NCT04045457

Brief Summary

Determine the effect of dry needling using a 32 gauge needle on active trigger points in subjects with chronic myofascial pain. Participants will receive treatment for active trigger points (3 on successive weeks) and will have pain, status of the trigger point and functional measures assessed at baseline, after treatment and eight weeks later.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

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

August 1, 2010

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2016

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

5.6 years

First QC Date

June 10, 2016

Last Update Submit

August 2, 2019

Conditions

Keywords

active trigger points

Outcome Measures

Primary Outcomes (3)

  • Verbal Analog Scale

    scale of 0-10 as a measure of pain severity

    change from baseline to 3 weeks and at 8 weeks

  • Presence of myofascial trigger point

    Digital palpation of the trigger point was performed by investigators and scored as present or absent; if present was it associated with spontaneous pain or was pain induced with palpation

    change from baseline to 3 weeks and at 8 weeks

  • Brief Pain Inventory

    Validated scale of pain severity and interference

    change from baseline to 3 weeks and at 8 weeks

Secondary Outcomes (5)

  • Oswestry Disability Scale

    change from baseline to 3 weeks and at 8 weeks

  • MOS-short form 36 v2

    change from baseline to 3 weeks and at 8 weeks

  • Manual Muscle test

    change from baseline to 3 weeks and at 8 weeks

  • Profile of Mood States

    change from baseline to 3 weeks and at 8 weeks

  • range of motion

    change from baseline to 3 weeks and at 8 weeks

Study Arms (1)

SIngle arm

OTHER

Single arm, intervention All recipients were treated with dry needling technique into active myofascial trigger points They received 1 treatment weekly for three weeks.

Procedure: dry needling

Interventions

dry needlingPROCEDURE

insertion of needle into active myofascial trigger point

SIngle arm

Eligibility Criteria

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

You may qualify if:

  • spontaneous soft tissue pain in shoulder and neck region

You may not qualify if:

  • recent fracture, neurological injury or history of stroke, use of opioids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Turo D, Otto P, Hossain M, Gebreab T, Armstrong K, Rosenberger WF, Shao H, Shah JP, Gerber LH, Sikdar S. Novel Use of Ultrasound Elastography to Quantify Muscle Tissue Changes After Dry Needling of Myofascial Trigger Points in Patients With Chronic Myofascial Pain. J Ultrasound Med. 2015 Dec;34(12):2149-61. doi: 10.7863/ultra.14.08033. Epub 2015 Oct 21.

  • Gerber LH, Shah J, Rosenberger W, Armstrong K, Turo D, Otto P, Heimur J, Thaker N, Sikdar S. Dry Needling Alters Trigger Points in the Upper Trapezius Muscle and Reduces Pain in Subjects With Chronic Myofascial Pain. PM R. 2015 Jul;7(7):711-718. doi: 10.1016/j.pmrj.2015.01.020. Epub 2015 Feb 4.

  • Gerber LH, Sikdar S, Armstrong K, Diao G, Heimur J, Kopecky J, Turo D, Otto P, Gebreab T, Shah J. A systematic comparison between subjects with no pain and pain associated with active myofascial trigger points. PM R. 2013 Nov;5(11):931-8. doi: 10.1016/j.pmrj.2013.06.006. Epub 2013 Jun 28.

  • Turo D, Otto P, Shah JP, Heimur J, Gebreab T, Zaazhoa M, Armstrong K, Gerber LH, Sikdar S. Ultrasonic characterization of the upper trapezius muscle in patients with chronic neck pain. Ultrason Imaging. 2013 Apr;35(2):173-87. doi: 10.1177/0161734612472408.

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 10, 2016

First Posted

August 5, 2019

Study Start

August 1, 2010

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 5, 2019

Record last verified: 2019-08