasound-measured side-effects: hematoma, GMe or GMi tear, tendinosis or calcification post-intervention that had not been visualised on the initial US prior to the first injection. Measured at 4 weeks and at 6 months
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane Genevay, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Geneva
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Local Injection Under US Control in GTPS.

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