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Effect of Extracorporeal Shockwave Therapy Before Postural Correction Exercise in Adults With Forward Head Posture

Primary Purpose

Neck Pain, Extracorporeal Shock Waves Therapy, Exercise Program

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Extracorporeal shock waves
Posture Correction Exercise Program
Sponsored by
Sahmyook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Forward head posture, Extracorporeal shock waves, Posture Corrective Exercise Program, Trigger point, Upper trapezius, Serratus anterior, Middle trapezius, lower trapezius, Musculoskeletal Pain

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Sahmyook university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

posture corrective exercise programs[PCEP]

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Photogrammetry(CVA)
To check the angle of the head spine, the subjects' profile will be photographed at a distance of 265 centimeters. We would like to measure the angle of the line connecting the migration and cervical spine 7 spinous process in a vertical line to check the change in the angle of the head that comes out forward.
Pressure pain threshold
It is intended to obtain a quantitative value related to mechanical sensitivity to deep structural pain by applying the metal rod of the pain system vertically to the trigger point area of the upper trapezius.
Neck Disability Index
We would like to check the difference in the degree of pain and the degree of limitation in daily life due to neck pain by evaluating the items of self-management, lifting objects, reading, headache, concentration, work, driving, sleep and leisure activities as scores.

Full Information

First Posted
April 26, 2023
Last Updated
September 3, 2023
Sponsor
Sahmyook University
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1. Study Identification

Unique Protocol Identification Number
NCT05855772
Brief Title
Effect of Extracorporeal Shockwave Therapy Before Postural Correction Exercise in Adults With Forward Head Posture
Official Title
Effect of Extracorporeal Shockwave Therapy Before Postural Correction Exercise on EMG Ratio, CVA, PPT, and NDI in Adults With Forward Head Posture
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
June 19, 2023 (Actual)
Study Completion Date
June 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahmyook University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Experimental participants who meet the criteria of the study subjects will be selected, and the experiment will be conducted by coordinating the schedules of the subjects. The experiment will be conducted in an independent space, and the general characteristics of the subjects will be investigated collectively before the experiment. Subjects will take a side photograph from a distance of 265 cm to check the CVA. In addition, the basic value will be obtained by measuring the activity of the UT, MT, LT and SA when the arm is lifted in the direction of the scapula plane, and the pressure pain threshold of the UT Trigger point will be measured using a pain threshold will be measured. In addition, NDI will be self-measured to evaluate neck pain and function. The experiment will be divided into groups that conduct in ESWT and posture correction exercise programs together and groups that conduct only posture correction exercise programs, and the subjects will be randomly assigned to the two groups. After the experiment is completed, the muscle activity, head spine angle, pressure pain threshold, and ranch index measured in advance will be measured again. ESWT: Radial shock waves will be applied to the main muscles with Trigger points, the Upper trapezius and Levator scapulae muscles. This is conducted twice a week, with 1000impulses, 60mJ/m (2), and 5Hz frequency for a total of four weeks. Posture Correction Exercise Program: Muscles such as weakened deep neck flexors, middle trapezius, lower trapezius, and serratus anterior muscles will undergo strengthening exercises, while muscles such as shortened and overactive upper trapezius, Levator scapulae, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Extracorporeal Shock Waves Therapy, Exercise Program
Keywords
Forward head posture, Extracorporeal shock waves, Posture Corrective Exercise Program, Trigger point, Upper trapezius, Serratus anterior, Middle trapezius, lower trapezius, Musculoskeletal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extracorporeal shock waves therapy[ESWT] + posture corrective exercise programs[PCEP]
Arm Type
Experimental
Arm Description
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.
Arm Title
posture corrective exercise programs[PCEP]
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Extracorporeal shock waves
Other Intervention Name(s)
ESWT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Posture Correction Exercise Program
Other Intervention Name(s)
PCEP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Electromyography
Description
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.
Time Frame
6weeks
Secondary Outcome Measure Information:
Title
Photogrammetry(CVA)
Description
To check the angle of the head spine, the subjects' profile will be photographed at a distance of 265 centimeters. We would like to measure the angle of the line connecting the migration and cervical spine 7 spinous process in a vertical line to check the change in the angle of the head that comes out forward.
Time Frame
6weeks
Title
Pressure pain threshold
Description
It is intended to obtain a quantitative value related to mechanical sensitivity to deep structural pain by applying the metal rod of the pain system vertically to the trigger point area of the upper trapezius.
Time Frame
6weeks
Title
Neck Disability Index
Description
We would like to check the difference in the degree of pain and the degree of limitation in daily life due to neck pain by evaluating the items of self-management, lifting objects, reading, headache, concentration, work, driving, sleep and leisure activities as scores.
Time Frame
6weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Soyeon
Organizational Affiliation
Sahmyook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahmyook university
City
Seoul
State/Province
Nowon-gu
ZIP/Postal Code
01795
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Extracorporeal Shockwave Therapy Before Postural Correction Exercise in Adults With Forward Head Posture

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