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

Primary Purpose

Sub-acute and Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
trigger point dry needling
Electrical Stimulation
Sponsored by
William Beaumont Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sub-acute and Chronic Low Back Pain focused on measuring dry needling, electrical stimulation, E-Stim, LBP, low back pain, trigger point, chronic, subacute

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • William BAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Treatment group 1

Treatment Group 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale to assess change
an 11 point scale on which the participant will grade their pain

Secondary Outcome Measures

Full Information

First Posted
March 10, 2017
Last Updated
May 16, 2018
Sponsor
William Beaumont Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03539588
Brief Title
Trigger Point Dry Needling vs Trigger Point Dry Needling With Intramuscular Electrical Stimulation
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 12, 2017 (Actual)
Primary Completion Date
November 13, 2017 (Actual)
Study Completion Date
November 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
William Beaumont Army Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sub-acute and Chronic Low Back Pain
Keywords
dry needling, electrical stimulation, E-Stim, LBP, low back pain, trigger point, chronic, subacute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment Group 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
trigger point dry needling
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Electrical Stimulation
Intervention Description
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 Measure Information:
Title
Numeric Pain Rating Scale to assess change
Description
an 11 point scale on which the participant will grade their pain
Time Frame
Baseline and before and after each treatment session, duration per subject is approximately 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David K Hulsizer, DPT
Organizational Affiliation
WBAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
William BAMC
City
El Paso
State/Province
Texas
ZIP/Postal Code
79920
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Trigger Point Dry Needling vs Trigger Point Dry Needling With Intramuscular Electrical Stimulation

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