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Trigger Point Dry Needling vs Trigger Point Dry Needling With Intramuscular Electrical Stimulation

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ClinicalTrials.gov Identifier: NCT03539588
Recruitment Status : Completed
First Posted : May 29, 2018
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
William Beaumont Army Medical Center

Brief Summary:
trigger point dry needling with intramuscular electrical stimulation vs trigger point dry needling

Condition or disease Intervention/treatment Phase
Sub-acute and Chronic Low Back Pain Device: trigger point dry needling Device: Electrical Stimulation Not Applicable

Detailed Description:
The purpose of this study is to evaluate if trigger point dry needling with intramuscular electrical stimulation is more effective in decreasing pain and disability in individuals with sub-acute and chronic low back pain (LBP) than with trigger point dry needling alone. The investigators are using a within subjects randomized crossover study that will recruit 30 active duty military personnel or beneficiaries from William Beaumont Army Medical Center and all associated clinics. The investigators hypothesize that individuals with LBP will exhibit larger improvements in pain and disability when receiving trigger point dry needling with intramuscular electrical stimulation than when receiving trigger point dry needling alone.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trigger Point Dry Needling vs Trigger Point Dry Needling With Intramuscular Electrical Stimulation for the Treatment of Sub-acute and Chronic Low Back Pain in a Military Population: A Randomized Crossover Design
Actual Study Start Date : April 12, 2017
Actual Primary Completion Date : November 13, 2017
Actual Study Completion Date : November 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Treatment group 1
In this group participants will receive trigger point dry needling with electrical stimulation first and receive trigger point needling by itself second. Only MYOTECH dry needles will be used in this study. However we are not studying the equipment.
Device: trigger point dry needling
placement of the dry needle into the muscle tissue to elicit a local twitch response. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.

Device: Electrical Stimulation
uses the dry needles as nodes to stimulate muscular contraction. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.

Active Comparator: Treatment Group 2
In this group the participants will receive trigger point dry needling first and receive trigger point dry needling with electrical stimulation second. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.
Device: trigger point dry needling
placement of the dry needle into the muscle tissue to elicit a local twitch response. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.

Device: Electrical Stimulation
uses the dry needles as nodes to stimulate muscular contraction. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.




Primary Outcome Measures :
  1. Numeric Pain Rating Scale to assess change [ Time Frame: Baseline and before and after each treatment session, duration per subject is approximately 3 weeks ]
    an 11 point scale on which the participant will grade their pain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently experience low back pain for greater than 4 weeks (Low back pain defined as pain below the T12th vertebrae with or without radiation) Military or DOD Beneficiary (any branch; 18-65 years of age)

Exclusion Criteria:

  • Structural Deformity (ankylosing Spondylitis, Scoliosis)
  • Has any other Orthopedic condition that may keep subject from performing Low - Back Exercises
  • Tumors
  • Spinal infection or local infection
  • Pregnancy-All female subjects will be given either a blood serum or urine pregnancy test.
  • Spinal cord compression or Cauda Equina Syndrome
  • Subject with the inability to keep appointments
  • Has History of prior surgery
  • Has received Dry Needling or Acupuncture in the last 6 months
  • History of bleeding disorders
  • High anti-coagulant use
  • History of immune suppression

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): NCT03539588


Locations
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United States, Texas
William BAMC
El Paso, Texas, United States, 79920
Sponsors and Collaborators
William Beaumont Army Medical Center
Investigators
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Principal Investigator: David K Hulsizer, DPT WBAMC
Publications:
April 2012 - v19_n04 - v19_n04.pdf." Accessed May 18, 2016. https://www.afhsc.mil/documents/pubs/msmrs/2012/v19_n04.pdf#Page=2.
Tough, Elizabeth A., and Adrian R. White. "Effectiveness of Acupuncture/dry Needling for Myofascial Trigger Point Pain." Physical Therapy Reviews 16, no. 2 (2011): 147-54.

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Responsible Party: William Beaumont Army Medical Center
ClinicalTrials.gov Identifier: NCT03539588    
Other Study ID Numbers: 16-26
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: May 29, 2018
Last Verified: May 2018
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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by William Beaumont Army Medical Center:
dry needling
electrical stimulation
E-Stim
LBP
low back pain
trigger point
chronic
subacute
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations