- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04057781
Pain and Neck Dysfunction Following Dry Needling With and Without Intramuscular Electrical Stimulus. (DNvDNES-2019)
Pain and Neck Dysfunction Following Dry Needling With and Without Intramuscular Electrical Stimulus With 6 Week Follow Up
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Belton, Texas, United States, 76513
- University of Mary Hardin-Baylor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Active Comparator: 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). |
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.
|
Active Comparator: Dry Needling with Intramuscular ES (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). |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in numerical pain rating scale (NPRS)between groups
Time Frame: 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.
|
6 weeks
|
Change in Neck Disability Index (NDI)
Time Frame: 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.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maintenance of improvement in pain scores (NPRS)
Time Frame: 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.
|
Compare 6 week data to 12 week data
|
Maintenance of improvement in disability (NDI)
Time Frame: 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. |
Compare 6 week data to 12 week data
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DNvDNES-2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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