Trapezius Muscle StrainNCT05277259
Comparative Effects of Conventional Physical Therapy, Kinesio Taping and ESWT in Upper Trapezius MPS.
A study testing Extracorporeal Shock Wave Therapy, Kinesiotaping and Conventional Physical Therapy in people with Trapezius Muscle Strain, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
There is no study in the literature comparing both kinesiotaping and Extracorporeal Shock Wave Therapy (ESWT) with conventional physical therapy in upper trapezius myofascial pain syndrome. In this study, we aimed to make this comparison. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Trapezius Muscle Strain
- What is being tested?
- Extracorporeal Shock Wave Therapy, Kinesiotaping and Conventional Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Apr 2022to 2 May 2022
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presence of at least 1 active trigger point in the upper trapezius muscle, exacerbation of pain when this point(s) is pressed, painful limitation of cervical lateral flexion and extension.
Who cannot join
- Having a history of spine and upper extremity surgery, neuromuscular disease, active rheumatologic disease, active infection, malignancy, having previously applied ESWT or Kinesio Taping to the back and neck region.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Conventional Physical Therapy, Kinesio Taping and Extracorporeal Shock Wave Therapies in Upper Trapezius Myofascial Pain Syndrome.
There is no study in the literature comparing both kinesiotaping and Extracorporeal Shock Wave Therapy (ESWT) with conventional physical therapy in upper trapezius myofascial pain syndrome. In this study, we aimed to make this comparison.
- Conditions
- Trapezius Muscle Strain
- Being tested
- Extracorporeal Shock Wave Therapy, Kinesiotaping, Conventional Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave TherapyDevice
Device named 'Elettronica Pagani,Italy' and will be used with radial probe.
KinesiotapingOther
Elastic band to be used to stretch the upper trapezius muscle in the desired direction.
Conventional Physical TherapyOther
Conventional physical therapy will be consisted of hotpack, therapeutic ultrasound and tens applications.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal Shock Wave Therapy | Active comparator | Extracorporeal shock wave therapy (ESWT) is a noninvasive treatment that involves delivery of shock waves to injured soft tissue to reduce pain and promote healing. Receives: Device: Extracorporeal Shock Wave Therapy |
| Kinesiotaping | Active comparator | The Kinesiotaping method is a therapeutic taping technique which alleviates pain. Receives: Other: Kinesiotaping |
| Conventional Physical Therapy | Active comparator | Hotpack, therapeutic ultrasound and tens applications. Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.
Measured: at baseline (before the treatment)
Visual Analogue Scale (VAS)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome
Measured: 2 weeks after baseline (at the end of treatment)
Visual Analogue Scale (VAS)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome
Measured: 6 weeks after baseline (one month after the end of treatment)
Neck Disability Index (NDI)
a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. The total score ranges from 0 (no disability) to 50 (total disability).
Measured: at baseline (before the treatment)
Neck Disability Index (NDI)
a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. The total score ranges from 0 (no disability) to 50 (total disability).
Measured: 2 weeks after baseline (at the end of treatment)
Neck Disability Index (NDI)
a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. The total score ranges from 0 (no disability) to 50 (total disability).
Measured: 6 weeks after baseline (one month after the end of treatment)
Secondary outcomes (3)
Measurement of Cervical range of motion (Cervikal ROM)
Measuring cervical lateral flexion and cervical extension with a manual goniometer.
Measured: at baseline (before the treatment)
Measurement of Cervical range of motion (Cervikal ROM)
Measuring cervical lateral flexion and cervical extension with a manual goniometer.
Measured: 2 weeks after baseline (at the end of treatment).
Measurement of Cervical range of motion (Cervikal ROM)
Measuring cervical lateral flexion and cervical extension with a manual goniometer.
Measured: 6 weeks after baseline (one month after the end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start4 Apr 2022
- Primary completion18 Apr 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trapezius Muscle StrainStudies 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
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Şah, Yuzuncu Yil University
- Investigators
- Volkan Şah, Principal investigator, Yüzüncü Yıl Üniversitesi Tıp Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277259
- Sponsor's protocol ID
- van yyü university
- Status last verified
- May 2022
- First submitted
- 3 Mar 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- 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 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Conventional Physical Therapy, Kinesio Taping and Extracorporeal Shock Wave Therapies in Upper Trapezius Myofascial Pain Syndrome.
- ClinicalTrials.gov ID
- NCT05277259
- Acronym / sponsor ID
- van yyü university
- Conditions
- Trapezius Muscle Strain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 14 Mar 2022 (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.
There is no study in the literature comparing both kinesiotaping and Extracorporeal Shock Wave Therapy (ESWT) with conventional physical therapy in upper trapezius myofascial pain syndrome. In this study, we aimed to make this comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Shock Wave Therapy | Active comparator | Device: Extracorporeal Shock Wave TherapyExtracorporeal shock wave therapy (ESWT) is a noninvasive treatment that involves delivery of shock waves to injured soft tissue to reduce pain and promote healing. |
| Kinesiotaping | Active comparator | Other: KinesiotapingThe Kinesiotaping method is a therapeutic taping technique which alleviates pain. |
| Conventional Physical Therapy | Active comparator | Other: Conventional Physical TherapyHotpack, therapeutic ultrasound and tens applications. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of at least 1 active trigger point in the upper trapezius muscle, exacerbation of pain when this point(s) is pressed, painful limitation of cervical lateral flexion and extension.
Key exclusion criteria (1 listed)
- Having a history of spine and upper extremity surgery, neuromuscular disease, active rheumatologic disease, active infection, malignancy, having previously applied ESWT or Kinesio Taping to the back and neck region.
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 Wave TherapyDevice named 'Elettronica Pagani,Italy' and will be used with radial probe. | Device | Extracorporeal Shock Wave Therapy |
| KinesiotapingElastic band to be used to stretch the upper trapezius muscle in the desired direction. | Other | Kinesiotaping |
| Conventional Physical TherapyConventional physical therapy will be consisted of hotpack, therapeutic ultrasound and tens applications. | Other | Conventional Physical Therapy |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: at baseline (before the treatment)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.
Visual Analogue Scale (VAS)
Time frame: 2 weeks after baseline (at the end of treatment)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome
Visual Analogue Scale (VAS)
Time frame: 6 weeks after baseline (one month after the end of treatment)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome
Neck Disability Index (NDI)
Time frame: at baseline (before the treatment)
a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. The total score ranges from 0 (no disability) to 50 (total disability).
Neck Disability Index (NDI)
Time frame: 2 weeks after baseline (at the end of treatment)
a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. The total score ranges from 0 (no disability) to 50 (total disability).
Neck Disability Index (NDI)
Time frame: 6 weeks after baseline (one month after the end of treatment)
a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. The total score ranges from 0 (no disability) to 50 (total disability).
3 secondary outcomes
Measurement of Cervical range of motion (Cervikal ROM)
Time frame: at baseline (before the treatment)
Measurement of Cervical range of motion (Cervikal ROM)
Time frame: 2 weeks after baseline (at the end of treatment).
Measurement of Cervical range of motion (Cervikal ROM)
Time frame: 6 weeks after baseline (one month after the end of treatment)
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 1 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Trapezius Muscle Strain
Not yet recruiting
Kinesio Taping for Upper Trapezius Myofascial Trigger Points
Myofascial Pain Syndromes, Myofascial Trigger Point Pain
Active, not recruiting
To Compare the Efficacy of Instrument Assisted STM vs BT in Alleviating Pain and Tightness of Trapezius Muscle
Trapezius Muscle Strain
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.
Volkan Şah principal investigator
Yüzüncü Yıl Üniversitesi Tıp Fakültesi
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 Wave Therapy, Kinesiotaping and Conventional Physical Therapy in people with Trapezius Muscle Strain, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 1 Jun 2022. 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 Turkey (Türkiye). 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?
Visual Analogue Scale (VAS) (time frame: at baseline (before the treatment)). The study lists 6 primary outcomes in all. 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 1 Jun 2022.