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Clinical Trials/NCT03539588
NCT03539588CompletedNot Applicable

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

William Beaumont Army Medical Center1 site in 1 country30 target enrollmentStarted: April 12, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Numeric Pain Rating Scale to assess change

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •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

Arms & Interventions

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.

Intervention: trigger point dry needling (Device)

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.

Intervention: Electrical Stimulation (Device)

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.

Intervention: trigger point dry needling (Device)

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.

Intervention: Electrical Stimulation (Device)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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