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

NCT03539588 | Completed

• 1 other identifier: 16-26
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sub-acute and Chronic Low Back Pain

Keywords

dry needling; electrical stimulation; E-Stim; LBP; low back pain; trigger point; chronic; subacute

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale to assess change

  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

Study Arms (2)

Treatment group 1

ACTIVE COMPARATOR

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; Device: Electrical Stimulation

Treatment Group 2

ACTIVE COMPARATOR

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; Device: Electrical Stimulation

Interventions

trigger point dry needling DEVICE

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.

Treatment Group 2; Treatment group 1

Electrical Stimulation DEVICE

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.

Treatment Group 2; Treatment group 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• William Beaumont Army Medical Center: lead

Study Sites (1)

William BAMC

El Paso, Texas, 79920, United States

Location

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MeSH Terms

Conditions

Low Back Pain; Bronchiolitis Obliterans Syndrome

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• David K Hulsizer, DPT

  WBAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: May 29, 2018
• Study Start: April 12, 2017
• Primary Completion: November 13, 2017
• Study Completion: November 13, 2017
• Last Updated: May 29, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)