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

Study Overview
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Brief Summary
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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: 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)? 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?

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

Conditions
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Myofascial Pain, Neck Pain, Shoulder 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 two groups in this study, DN alone and DN/IES. Each group will have approximately 22 subjects, resulting in approximately 44 subjects total. Subjects will be randomized into one of the two 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 |
| --- | --- |
| Active Comparator: Dry Needling (DN)<br>Subjects will receive dry needling treatment, once a week, for 6 weeks. Outcomes will be measured at baseline (week 0), 3 weeks after initiation of study (week 3), 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 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.<br>|
| Active Comparator: Dry Needling with Intramuscular electrical stimulation (DNES)<br>Subjects will receive dry needling treatment with electrical stimulation, once a week, for 6 weeks. Outcomes will be measured at baseline (week 0), 3 weeks after initiation of study (week 3), 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 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of improvement in numerical pain rating scale between groups | Between group difference in within group pain changes | 6 weeks | 
| Rate of improvement in Neck Disability Index between groups | Between group difference of within group disability changes | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |