Osteoarthritis
Conditions
Brief summary
Trochanteric pain can be caused by osteoarthritis of the hip, fracture, tendinitis, nerve pathology and trochanteric bursitis. Trochanteric bursitis is often seen at the outpatient clinic and is characterized by chronic lateral hip pain in the vicinity of the trochanter major, overlying the lateral aspect of the hip. When pain is persistent after conventional therapies, anesthetic and corticosteroid (CS) injections can provide short term to intermediate relief of pain, but relapse is common. Only one retrospective study showed the efficacy of intra-bursal trochanteric injections with HA and CS. They concluded that the pain release is significant with large effect sizes for both treatment. However, the efficacy of CS appeared to be short lived and it was shown that the efficacy of HA at 6 and 12 months is significant compared to CS (p\<0.05). In this study we want to compare the efficacy of corticosteroids and hyaluronic acid in the treatment of trochanteric bursitis.
Detailed description
See brief summary
Interventions
DRUGCorticosteroids
Intra-bursal injection
DEVICEHyaluronic acid
Intra-bursal injection
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, 18 years and older, but \<75 years; * VAS for pain \> 30mm; * Diagnosis of trochanteric bursitis as suggested by Brinks et al with symptoms for more than 3 months (3); * Failure of conservative therapy of more than one month; * Written informed consent; * Available for the duration of the investigation.
Exclusion criteria
* Previous surgery in the same region; * Current other problem(s) in the affected extremity; * Diabetes mellitus; * Patient who received a local (CS) injection within 3 months from the baseline visit; * Allergic or hypersensitive to CS or HA; * Patients suffering (chronic) low back pain with or without sciatic pain; * Patients with radiographic signs of moderate or severe hip osteoarthritis (Kellgren and Lawrence \>1); * Pregnant or lactating, or woman of childbearing potential not willing to use an acceptable method of contraception during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS for pain | 26 weeks after administration |
Secondary
| Measure | Time frame |
|---|---|
| Harris Hip Score | 6, 12, 26 weeks |
| VAS for pain | 6 and 12 weeks after administration |
Other
| Measure | Time frame |
|---|---|
| Patient's Global Assessment of Normal Function/Activity | 6, 12, 26 weeks |
Countries
Belgium
Contacts
Primary ContactSascha Colen, MD
Outcome results
None listed