- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07695402
Combined Therapy and Jones Technique for Upper Trapezius Myofascial Trigger Points
Clinical Effects of Combined Therapy, Jones Technique, and Their Combination in Women With Upper Trapezius Myofascial Trigger Points: A Four-Arm Randomized Controlled Trial
Study Overview
Status
Detailed Description
Myofascial trigger points (MTrPs) in the upper trapezius muscle are frequently associated with neck pain, reduced pressure pain threshold, and impaired upper limb function. Several conservative interventions have been proposed for the treatment of MTrPs; however, evidence comparing manual therapy and combined electrotherapy remains limited.
This single-center, randomized, sham-controlled, parallel-group clinical trial evaluated the effects of the Jones Technique and combined therapy (therapeutic ultrasound plus transcutaneous electrical nerve stimulation [TENS]) in women aged 18 to 40 years presenting with active myofascial trigger points in the upper trapezius muscle.
Participants were randomly allocated (1:1:1:1) into four groups: (1) Jones Technique; (2) combined therapy; (3) combined therapy plus Jones Technique; and (4) sham control. Randomization was performed using block randomization stratified by age. Participants underwent a single treatment session.
Baseline assessments included demographic data, pain intensity measured using the Visual Analog Scale (VAS), pressure pain threshold measured with a pressure algometer, upper limb disability (DASH), sleep quality (Pittsburgh Sleep Quality Index), quality of life (SF-36), and physical activity level (IPAQ). Immediately after the intervention, pain intensity, pressure pain threshold, and participant satisfaction were reassessed.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rio Grande do Sul
-
São Leopoldo, Rio Grande do Sul, Brazil
- Physical Therapy Teaching Clinic, Universidade do Vale do Rio dos Sinos (UNISINOS)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Jones Technique
Participants received a single session of the Jones Technique for the treatment of active myofascial trigger points in the upper trapezius muscle.
|
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.
|
|
Experimental: Combined Therapy
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.
|
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.
|
|
Experimental: Combined Therapy + 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.
|
Participants received the Jones Technique followed immediately by combined therapy (therapeutic ultrasound plus transcutaneous electrical nerve stimulation [TENS]) during a single treatment session.
|
|
Sham Comparator: Sham Control
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.
|
Participants underwent sham treatment consisting of inactive combined therapy with the device turned off and a simulated Jones Technique performed without therapeutic pressure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Pain Threshold (PPT)
Time Frame: Baseline and immediately after the intervention (single treatment session)
|
Pressure pain threshold measured with a pressure algometer at five active myofascial trigger points in the upper trapezius muscle.
Three measurements were obtained at each assessment
|
Baseline and immediately after the intervention (single treatment session)
|
|
Pain Intensity
Time Frame: Baseline and immediately after the intervention
|
Pain intensity measured using a 10-cm Visual Analog Scale (VAS).
|
Baseline and immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper Limb Disability
Time Frame: Baseline
|
Upper limb disability assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
|
Baseline
|
|
Sleep Quality
Time Frame: Baseline
|
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).
|
Baseline
|
|
Quality of life
Time Frame: Baseline
|
Quality of life assessed using the 36-Item Short Form Health Survey (SF-36).
|
Baseline
|
|
Physical Activity Level
Time Frame: Baseline
|
Physical activity level assessed using the International Physical Activity Questionnaire (IPAQ).
|
Baseline
|
|
Participant Satisfaction
Time Frame: Immediately after the intervention
|
Participant satisfaction assessed immediately after treatment using a Likert scale.
|
Immediately after the intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7.119.287
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myofascial Trigger Points
-
Beijing Tiantan HospitalRecruitingShoulder Osteoarthritis | Chronic Musculoskeletal Pain | Myofascial Trigger PointsChina
-
Kyungnam UniversityCompletedLatent Myofascial Trigger Points | Upper Trapezius MuscleSouth Korea
-
University of Castilla-La ManchaCompletedMyofascial Pain | Myofascial Trigger PointsSpain
-
GF Strong Rehabilitation CentreCompletedMyofascial Trigger Points
-
Mayuben Private ClinicCompletedBilateral Latent Myofascial Trigger Points of Flexor Digitorum BrevisSpain
-
Eastern Mediterranean UniversityNot yet recruitingChronic Neck Pain | Myofascial Trigger Points | Non-specific Neck Pain | Myofascial Pain Syndrome - NeckCyprus
-
Canadian Memorial Chiropractic CollegeUniversity of GuelphCompletedMyofascial Pain Syndrome | Myofascial Trigger Points | Trigger Points, MyofascialCanada
-
Beijing Tiantan HospitalRecruitingChronic Migraine Headache | Myofascial Trigger Points | Greater Occipital Nerve BlockChina
-
Foundation University IslamabadRecruitingMyofascial Pain Syndromes | Trigger Points | Gastrocnemius MusclePakistan
-
University of KyreniaRecruitingTrigger Points, Myofascial | Myofascial Pain Dysfunction Syndrome | Trigger Point in Trapezius MuscleCyprus
Clinical Trials on Jones Technique
-
Blanca González SanchezCompleted
-
Riphah International UniversityNot yet recruitingCervicogenic HeadachePakistan
-
Riphah International UniversityRecruitingCervicogenic HeadachePakistan
-
King Edward Medical UniversityMayo Hospital LahoreRecruiting
-
Mahidol UniversityCompletedPostoperative Blood LossThailand
-
Cairo UniversityNot yet recruiting
-
Universidad Católica San Antonio de MurciaCompletedLow Back Pain | Trigger Point Pain, MyofascialSpain
-
Universidad Católica San Antonio de MurciaCompletedNeck Pain | Trigger Point Pain, MyofascialSpain
-
University of DuhokCompletedChildren, Only | Fracture Distal RadiusIraq
-
University of BolognaRecruitingAbdominal Aortic Aneurysm | Endovascular Aortic RepairItaly