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Completed

NCT Number: NCT03539588

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

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

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Key information

Conditions

Sub-Acute and Chronic Low Back Pain Back Pain Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Low Back Pain Lung Diseases Lung Diseases, Obstructive Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

William BAMC

El Paso, Texas, 79920, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

William Beaumont Army Medical Center

Fed

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 29, 2018
Registry last updated
May 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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