Clinical Trial: Local Injection Under US Control in GTPS.

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomised Double Blind Controlled Trial of Injection of Local Anaesthetic and Corticosteroid Under Ultrasound Control in the Greater Trochanteric Pain Syndrome.

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

Detailed Summary:

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.

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).



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.

  • PGI patient [ Time Frame: 4 weeks ]
    Patient Global Assessment
  • Lumbar spine function [ Time Frame: 4 weeks ]
    Lumbar spine function measured with the Oswestry questionnaire at 4 weeks and at 6 months
  • Hip joint function [ Time Frame: 4 weeks ]
    Hip joint function (Womac questionnaire)at 4 weeks and 6 months
  • QoL [ Time Frame: 4 weeks ]
    Quality of life (SF-12)at 4 weeks and 6 months
  • Requirement for oral analgesics [ Time Frame: 4 weeks ]
  • 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



Original Secondary Outcome: Same as current

Information By: University Hospital, Geneva

Dates:
Date Received: March 7, 2013
Date Started: November 2011
Date Completion: May 2013
Last Updated: March 7, 2013
Last Verified: March 2013