Female Patients With Myofascial Pain Syndrome (MPS) Related to Upper Trapezius Active Trigger Points (TP)NCT03949010
Investigation of the Effectiveness of Muscle Inhibition and Space Correction Techniques of Kinesiotaping Method in Female Patients With Myofascial Pain Syndrome Related to Upper Trapezius Active Trigger Points
A study testing Kinesiotaping with space correction technique, Kinesiotaping with muscle inhibition technique and Home exercise program in people with Female Patients With Myofascial Pain Syndrome (MPS) Related to Upper Trapezius Active Trigger Points (TP), run by Dilşad Sindel.
Trial summary
To investigate the effectiveness of muscle inhibition and space correction techniques of kinesiotaping (KT) method; on pain, functional status and quality of life in female patients with myofascial pain syndrome (MPS) related to upper trapezius active trigger points (TP) in comparison to control group and to determine… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Female Patients With Myofascial Pain Syndrome (MPS) Related to Upper Trapezius Active Trigger Points (TP)
- What is being tested?
- Kinesiotaping with space correction technique, Kinesiotaping with muscle inhibition technique and Home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Dec 2014
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- being female
- being aged between 18 and 45 years old
- not being in menopausal period
- having pain in upper trapezius region
- determining a taut band in examination
- having at least one active TP in this taut band
Show all 10Show fewer
- the pain produced by palpation of this TP is the pain that the patient complains
- painfull restriction of cervical lateral flexion
- having pain score 4 or more according to NRS
- signing informed consent.
Who cannot join
- having major surgery or trauma related to the musculoskeletal system (primarily including the spine and upper extremity)
- having any operative history including the head and neck region
- having a neuromuscular disease
- having an active rheumatic disease
- having a systemic disease (diabetes, hypothyroidism, infection, malignancy...)
- having any pathology related to musculoskeletal diseases -especially including the cervical region- (cervical discopathy, cervical spondylosis, pathologies related to shoulder joint and surrounding soft tissues, scoliosis, kyphosis, limb length discrepancy, polio sequelae, developmental hip dysplasia...)
Show all 9Show fewer
- having serious psychological problems (having score of 30 or more from Beck Depression Inventory)
- being obese (Body Mass Index≥30 kg/m2)
- having allergy to kinesiotapes
About this study
To investigate the effectiveness of muscle inhibition and space correction techniques of kinesiotaping (KT) method; on pain, functional status and quality of life in female patients with myofascial pain syndrome (MPS) related to upper trapezius active trigger points (TP) in comparison to control group and to determine the advantage of each technique over another.
Read the detailed description
The investigators conducted a prospective, randomized, controlled trial involving 93 female patients with MPS related to upper trapezius TPs and randomized the patients to KT treatment group with space correction technique and home exercise program (KSCT, n=20), KT treatment group with muscle inhibition technique and home exercise program (KMIT, n=24) and control group (CG, n=27) which received home exercise program only. Patients were evaluated by numerical rating scale (NRS) for their average and maximum pain intensity, Turkish version of neck disability index (NDI), and short form-36 (SF-36) scales. Statistical tests were conducted at the 0.05 significance level for all outcome measures.
- Being tested
- Kinesiotaping with space correction technique, Kinesiotaping with muscle inhibition technique, Home exercise program
- Keywords
- Myofascial pain syndrome, kinesiotaping, upper trapezius, home exercise program
- 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.
Kinesiotaping with space correction techniqueOther
Kinesiotaping with space correction technique twice per week for two weeks along with home exercise program
Kinesiotaping with muscle inhibition techniqueOther
Kinesiotaping with muscle inhibition technique twice per week for two weeks along with home exercise program
Home exercise programOther
Home exercise program which consists of stretching exercises towards neck area
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotaping with space correction technique | Experimental | Not described Receives: Other: Kinesiotaping with space correction technique; Other: Home exercise program |
| Kinesiotaping with muscle inhibition technique | Experimental | Not described Receives: Other: Kinesiotaping with muscle inhibition technique; Other: Home exercise program |
| Home exercise program | Active comparator | Not described Receives: Other: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain related to myofascial pain syndrome due to upper trapezius active trigger points from baseline to first, second and six weeks
Pain intensity mesaurement via Numerical Rating Scale, range between 0 to 10, higher scores indicating more pain intensity
Measured: Initial assessment, First week, second week, sixth week
Change in disability related to myofascial pain syndrome due to upper trapezius active trigger points from baseline to second and six weeks
Functional status measurement via Neck Disability Index
Measured: Initial assessment, second week, sixth week
Change in quality of life affected by myofascial pain syndrome due to upper trapezius active trigger points from baseline to second and six weeks
Quality of life measurement via Short Form-36
Measured: Initial assessment, second week, sixth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study startDec 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Patients With Myofascial Pain Syndrome (MPS) Related to Upper Trapezius Active Trigger Points (TP)Studies 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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilşad Sindel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dilşad Sindel, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949010
- Sponsor's protocol ID
- KSCT&KMIT
- Status last verified
- May 2019
- First submitted
- 10 May 2019
- Last updated
- 16 May 2019
- 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 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Muscle Inhibition and Space Correction Techniques of Kinesiotaping Method in Female Patients With Myofascial Pain Syndrome Related to Upper Trapezius Active Trigger Points
- ClinicalTrials.gov ID
- NCT03949010
- Acronym / sponsor ID
- KSCT&KMIT
- Keywords
- Myofascial pain syndrome, kinesiotaping, upper trapezius, home exercise program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Dilşad SindelUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 May 2019 (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.
To investigate the effectiveness of muscle inhibition and space correction techniques of kinesiotaping (KT) method; on pain, functional status and quality of life in female patients with myofascial pain syndrome (MPS) related to upper trapezius active trigger points (TP) in comparison to control group and to determine the advantage of each technique over another.
Detailed description
The investigators conducted a prospective, randomized, controlled trial involving 93 female patients with MPS related to upper trapezius TPs and randomized the patients to KT treatment group with space correction technique and home exercise program (KSCT, n=20), KT treatment group with muscle inhibition technique and home exercise program (KMIT, n=24) and control group (CG, n=27) which received home exercise program only. Patients were evaluated by numerical rating scale (NRS) for their average and maximum pain intensity, Turkish version of neck disability index (NDI), and short form-36 (SF-36) scales. Statistical tests were conducted at the 0.05 significance level for all outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesiotaping with space correction technique | Experimental | Other: Kinesiotaping with space correction technique, Other: Home exercise program |
| Kinesiotaping with muscle inhibition technique | Experimental | Other: Kinesiotaping with muscle inhibition technique, Other: Home exercise program |
| Home exercise program | Active comparator | Other: Home exercise program |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- being female
- being aged between 18 and 45 years old
- not being in menopausal period
- having pain in upper trapezius region
- determining a taut band in examination
Key exclusion criteria (9 listed)
- having major surgery or trauma related to the musculoskeletal system (primarily including the spine and upper extremity)
- having any operative history including the head and neck region
- having a neuromuscular disease
- having an active rheumatic disease
- having a systemic disease (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 |
|---|---|---|
| Kinesiotaping with space correction techniqueKinesiotaping with space correction technique twice per week for two weeks along with home exercise program | Other | Kinesiotaping with space correction technique |
| Kinesiotaping with muscle inhibition techniqueKinesiotaping with muscle inhibition technique twice per week for two weeks along with home exercise program | Other | Kinesiotaping with muscle inhibition technique |
| Home exercise programHome exercise program which consists of stretching exercises towards neck area | Other | Home exercise program, Kinesiotaping with muscle inhibition technique, Kinesiotaping with space correction technique |
Primary outcome
Change in pain related to myofascial pain syndrome due to upper trapezius active trigger points from baseline to first, second and six weeks
Time frame: Initial assessment, First week, second week, sixth week
Pain intensity mesaurement via Numerical Rating Scale, range between 0 to 10, higher scores indicating more pain intensity
Change in disability related to myofascial pain syndrome due to upper trapezius active trigger points from baseline to second and six weeks
Time frame: Initial assessment, second week, sixth week
Functional status measurement via Neck Disability Index
Change in quality of life affected by myofascial pain syndrome due to upper trapezius active trigger points from baseline to second and six weeks
Time frame: Initial assessment, second week, sixth week
Quality of life measurement via Short Form-36
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 16 May 2019.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping with space correction technique, Kinesiotaping with muscle inhibition technique and Home exercise program in people with Female Patients With Myofascial Pain Syndrome (MPS) Related to Upper Trapezius Active Trigger Points (TP), run by Dilşad Sindel.
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 10 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 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in pain related to myofascial pain syndrome due to upper trapezius active trigger points from baseline to first, second and six weeks (time frame: Initial assessment, First week, second week, sixth week). The study lists 3 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 16 May 2019.