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

NCT ID: NCT04057781

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-01-01

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.

Conditions

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Neck Pain Shoulder Pain Myofascial Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type ACTIVE_COMPARATOR

Dry Needling (DN)

Intervention Type PROCEDURE

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.

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).

Group Type ACTIVE_COMPARATOR

Dry needling with Intramuscular electrical stimulation (DNES)

Intervention Type PROCEDURE

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.

Interventions

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Dry Needling (DN)

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.

Intervention Type PROCEDURE

Dry needling with Intramuscular electrical stimulation (DNES)

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Mary Hardin-Baylor

OTHER

Sponsor Role lead

Responsible Party

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Kindyle Brennan

Associate Professor, Doctor of Physical Therapy Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Mary Hardin-Baylor

Belton, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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DNvDNES-2019

Identifier Type: -

Identifier Source: org_study_id