Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.

Osteoarthritis Clinical Trial

Official title:

Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02039804
• Other study ID #: Trochanter Bursitis
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 24, 2013
• Last updated: March 25, 2014
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Sascha Colen, MD
• Phone: 0032-497180798
• Email: sascolen[@]hotmail.com
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Description:

See brief summary

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Corticosteroids
Intra-bursal injection

Device:
• Hyaluronic acid
Intra-bursal injection

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient's Global Assessment of Normal Function/Activity		6, 12, 26 weeks	No
Primary	VAS for pain		26 weeks after administration	No
Secondary	Harris Hip Score		6, 12, 26 weeks	Yes
Secondary	VAS for pain		6 and 12 weeks after administration	No