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

NCT04057781 | Completed

• 1 other identifier: DNvDNES-2019
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain; Shoulder Pain; Myofascial Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Maintenance of improvement in pain scores (NPRS)

  Compare 6 week data to 12 week data

• Maintenance of improvement in disability (NDI)

  Compare 6 week data to 12 week data

Study Arms (3)

Control

NO INTERVENTION

Dry Needling (DN)

ACTIVE COMPARATOR

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)

Dry Needling with Intramuscular ES (DNES)

ACTIVE COMPARATOR

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)

Interventions

Dry Needling (DN) 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 (DN)

Dry needling with Intramuscular electrical stimulation (DNES) 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.

Dry Needling with Intramuscular ES (DNES)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mary Hardin-Baylor: lead

Study Sites (1)

University of Mary Hardin-Baylor

Belton, Texas, 76513, United States

Location

MeSH Terms

Conditions

Neck Pain; Shoulder Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Doctor of Physical Therapy Program

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 15, 2019
• Study Start: September 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)