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Completed

NCT Number: NCT04057781

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

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.

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Key information

Conditions

Neck Pain Arthralgia Joint Diseases Musculoskeletal Diseases Myofascial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Mary Hardin-Baylor

Belton, Texas, 76513, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Mary Hardin-Baylor

Other

Registry information

Official study title

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

Acronym: DNvDNES-2019

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 15, 2019
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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