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

Sponsor
Scott and White Hospital & Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02639039
Collaborator
(none)
50
Enrollment
2
Arms
28.9
Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
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 :
Feb 1, 2013
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Participants change in pain rating scores from baseline to 6 weeks will be accessed. [Baseline and 6 weeks]

    2. Patient specific function score (PSPS) from baseline to 6 weeks will be accessed. [Baseline and 6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Scott and White Hospital & Clinic

    Investigators

    • Principal Investigator: Kindyle L Brennan, PhD, Orthopedic Therapist

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Scott and White Hospital & Clinic
    ClinicalTrials.gov Identifier:
    NCT02639039
    Other Study ID Numbers:
    • 110495
    First Posted:
    Dec 24, 2015
    Last Update Posted:
    Dec 29, 2015
    Last Verified:
    Dec 1, 2015
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Hip Injuries
    Cortisone

    Study Results

    No Results Posted as of Dec 29, 2015