Mobility LimitationNCT02913976
Changes on Pain and Range of Motion by the Use of Kinesio Taping in Patients Diagnosed With Cervical Pain
A study testing Kinesio Taping in people with Mobility Limitation and Myofascial Trigger Point Pain, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
The aim of this study is to demonstrate that the application of Kinesio Taping on a myofascial trigger point in the trapezius muscle able to cause a decrease of the pain and an increase of the cervical range of motion in patients diagnosed with cervical pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mobility Limitation, Myofascial Trigger Point Pain
- What is being tested?
- Kinesio Taping
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2016to Dec 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agree to participate in the study (signed informed consent)
- Presence of active myofascial trigger point in upper trapezius.
- Presence of neck pain
Who cannot join
- Subjects in which not clearly identified myofascial trigger point in the upper trapezius .
- Subjects who suffer or have suffered pathologies of upper limb deformities or orthopedic injuries that can alter static and biomechanics of shoulder and neck.
- Subjects who suffer or have suffered rheumatic or neurological disease or chronic shoulder pain and/or neck
- Subjects diagnosed with fibromyalgia, myelopathy or radiculopathy.
- Subjects suffering from any psychiatric disorder (such as anxiety or depression).
- Subjects who have suffered post-traumatic alteration (whiplash type) or cervical surgery.
Show all 11Show fewer
- Pregnancy risk of abortion.
- Have used analgesics in the 48 hours before participating in the study
- Subjects presenting any contraindications to the application of Kinesio Taping.
- Know the Kinesio Taping technique applied in the study.
- Be receiving physical therapy for any shoulder or neck pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes on Pain and Range of Motion by the Use of Kinesio Taping in With Its Corrective of Space Variant on Upper Trapezius Muscle in Patients Diagnosed With Cervical Pain
The aim of this study is to demonstrate that the application of Kinesio Taping on a myofascial trigger point in the trapezius muscle able to cause a decrease of the pain and an increase of the cervical range of motion in patients diagnosed with cervical pain.
Read the detailed description
The use of Kinesio Taping has become very popular for the treatment of many musculoskeletal disorders in recent decades. Of the six variants of application that has the Kinesio Taping, the space correction technique is suggested for pain management. The increased space achieved with this variant decreases the pressure by raising the skin directly over the treatment area, reducing chemical irritation receptors and therefore pain. The aim of this study is to demonstrate that the application of this variant of Kinesio Taping on a myofascial trigger point in the trapezius muscle able to cause a decrease of the pain and an increase of the cervical range of motion in patients diagnosed with cervical pain. For this, the pressure pain threshold will be measured with a algometer on the trigger point, the perception of pain with a visual analog scale and the range of motion with a cervical goniometer.
- Conditions
- Mobility Limitation, Myofascial Trigger Point Pain
- Being tested
- Kinesio Taping, Sham Kinesio Taping
- Medical subject headings
- Mobility Limitation, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapingDevice
Four Kinesio Taping strips will be placed with tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin
Sham Kinesio TapingDevice
Four Kinesio Taping strips will be placed without tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Taping | Experimental | Four Kinesio Taping strips will be placed with tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin Receives: Device: Kinesio Taping |
| Sham Kinesio Taping | Placebo comparator | Four Kinesio Taping strips will be placed without tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin Receives: Device: Sham Kinesio Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pressure pain threshold
Is defined as the minimum force applied which induces pain on myofascial trigger point. Pressure will be applied with algometer
Measured: At the beginning, immediately after intervention and at 72 hours
Secondary outcomes (2)
Changes in pain perception
It is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage. Will be measured with a visual analog scale
Measured: At the beginning, immediately after intervention and at 72 hours
Changes in cervical range of motion
Cervical range of motion is measuring movement around this segment of the spine. Lateral flexion and rotation. Will be measured with a cervical goniometer
Measured: At the beginning, immediately after intervention and at 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies 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, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fco. Javier Montanez Aguilera, Cardenal Herrera University
- Investigators
- F Javier Montañez-Aguilera, PhD, Study director, CEU Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913976
- Sponsor's protocol ID
- CEU Cardenal Herrera
- Status last verified
- Sep 2016
- First submitted
- 18 Sep 2016
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Silva Parreira Pdo C, Menezes Costa Lda C, Takahashi R, Hespanhol Junior LC, Motta Silva T, da Luz Junior MA, Pena Costa LO. Do convolutions in Kinesio Taping matter? Comparison of two Kinesio Taping approaches in patients with chronic non-specific low back pain: protocol of a randomised trial. J Physiother. 2013 Mar;59(1):52; discussion 52. doi: 10.1016/S1836-9553(13)70147-4.
PubMed 23419916Ekiz T, Aslan MD, Ozgirgin N. Effects of Kinesio Tape application to quadriceps muscles on isokinetic muscle strength, gait, and functional parameters in patients with stroke. J Rehabil Res Dev. 2015;52(3):323-31. doi: 10.1682/JRRD.2014.10.0243.
PubMed 26220179Gusella A, Bettuolo M, Contiero F, Volpe G. Kinesiologic taping and muscular activity: a myofascial hypothesis and a randomised, blinded trial on healthy individuals. J Bodyw Mov Ther. 2014 Jul;18(3):405-11. doi: 10.1016/j.jbmt.2013.11.007. Epub 2013 Nov 8.
PubMed 25042311Wu WT, Hong CZ, Chou LW. The Kinesio Taping Method for Myofascial Pain Control. Evid Based Complement Alternat Med. 2015;2015:950519. doi: 10.1155/2015/950519. Epub 2015 Jun 21.
PubMed 26185522Gerwin RD, Shannon S, Hong CZ, Hubbard D, Gevirtz R. Interrater reliability in myofascial trigger point examination. Pain. 1997 Jan;69(1-2):65-73. doi: 10.1016/s0304-3959(96)03248-4.
PubMed 9060014Akamatsu FE, Ayres BR, Saleh SO, Hojaij F, Andrade M, Hsing WT, Jacomo AL. Trigger points: an anatomical substratum. Biomed Res Int. 2015;2015:623287. doi: 10.1155/2015/623287. Epub 2015 Feb 24.
PubMed 25811029Vanderweeen L, Oostendorp RA, Vaes P, Duquet W. Pressure algometry in manual therapy. Man Ther. 1996 Dec;1(5):258-265. doi: 10.1054/math.1996.0276.
PubMed 11440515Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
PubMed 6226917Walton DM, Levesque L, Payne M, Schick J. Clinical pressure pain threshold testing in neck pain: comparing protocols, responsiveness, and association with psychological variables. Phys Ther. 2014 Jun;94(6):827-37. doi: 10.2522/ptj.20130369. Epub 2014 Feb 20.
PubMed 24557645
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes on Pain and Range of Motion by the Use of Kinesio Taping in With Its Corrective of Space Variant on Upper Trapezius Muscle in Patients Diagnosed With Cervical Pain
- ClinicalTrials.gov ID
- NCT02913976
- Acronym / sponsor ID
- CEU Cardenal Herrera
- Conditions
- Mobility Limitation, Myofascial Trigger Point Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Sep 2016 (estimated)
- 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 aim of this study is to demonstrate that the application of Kinesio Taping on a myofascial trigger point in the trapezius muscle able to cause a decrease of the pain and an increase of the cervical range of motion in patients diagnosed with cervical pain.
Detailed description
The use of Kinesio Taping has become very popular for the treatment of many musculoskeletal disorders in recent decades. Of the six variants of application that has the Kinesio Taping, the space correction technique is suggested for pain management. The increased space achieved with this variant decreases the pressure by raising the skin directly over the treatment area, reducing chemical irritation receptors and therefore pain. The aim of this study is to demonstrate that the application of this variant of Kinesio Taping on a myofascial trigger point in the trapezius muscle able to cause a decrease of the pain and an increase of the cervical range of motion in patients diagnosed with cervical pain. For this, the pressure pain threshold will be measured with a algometer on the trigger point, the perception of pain with a visual analog scale and the range of motion with a cervical goniometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping | Experimental | Device: Kinesio TapingFour Kinesio Taping strips will be placed with tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin |
| Sham Kinesio Taping | Placebo comparator | Device: Sham Kinesio TapingFour Kinesio Taping strips will be placed without tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Agree to participate in the study (signed informed consent)
- Presence of active myofascial trigger point in upper trapezius.
- Presence of neck pain
Key exclusion criteria (11 listed)
- Subjects in which not clearly identified myofascial trigger point in the upper trapezius .
- Subjects who suffer or have suffered pathologies of upper limb deformities or orthopedic injuries that can alter static and biomechanics of shoulder and neck.
- Subjects who suffer or have suffered rheumatic or neurological disease or chronic shoulder pain and/or neck
- Subjects diagnosed with fibromyalgia, myelopathy or radiculopathy.
- Subjects suffering from any psychiatric disorder (such as anxiety or depression).
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 |
|---|---|---|
| Kinesio TapingFour Kinesio Taping strips will be placed with tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin | Device | Kinesio Taping |
| Sham Kinesio TapingFour Kinesio Taping strips will be placed without tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin | Device | Sham Kinesio Taping |
Primary outcome
Changes in pressure pain threshold
Time frame: At the beginning, immediately after intervention and at 72 hours
Is defined as the minimum force applied which induces pain on myofascial trigger point. Pressure will be applied with algometer
2 secondary outcomes
Changes in pain perception
Time frame: At the beginning, immediately after intervention and at 72 hours
Changes in cervical range of motion
Time frame: At the beginning, immediately after intervention and at 72 hours
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 22 Dec 2016.
- Background: PubMed 23419916Silva Parreira Pdo C, Menezes Costa Lda C, Takahashi R, Hespanhol Junior LC, Motta Silva T, da Luz Junior MA, Pena Costa LO. Do convolutions in Kinesio Taping matter? Comparison of two Kinesio Taping approaches in patients with chronic non-specific low back pain: protocol of a randomised trial. J Physiother. 2013 Mar;59(1):52; discussion 52. doi: 10.1016/S1836-9553(13)70147-4.
- Background: PubMed 26220179Ekiz T, Aslan MD, Ozgirgin N. Effects of Kinesio Tape application to quadriceps muscles on isokinetic muscle strength, gait, and functional parameters in patients with stroke. J Rehabil Res Dev. 2015;52(3):323-31. doi: 10.1682/JRRD.2014.10.0243.
- Background: PubMed 25042311Gusella A, Bettuolo M, Contiero F, Volpe G. Kinesiologic taping and muscular activity: a myofascial hypothesis and a randomised, blinded trial on healthy individuals. J Bodyw Mov Ther. 2014 Jul;18(3):405-11. doi: 10.1016/j.jbmt.2013.11.007. Epub 2013 Nov 8.
- Background: PubMed 26185522Wu WT, Hong CZ, Chou LW. The Kinesio Taping Method for Myofascial Pain Control. Evid Based Complement Alternat Med. 2015;2015:950519. doi: 10.1155/2015/950519. Epub 2015 Jun 21.
- Background: PubMed 9060014Gerwin RD, Shannon S, Hong CZ, Hubbard D, Gevirtz R. Interrater reliability in myofascial trigger point examination. Pain. 1997 Jan;69(1-2):65-73. doi: 10.1016/s0304-3959(96)03248-4.
- Background: PubMed 25811029Akamatsu FE, Ayres BR, Saleh SO, Hojaij F, Andrade M, Hsing WT, Jacomo AL. Trigger points: an anatomical substratum. Biomed Res Int. 2015;2015:623287. doi: 10.1155/2015/623287. Epub 2015 Feb 24.
- Background: PubMed 11440515Vanderweeen L, Oostendorp RA, Vaes P, Duquet W. Pressure algometry in manual therapy. Man Ther. 1996 Dec;1(5):258-265. doi: 10.1054/math.1996.0276.
- Background: PubMed 6226917Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
- Background: PubMed 24557645Walton DM, Levesque L, Payne M, Schick J. Clinical pressure pain threshold testing in neck pain: comparing protocols, responsiveness, and association with psychological variables. Phys Ther. 2014 Jun;94(6):827-37. doi: 10.2522/ptj.20130369. Epub 2014 Feb 20.
- 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.
F Javier Montañez-Aguilera, PhD study director
CEU Cardenal Herrera 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 Kinesio Taping in people with Mobility Limitation and Myofascial Trigger Point Pain, run by Cardenal Herrera University at 1 site in Spain.
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 11 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 22 Dec 2016. 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 Spain. 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?
Changes in pressure pain threshold (time frame: At the beginning, immediately after intervention and at 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02913976, which also lists 9 linked publications.
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 22 Dec 2016.