Comparison of Steroid Dosages on the Efficacy of Trochanteric Bursa Injection

NCT02126878 | Completed Results

• 1 other identifier: 1401174207
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammation of the trochanteric bursa is a common cause of hip pain. A bursa is a closed fluid filled sac or sac-like cavity found between tissues that function as a gliding surface to reduce friction. Bursitis is the inflammation of the bursa. Inflammation between the trochanteric process of the femur and gluteus medius tendon/ iliotibial tract is the cause of trochanteric bursitis. Several treatments exist for trochanteric bursitis, including a local steroid injection. The injection consists of a mixture of local anesthetic and steroid medications. The steroid is routinely mixed with a local anesthetic. The anesthetic acts to diluent the steroid as well as act as a pain reliever. Various steroid preparations have been used, at varying doses, for trochanteric bursitis. The steroid preparation, triamcinolone is commonly used for various reasons. Besides the procedure associated and injection site risks, risks associated with the use of steroids, though rare, exist. Short term, the steroid can raise blood sugar levels and should be used with caution and be appropriately monitored in diabetics. Additionally, the steroid can suppress the immune system. Long-term risks are related to the dose and frequency of use. These risks include thinning of the skin, easy bruising, weight gain, elevated blood pressure, cataract formation, thinning of bones and joints. Studies have shown the effectiveness of local steroid injections for trochanteric bursitis. Unfortunately, there is limited data on the ideal dose of the steroid preparation. Triamcinolone of 40mg/ mL is commonly used, but, studies have shown effectiveness at various doses, ranging 20 to 160 mg/mL. The aim of this study is to evaluate and compare the effectiveness of local steroid injections of various steroid dosages for the treatment of trochanteric bursitis.

Conditions

Bursitis

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Measured on Visual Analog Scale and Percent Improvement

  3 month

Secondary Outcomes (2)

• Disability Measured on Becks Disability Scale

  Baseline, 1 month, 3 month

• Safety, Adverse Affects

  1 month,3 months

Study Arms (3)

Kenalog 20mg

ACTIVE COMPARATOR

20mg/ 2ml and local anesthetic

Drug: Kenalog

Kenalog 40mg

ACTIVE COMPARATOR

40mg/ 2ml with local anesthetic

Drug: Kenalog

Kenalog 80mg

ACTIVE COMPARATOR

80mg/ 2ml and local anesthetic

Drug: Kenalog

Interventions

Kenalog DRUG

Kenalog 20mg; Kenalog 40mg; Kenalog 80mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of trochanteric bursitis
• years of age or older when written informed consent is obtained
• Signed institutional review board approved informed consent form

You may not qualify if:

• Meets any contraindication for treatment
• Allergy to triamcinolone, lidocaine
• Previous surgery to bursa
• Coagulopathy
• Active Infection
• Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University Hospitals

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Bursitis

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

This study is considered to be completed, because before leaving the institution the PI indicated the study status as completed and entered that actual enrollment number of 120 participants. No other information could be located or obtained for the study and therefore no specific results information can be included. The study status as completed and actual enrollment number of 120 participants should be considered an accurate representation of all available study information.

Results Point of Contact

• Title: Clinical Trials Compliance Coordinator
• Organization: West Virginia Universtiy, WVCTSI

ctgovadmin@hsc.wvu.edu

304-293-0216

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2014
• First Posted: April 30, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 19, 2021
• Results First Posted: January 20, 2021

Record last verified: 2021-09

Locations

US (1)