Clinical trial NCT04057781: Pain and Neck Dysfunction Following Dry Needling With and Without Intramuscular Electrical Stimulus.
Official title: Pain and Neck Dysfunction Following Dry Needling With and Without Intramuscular Electrical Stimulus With 6 Week Follow Up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Shoulder Pain
Myofascial Pain
Lead sponsor: University of Mary Hardin-Baylor
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental There will be three groups in this study; control, DN alone and DN/IES. Each group will have approximately 20 subjects, resulting in approximately 60 subjects total. Subjects will be randomized into one of the three groups via block randomization method based on order of entry into the study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in numerical pain rating scale (NPRS)between groups
timeFrame: 6 weeks
measure: Change in Neck Disability Index (NDI)
timeFrame: 6 weeks
Secondary outcomes:
measure: Maintenance of improvement in pain scores (NPRS)
timeFrame: Compare 6 week data to 12 week data
measure: Maintenance of improvement in disability (NDI)
timeFrame: Compare 6 week data to 12 week data
Other outcomes:
Locations:
city: Belton
country: United States
facility: University of Mary Hardin-Baylor
state: Texas
Study officials:
References: