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

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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

Tracking Information
First Submitted Date  ICMJE December 2, 2015
First Posted Date  ICMJE December 24, 2015
Last Update Posted Date December 29, 2015
Study Start Date  ICMJE February 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2015)
  • Participants change in pain rating scores from baseline to 6 weeks will be accessed. [ Time Frame: Baseline and 6 weeks ]
  • Patient specific function score (PSPS) from baseline to 6 weeks will be accessed. [ Time Frame: Baseline and 6 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
  • Participants change in pain rating scores from baseline to 6 weeks will be accessed. [ Time Frame: 6 weeks ]
  • Patient specific function score (PSPS) from baseline to 6 weeks will be accessed. [ Time Frame: 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cortisone Injection vs Trigger Point Dry Needling Fin the Treatment of Greater Trochanter Pain Syndrome: A Pilot Study
Official Title  ICMJE Cortisone Injection vs Trigger Point Dry Needling Fin the Treatment of Greater Trochanter Pain Syndrome: A Pilot Study
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hip Injuries
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Cortisone 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.
    Intervention: Procedure: Trigger Point Dry Needling
Publications * Brennan KL, Allen BC, Maldonado YM. Dry Needling Versus Cortisone Injection in the Treatment of Greater Trochanteric Pain Syndrome: A Noninferiority Randomized Clinical Trial. J Orthop Sports Phys Ther. 2017 Apr;47(4):232-239. doi: 10.2519/jospt.2017.6994. Epub 2017 Mar 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2015)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02639039
Other Study ID Numbers  ICMJE 110495
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Scott and White Hospital & Clinic
Study Sponsor  ICMJE Scott and White Hospital & Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kindyle L Brennan, PhD Orthopedic Therapist
PRS Account Scott and White Hospital & Clinic
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP