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

Sub-acute and Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03539588
• Other study ID #: 16-26
• Status: Completed
• Phase: N/A
• Start date: April 12, 2017
• Est. completion date: November 13, 2017

Study information

• Verified date: May 2018
• Source: William Beaumont Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 13, 2017
• Est. primary completion date: November 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Sub-acute and Chronic Low Back Pain

Intervention

Device:
• trigger point dry needling
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
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.

Locations

Country	Name	City	State
United States	William BAMC	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (52)

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* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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