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Efficacy of Platelet Rich Plasma vs. Corticosteroid Injections for Treating Greater Trochanteric Pain Syndrome

Primary Purpose

Greater Trochanteric Pain Syndrome

Status

Unknown status

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Triamcinolone Acetonide

Platelet Rich Plasma

About this trial

This is an interventional treatment trial for Greater Trochanteric Pain Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males or females ages 18 and older.
Active duty soldiers and military health care beneficiaries.
Have lateral hip pain in the region of the greater trochanter for at least 6 weeks and have done physical therapy.
Reproducible pain on palpation of the greater trochanteric region.
Tendinopathy diagnosed with ultrasound. The criteria is as follows: a well-defined hypoechoic area with partial tear or complete tendon rupture that is suggestive of a tendon tear. A hyperechoic intratendinous area with posterior acoustic shadowing suggestive of a calcification, or both

Exclusion Criteria:

Received corticosteroid for the condition in last 6 months.
History of surgery in affected hip.
Allergy to Lidocaine.
Allergy to Corticosteroid.
Unavailable for follow up by telephone for 12 months after initial injection.
Patients with broken skin or skin infections immediately overlying the area to be injected.
Patients with complete tears of the gluteal tendons with retraction of the muscle and or tendon, as determined by ultrasound.
If they are pregnant or planning on becoming pregnant during the study time. Because of the physiologic changes during pregnancy we cannot predict how Corticosteroids will affect the mother and the infant. Also, this will increase stress to an already immunocompromised state.
Have not attended formal physical therapy

Sites / Locations

Carl R. Darnall Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Corticosteroid

Platelet Rich Plasma

Arm Description

Outcomes

Primary Outcome Measures

Pain

Will use Visual Analog scale to measure overalll pain at 0, 1, 3, 6, 9, and 12 months of both groups to compare efficacy of both treatments.

Secondary Outcome Measures

Functional outcomes

Will use Nonarthritic Hip score at 0, 1, 3, 6, 9, and 12 months to evaluate overall function of the patients between the two groups.

Full Information

NCT ID

NCT02031367

First Posted

January 8, 2014

Last Updated

January 8, 2014

Sponsor

C.R.Darnall Army Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02031367

Brief Title

Efficacy of Platelet Rich Plasma vs. Corticosteroid Injections for Treating Greater Trochanteric Pain Syndrome

Official Title

Efficacy of Platelet Rich Plasma vs. Corticosteroid Injections for Treating Greater

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Unknown status

Study Start Date

March 2014 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

C.R.Darnall Army Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The object of this study is to compare the effect of PRP versus Corticosteroid injection on pain in patients with Greater Trochanteric Pain Syndrome up to 12 months after treatment. It is believed that PRP will be as good as corticosteroids for short term pain relief, and will produce longer lasting pain reduction.

Detailed Description

The purpose of this study is to compare the efficacy of Platelet Rich Plasma (PRP) injections versus Corticosteroid injections in treating patients that have failed noninvasive management for Greater Trochanteric Pain Syndrome (GTPS). We will be comparing in both the short term (0-6 months) and in the long term (6-12 months). It will be a Double-Blinded Randomized Clinical Trial. Patients with GTPS will be randomly assigned to either the Corticosteroid group or PRP group. There will be a total of 50 participants enrolled with 25 in each group. The PRP group will receive 3 mL of autologous plasma injection into the area of tendinopathy utilizing ultrasound guidance. One (1) injection per month will be administered for a total of three (3) injections. The Corticosteroid Group will receive 2.0 mL's injection of lidocaine and 40mg of Triamcinolone into the area of tendinopathy utilizing ultrasound guidance on their first injection. They will then receive 2.0 mL's of 1% lidocaine and 3.0 mL's of 0.9% Sodium Chloride per month for a total of three (3) injections. Both groups will be referred to physical therapy. Participant's pain will be assessed using a Visual Analog Scale (VAS) and the Nonarthritic Hip Score (NHS) for function at the beginning of the treatment and then again at 1, 3, 6, 9, and 12 months after the initial injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Greater Trochanteric Pain Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Corticosteroid

Arm Type

Active Comparator

Arm Title

Platelet Rich Plasma

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Acetonide

Intervention Description

Corticosteroid arm

Intervention Type

Other

Intervention Name(s)

Platelet Rich Plasma

Other Intervention Name(s)

PRP

Intervention Description

Platelet Rich Plasma

Primary Outcome Measure Information:

Title

Pain

Description

Will use Visual Analog scale to measure overalll pain at 0, 1, 3, 6, 9, and 12 months of both groups to compare efficacy of both treatments.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Functional outcomes

Description

Will use Nonarthritic Hip score at 0, 1, 3, 6, 9, and 12 months to evaluate overall function of the patients between the two groups.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or females ages 18 and older. Active duty soldiers and military health care beneficiaries. Have lateral hip pain in the region of the greater trochanter for at least 6 weeks and have done physical therapy. Reproducible pain on palpation of the greater trochanteric region. Tendinopathy diagnosed with ultrasound. The criteria is as follows: a well-defined hypoechoic area with partial tear or complete tendon rupture that is suggestive of a tendon tear. A hyperechoic intratendinous area with posterior acoustic shadowing suggestive of a calcification, or both Exclusion Criteria: Received corticosteroid for the condition in last 6 months. History of surgery in affected hip. Allergy to Lidocaine. Allergy to Corticosteroid. Unavailable for follow up by telephone for 12 months after initial injection. Patients with broken skin or skin infections immediately overlying the area to be injected. Patients with complete tears of the gluteal tendons with retraction of the muscle and or tendon, as determined by ultrasound. If they are pregnant or planning on becoming pregnant during the study time. Because of the physiologic changes during pregnancy we cannot predict how Corticosteroids will affect the mother and the infant. Also, this will increase stress to an already immunocompromised state. Have not attended formal physical therapy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aaron D Williams, DO

Phone

2542867143

aaron.d.williams7.mil@mail.mil

Facility Information:

Facility Name

Carl R. Darnall Army Medical Center

City

Ft. Hood

State/Province

Texas

ZIP/Postal Code

76544

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aaron D Williams, DO

12. IPD Sharing Statement

Citations:

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19372352

Citation

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Citation

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Efficacy of Platelet Rich Plasma vs. Corticosteroid Injections for Treating Greater Trochanteric Pain Syndrome

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