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Pain and Neck Dysfunction Following Dry Needling With and Without Intramuscular Electrical Stimulus. (DNvDNES-2019)

U

University of Mary Hardin-Baylor

Status

Completed

Conditions

Shoulder Pain
Myofascial Pain
Neck Pain

Treatments

Procedure: Dry Needling (DN)
Procedure: Dry needling with Intramuscular electrical stimulation (DNES)

Study type

Interventional

Funder types

Other

Identifiers

NCT04057781
DNvDNES-2019

Details and patient eligibility

About

Participants will be 18-59 years old who are recruited through a convenience sample from the UMHB/Belton community. There will be a randomized control trial consisting of three groups. Each participant will be assigned based on their order of entry to the study group assignment and then randomly organized via computer generation into 3 groups of 20 participants including a control group, a dry needling group (DN), and a dry needling E-stim group (DN-ES), resulting in approximately 60 total participants. Participants in the DN and DN-ES groups will be treated four times; at weeks 0, 2, 4 and 6 of the study. Data will be collected at weeks 4, 6 and 12 in all groups.

Full description

Interventions per group:

Control: none

DN: 20-30 seconds of DN per trigger point in each involved trapezius muscle, needles rest in situ 10 min, needles removed.

DN-ES: 20-30 seconds of DN per trigger point (TrP) in each involved trapezius muscle, DC ES attached to needles crossing the most reactive TrP and current set to strong, but comfortable intensity at 10 MHz for 10 min, needles removed.

Enrollment

23 patients

Sex

All

Ages

18 to 59 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. 18-59 years old
  2. have an active email account
  3. have at least one palpable active trigger point (TrP) (located in one or both upper trapezius)
  4. English speaking

Exclusion criteria

  1. current treatment or diagnosis related to cancer
  2. active local or systemic infection
  3. neurologic deficit
  4. cognitive deficit
  5. pregnancy
  6. connective tissue disease and/or autoimmune disorder
  7. tobacco use
  8. received previous DN treatments within 6 weeks of the study,
  9. experienced unilateral or bilateral neck/shoulder pain continuously for 3 months or longer
  10. Neck Disability Index score < 6
  11. Numerical Pain Rating Scale score < 3

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

23 participants in 3 patient groups

Control
No Intervention group
Dry Needling (DN)
Active Comparator group
Description:
Subjects will receive dry needling treatment every 2 weeks for 6 weeks (weeks 0, 2, 4, 6). Outcomes will be measured at baseline (week 0), 4 weeks after initiation of study (week 4), 6 weeks after initiation of study (week 6), and 6 weeks after last treatment (week 12).
Treatment:
Procedure: Dry Needling (DN)
Dry Needling with Intramuscular ES (DNES)
Active Comparator group
Description:
Subjects will receive dry needling treatment with electrical stimulation every 2 weeks for 6 weeks (week 0, 2, 4, 6) Outcomes will be measured at baseline (week 0), 4 weeks after initiation of study (week 4), 6 weeks after initiation of study (week 6), and 6 weeks after last treatment (week 12).
Treatment:
Procedure: Dry needling with Intramuscular electrical stimulation (DNES)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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