NCT02639039

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2013

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 24, 2015

Completed
Last Updated

December 29, 2015

Status Verified

December 1, 2015

Enrollment Period

2.4 years

First QC Date

December 2, 2015

Last Update Submit

December 28, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Participants change in pain rating scores from baseline to 6 weeks will be accessed.

    Baseline and 6 weeks

  • Patient specific function score (PSPS) from baseline to 6 weeks will be accessed.

    Baseline and 6 weeks

Study Arms (2)

Cortisone Injection

ACTIVE COMPARATOR

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

Trigger Point Dry Needling

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Steroid injection
Cortisone Injection

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.

Trigger Point Dry Needling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hip Injuries

Interventions

CortisoneSteroids

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

PregnenesPregnanesFused-Ring CompoundsPolycyclic Compounds17-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Kindyle L Brennan, PhD

    Orthopedic Therapist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 24, 2015

Study Start

February 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 29, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share