NCT05683288

Brief Summary

The aim of this study is to determine whether EYYDM and myofascial applications have short and long-term effects on pain and disability in individuals diagnosed with chronic neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 28, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2023

Completed
Last Updated

July 18, 2024

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

December 28, 2022

Last Update Submit

July 17, 2024

Conditions

Chronic Neck Pain

Keywords

Chronic Neck PainDisabilityPain

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Cervical Pain assessed by Numeric Pain Scale.

    Pain will be evaluated with a 10-point Likert Numerical Pain Scale. 0 means no pain, 10 means unbearable pain.

    Baseline, 4 weeks

Secondary Outcomes (1)

  • Change from Baseline Cervical Disability assessed by Neck Disability Index

    Baseline, 4 weeks

Study Arms (3)

IASTM

EXPERIMENTAL

EYYDM will be applied to the upper trapezius and sternocleideomastoid muscles of the participants for 90 seconds, with a frequency of 60 beats per minute. The instruments will be applied to the soft tissue at 30º-60º angles with multidirectional strokes ("stroking") movements.

Other: IASTM

Myofascial Release

EXPERIMENTAL

Basic movements will be used in the rectus capitis, sternocleidomastoideus, hyoid region and upper trapezius regions within the scope of myofascial release application. The application will take 3 minutes for each region.

Other: Myofascial Release

Control

EXPERIMENTAL

It will include 250W infrared application on the cervical region from 50cm away for 15 minutes and TENS application for 20 minutes at 80Hz frequency with 150ms current transit time, home exercise program.

Other: 250W infrared applicationDevice: TENSOther: Home exercise

Interventions

IASTMOTHER

IASTM will be applied to the upper trapezius and sternocleidomastoid muscles of the participants for 90 seconds, with a frequency of 60 beats per minute.

IASTM
Myofascial ReleaseOTHER

Basic movements will be performed for 3 minutes in the rectus capitis, sternocleidomastoideus, hyoid region and upper trapezius regions.

Myofascial Release
250W infrared applicationOTHER

For 15 minutes, 250W infrared application will be applied on the cervical region from a distance of 50 cm

Control
TENSDEVICE

TENS will be applied for 20 minutes at 80Hz frequency, with a current transit time of 150ms.

Control
Home exerciseOTHER

Cervical strengthening and stretching exercises five days a week will given

Control

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • having a diagnosis of chronic neck pain,
  • To have given at least 3 values to the pain with the Numerical Pain Scale
  • having bilateral muscle spasms in the cervical region

You may not qualify if:

  • those who are taking any analgesic medication,
  • those with acute injury or infection,
  • those with open wounds,
  • osteoporosis,
  • fracture,
  • hematoma,
  • those with acute cardiac, liver and kidney problems,
  • those with connective tissue disease,
  • rheumatoid arthritis, osteoarthritis,
  • cancer,
  • those with circulation problems,
  • those with peripheral vascular disease,
  • epilepsy,
  • history of surgery in the cervical region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, Karatay, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Myofascial Release TherapyTranscutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationElectric Stimulation TherapyAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2022

First Posted

January 13, 2023

Study Start

December 28, 2022

Primary Completion

February 22, 2023

Study Completion

February 22, 2023

Last Updated

July 18, 2024

Record last verified: 2022-12

Locations

TU(1)