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
About this trial
This is an interventional treatment trial for Hip Injuries
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
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
NCT ID
NCT02639039
First Posted
December 2, 2015
Last Updated
December 28, 2015
Sponsor
Scott and White Hospital & Clinic
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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