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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pain and Neck Dysfunction Following Dry Needling With and Without Intramuscular Electrical Stimulus With 6 Week Follow Up

Conditions
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Neck Pain, Shoulder Pain, Myofascial Pain

Intervention / Treatment
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* Procedure: Dry Needling (DN)
* Procedure: Dry needling with Intramuscular electrical stimulation (DNES)


Participation Criteria
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Eligibility Criteria
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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 treatment or diagnosis related to cancer active local or systemic infection neurologic deficit cognitive deficit pregnancy connective tissue disease and/or autoimmune disorder tobacco use received previous DN treatments within 6 weeks of the study, experienced unilateral or bilateral neck/shoulder pain continuously for 3 months or longer Neck Disability Index score < 6 Numerical Pain Rating Scale score < 3

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Active Comparator: Dry Needling (DN)<br>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). | Procedure: Dry Needling (DN)<br>* One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the trigger point(s) of the muscle. The needles will be repositioned a few times to make the muscle twitch (local twitch response). After several twitches occur, the researcher will leave the needles as they are, and the subject will lie on a treatment table without moving arms or head, for 10 minutes. After 10 minutes the needles are removed and discarded.<br>|
| Active Comparator: Dry Needling with Intramuscular ES (DNES)<br>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). | Procedure: Dry needling with Intramuscular electrical stimulation (DNES)<br>* One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the trigger point(s) of the muscle. The needles will be repositioned a few times to make the muscle twitch (local twitch response). 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 lies on a treatment table without moving arms or head. After 10 minutes, the electrical stimulus will be turned off and detached, and the needles removed and discarded.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in numerical pain rating scale (NPRS)between groups | 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. | 6 weeks | 
| Change in Neck Disability Index (NDI) | 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of improvement in pain scores (NPRS) | 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. | Compare 6 week data to 12 week data | 
| Maintenance of improvement in disability (NDI) | 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. | Compare 6 week data to 12 week data |