Clinical trial NCT03539588: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sub-acute and Chronic Low Back Pain
Keywords: dry needling
electrical stimulation
E-Stim
LBP
low back pain
trigger point
chronic
subacute
Lead sponsor: William Beaumont Army Medical Center
Sponsor class: FED
First posted: 2018-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numeric Pain Rating Scale to assess change
timeFrame: Baseline and before and after each treatment session, duration per subject is approximately 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: El Paso
country: United States
facility: William BAMC
state: Texas
Study officials:
affiliation: WBAMC
name: David K Hulsizer, DPT
role: PRINCIPAL_INVESTIGATOR
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