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Dry Needling vs Dry Needling With ES in Patients With Neck/Shoulder Pain

Primary Purpose

Myofascial Pain, Neck Pain, Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry needling (DN)
Dry needling with intramuscular electrical stimulation (DNES)
Sponsored by
Kindyle Brennan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

18-59 years old have an active email account have at least one palpable active trigger point (TrP) (located in one or both upper trapezius) English speaking

Exclusion Criteria:

current or previous history of cancer active infection neurologic deficit cognitive deficit pregnancy connective tissue disease and/or autoimmune disorder smoke tobacco received previous DN treatments within 6 weeks of the study, experienced unilateral or bilateral neck/shoulder pain continuously for 3 months or longer

Sites / Locations

  • University of Mary Hardin-Baylor

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dry Needling (DN)

Dry Needling with Intramuscular electrical stimulation (DNES)

Arm Description

Subjects will receive dry needling treatment, once a week, for 6 weeks. Outcomes will be measured at baseline (week 0), 3 weeks after initiation of study (week 3), 6 weeks after initiation of study (week 6), and 6 weeks after last treatment (week 12).

Subjects will receive dry needling treatment with electrical stimulation, once a week, for 6 weeks. Outcomes will be measured at baseline (week 0), 3 weeks after initiation of study (week 3), 6 weeks after initiation of study (week 6), and 6 weeks after last treatment (week 12).

Outcomes

Primary Outcome Measures

Rate of improvement in numerical pain rating scale between groups
Between group difference in within group pain changes
Rate of improvement in Neck Disability Index between groups
Between group difference of within group disability changes

Secondary Outcome Measures

Maintenance of pain improvement in both groups
Difference between pain scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment.
Maintenance of disability improvement in both groups
Difference between neck disability scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment.

Full Information

First Posted
August 16, 2018
Last Updated
March 21, 2019
Sponsor
Kindyle Brennan
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1. Study Identification

Unique Protocol Identification Number
NCT03638388
Brief Title
Dry Needling vs Dry Needling With ES in Patients With Neck/Shoulder Pain
Official Title
Rate and Maintenance of Improvement in Myofascial Pain: Dry Needling Alone vs Dry Needling With Intramuscular Electrical Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 16, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kindyle Brennan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
First, we aim to determine if there is a difference in the rate of improvement, as measured by the Neck Disability Index (NDI) and Numerical Pain Rating Scale (NPRS), across a 6 week treatment period between those treated with DN only and those treated with DN and intramuscular electrical stimulation (IES) in subjects with upper trapezius active trigger points (aTrPs). Secondly, we want to determine if improvements in clinical outcomes (NDI and NPRS) of patients with upper trapezius active trigger points (aTrPs) treated with dry needling (DN) alone or dry needling with intramuscular electrical stimulation (DN/IES) are maintained 6 weeks post treatment without further intervention. Research Questions: Is there a difference in the rate of improvement in NDI and NPRS across a 6 week treatment period in subjects with upper trapezius active trigger points (aTrPs) between those treated with DN only and those treated with DN and intramuscular electrical stimulation (IES)? Are improvements in clinical outcomes (NDI and NPRS) of patients with upper trapezius active trigger points (aTrPs) treated with dry needling (DN) maintained 6 weeks post treatment without further intervention? Tertiary exploration: If improvement is maintained, is there a difference in outcome maintenance between groups? Did improvement increase between 6 and 12 weeks?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain, Neck Pain, Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental There will be two groups in this study, DN alone and DN/IES. Each group will have approximately 22 subjects, resulting in approximately 44 subjects total. Subjects will be randomized into one of the two groups via block randomization method based on order of entry into the study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Needling (DN)
Arm Type
Active Comparator
Arm Description
Subjects will receive dry needling treatment, once a week, for 6 weeks. Outcomes will be measured at baseline (week 0), 3 weeks after initiation of study (week 3), 6 weeks after initiation of study (week 6), and 6 weeks after last treatment (week 12).
Arm Title
Dry Needling with Intramuscular electrical stimulation (DNES)
Arm Type
Active Comparator
Arm Description
Subjects will receive dry needling treatment with electrical stimulation, once a week, for 6 weeks. Outcomes will be measured at baseline (week 0), 3 weeks after initiation of study (week 3), 6 weeks after initiation of study (week 6), and 6 weeks after last treatment (week 12).
Intervention Type
Procedure
Intervention Name(s)
Dry needling (DN)
Intervention Description
One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the tender area of my muscle. The needles will be repositioned a few times to make the muscle twitch. After several twitches occur, the researcher will leave the needles as they are, and the subject will sit in a chair without moving my arms or head, for 10 minutes. After 10 minutes the needles are removed and discarded.
Intervention Type
Procedure
Intervention Name(s)
Dry needling with intramuscular electrical stimulation (DNES)
Intervention Description
One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the tender area of the muscle. The needles will be repositioned a few times to make the muscle twitch. After several twitches occur, the researcher will leave the needles as they are, and attach alligator clips to the needles to provide electrical stimulus for 10 minutes while the subject sits in a chair without moving arms or head. After 10 minutes, the electrical stimulus will be turned off and detached, and the needles removed and discarded.
Primary Outcome Measure Information:
Title
Rate of improvement in numerical pain rating scale between groups
Description
Between group difference in within group pain changes
Time Frame
6 weeks
Title
Rate of improvement in Neck Disability Index between groups
Description
Between group difference of within group disability changes
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Maintenance of pain improvement in both groups
Description
Difference between pain scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment.
Time Frame
week 6 compared to week 12 data
Title
Maintenance of disability improvement in both groups
Description
Difference between neck disability scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment.
Time Frame
week 6 compared to week 12 data

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-59 years old have an active email account have at least one palpable active trigger point (TrP) (located in one or both upper trapezius) English speaking Exclusion Criteria: current or previous history of cancer active infection neurologic deficit cognitive deficit pregnancy connective tissue disease and/or autoimmune disorder smoke tobacco received previous DN treatments within 6 weeks of the study, experienced unilateral or bilateral neck/shoulder pain continuously for 3 months or longer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kindyle L. Brennan, PHD,PT
Organizational Affiliation
University of Mary Hardin-Baylor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mary Hardin-Baylor
City
Belton
State/Province
Texas
ZIP/Postal Code
76513
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28025371
Citation
Cerezo-Tellez E, Torres-Lacomba M, Mayoral-Del Moral O, Sanchez-Sanchez B, Dommerholt J, Gutierrez-Ortega C. Prevalence of Myofascial Pain Syndrome in Chronic Non-Specific Neck Pain: A Population-Based Cross-Sectional Descriptive Study. Pain Med. 2016 Dec;17(12):2369-2377. doi: 10.1093/pm/pnw114. Epub 2016 Jun 20.
Results Reference
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Citation
Pilgrim J, Engelke Z. Patient Education: Teaching the patient about myofascial pain syndrome. CINAHL Nursing Guide. December 8, 2017;Available from: Nursing Reference Center Plus, Ipswich, MA. Accessed April 13, 2018.
Results Reference
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PubMed Identifier
25576642
Citation
Liu L, Huang QM, Liu QG, Ye G, Bo CZ, Chen MJ, Li P. Effectiveness of dry needling for myofascial trigger points associated with neck and shoulder pain: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2015 May;96(5):944-55. doi: 10.1016/j.apmr.2014.12.015. Epub 2015 Jan 7.
Results Reference
background
PubMed Identifier
25328832
Citation
Rock JM, Rainey CE. Treatment of nonspecific thoracic spine pain with trigger point dry needling and intramuscular electrical stimulation: a case series. Int J Sports Phys Ther. 2014 Oct;9(5):699-711.
Results Reference
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Dry Needling vs Dry Needling With ES in Patients With Neck/Shoulder Pain

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