NCT06899685

Brief Summary

This study would answer the following question: Is there a difference in the effects between IASTM and KT on pain intensity level, pain pressure threshold, cervical range of motion (ROM), functional disability level and satisfaction level in subjects with upper trapezius myofascial trigger points? The aims of this study are:

  1. 1.To investigate the effect of KT and IASTM on pain intensity level in subjects with upper trapezius myofascial trigger points.
  2. 2.To investigate the effects of KT and IASTM on pain pressure threshold in subjects with upper trapezius myofascial trigger points.
  3. 3.To investigate the effects of KT and IASTM on cervical range of motion (ROM) in subjects with myofascial trigger points.
  4. 4.To investigate the effect of KT and IASTM on functional disability level in subjects with upper trapezius myofascial trigger points.
  5. 5.To investigate the effects of KT and IASTM on satisfaction level in subjects with myofascial trigger points.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Start

First participant enrolled

August 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 28, 2025

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

March 21, 2025

Last Update Submit

March 26, 2025

Conditions

Myofacial Pain Syndromes

Outcome Measures

Primary Outcomes (2)

  • KT vs IASTM on upper trapezius myofascial trigger points

    one month

  • pain intensity level

    pain intensity level of neck pain

    change at pain intensity level through 4 weeks

Secondary Outcomes (2)

  • pain pressure threshold

    change at pain pressure threshold through 4 weeks

  • cervical range of motion

    change at cervical range of motion through 4 weeks

Other Outcomes (1)

  • functional disability level

    change at functional disability level through 4 weeks

Study Arms (3)

tradional physical therapy

ACTIVE COMPARATOR

This group received traditional therapy( Instructions, hot backs, Deep transverse friction massage, passive \&self stretch, Neck isometric and Scapular retraction exercises) (three sessions per week for 4 weeks).

Other: tradional physical therapy treatment

Kinesiotaping

EXPERIMENTAL

This group received KT in addition to Traditional physical therapy program (two sessions per week for 4 weeks).

Other: tradional physical therapy treatmentOther: KT

IASTM

EXPERIMENTAL

This group received IASTM in addition to Traditional physical therapy program (three sessions per week for 4 weeks).

Other: tradional physical therapy treatmentDevice: IASTM

Interventions

tradional physical therapy treatmentOTHER

Instructions, hot backs, Deep transverse friction massage, passive \&self stretch, Neck isometric and Scapular retraction exercises

IASTMKinesiotapingtradional physical therapy
KTOTHER

Kinesiotaping

Kinesiotaping
IASTMDEVICE

Instrument Assisted Soft Tissue Mobolization

IASTM

Eligibility Criteria

Age19 Years - 23 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 1) Fifty subjects with age ranged from 18 to 23 years old (Formen et al., 2014).
  • \) From both genders with normal BMI ranges between 18.5:24.9 kg/m2. Had MTrPs of unilateral UT muscle (Shamseldeen et al., 2023).

You may not qualify if:

  • \. History of whiplash injury (Emshi et al., 2021). 2. History of head, neck, cervical spine or shoulder surgery (Emshi., et al 2021) 3. History of cervical radiculopathy (Emshi et al., 2021) 4. Patients with malignancy (Shamseldeen et al., 2023). 5. Cervical spine fractures (Shamseldeen et al., 2023). 6. Myelopathy (Shamseldeen et al., 2023). 7. Having undergone physical therapy within the past three months before the study.
  • \. Non - rheumatologic diseases as multiple sclerosis, thyroid dysfunction and chronic infection.
  • \. Rheumatologic condition as poly-articular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative diseases.
  • \. Presence of skin diseases (Luz Júnior et al., 2015). 11. Pregnancy (Luz Júnior et al., 2015).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic

Banī Suwayf, Egypt

RECRUITING

MeSH Terms

Conditions

Facial Neuralgia

Condition Hierarchy (Ancestors)

Facial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

Central Study Contacts

Reham Sayed Mesaed

CONTACT

01091892299reham.sayed995@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master's Student Researcher

Study Record Dates

First Submitted

March 21, 2025

First Posted

March 28, 2025

Study Start

August 1, 2024

Primary Completion

September 1, 2024

Study Completion

April 1, 2025

Last Updated

March 28, 2025

Record last verified: 2024-06

Locations

EG(1)