NCT06982456

Brief Summary

The main objective of this study is to evaluate the effectiveness of different manual therapy techniques in the treatment of cervical pain related to the upper trapezius muscle. The intervention will compare the effects of superficial massage, deep massage, and pressure release technique on pain intensity, assessed through algometry. Additionally, the study aims to determine whether the application of passive stretching following manual treatment leads to a significantly greater reduction in pain compared to groups that do not receive stretching. Finally, the persistence of treatment effects will be evaluated one and two weeks after the intervention.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

May 13, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

May 19, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

18 days

First QC Date

May 13, 2025

Last Update Submit

May 13, 2025

Conditions

Keywords

Trigger PointsPain MeasurementPhysical TherapyPassive Stretching

Outcome Measures

Primary Outcomes (1)

  • PPT - Pressure Pain Threshold

    Pressure Pain Threshold (PPT) measured with an algometer (kg/cm²) on the upper trapezius fibers. Measurements will be taken pre-treatment, immediately post-treatment, and at one and two weeks post-intervention.

    Three weeks

Secondary Outcomes (2)

  • Brief questionnaire (self-reported).

    Time of assessment: The day after the intervention

  • Data collection form (demographic questionnaire).

    Prior to the intervention (baseline).

Study Arms (3)

Experimental Group 1

EXPERIMENTAL

The intervention will consist of superficial massage, deep massage, and the pressure release technique applied to the upper trapezius. Following this, a post-treatment algometric measurement will be taken. Experimental Group 1: Will receive only the manual treatment. Follow-up algometric measurements will be performed on the upper trapezius one week and two weeks after the intervention.

Other: Manual Therapy on the Upper Trapezius with or without Passive Stretching

Experimental Group 2

EXPERIMENTAL

The intervention will consist of superficial massage, deep massage, and the pressure release technique applied to the upper trapezius. Following this, a post-treatment algometric measurement will be taken. Experimental Group 2: Will receive the same manual treatment followed by passive stretching of the upper trapezius. An algometric measurement will be conducted immediately after stretching, as well as follow-up assessments one week and two weeks later.

Other: Manual Therapy on the Upper Trapezius with or without Passive Stretching

Control Group

PLACEBO COMPARATOR

Control Group: Will not receive any intervention but will undergo algometric assessments under the same conditions to enable comparisons with the experimental groups.

Other: Manual Therapy on the Upper Trapezius with or without Passive Stretching

Interventions

The intervention consists of manual therapy techniques applied to the upper fibers of the trapezius muscle, including superficial massage, deep massage, and pressure release technique. In one of the experimental groups, this treatment is followed by passive stretching. The control group receives no intervention. Algometric measurements (pressure pain threshold) are taken before and after the intervention, and at one-week and two-week follow-up points to assess the effectiveness and persistence of the treatment.

Control GroupExperimental Group 1Experimental Group 2

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Be an undergraduate student in Physiotherapy.
  • Be between 18 and 40 years old.
  • Have experienced cervical pain at least once in their life.
  • Present pain localized in the upper fibers of the trapezius muscle.
  • Voluntarily agree to participate in the study by signing an informed consent form.

You may not qualify if:

  • Suffer from migraines.
  • Have any diagnosed neurological disorders.
  • Have suffered a recent injury or trauma in the cervical region.
  • Have scoliosis or any other relevant spinal pathology.
  • Present any musculoskeletal condition that could interfere with the study outcomes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Murcia

Murcia, 30120, Spain

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Masking: Double (Participant, Outcomes Assessor) Description: Participants will not be informed about the specific nature of the interventions (e.g., which techniques are expected to be more effective). The assessor conducting the post-intervention measurements will be blinded to group allocation. Therapists cannot be blinded due to the hands-on nature of the treatments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial with three parallel groups. Participants will be randomly assigned to Experimental Group 1, Experimental Group 2, or Control Group. The intervention groups will receive manual therapy techniques (superficial massage, deep massage, and pressure release technique), with or without passive stretching, while the control group will undergo only pressure pain threshold evaluations. Algometric measurements will be performed pre-treatment, post-treatment, and during follow-up at one and two weeks after the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

May 13, 2025

First Posted

May 21, 2025

Study Start

May 19, 2025

Primary Completion

June 6, 2025

Study Completion

June 13, 2025

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations