NCT06054672

Brief Summary

This study will investigate the effect of subthreshold stimulation on pain and muscle activity in patients with chronic low neck pain and myofascial trigger points.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

September 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

September 8, 2023

Last Update Submit

September 19, 2023

Conditions

Chronic Neck Pain

Outcome Measures

Primary Outcomes (2)

  • Electromyographical signals

    We will record the the Trapezius muscle activity of both sides.

    2 months

  • Pressure sensitivity using pressure ergometer

    We will measure pain threshold produced from Trapezius muscle

    2 months

Secondary Outcomes (2)

  • Neck pain and disability

    2 months

  • Functional ability

    2 months

Study Arms (2)

Group 1

EXPERIMENTAL

This group will receive subthreshold stimulation

Device: Subthreshold Electrical stimulation

Group II

NO INTERVENTION

This group will receive no stimulation

Interventions

Subthreshold Electrical stimulationDEVICE

We will use a electrotherapy device to deliver subthreshold Electrical stimulation

Group 1

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic neck pain
  • One or more trigger point

You may not qualify if:

  • any musculoskeletal or neuromuscular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 26, 2023

Study Start

September 30, 2023

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

September 26, 2023

Record last verified: 2023-09