Dry Needling vs Dry Needling With ES in Patients With Neck/Shoulder Pain

Neck Pain Clinical Trial

Official title:

Rate and Maintenance of Improvement in Myofascial Pain: Dry Needling Alone vs Dry Needling With Intramuscular Electrical Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638388
• Other study ID #: DNvDN-ES
• Status: Completed
• Phase: N/A
• Start date: August 16, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: March 2019
• Source: University of Mary Hardin-Baylor
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

First, we aim to determine if there is a difference in the rate of improvement, as measured by the Neck Disability Index (NDI) and Numerical Pain Rating Scale (NPRS), across a 6 week treatment period between those treated with DN only and those treated with DN and intramuscular electrical stimulation (IES) in subjects with upper trapezius active trigger points (aTrPs). Secondly, we want to determine if improvements in clinical outcomes (NDI and NPRS) of patients with upper trapezius active trigger points (aTrPs) treated with dry needling (DN) alone or dry needling with intramuscular electrical stimulation (DN/IES) are maintained 6 weeks post treatment without further intervention.

Research Questions:

1. Is there a difference in the rate of improvement in NDI and NPRS across a 6 week treatment period in subjects with upper trapezius active trigger points (aTrPs) between those treated with DN only and those treated with DN and intramuscular electrical stimulation (IES)?

2. Are improvements in clinical outcomes (NDI and NPRS) of patients with upper trapezius active trigger points (aTrPs) treated with dry needling (DN) maintained 6 weeks post treatment without further intervention? Tertiary exploration: If improvement is maintained, is there a difference in outcome maintenance between groups? Did improvement increase between 6 and 12 weeks?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

18-59 years old have an active email account have at least one palpable active trigger point (TrP) (located in one or both upper trapezius) English speaking

Exclusion Criteria:

current or previous history of cancer active infection neurologic deficit cognitive deficit pregnancy connective tissue disease and/or autoimmune disorder smoke tobacco received previous DN treatments within 6 weeks of the study, experienced unilateral or bilateral neck/shoulder pain continuously for 3 months or longer

Related Conditions & MeSH terms

• Myofascial Pain
• Myofascial Pain Syndromes
• Neck Pain
• Shoulder Pain

Intervention

Procedure:
• Dry needling (DN)
One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the tender area of my muscle. The needles will be repositioned a few times to make the muscle twitch. After several twitches occur, the researcher will leave the needles as they are, and the subject will sit in a chair without moving my arms or head, for 10 minutes. After 10 minutes the needles are removed and discarded.
• Dry needling with intramuscular electrical stimulation (DNES)
One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the tender area of the muscle. The needles will be repositioned a few times to make the muscle twitch. After several twitches occur, the researcher will leave the needles as they are, and attach alligator clips to the needles to provide electrical stimulus for 10 minutes while the subject sits in a chair without moving arms or head. After 10 minutes, the electrical stimulus will be turned off and detached, and the needles removed and discarded.

Locations

Country	Name	City	State
United States	University of Mary Hardin-Baylor	Belton	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Kindyle Brennan

Country where clinical trial is conducted

United States, 

References & Publications (4)

Cerezo-Téllez E, Torres-Lacomba M, Mayoral-Del Moral O, Sánchez-Sánchez B, Dommerholt J, Gutiérrez-Ortega C. Prevalence of Myofascial Pain Syndrome in Chronic Non-Specific Neck Pain: A Population-Based Cross-Sectional Descriptive Study. Pain Med. 2016 Dec;17(12):2369-2377. doi: 10.1093/pm/pnw114. Epub 2016 Jun 20. — View Citation

Liu L, Huang QM, Liu QG, Ye G, Bo CZ, Chen MJ, Li P. Effectiveness of dry needling for myofascial trigger points associated with neck and shoulder pain: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2015 May;96(5):944-55. doi: 10.1016/j.apmr.2014.12.015. Epub 2015 Jan 7. Review. — View Citation

Pilgrim J, Engelke Z. Patient Education: Teaching the patient about myofascial pain syndrome. CINAHL Nursing Guide. December 8, 2017;Available from: Nursing Reference Center Plus, Ipswich, MA. Accessed April 13, 2018.

Rock JM, Rainey CE. Treatment of nonspecific thoracic spine pain with trigger point dry needling and intramuscular electrical stimulation: a case series. Int J Sports Phys Ther. 2014 Oct;9(5):699-711. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of improvement in numerical pain rating scale between groups	Between group difference in within group pain changes	6 weeks
Primary	Rate of improvement in Neck Disability Index between groups	Between group difference of within group disability changes	6 weeks
Secondary	Maintenance of pain improvement in both groups	Difference between pain scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment.	week 6 compared to week 12 data
Secondary	Maintenance of disability improvement in both groups	Difference between neck disability scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment.	week 6 compared to week 12 data