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Local Injection Under US Control in GTPS.

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ClinicalTrials.gov Identifier: NCT01807962
Recruitment Status : Terminated (Slower than planned recruitement)
First Posted : March 8, 2013
Last Update Posted : June 8, 2017
Sponsor:
Collaborator:
University Hospital, Geneva
Information provided by (Responsible Party):
Stephane Genevay, University Hospital, Geneva

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

Condition or disease Intervention/treatment Phase
Periarthritis Bursitis Drug: rapidocain and bethametsaone Drug: sterile saline Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Active Comparator: 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)

Drug: 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)

Other Names:
  • diprophos
  • lidocaine

Placebo Comparator: sterile saline
Placebo arm with 5ml of sterile saline (NaCl) solution
Drug: sterile saline
Placebo = 5ml of sterile saline solution
Other Name: NaCl




Primary Outcome Measures :
  1. The efficacy of ultrasound-guided injection with corticosteroid and local anaesthetic for GTPS. [ Time Frame: 4 weeks ]
    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 :
  1. Number of "responders" [ Time Frame: 4 weeks ]
    Number of "responders" (defined as a reduction in NRS ≥ 1.5)at 4 weeks and at 6 months.

  2. Number of patients with "low residual disease activity" [ Time Frame: 4 weeks ]

    Number of patients with "low residual disease activity" (defined as NRS

    ≤ 2.0)at 4 weeks and at 6 months.


  3. PGI patient [ Time Frame: 4 weeks ]
    Patient Global Assessment

  4. Lumbar spine function [ Time Frame: 4 weeks ]
    Lumbar spine function measured with the Oswestry questionnaire at 4 weeks and at 6 months

  5. Hip joint function [ Time Frame: 4 weeks ]
    Hip joint function (Womac questionnaire)at 4 weeks and 6 months

  6. QoL [ Time Frame: 4 weeks ]
    Quality of life (SF-12)at 4 weeks and 6 months

  7. Requirement for oral analgesics [ Time Frame: 4 weeks ]
    Recording patient requirements for analgesics at weekly intervals following the intervention

  8. Side effects of the intervention [ Time Frame: 4 weeks ]

    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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807962


Locations
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Switzerland
University Hospital, Geneva
Geneva, Switzerland
Sponsors and Collaborators
Stephane Genevay
University Hospital, Geneva
Investigators
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Principal Investigator: Stephane Genevay, MD University Hospital, Geneva

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Responsible Party: Stephane Genevay, Médecin adjoint, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01807962     History of Changes
Other Study ID Numbers: CE 10-213
First Posted: March 8, 2013    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Stephane Genevay, University Hospital, Geneva:
Injections, Subcutaneous
Cortisone
Anesthetics, Local
Additional relevant MeSH terms:
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Bursitis
Periarthritis
Joint Diseases
Musculoskeletal Diseases
Arthritis
Betamethasone
Betamethasone dipropionate, betamethasone sodium phosphate drug combination
Lidocaine
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Respiratory System Agents