Comparison of Steroid Dosages on the Efficacy of Trochanteric Bursa Injection

• Sponsor: West Virginia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02126878
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Duration (Months): 14
• Patients Per Site Per Month: 8.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bursitis	Drug: Kenalog	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prospective, Randomized, Double-blinded Comparison of Steroid Dosages on the Efficacy of Trochanteric Bursa Injection
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Kenalog 20mg 20mg/ 2ml and local anesthetic	Drug: Kenalog
Active Comparator: Kenalog 40mg 40mg/ 2ml with local anesthetic	Drug: Kenalog
Active Comparator: Kenalog 80mg 80mg/ 2ml and local anesthetic	Drug: Kenalog

Outcome Measures

Primary Outcome Measures

1. Pain Intensity Measured on Visual Analog Scale and Percent Improvement [3 month]

Secondary Outcome Measures

1. Disability Measured on Becks Disability Scale [Baseline, 1 month, 3 month]

2. Safety, Adverse Affects [1 month,3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Clinical diagnosis of trochanteric bursitis

2. 18 years of age or older when written informed consent is obtained

3. Signed institutional review board approved informed consent form

Exclusion Criteria:

1. Meets any contraindication for treatment

2. Allergy to triamcinolone, lidocaine

3. Previous surgery to bursa

4. Coagulopathy

5. Active Infection

6. Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Virginia University Hospitals	Morgantown	West Virginia	United States	26505

Sponsors and Collaborators

• West Virginia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: West Virginia University
• ClinicalTrials.gov Identifier: NCT02126878
• Other Study ID Numbers: 1401174207
• First Posted: Apr 30, 2014
• Last Update Posted: Oct 19, 2021
• Last Verified: Sep 1, 2021

• Additional relevant MeSH terms: Bursitis; Triamcinolone Acetonide

Study Results

Participant Flow

Recruitment Details	The study was ended and the PI has left the institution. The numbers presented are what was initially entered by the research team. From data available, 120 participants were enrolled on the study; no information about those participants could be located. No other data could be located and it cannot be determined which arm the120 participants were enrolled in or if they completed the study.

Arm/Group Title	Kenaglog 20mg	Kenalog 40mg	Kenalog 80mg
Arm/Group Description	20mg/ 2ml and local anesthetic Kenalog	40mg/ 2ml with local anesthetic Kenalog	80mg/ 2ml and local anesthetic Kenalog
Period Title: Overall Study
STARTED	0	0	0
COMPLETED	0	0	0
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Kenaglog 20mg	Kenalog 40mg	Kenalog 80mg	Total
Arm/Group Description	20mg/ 2ml and local anesthetic Kenalog	40mg/ 2ml with local anesthetic Kenalog	80mg/ 2ml and local anesthetic Kenalog	Total of all reporting groups
Overall Participants	0	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male () []
Female
Male
Race and Ethnicity Not Collected () []

Outcome Measures

1. Primary Outcome

Title	Pain Intensity Measured on Visual Analog Scale and Percent Improvement
Time Frame	3 month

Outcome Measure Data

Analysis Population Description

The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.

Arm/Group Title	Kenaglog 20mg	Kenalog 40mg	Kenalog 80mg
Arm/Group Description	20mg/ 2ml and local anesthetic Kenalog	40mg/ 2ml with local anesthetic Kenalog	80mg/ 2ml and local anesthetic Kenalog
Measure Participants	0	0	0

2. Secondary Outcome

Title	Disability Measured on Becks Disability Scale
Time Frame	Baseline, 1 month, 3 month

Outcome Measure Data

Analysis Population Description

The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.

Arm/Group Title	Kenaglog 20mg	Kenalog 40mg	Kenalog 80mg
Arm/Group Description	20mg/ 2ml and local anesthetic Kenalog	40mg/ 2ml with local anesthetic Kenalog	80mg/ 2ml and local anesthetic Kenalog
Measure Participants	0	0	0

3. Secondary Outcome

Title	Safety, Adverse Affects
Time Frame	1 month,3 months

Outcome Measure Data

Analysis Population Description

The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.

Arm/Group Title	Kenaglog 20mg	Kenalog 40mg	Kenalog 80mg
Arm/Group Description	20mg/ 2ml and local anesthetic Kenalog	40mg/ 2ml with local anesthetic Kenalog	80mg/ 2ml and local anesthetic Kenalog
Measure Participants	0	0	0

Adverse Events

Adverse Event Reporting Description	The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.
Arm/Group Title	Kenaglog 20mg		Kenalog 40mg		Kenalog 80mg
Arm/Group Description	20mg/ 2ml and local anesthetic Kenalog		40mg/ 2ml with local anesthetic Kenalog		80mg/ 2ml and local anesthetic Kenalog
All Cause Mortality
	Kenaglog 20mg		Kenalog 40mg		Kenalog 80mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Kenaglog 20mg		Kenalog 40mg		Kenalog 80mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Kenaglog 20mg		Kenalog 40mg		Kenalog 80mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.