NCT05855772

Brief Summary

Currently, as digital leisure activities increase, more time is spent at home. According to these social trends, it is necessary to establish a program that can safely and effectively perform exercise at home.Therefore, this study assumed that if the trigger point and tension of the upper trapezius are resolved by applying ESWT before implementing the exercise program, it will have a significant effect on pain, functional aspects, and posture improvement. On this account, investigator would like to study the effect of applying ESWT before conducting the exercise program on the muscle activity ratio, craniovertebral angle, pressure pain threshold, and Neck disability index in adults with FHP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

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

April 26, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

May 8, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

1 month

First QC Date

April 26, 2023

Last Update Submit

September 3, 2023

Conditions

Keywords

Forward head postureExtracorporeal shock wavesPosture Corrective Exercise ProgramTrigger pointUpper trapeziusSerratus anteriorMiddle trapeziuslower trapeziusMusculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

  • Electromyography

    It will measure muscle activity when the arm is raised in the direction of the scapula plane. Each muscle measured is an upper trapezius, middle trapezius, lower trapezius, and serratus anterior, and the values obtained are to obtain the muscle activity ratio of each of the upper trapezius/lower trapezius, upper trapezius/middle trapezius, upper trapezius/serratus anterior.

    6weeks

Secondary Outcomes (3)

  • Photogrammetry(CVA)

    6weeks

  • Pressure pain threshold

    6weeks

  • Neck Disability Index

    6weeks

Study Arms (2)

Extracorporeal shock waves therapy[ESWT] + posture corrective exercise programs[PCEP]

EXPERIMENTAL

Before proceeding with the exercise, apply a radial-type Extracorporeal shock waves. This applies to the main muscles with TrP, the upper trapezius and Leavator scapulae muscle. It is conducted twice a week at 1000 impulse, 60 mJ/m (2), and 5 Hz frequencies. In addition, a posture correction exercise program will be conducted along with ESWT. Muscles such as weakened deep neck flexors, middle trapezius muscles, lower trapezius muscles, and serratus anterior muscles will undergo strengthening exercises, while muscles such as shortened and overactive upper trapezius muscle, Leavator scapulae muscle, and sternocleidomastoid muscle will apply relaxation stretching. This will be conducted privately at home by providing exercise leaflets, and will be conducted for a total of four weeks with a 30-minute program three times a week.

Device: Extracorporeal shock wavesBehavioral: Posture Correction Exercise Program

posture corrective exercise programs[PCEP]

ACTIVE COMPARATOR

Only posture correction exercise programs are conducted. Muscles such as weakened deep neck flexors, middle trapezius muscles, lower trapezius muscles, and serratus anterior muscles will undergo strengthening exercises, while muscles such as shortened and overactive upper trapezius muscle, Leavator scapulae muscle, and sternocleidomastoid muscle will apply relaxation stretching. This will be conducted privately at home by providing exercise leaflets, and will be conducted for a total of four weeks with a 30-minute program three times a week.

Behavioral: Posture Correction Exercise Program

Interventions

Extracorporeal shock waves are non-invasive and simple treatments that are easy to apply to a wide surface and have fewer side effects with low intensity. In addition, there is an advantage of improving blood circulation through an increase in reactive blood flow and creation of new blood vessels.

Also known as: ESWT
Extracorporeal shock waves therapy[ESWT] + posture corrective exercise programs[PCEP]

The exercise program mainly consists of stretching and muscle strengthening exercises, which have shown improvement effects in terms of head vertebrae and pain. In order to optimize the muscle activity between pairs due to FHP, the selected exercise should focus on providing an appropriate proportion of muscle activity for each other as well as muscle strength.

Also known as: PCEP
Extracorporeal shock waves therapy[ESWT] + posture corrective exercise programs[PCEP]posture corrective exercise programs[PCEP]

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Those with CVA≤53 or less when measuring the Craniovertbral angle through photometric method
  • A person who uses a smartphone or computer for an average of 4 hours or more per day
  • A person who has not exercised regularly in the past six months

You may not qualify if:

  • A person who is subject to extracorporeal shock wave contraindication
  • A person with a history of fractures or surgery
  • A person who is unable to exercise due to medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahmyook university

Seoul, Nowon-gu, 01795, South Korea

Location

MeSH Terms

Conditions

Neck PainMusculoskeletal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Kim Soyeon

    Sahmyook University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 11, 2023

Study Start

May 8, 2023

Primary Completion

June 19, 2023

Study Completion

June 19, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations