Pain and Neck Dysfunction Following Dry Needling With and Without Intramuscular Electrical Stimulus.

Not Applicable

Completed

• Conditions: Shoulder Pain; Myofascial Pain; Neck Pain
• Interventions: Procedure: Dry Needling (DN); Procedure: Dry needling with Intramuscular electrical stimulation (DNES)

• Registration Number: NCT04057781
• Lead Sponsor: University of Mary Hardin-Baylor

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.

Study Timeline

• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-15
• Study Start: 2019-09-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dry Needling (DN)	Dry Needling (DN)	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).
Dry Needling with Intramuscular ES (DNES)	Dry needling with Intramuscular electrical stimulation (DNES)	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).

Primary Outcome Measures

Name	Time	Method
Change in Neck Disability Index (NDI)	6 weeks	Between group difference in within group disability changes. The NDI is a questionnaire with 10 items including personal care, pain, reading, lifting, headaches, concentration, sleeping, work, driving, and recreation. Each section is scored on a 0 to 5 rating scale. Zero means 'No pain' and 5 means 'Worst imaginable pain'. Al the points can be summed to a total score. The test can be reported as a raw score, with a maximum score of 50, or as a percentage.
Change in numerical pain rating scale (NPRS)between groups	6 weeks	Between group difference in within group pain changes. The NPRS is an 11 point (0-10) scale with 10 meaning "the worst imaginable pain" and 0 meaning "no pain". It is reported as a whole number out of 10, and multiple ratings, i.e. worst, average, and best pain scores over the past 48 hours, can be averaged and reported as a single score.

Secondary Outcome Measures

Name	Time	Method
Maintenance of improvement in pain scores (NPRS)	Compare 6 week data to 12 week data	Difference between pain scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment. Scale is 11 points (0-10) with 10 being "the Analysis of within group pain scores. The NPRS is an 11 point (0-10) scale with 10 meaning "the worst imaginable pain" and 0 meaning "no pain". It is reported as a whole number out of 10, and multiple ratings, i.e. worst, average, and best pain scores over the past 48 hours, can be averaged and reported as a single score.
Maintenance of improvement in disability (NDI)	Compare 6 week data to 12 week data	Difference between neck disability scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment. Between group difference in Analysis of within group disability changes. The NDI is a questionnaire with 10 items including personal care, pain, reading, lifting, headaches, concentration, sleeping, work, driving, and recreation. Each section is scored on a 0 to 5 rating scale. Zero means 'No pain' and 5 means 'Worst imaginable pain'. Al the points can be summed to a total score.; Difference between neck disability scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment.

Trial Locations

Locations (1)

University of Mary Hardin-Baylor; 🇺🇸 Belton, Texas, United States