NCT05846022

Brief Summary

The goal of this clinical trial is to compare the immediate effects of stimulating shoulder muscles with an acupuncture needle (dry needling) on people from thirty to forty-five years old with recurrent neck pain. The main questions this trial aims to answer are does dry needling tight shoulder muscles have an effect on:

  1. 1.the ability to turn your head with speed and accuracy,
  2. 2.your neck mobility,
  3. 3.pain,
  4. 4.the tenderness in the muscles,
  5. 5.change in your everyday function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

May 9, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

April 25, 2023

Last Update Submit

October 2, 2024

Conditions

Neck PainPsychomotor Disorders

Keywords

Dry needlingMyofascial trigger pointsUpper trapezius

Outcome Measures

Primary Outcomes (1)

  • Fitts' Head Turning Task

    The Fitts' head turning task, measures motor performance through the analysis of movement time. Fitts task experiments explore the relationship between speed and accuracy with tasks of varying degrees of difficulty- the goal of the Fitts' task is to move as quickly and accurately as possible to acquire a target. This head turning task employs a head mouse to track left and right movements with varying degrees of challenge (low, moderate, high).

    15 minutes

Secondary Outcomes (4)

  • Pressure algometry

    5 minutes

  • Visual Analogue Scale (VAS)

    1 minute

  • Neck Disability Index (NDI)

    5 minutes

  • Cervical Range of Motion (CROM)

    5-10 minutes

Study Arms (2)

Dry needling

EXPERIMENTAL

Dry needling involves the insertion of solid monofilament needles into tender points in tight muscle bands for therapeutic purposes.

Other: Dry Needling

Sham needling

SHAM COMPARATOR

Shallow penetration of a solid monofilament needle into the skin alone with the "in and out" plunging movement of the needle simulated with the needle's guide tube.

Other: Sham Needle

Interventions

Dry NeedlingOTHER

This dry needling study involves bilaterally insertion of a fine sterile needle into upper trapezius muscle fibers using a clean needling technique.

Dry needling
Sham NeedleOTHER

Shallow penetration of a solid monofilament needle into the skin alone with the "in and out" plunging movement of the needle simulated with the needle's guide tube.

Sham needling

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Recurrent neck pain (with a minimum of one episode of acute neck pain corresponding to the area covered by the UT muscle in the last three months)
  • a minimum of one palpable tender, taut band of muscle in the upper trapezius
  • dry needling naïve
  • have normal/corrected vision required for the Fitts' task
  • fluent in English.

You may not qualify if:

  • Currently experiencing an acute episode of neck pain,
  • treatment to the UT or cervical spine in the last 60 days
  • currently taking pain/nerve medications
  • presence of upper limb neurological signs or symptoms
  • any history of pathology, surgery to the cervical spine
  • trauma or accident involving the cervical spine
  • having general contraindications to needling (including pregnancy, acute trauma, fever or systemic infection and needle phobia)
  • local contraindications at the site of the needle insertion (including local infection, open wounds, burns, inflammation, cellulitis, and undiagnosed lumps)
  • precautions to needling (including history of bacterial endocarditis, heart valve replacement, pace-maker and near joint replacements).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

Location

MeSH Terms

Conditions

Neck PainPsychomotor Disorders

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Brian MacNeil, PhD

    University of Manitoba

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Only the physiotherapist administering the intervention of dry needling is aware of the group allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 6, 2023

Study Start

May 9, 2023

Primary Completion

June 19, 2023

Study Completion

June 30, 2023

Last Updated

October 4, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)