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Cortisone Injection vs Trigger Point Dry Needling Fin the Treatment of Greater Trochanter Pain Syndrome: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639039
Recruitment Status : Completed
First Posted : December 24, 2015
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Scott and White Hospital & Clinic

Brief Summary:
The purpose of this study is to determine if trigger point dry needling (TDN) is as effective as cortisone injection (CI) in reducing pain and improving function in patients with greater trochanteric pain syndrome (GTPS).

Condition or disease Intervention/treatment Phase
Hip Injuries Drug: Cortisone Injection Procedure: Trigger Point Dry Needling Phase 4

Detailed Description:

This study aims to investigate the potential of TDN as an effective alternative to CI for patients with GTPS by directly comparing pain and functional outcomes of patients receiving TDN or CI for the treatment of GTPS over a 6 week period. The investigators hypothesize that patients treated with TDN will be equally improved in pain and function as those treated with CI. If TDN is demonstrated to be equally or more effective than steroid injection in this pilot study, then the investigators have the basis to launch larger studies. Ultimately, the investigators want to determine if TDN is an effective treatment alternative for GTPS for providers and patients who want to avoid the potential detrimental side-effects of steroids.

Approach: Prospective, randomized, partially-blinded design

Aim: To determine if administration of TDN is as effective as CI in reducing lateral hip pain and improving function in patients diagnosed with greater trochanteric pain syndrome. The investigators expect to demonstrate effectiveness of TDN in the treatment of GTPS to a degree that is equal to CI. Doing so would prompt further outcomes research for TDN. Supportive research and subsequent clinical acceptance of TDN as a primary treatment for this condition would offer an alternative to patients who want or need to avoid steroids.

Based on the literature, this is the first study to investigate the effectiveness of TDN in the treatment of GTPS and directly compare pain and functional outcomes of patients receiving TDN versus CI for the treatment of GTPS.

Methods. Fifty patients with GTPS will be randomized into a CI or TDN group. Treatment will be administered according to standard of care for up to 6 weeks. Numerical pain and functional ratings for each patient will be collected at 0, 1, 3, and 6 weeks of treatment. Data analysis will determine if TDN is as effective as cortisone.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cortisone Injection vs Trigger Point Dry Needling Fin the Treatment of Greater Trochanter Pain Syndrome: A Pilot Study
Study Start Date : February 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cortisone Injection
Fifty patients with GTPS will be randomized into a CI or TDN group. Treatment will be carried out at the 1st visit following consent according to SOC. Treatment will be administered according to standard of care for up to 6 weeks.
Drug: Cortisone Injection
Exact location and technique of injection within the region of the involved greater trochanter will be determined by the provider. The number of f/u visits within 6 wks following initiation of treatment will be determined by the provider, but CI is the only treatment.
Other Name: Steroid injection

Active Comparator: Trigger Point Dry Needling
Fifty patients with GTPS will be randomized into a CI or TDN group. Treatment will be carried out at the 1st visit following consent according to SOC. Treatment will be administered according to standard of care for up to 6 weeks.
Procedure: Trigger Point Dry Needling
Exact location of needle insertion, technique and number of penetrations within the region of the involved posterolateral hip will be determined by the provider. The number of f/u visits within 6 wks following initiation of treatment will be determined by the provider, but TDN is the only treatment.




Primary Outcome Measures :
  1. Participants change in pain rating scores from baseline to 6 weeks will be accessed. [ Time Frame: Baseline and 6 weeks ]
  2. Patient specific function score (PSPS) from baseline to 6 weeks will be accessed. [ Time Frame: Baseline and 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18+ years old
  • lateral hip pain (anywhere from iliac crest to mid ITB)
  • active email account

Exclusion Criteria:

  • low back pain associated with the hip pain
  • motor and/or sensory impairment consistent with radiculopathy
  • active infection/malignancy of the hip
  • connective tissue disease
  • pregnancy
  • non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639039


Sponsors and Collaborators
Scott and White Hospital & Clinic
Investigators
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Principal Investigator: Kindyle L Brennan, PhD Orthopedic Therapist

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier: NCT02639039    
Other Study ID Numbers: 110495
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hip Injuries
Wounds and Injuries
Cortisone
Anti-Inflammatory Agents