Myofascial Pain SyndromeNCT05879016
Different Taping Methods in Myofascial Pain Syndrome
A study testing Functional Correction Technique, Fascia Correction Technique and Star Taping Technique in people with Myofascial Pain Syndrome and Trigger Point Pain, Myofascial, run by Kubra Koce at 1 site in Turkey (Türkiye).
Trial summary
Myofascial pain syndrome is a musculoskeletal pain condition that originates from localized, tight areas of skeletal muscle and fascia, called trigger points. Myofascial pain syndrome is the most common cause of musculoskeletal pain and its prevalence in the community is reported to be 12-55%. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Myofascial Pain Syndrome, Trigger Point Pain, Myofascial
- What is being tested?
- Functional Correction Technique, Fascia Correction Technique and Star Taping Technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2023to 8 Aug 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be between the ages of 18-30
- Being diagnosed with myofascial pain syndrome
- Pain in the upper trapezius area
- Detection of a taut band in the upper trapezius region on examination
- Presence of at least one active trigger point within the taut band in the upper trapezius -region on examination
- The pain caused by the compression of the trigger point is the pain that the patient complains about
- Having signed the informed consent form
Who cannot join
- Those who have had major surgery or trauma related to the musculoskeletal system, especially the spine and upper extremities
- Those who have a history of any operation related to the head, neck and shoulder region
- Those with neuromuscular disease
- Those with rheumatic disease in the active period
- Those with systemic diseases (Diabetes, hypothyroidism, infection, malignancy...)
- Those with any pathology related to musculoskeletal disease, especially in the cervical region (cervical discopathy, cervical spondylosis, pathologies related to the shoulder joint and surrounding soft tissues, scoliosis, kyphosis, leg length difference, polio sequelae, developmental hip dysplasia...)
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- Those with serious psychological problems (BDI score of 30 and above)
- Those with obesity (BMI≥30 kg/m2)
- Those with tape allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficiency of Three Different Taping Methods in Individuals With Myofascial Pain Syndrome With Trigger Point in the Trapezius
Myofascial pain syndrome is a musculoskeletal pain condition that originates from localized, tight areas of skeletal muscle and fascia, called trigger points. Myofascial pain syndrome is the most common cause of musculoskeletal pain and its prevalence in the community is reported to be 12-55%. Patients with myofascial pain syndrome have pain, stiffness, tenderness, burning, and squeezing sensations in the muscles. In treating myofascial pain syndrome, trigger points should be inactivated and normal body mechanics should be corrected as much as possible. Treatment of the trigger point may be the main goal of a physiotherapy rehabilitation program as it can rapidly reduce acute pain. The goal is to control pain, restore limited ROM, and return the muscle to its optimal length and position. One of the treatment methods applied in MAS is kinesio taping. Kinesio Taping is a non-invasive, painless and less time-consuming method with fewer side effects, widely used as a therapeutic tool in various prevention and rehabilitation protocols. It differs from other rigid tapes because it can stretch significantly (130-140% of its original length), reducing mechanical movement limitations and mimicking skin thickness and elasticity. It has been found to be effective in reducing pain and muscle spasm, increasing range of motion, improving local blood and lymph circulation, reducing edema, strengthening weakened muscles, and controlling joint instability and postural alignment.
Kinesiological tapes can be applied with different shapes and techniques according to the shape and size of the application area and the purpose of the application. Application techniques can be listed as muscle techniques, functional correlation techniques, fascia correlation techniques, star techniques (circulation / lymphatic correction technique), ligament/tendon correction (ligament) technique, mechanical correction techniques, and neural techniques. Functional correlation technique, which is one of the techniques the investigators will prefer in our study, is just above the area of pain, it lifts the skin, fascia, and soft tissue thanks to the elastic properties of the band, thereby reducing the pressure under the application area, reducing the irritation in the chemical receptors and nociceptors, reducing the lymphatic circulation. It is claimed that it increases blood circulation and helps to remove exudate more effectively, and as a result, it helps to reduce pain. The fascia correlation technique, which is the other technique the investigators would prefer to use in our study, is used to bring the fascial tissue to the desired position. The main goal is to reduce tension and adhesions by making vibration (oscillation) movement between the fascia layers. Another technique the investigators will use in our study is the star technique. This technique is aimed at reducing the pressure on the lymphatic vessels and creating a gap that allows circulation in the tissue. Fan-cut tape is often used. Our study aims to compare the effects of 3 different taping techniques (correction, fascia correction, and star technique) in individuals with Myofascial Pain Syndrome with a trigger point in the trapezius muscle.
- Being tested
- Functional Correction Technique, Fascia Correction Technique, Star Taping Technique, Sham Comparator
- 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.
Functional Correction TechniqueOther
A single I strip will be used for this technique. Taping will be done by applying moderate (25-35%) degree of stretching to the middle 1/3 of the tape, with the stretched area centered on the trigger point. The ends of the tape will be adhered without stretching.
Fascia Correction TechniqueOther
Y tape will be applied to prevent fascia adhesions. In the Y tape application, first the tail strips of the Y will be adhered with maximum tension so that the muscle fiber is transverse. Then it will be glued so that its base is in front of the pain point. No tension will be applied to the ends of the tape. The application will be applied when the patient is in a resting position and his joints are in a tense position.
Star Taping TechniqueOther
4 I tapes of the same length between 15 cm and 20 cm will be glued on top of each other. After the first I tape is adhered, the 2nd I tape will be adhered at 90 degrees, then the 3rd and 4th I tapes will be adhered at 45 degrees to obtain a star appearance. There will be no tension at the ends of the tapes
Sham ComparatorOther
I shape tape will be adhered for sham purpose without applying any tension.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Functional Correction Technique Receives: Other: Functional Correction Technique |
| Group 2 | Experimental | Fascia Correction Technique Receives: Other: Fascia Correction Technique |
| Group 3 | Experimental | Star Taping Technique Receives: Other: Star Taping Technique |
| Group 4 | Sham comparator | I taping technique without tension Receives: Other: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The Visual Analogue Scale is a simple, sensitive and reproducible tool that is often used to assess pain severity. Due to its easy application, it has become the most frequently used self-assessment scale in studies on neck pain. It consists of a ten cm long horizontal or vertical line. The starting point of the line represents no pain, and the end represents the most severe pain imaginable. It is stated that the severity of pain increases when the patient goes from the beginning of the line to the end, and the patient is asked to mark the severity of his pain on the line, the point marked by the patient is recorded in cm.
Measured: 1 week
Muscle Strength
With myometer, cervical region flexion, extension, lateral flexion and rotation movements, upper extremity shoulder flexion, abduction, internal and external rotation and elbow flexion angles will be measured bilaterally. Measurements will be repeated 3 times and the average value will be recorded as Newton(N).
Measured: 1 week
Joint Range of Motion
With the universal goniometer, cervical region flexion, extension, lateral flexion and rotation movements, upper extremity shoulder flexion, extension, abduction, adduction, internal and external rotation and elbow flexion and extension angles will be measured bilaterally. Measurements will be repeated 3 times and the average value will be recorded in degrees.
Measured: 1 week
Hand Grip Strength
The maximum isometric contraction strength of the hand and forearm muscles will be measured bilaterally with the hand dynamometer.
Measured: 1 week
Pressure Pain Threshold
The pressure pain threshold that individuals feel will be measured with the Algometer. Algometry is used in many musculoskeletal diseases to evaluate pain and determine therapeutic effects
Measured: 1 week
Number of Active Trigger Points
Trapezius fibers will be evaluated for the number of trigger points by manual palpation.
Measured: 1 week
Secondary outcomes (2)
Nottingham Health Profile
The Nottingham Health Profile was developed in England in 1985 to assess health-related quality of life in individuals and has been translated into many languages. The Nottingham Health Profile is a general quality of life questionnaire that assesses individuals' health problems and the extent to which the problems affect their activities of daily living. The Nottingham Health Profile Questionnaire consists of 38 questions and 6 subtitles. Sub-headings were classified as energy (3 items), social isolation (5 items), pain (8 items), sleep (5 items), physical activity (8 items) and emotional reactions (9 items). The answers to the questions are defined as Yes/No. Each subheading is scored between 0-100. A high total score indicates poor health.
Measured: 1 week
Neck Disability Index
The Neck Disability Index was published in 1991, modified from the Oswestry low back pain disability questionnaire, by Vernon and Mior to evaluate the activities of daily living of patients with neck pain. The Neck Disability Index is the most widely used, translated and the oldest scale in the world to evaluate disability associated with neck pain of non-specific mechanical character. The Neck Disability Index has a total of ten sections. Each section has six possible answers. Each item is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no disability) to 50 (complete disability) or 0% to 100% in percent terms. With increasing scores, the degree of disability due to neck pain perceived by the patient increases.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start30 May 2023
- Primary completion30 Jul 2023
- Study completion8 Aug 2023
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.
- 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
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kubra Koce
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kubra Koce, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879016
- Sponsor's protocol ID
- 21-38
- Status last verified
- Aug 2023
- First submitted
- 18 May 2023
- Last updated
- 9 Aug 2023
- 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 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Three Different Taping Methods in Individuals With Myofascial Pain Syndrome With Trigger Point in the Trapezius
- ClinicalTrials.gov ID
- NCT05879016
- Acronym / sponsor ID
- 21-38
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kubra KoceUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 30 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.
Myofascial pain syndrome is a musculoskeletal pain condition that originates from localized, tight areas of skeletal muscle and fascia, called trigger points. Myofascial pain syndrome is the most common cause of musculoskeletal pain and its prevalence in the community is reported to be 12-55%. Patients with myofascial pain syndrome have pain, stiffness, tenderness, burning, and squeezing sensations in the muscles. In treating myofascial pain syndrome, trigger points should be inactivated and normal body mechanics should be corrected as much as possible. Treatment of the trigger point may be the main goal of a physiotherapy rehabilitation program as it can rapidly reduce acute pain. The goal is to control pain, restore limited ROM, and return the muscle to its optimal length and position. One of the treatment methods applied in MAS is kinesio taping. Kinesio Taping is a non-invasive, painless and less time-consuming method with fewer side effects, widely used as a therapeutic tool in various prevention and rehabilitation protocols. It differs from other rigid tapes because it can stretch significantly (130-140% of its original length), reducing mechanical movement limitations and mimicking skin thickness and elasticity. It has been found to be effective in reducing pain and muscle spasm, increasing range of motion, improving local blood and lymph circulation, reducing edema, strengthening weakened muscles, and controlling joint instability and postural alignment.
Kinesiological tapes can be applied with different shapes and techniques according to the shape and size of the application area and the purpose of the application. Application techniques can be listed as muscle techniques, functional correlation techniques, fascia correlation techniques, star techniques (circulation / lymphatic correction technique), ligament/tendon correction (ligament) technique, mechanical correction techniques, and neural techniques. Functional correlation technique, which is one of the techniques the investigators will prefer in our study, is just above the area of pain, it lifts the skin, fascia, and soft tissue thanks to the elastic properties of the band, thereby reducing the pressure under the application area, reducing the irritation in the chemical receptors and nociceptors, reducing the lymphatic circulation. It is claimed that it increases blood circulation and helps to remove exudate more effectively, and as a result, it helps to reduce pain. The fascia correlation technique, which is the other technique the investigators would prefer to use in our study, is used to bring the fascial tissue to the desired position. The main goal is to reduce tension and adhesions by making vibration (oscillation) movement between the fascia layers. Another technique the investigators will use in our study is the star technique. This technique is aimed at reducing the pressure on the lymphatic vessels and creating a gap that allows circulation in the tissue. Fan-cut tape is often used. Our study aims to compare the effects of 3 different taping techniques (correction, fascia correction, and star technique) in individuals with Myofascial Pain Syndrome with a trigger point in the trapezius muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Functional Correction TechniqueFunctional Correction Technique |
| Group 2 | Experimental | Other: Fascia Correction TechniqueFascia Correction Technique |
| Group 3 | Experimental | Other: Star Taping TechniqueStar Taping Technique |
| Group 4 | Sham comparator | Other: Sham ComparatorI taping technique without tension |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Be between the ages of 18-30
- Being diagnosed with myofascial pain syndrome
- Pain in the upper trapezius area
- Detection of a taut band in the upper trapezius region on examination
- Presence of at least one active trigger point within the taut band in the upper trapezius -region on examination
Key exclusion criteria (9 listed)
- Those who have had major surgery or trauma related to the musculoskeletal system, especially the spine and upper extremities
- Those who have a history of any operation related to the head, neck and shoulder region
- Those with neuromuscular disease
- Those with rheumatic disease in the active period
- Those with systemic diseases (Diabetes, hypothyroidism, infection, malignancy...)
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 |
|---|---|---|
| Functional Correction TechniqueA single I strip will be used for this technique. Taping will be done by applying moderate (25-35%) degree of stretching to the middle 1/3 of the tape, with the stretched area centered on the trigger point. The ends of the tape will be adhered without stretching. | Other | Group 1 |
| Fascia Correction TechniqueY tape will be applied to prevent fascia adhesions. In the Y tape application, first the tail strips of the Y will be adhered with maximum tension so that the muscle fiber is transverse. Then it will be glued so that its base is in front of the pain point. No tension will be applied to the ends of the tape. The application will be applied when the patient is in a resting position and his joints are in a tense position. | Other | Group 2 |
| Star Taping Technique4 I tapes of the same length between 15 cm and 20 cm will be glued on top of each other. After the first I tape is adhered, the 2nd I tape will be adhered at 90 degrees, then the 3rd and 4th I tapes will be adhered at 45 degrees to obtain a star appearance. There will be no tension at the ends of the tapes | Other | Group 3 |
| Sham ComparatorI shape tape will be adhered for sham purpose without applying any tension. | Other | Group 4 |
Primary outcome
Visual Analogue Scale
Time frame: 1 week
The Visual Analogue Scale is a simple, sensitive and reproducible tool that is often used to assess pain severity. Due to its easy application, it has become the most frequently used self-assessment scale in studies on neck pain. It consists of a ten cm long horizontal or vertical line. The starting point of the line represents no pain, and the end represents the most severe pain imaginable. It is stated that the severity of pain increases when the patient goes from the beginning of the line to the end, and the patient is asked to mark the severity of his pain on the line, the point marked by the patient is recorded in cm.
Muscle Strength
Time frame: 1 week
With myometer, cervical region flexion, extension, lateral flexion and rotation movements, upper extremity shoulder flexion, abduction, internal and external rotation and elbow flexion angles will be measured bilaterally. Measurements will be repeated 3 times and the average value will be recorded as Newton(N).
Joint Range of Motion
Time frame: 1 week
With the universal goniometer, cervical region flexion, extension, lateral flexion and rotation movements, upper extremity shoulder flexion, extension, abduction, adduction, internal and external rotation and elbow flexion and extension angles will be measured bilaterally. Measurements will be repeated 3 times and the average value will be recorded in degrees.
Hand Grip Strength
Time frame: 1 week
The maximum isometric contraction strength of the hand and forearm muscles will be measured bilaterally with the hand dynamometer.
Pressure Pain Threshold
Time frame: 1 week
The pressure pain threshold that individuals feel will be measured with the Algometer. Algometry is used in many musculoskeletal diseases to evaluate pain and determine therapeutic effects
Number of Active Trigger Points
Time frame: 1 week
Trapezius fibers will be evaluated for the number of trigger points by manual palpation.
2 secondary outcomes
Nottingham Health Profile
Time frame: 1 week
Neck Disability Index
Time frame: 1 week
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 9 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Correction Technique, Fascia Correction Technique and Star Taping Technique in people with Myofascial Pain Syndrome and Trigger Point Pain, Myofascial, run by Kubra Koce 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 7 inclusion and 9 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 9 Aug 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 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. Some participants in this study may receive a placebo. 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 (time frame: 1 week). 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 9 Aug 2023.