Neck PainNCT05855772
Effect of Extracorporeal Shockwave Therapy Before Postural Correction Exercise in Adults With Forward Head Posture
A study testing Extracorporeal shock waves and Posture Correction Exercise Program in people with Neck Pain and Extracorporeal Shock Waves Therapy, run by Sahmyook University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Extracorporeal Shock Waves Therapy, Exercise Program
- What is being tested?
- Extracorporeal shock waves and Posture Correction Exercise Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 May 2023to 19 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Extracorporeal Shockwave Therapy Before Postural Correction Exercise on EMG Ratio, CVA, PPT, and NDI in Adults With Forward Head Posture
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.
Read the 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.
- Being tested
- Extracorporeal shock waves, Posture Correction 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
- Medical subject headings
- Neck Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wavesDevice
Also called ESWT
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.
Posture Correction Exercise ProgramBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Extracorporeal shock waves; Behavioral: 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. Receives: Behavioral: Posture Correction Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6weeks
Secondary outcomes (3)
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.
Measured: 6weeks
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.
Measured: 6weeks
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.
Measured: 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start8 May 2023
- Primary completion19 Jun 2023
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soyeon Kim, Sahmyook University
- Investigators
- Kim Soyeon, Principal investigator, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855772
- Sponsor's protocol ID
- SYU 2023-02-007-001
- Status last verified
- Sep 2023
- First submitted
- 26 Apr 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extracorporeal Shockwave Therapy Before Postural Correction Exercise on EMG Ratio, CVA, PPT, and NDI in Adults With Forward Head Posture
- ClinicalTrials.gov ID
- NCT05855772
- Acronym / sponsor ID
- SYU 2023-02-007-001
- Keywords
- Forward head posture, Extracorporeal shock waves, Posture Corrective Exercise Program, Trigger point, Upper trapezius, Serratus anterior, Middle trapezius, lower trapezius
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal shock waves therapy[ESWT] + posture corrective exercise programs[PCEP] | Experimental | Device: Extracorporeal shock waves, Behavioral: Posture Correction Exercise ProgramBefore 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. |
| posture corrective exercise programs[PCEP] | Active comparator | Behavioral: Posture Correction Exercise ProgramOnly 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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal shock wavesAlso: ESWTExtracorporeal 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. | Device | Extracorporeal shock waves therapy[ESWT] + posture corrective exercise programs[PCEP] |
| Posture Correction Exercise ProgramAlso: PCEPThe 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. | Behavioural | Extracorporeal shock waves therapy[ESWT] + posture corrective exercise programs[PCEP], posture corrective exercise programs[PCEP] |
Primary outcome
Electromyography
Time frame: 6weeks
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.
3 secondary outcomes
Photogrammetry(CVA)
Time frame: 6weeks
Pressure pain threshold
Time frame: 6weeks
Neck Disability Index
Time frame: 6weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Soyeon principal investigator
Sahmyook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock waves and Posture Correction Exercise Program in people with Neck Pain and Extracorporeal Shock Waves Therapy, run by Sahmyook University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography (time frame: 6weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.