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

Primary Purpose

Hip Injuries

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cortisone Injection
Trigger Point Dry Needling
Sponsored by
Scott and White Hospital & Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Injuries

Eligibility Criteria

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Cortisone Injection

    Trigger Point Dry Needling

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Participants change in pain rating scores from baseline to 6 weeks will be accessed.
    Patient specific function score (PSPS) from baseline to 6 weeks will be accessed.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 2, 2015
    Last Updated
    December 28, 2015
    Sponsor
    Scott and White Hospital & Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02639039
    Brief Title
    Cortisone Injection vs Trigger Point Dry Needling Fin the Treatment of Greater Trochanter Pain Syndrome: A Pilot Study
    Official Title
    Cortisone Injection vs Trigger Point Dry Needling Fin the Treatment of Greater Trochanter Pain Syndrome: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Scott and White Hospital & Clinic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cortisone Injection
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Trigger Point Dry Needling
    Arm Type
    Active Comparator
    Arm Description
    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 Type
    Drug
    Intervention Name(s)
    Cortisone Injection
    Other Intervention Name(s)
    Steroid injection
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Trigger Point Dry Needling
    Intervention Description
    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 Measure Information:
    Title
    Participants change in pain rating scores from baseline to 6 weeks will be accessed.
    Time Frame
    Baseline and 6 weeks
    Title
    Patient specific function score (PSPS) from baseline to 6 weeks will be accessed.
    Time Frame
    Baseline and 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kindyle L Brennan, PhD
    Organizational Affiliation
    Orthopedic Therapist
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28257614
    Citation
    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.
    Results Reference
    derived

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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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