Myofascial Pain SyndromeNCT05265884
Effect of Kinesiotaping on Myofascial Pain Syndrome Post Neck Dissection Surgery
A study testing Kinesiotaping and traditional therapy intervention in people with Myofascial Pain Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to evaluate the effect of Kinesio taping on myofascial pain syndrome post neck dissection surgery. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Kinesiotaping and traditional therapy intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to Mar 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 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders with age range between 30 to 45 years will participate in this study.
- A history of MPS involving upper trapezius for at least 3 months.
- Moderate to severe pain (VAS score >4).
Who cannot join
- The potential participants will be excluded if they meet one of the following criteria:
- A wound in the affected area
- A cervical disk lesion
- Myelopathy or radiculopathy
- Cervical spine fracture or spondylolisthesis
- Rheumatoid arthritis,
- Epilepsy or any psychological disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty Of phyical tehrapy
Dokki, Giza Governorate, 12611
faculty of physical therapy, 02 37617691, Info@pt.cu.edu.eg
About this study
The purpose of the study is to evaluate the effect of Kinesio taping on myofascial pain syndrome post neck dissection surgery.
Read the detailed description
In this part of the study, the materials and methods will be presented under the following headings: subjects, equipment, procedures of the study and the statistical procedures.
- Subjects: Sixty patients from both genders who have cervical myofascial pain syndrome (MPS) following a neck dissection surgery will participate in this study. Their ages will be ranged from 30 to 45 years. The participants will be selected from the National Cancer Institute, Cairo University and randomly distributed into two equal groups. 1.1 Design of the study: In this study the patients will be randomly assigned into two equal groups (30 patients for each group): 1.1(a) Group A (Kinesio taping group): This group includes 30 patients who will receive Kinesiotaping, in additional to traditional treatment (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for one month. 1.1(b) Group B This group includes 30 patients who will receive traditional treatment only (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for 1 month.
- Equipment:
2.1- Measurement equipment: 2.1.a-Visual analogue scale (VAS): The Visual analogue Scale (VAS) has been in use for the measurement of intangible quantities such as pain, quality of life and anxiety since the 1920s. It consists of a line usually 100 mm in length, with anchor descriptors such as (in the pain context) "no pain" and "worst pain imaginable". The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm. The VAS was initially used in psychology for the measurement of mood disorders, and was used for the measurement of pain from the mid-1960s .
2.1.b- A pressure algometer: - A pressure algometer will be used for pressure pain threshold (PPT) assessment on the trigger spots. It contains a rubber disk (1 cm2surface), attached to a pressure pole and inserted into a gauge, for recording the pressure in kilograms .
2.1.C-Goniometer: The term goniometry is derived from two Greek words, gonia, meaning "angle" and metron, meaning "measurement". Goniometer has different types; the most used is the universal standard goniometer, which is either made with plastic or metal tool. It consists of a stationary arm, a movable arm, and a fulcrum. By aligning this with the axis of a joint, the degree of motion can be measured in a single plane .
-The active ROM of neck joint (lateral flexion and rotation on both sides.) will be measured using a universal standard goniometer when the patient is in sitting position.
2.2-Therapeutic equipment and tools:
Kinesio tape:
The tape (Kinesio Tex Tape; Kinesio Holding Corporation, Albuquerque, NM) is waterproof, porous, and adhesive. The width is 5 cm and thickness of 0.5 mm will be used in this study. This tape is with elastic core wrapped within cotton and capable of stretching up to 140-150%, applies heat-sensitive acrylic adhesive to avoid risk of latex allergy .The tape without medicinal properties is water resistant and can remain on the skin for 3 to 5 days. It will be applied two times per week for one month.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Kinesiotaping, traditional therapy intervention
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingDevice
The tape is waterproof, porous, and adhesive. The width is 5 cm and thickness of 0.5 mm will be used in this study. This tape is with elastic core wrapped within cotton and capable of stretching up to 140-150%, applies heat-sensitive acrylic adhesive to avoid risk of latex allergy .The tape without medicinal properties is water resistant and can remain on the skin for 3 to 5 days. It will be applied two times per week for one month
traditional therapy interventionBehavioural
traditional treatment (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for one month.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Kinesio taping group)(Experimental group): | Experimental | This group includes 30 patients who will receive Kinesiotaping, in additional to traditional treatment (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for one month. Receives: Device: Kinesiotaping; Behavioral: traditional therapy intervention |
| Group B (control group) | Active comparator | This group includes 30 patients who will receive traditional treatment only (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for 1 month. Receives: Behavioral: traditional therapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessing and quantifying pain exhibited by the patients
Visual analogue scale (VAS):
The Visual analogue Scale (VAS) has been in use for the measurement of intangible quantities such as pain, quality of life and anxiety since the 1920s. It consists of a line usually 100 mm in length, with anchor descriptors such as (in the pain context) "no pain" and "worst pain imaginable". The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm. The VAS was initially used in psychology for the measurement of mood disorders, and was used for the measurement of pain from the mid-1960s The VAS will be used for assessing and quantifying pain exhibited by the patients through a 0-10 scale. Each subject twill be informed to mark the line according to the pain intensity experienced at that particular time where 0 means no pain and 10 means worst conceivable pain
Measured: 1 month
Secondary outcomes (1)
pressure pain threshold (PPT)
A pressure algometer:
Pressure algometer(Somedic AB, Farsta, Sweden)will be used for pressure pain threshold (PPT) assessment on the trigger spots. Participants will be informed to elucidate when the pressure sensation became painful and to immediately release the pressure. The most painful point will be marked by a waterproof marker on the initial visit. The average of three measurements will be recorded
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Mar 2022
- Primary completionFeb 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moshira Medhat Mahmoud Esmail, Cairo University
- Investigators
- faculty of physical therapy, Study director, teaching assistant at faculty of physical therapy Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265884
- Sponsor's protocol ID
- P.T.REC/012/003435
- Status last verified
- Mar 2022
- First submitted
- 15 Jan 2022
- Last updated
- 4 Mar 2022
- 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 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesiotaping on Myofascial Pain Syndrome Post Neck Dissection Surgery
- ClinicalTrials.gov ID
- NCT05265884
- Acronym / sponsor ID
- P.T.REC/012/003435
- Conditions
- Myofascial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 4 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.
The purpose of the study is to evaluate the effect of Kinesio taping on myofascial pain syndrome post neck dissection surgery.
Detailed description
In this part of the study, the materials and methods will be presented under the following headings: subjects, equipment, procedures of the study and the statistical procedures.
- Subjects: Sixty patients from both genders who have cervical myofascial pain syndrome (MPS) following a neck dissection surgery will participate in this study. Their ages will be ranged from 30 to 45 years. The participants will be selected from the National Cancer Institute, Cairo University and randomly distributed into two equal groups. 1.1 Design of the study: In this study the patients will be randomly assigned into two equal groups (30 patients for each group): 1.1(a) Group A (Kinesio taping group): This group includes 30 patients who will receive Kinesiotaping, in additional to traditional treatment (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for one month. 1.1(b) Group B This group includes 30 patients who will receive traditional treatment only (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for 1 month.
- Equipment:
2.1- Measurement equipment: 2.1.a-Visual analogue scale (VAS): The Visual analogue Scale (VAS) has been in use for the measurement of intangible quantities such as pain, quality of life and anxiety since the 1920s. It consists of a line usually 100 mm in length, with anchor descriptors such as (in the pain context) "no pain" and "worst pain imaginable". The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm. The VAS was initially used in psychology for the measurement of mood disorders, and was used for the measurement of pain from the mid-1960s .
2.1.b- A pressure algometer: - A pressure algometer will be used for pressure pain threshold (PPT) assessment on the trigger spots. It contains a rubber disk (1 cm2surface), attached to a pressure pole and inserted into a gauge, for recording the pressure in kilograms .
2.1.C-Goniometer: The term goniometry is derived from two Greek words, gonia, meaning "angle" and metron, meaning "measurement". Goniometer has different types; the most used is the universal standard goniometer, which is either made with plastic or metal tool. It consists of a stationary arm, a movable arm, and a fulcrum. By aligning this with the axis of a joint, the degree of motion can be measured in a single plane .
-The active ROM of neck joint (lateral flexion and rotation on both sides.) will be measured using a universal standard goniometer when the patient is in sitting position.
2.2-Therapeutic equipment and tools:
Kinesio tape:
The tape (Kinesio Tex Tape; Kinesio Holding Corporation, Albuquerque, NM) is waterproof, porous, and adhesive. The width is 5 cm and thickness of 0.5 mm will be used in this study. This tape is with elastic core wrapped within cotton and capable of stretching up to 140-150%, applies heat-sensitive acrylic adhesive to avoid risk of latex allergy .The tape without medicinal properties is water resistant and can remain on the skin for 3 to 5 days. It will be applied two times per week for one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Kinesio taping group)(Experimental group): | Experimental | Device: Kinesiotaping, Behavioral: traditional therapy interventionThis group includes 30 patients who will receive Kinesiotaping, in additional to traditional treatment (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for one month. |
| Group B (control group) | Active comparator | Behavioral: traditional therapy interventionThis group includes 30 patients who will receive traditional treatment only (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for 1 month. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both genders with age range between 30 to 45 years will participate in this study.
- A history of MPS involving upper trapezius for at least 3 months.
- Moderate to severe pain (VAS score >4).
Key exclusion criteria (7 listed)
- The potential participants will be excluded if they meet one of the following criteria:
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 |
|---|---|---|
| KinesiotapingThe tape is waterproof, porous, and adhesive. The width is 5 cm and thickness of 0.5 mm will be used in this study. This tape is with elastic core wrapped within cotton and capable of stretching up to 140-150%, applies heat-sensitive acrylic adhesive to avoid risk of latex allergy .The tape without medicinal properties is water resistant and can remain on the skin for 3 to 5 days. It will be applied two times per week for one month | Device | Group A (Kinesio taping group)(Experimental group): |
| traditional therapy interventiontraditional treatment (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for one month. | Behavioural | Group A (Kinesio taping group)(Experimental group):, Group B (control group) |
Primary outcome
assessing and quantifying pain exhibited by the patients
Time frame: 1 month
Visual analogue scale (VAS): The Visual analogue Scale (VAS) has been in use for the measurement of intangible quantities such as pain, quality of life and anxiety since the 1920s. It consists of a line usually 100 mm in length, with anchor descriptors such as (in the pain context) "no pain" and "worst pain imaginable". The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm. The VAS was initially used in psychology for the measurement of mood disorders, and was used for the measurement of pain from the mid-1960s The VAS will be used for assessing and quantifying pain exhibited by the patients through a 0-10 scale. Each subject twill be informed to mark the line according to the pain intensity experienced at that particular time where 0 means no pain and 10 means worst conceivable pain
1 secondary outcome
pressure pain threshold (PPT)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- 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.
faculty of physical therapy study director
teaching assistant at faculty of physical therapy Cairo 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 Kinesiotaping and traditional therapy intervention in people with Myofascial Pain Syndrome, run by Cairo University at 1 site in Egypt.
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 7 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: status not confirmed, as of the sponsor's last update on 4 Mar 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moshira Mahmoud, Master (01226208270, moshiramedhat92@gmial.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessing and quantifying pain exhibited by the patients (time frame: 1 month). 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 4 Mar 2022.