NCT07594223

Brief Summary

This study will be conducted as a randomized controlled trial to evaluate the efficacy of trigger point activator and extracorporeal shock wave therapy in patients with active myofascial trigger points in the upper fibers of the trapezius muscle. Participants who meet the inclusion criteria will be recruited and informed consent will be obtained prior to participation. The subjects will then be randomly allocated into two equal groups. Group A: will receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle. Group B: will receive extracorporeal shock wave therapy applied to the same region. The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period. Outcome measures will be assessed before the beginning of the treatment program and after completion of the intervention period. Pain intensity and pressure pain threshold will be assessed using an algometer. Functional disability related to the neck will be evaluated using the Neck Disability Index (NDI). All collected data will be recorded and statistically analyzed to determine the effectiveness of both treatment modalities in reducing pain and improving functional outcomes.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 7, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2026

19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 7, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

cervicaltrigger pointsshock wave

Outcome Measures

Primary Outcomes (2)

  • Neck Disability Index (NDI)

    Questionnaire assessing neck function valid and reilable

    6 weeks

  • VAS

    Pain score

    6 weeks

Study Arms (2)

treatment

EXPERIMENTAL

receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle.

Device: Activator

Shockwave

ACTIVE COMPARATOR

will receive extracorporeal shock wave therapy applied to the same region. The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period.

Device: Shockwave

Interventions

ShockwaveDEVICE

will receive extracorporeal shock wave therapy applied to the same region. 12. The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period.

Shockwave
ActivatorDEVICE

will receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle.

treatment

Eligibility Criteria

Age27 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Male or female participants aged between 25 and 40 years. 2. Body Mass Index (BMI) between 20 and 30 kg/m². 3.Presence of active myofascial trigger points in the upper fibers of the trapezius muscle confirmed by clinical examination.
  • Complaints of neck pain associated with upper trapezius trigger points. 5. Ability and willingness to participate in the treatment sessions and follow the study protocol.

You may not qualify if:

  • \. History of neck trauma, cervical spine fracture, or cervical spine surgery. 2. Presence of neurological disorders affecting the cervical region. 3. Presence of cervical disc prolapse or severe cervical spine pathology. 4. Diagnosis of fibromyalgia or systemic musculoskeletal disorders. 5. Presence of skin diseases, wounds, or infections at the treatment area. 6. Patients with malignancy or severe systemic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Uni

Suez, Egypt

Location

MeSH Terms

Interventions

Activator Appliances

Intervention Hierarchy (Ancestors)

Orthodontic Appliances, FunctionalOrthodontic AppliancesOrthodonticsDentistryOrthodontic Appliances, Removable

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Physical Therapy for Orthopedics, Faculty of Physical Therapy

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 18, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

November 12, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations