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

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ClinicalTrials.gov Identifier: NCT03638388
Recruitment Status : Completed
First Posted : August 20, 2018
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Kindyle Brennan, University of Mary Hardin-Baylor

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:

  1. 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)?
  2. 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?

Condition or disease Intervention/treatment Phase
Myofascial Pain Neck Pain Shoulder Pain Procedure: Dry needling (DN) Procedure: Dry needling with intramuscular electrical stimulation (DNES) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Rate and Maintenance of Improvement in Myofascial Pain: Dry Needling Alone vs Dry Needling With Intramuscular Electrical Stimulation
Actual Study Start Date : August 16, 2018
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : February 1, 2019

Arm Intervention/treatment
Active Comparator: Dry Needling (DN)

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).

Procedure: Dry needling (DN)
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.

Active Comparator: Dry Needling with Intramuscular electrical stimulation (DNES)

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).

Procedure: Dry needling with intramuscular electrical stimulation (DNES)
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 Measures :
  1. Rate of improvement in numerical pain rating scale between groups [ Time Frame: 6 weeks ]
    Between group difference in within group pain changes

  2. Rate of improvement in Neck Disability Index between groups [ Time Frame: 6 weeks ]
    Between group difference of within group disability changes


Secondary Outcome Measures :
  1. Maintenance of pain improvement in both groups [ Time Frame: week 6 compared to week 12 data ]
    Difference between pain scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment.

  2. Maintenance of disability improvement in both groups [ Time Frame: week 6 compared to week 12 data ]
    Difference between neck disability scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638388


Locations
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United States, Texas
University of Mary Hardin-Baylor
Belton, Texas, United States, 76513
Sponsors and Collaborators
Kindyle Brennan
Investigators
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Principal Investigator: Kindyle L. Brennan, PHD,PT University of Mary Hardin-Baylor

Publications:
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Responsible Party: Kindyle Brennan, Dr. Kindyle L. Brennan, Associate Professor, Doctor of Physical Therapy Program, College of Health Sciences, University of Mary Hardin-Baylor
ClinicalTrials.gov Identifier: NCT03638388     History of Changes
Other Study ID Numbers: DNvDN-ES
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neck Pain
Shoulder Pain
Myofascial Pain Syndromes
Pain
Neurologic Manifestations
Signs and Symptoms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases