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

May 16, 2018 updated by: William Beaumont Army Medical Center

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

trigger point dry needling with intramuscular electrical stimulation vs trigger point dry needling

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • El Paso, Texas, United States, 79920
        • William BAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and before and after each treatment session, duration per subject is approximately 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Beaumont Army Medical Center

Investigators

  • Principal Investigator: David K Hulsizer, DPT, WBAMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2017

Primary Completion (Actual)

November 13, 2017

Study Completion (Actual)

November 13, 2017

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

May 16, 2018

First Posted (Actual)

May 29, 2018

Study Record Updates

Last Update Posted (Actual)

May 29, 2018

Last Update Submitted That Met QC Criteria

May 16, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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