NCT07695402

Brief Summary

Myofascial trigger points in the upper trapezius muscle are a common cause of neck pain and may negatively affect pressure pain threshold, upper limb function, sleep quality, and quality of life. This randomized, sham-controlled clinical trial aimed to compare the effects of the Jones Technique, combined therapy (therapeutic ultrasound plus transcutaneous electrical nerve stimulation \[TENS\]), their combination, and a sham intervention in women with active upper trapezius myofascial trigger points. The primary outcome was pressure pain threshold. Secondary outcomes included pain intensity, upper limb disability, sleep quality, quality of life, physical activity level, and participant satisfaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2024

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

13 days

First QC Date

July 4, 2026

Last Update Submit

July 10, 2026

Conditions

Keywords

Upper TrapeziusJones TechniqueStrain CounterstrainTherapeutic UltrasoundTranscutaneous Electrical Nerve Stimulation

Outcome Measures

Primary Outcomes (2)

  • Pressure Pain Threshold (PPT)

    Pressure pain threshold assessed using a pressure algometer at five active myofascial trigger points in the upper trapezius muscle. The pressure pain threshold is recorded in kg/cm². Higher values indicate greater pressure tolerance and therefore a better outcome.

    Baseline and immediately after the intervention (single treatment session)

  • Pain Intensity

    Pain intensity assessed using the Visual Analog Scale for Pain (VAS). Scores range from 0 to 10 cm, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.

    Baseline and immediately after the intervention

Secondary Outcomes (5)

  • Upper Limb Disability

    Baseline

  • Sleep Quality

    Baseline

  • Quality of life

    Baseline

  • Physical Activity Level

    Baseline

  • Participant Satisfaction

    Immediately after the intervention

Study Arms (4)

Jones Technique

EXPERIMENTAL

Participants received a single session of the Jones Technique for the treatment of active myofascial trigger points in the upper trapezius muscle.

Procedure: Jones Technique

Combined Therapy

EXPERIMENTAL

Participants received a single session of combined therapy consisting of therapeutic ultrasound combined with transcutaneous electrical nerve stimulation (TENS) applied to active myofascial trigger points in the upper trapezius muscle.

Device: Combined Therapy (Therapeutic Ultrasound + TENS)

Combined Therapy + Jones Technique

EXPERIMENTAL

Participants received the Jones Technique followed immediately by combined therapy (therapeutic ultrasound plus transcutaneous electrical nerve stimulation \[TENS\]) during a single treatment session.

Combination Product: Combined Therapy + Jones Technique

Sham Control

SHAM COMPARATOR

Participants underwent all study assessments and received sham treatment consisting of inactive combined therapy (device turned off) and a simulated Jones Technique without therapeutic pressure.

Procedure: Sham Intervention

Interventions

Manual therapy technique applied to active myofascial trigger points of the upper trapezius muscle. Participants were positioned in prone lying, and sustained pressure with positional release was applied to each trigger point for 90 seconds. Five trigger points were treated during a single treatment session.

Jones Technique

Participants received the Jones Technique followed immediately by combined therapy (therapeutic ultrasound plus transcutaneous electrical nerve stimulation \[TENS\]) during a single treatment session.

Combined Therapy + Jones Technique

Participants underwent sham treatment consisting of inactive combined therapy with the device turned off and a simulated Jones Technique performed without therapeutic pressure.

Sham Control

Combined therapy consisting of pulsed therapeutic ultrasound (1 MHz, 20% duty cycle, 1.0 W/cm²) delivered simultaneously with transcutaneous electrical nerve stimulation (TENS; biphasic asymmetric waveform, 200 μs pulse duration, 100 Hz). Treatment was applied to five active upper trapezius myofascial trigger points during a single 10-minute session.

Combined Therapy

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female participants aged 18 to 40 years.
  • Presence of active myofascial trigger points in the upper trapezius muscle for no longer than 12 weeks.
  • Neck pain lasting less than 3 months.
  • Pain intensity of at least 3 cm on the 10-cm Visual Analog Scale (VAS).
  • Ability to understand the study procedures and provide written informed consent.

You may not qualify if:

  • Presence of a cardiac pacemaker or other contraindications to electrotherapy.
  • Pregnancy.
  • Uncontrolled cardiovascular disease.
  • Psychiatric disorders that could interfere with study participation.
  • Thrombosis or coagulation disorders.
  • History of tumors or neoplasms.
  • Physical therapy or myofascial treatment within the previous 3 weeks.
  • Treatment for myofascial trigger points within the previous 3 months.
  • Current use of analgesic medications.
  • Cervical musculoskeletal disorders (e.g., cervical osteoarthritis or other cervical lesions).
  • History of cervical trauma or surgery.
  • Cervical spondylosis or spondylolisthesis with radiculopathy.
  • Fibromyalgia or other systemic rheumatic diseases.
  • Other musculoskeletal disorders that could interfere with the study outcomes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy Teaching Clinic, Universidade do Vale do Rio dos Sinos (UNISINOS)

São Leopoldo, Rio Grande do Sul, Brazil

Location

MeSH Terms

Interventions

Ultrasonic TherapyTranscutaneous Electric Nerve StimulationPsychotherapy, Multiple

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeuticsElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 4, 2026

First Posted

July 10, 2026

Study Start

October 7, 2024

Primary Completion

October 20, 2024

Study Completion

December 20, 2024

Last Updated

July 14, 2026

Record last verified: 2026-07

Locations