FibromyalgiaEffKtFbmNCT02763332
Effect of the Kinesio Taping in Fibromyalgia.
A study testing Upper trunk group (UTG) and Global trunk group (GTG) in people with Fibromyalgia, run by University of Valencia at 1 site in Spain.
Trial summary
The prevalence of the fibromyalgia is about 10-15% in the European countries. It is unclear the etiology and pathogenesis of the syndrome. Several factors such as dysfunction of the central and autonomic nervous systems, neurotransmitters, hormones, immune system, external stressors, psychiatric aspects, and others… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Upper trunk group (UTG) and Global trunk group (GTG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to Jun 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 70 years old and diagnosis of fibromyalgia based on the American College of Rheumatology (ACR) diagnostic criteria (Wolfe et al., 2011). Once they expressed their interest in taking part of the study, potential participants underwent an examination by a rheumatologist of the association to confirm the diagnosis of fibromyalgia.
Who cannot join
- People with other different diagnosis, musculoskeletal or neurological disorders that prevented the follow-up study, infections, whiplash, migraine, skin hypersensitivity or heart devices were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Kinesio Taping in Patients With Fibromyalgia.
The prevalence of the fibromyalgia is about 10-15% in the European countries. It is unclear the etiology and pathogenesis of the syndrome. Several factors such as dysfunction of the central and autonomic nervous systems, neurotransmitters, hormones, immune system, external stressors, psychiatric aspects, and others seem to be involved. But the symptom commonly expressed by the people who suffer from it is pain.
The main goal of the present study is to analyse the effect of the kinesiotaping on the pain, comfort and postural position of the patient with fibromyalgia.
Read the detailed description
All of the participants were recruited, in a non-probabilistic way, from the Valencian Association of Affected of Fibromyalgia from date to april 2016. Inclusion criteria include: age between 18 and 70 years old and diagnosis of fibromyalgia based on the American College of Rheumatology (ACR) diagnostic criteria. Once they expressed their interest in taking part of the study, potential participants underwent an examination by a rheumatologist of the association to confirm the diagnosis of fibromyalgia. People with other different diagnosis, musculoskeletal or neurological disorders that prevented the follow-up study, infections, whiplash, migraine, skin hypersensitivity or heart devices were excluded.
The participants were randomly allocated (random numbers table) to two different groups depending on the placement of the Kinesio Tape © (KT) by a physiotherapist which did not participated in the study. Thus, one group was composed by 18 women and was called "Upper trunk group" (UTG). The other group, composed by 17 women and called "Global trunk group" (GTG).
Patients were informed about the purpose of the study, procedures and risks, and they provided written informed consent before the treatment. The study protocol was approved by the authors´ University Ethic Committee where the study was conducted. All procedures were conducted in accordance to the Declaration of Helsinki.
A prospective, randomized, double blind, controlled trial was carried out. Participants were assessed two times, one before the intervention and another afterwards. They received a treatment of kinesiotaping during three weeks. Participants came to our laboratory each week in order to change their bandage and assure the adherence to the treatment.
The physiotherapist who conducted the assessments was blinded to the treatment received by the patients and the statistician was completely blinded to the goals of the study. The physiotherapist who applied the treatment had an extensive experience Kinesio Tape ©.
All enrolled participants were aware that they could receive two types of treatments but did not know the purposes of each treatment. They were instructed to not change their daily routines.
- Conditions
- Fibromyalgia
- Being tested
- Upper trunk group (UTG), Global trunk group (GTG)
- Keywords
- Fibromyalgia, Efficacy, Taping
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper trunk group (UTG)Other
Also called Upper trunk
This bandage was placed over the upper trapezius muscle.
Global trunk group (GTG)Other
Also called Global trunk
This bandage was placed globally along the back
| Study group | Role | What they receive |
|---|---|---|
| Upper trunk group (UTG) | Experimental | In the UTG, the bandage was applied over the superior fibbers of the trapezious and levator scapulae muscle using a strip in a 'Y' shape. The individuals were asked to remain in an upright sitting position and the base of the strip was attached to the skin beyond the acromion without any tension. Later, we placed the two straps of the bandage with a range of tension from 15 to 25%. The main goal of this shape is achieve muscular relaxation of the trapezius, scapula levator and supraspinatus. Receives: Other: Upper trunk group (UTG) |
| Global trunk group (GTG) | Active comparator | In the GTG the bandage was applied parallel to the paravertebral muscles in a 'C' shape. The individuals were sit in the same position with the head in the neutral position. The strip was pasted with approximately 25% of tension all over the paravertebral musculature. The main goal was procuring a global mechanical correction of the superior part of the trunk. Receives: Other: Global trunk group (GTG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
The pain intensity was recorded by a visual analogue scale (VAS) of pain. The pain was expressed on a scale of 0-10, with 0 being "no pain" and 10 "maximum tolerable pain."
Measured: three weeks
Secondary outcomes (5)
Comfort.
Five VAS were used to identify their level of comfort in the following corporal regions: head-neck, shoulders, thoracic segment, lumbar region and pelvic region (0=absolute discomfort and 10=full comfort). Participants placed a mark along the line in order to measure their comfort level, which was scored to the nearest centimeter.
Measured: three weeks
Impact on quality of life.
The Fibromyalgia Impact Questionnaire (FIQ) was used to assess the functional status of this population. This questionnaire is composed of 10 questions. Items 4 through 10 are horizontal linear scales marked in 10 increments on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression.
Measured: three weeks
Physical well-being
Was determined using self-administered questionnaire, designed for this purpose included a 16-item. The reliability of the questionnaire was analyzed by Cronbach's alpha coefficient, which indicated a good internal consistency (α = 0.70).
Measured: three weeks
Trunk posture.
To assess the position of the superior part of the trunk, the evaluation of the minor pectoral length in supine position was employed, taking the distance (with a tape measure) between the posterior edge of the acromion to the stretcher while the patients remain in that position with their hands laying on their belly.
Measured: three weeks
Perception of change
Was evaluated with the Patient's Global Impression of Change scale after treatment. Participants were asked to score their perception of changing after the intervention received with a one-item questionnaire with seven alternatives (1= maximum change to 7 = no change at all).
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
- Investigators
- Gemma Espí-López, PhD, Principal investigator, Faculty of Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763332
- Sponsor's protocol ID
- ID012
- Acronym
- EffKtFbm
- Status last verified
- Jun 2016
- First submitted
- 3 May 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lim EC, Tay MG. Kinesio taping in musculoskeletal pain and disability that lasts for more than 4 weeks: is it time to peel off the tape and throw it out with the sweat? A systematic review with meta-analysis focused on pain and also methods of tape application. Br J Sports Med. 2015 Dec;49(24):1558-66. doi: 10.1136/bjsports-2014-094151. Epub 2015 Jan 16.
PubMed 25595290Mostafavifar M, Wertz J, Borchers J. A systematic review of the effectiveness of kinesio taping for musculoskeletal injury. Phys Sportsmed. 2012 Nov;40(4):33-40. doi: 10.3810/psm.2012.11.1986.
PubMed 23306413
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Kinesio Taping in Patients With Fibromyalgia.
- ClinicalTrials.gov ID
- NCT02763332
- Acronym / sponsor ID
- EffKtFbm / ID012
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Efficacy, Taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 May 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 prevalence of the fibromyalgia is about 10-15% in the European countries. It is unclear the etiology and pathogenesis of the syndrome. Several factors such as dysfunction of the central and autonomic nervous systems, neurotransmitters, hormones, immune system, external stressors, psychiatric aspects, and others seem to be involved. But the symptom commonly expressed by the people who suffer from it is pain.
The main goal of the present study is to analyse the effect of the kinesiotaping on the pain, comfort and postural position of the patient with fibromyalgia.
Detailed description
All of the participants were recruited, in a non-probabilistic way, from the Valencian Association of Affected of Fibromyalgia from date to april 2016. Inclusion criteria include: age between 18 and 70 years old and diagnosis of fibromyalgia based on the American College of Rheumatology (ACR) diagnostic criteria. Once they expressed their interest in taking part of the study, potential participants underwent an examination by a rheumatologist of the association to confirm the diagnosis of fibromyalgia. People with other different diagnosis, musculoskeletal or neurological disorders that prevented the follow-up study, infections, whiplash, migraine, skin hypersensitivity or heart devices were excluded.
The participants were randomly allocated (random numbers table) to two different groups depending on the placement of the Kinesio Tape © (KT) by a physiotherapist which did not participated in the study. Thus, one group was composed by 18 women and was called "Upper trunk group" (UTG). The other group, composed by 17 women and called "Global trunk group" (GTG).
Patients were informed about the purpose of the study, procedures and risks, and they provided written informed consent before the treatment. The study protocol was approved by the authors´ University Ethic Committee where the study was conducted. All procedures were conducted in accordance to the Declaration of Helsinki.
A prospective, randomized, double blind, controlled trial was carried out. Participants were assessed two times, one before the intervention and another afterwards. They received a treatment of kinesiotaping during three weeks. Participants came to our laboratory each week in order to change their bandage and assure the adherence to the treatment.
The physiotherapist who conducted the assessments was blinded to the treatment received by the patients and the statistician was completely blinded to the goals of the study. The physiotherapist who applied the treatment had an extensive experience Kinesio Tape ©.
All enrolled participants were aware that they could receive two types of treatments but did not know the purposes of each treatment. They were instructed to not change their daily routines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper trunk group (UTG) | Experimental | Other: Upper trunk group (UTG)In the UTG, the bandage was applied over the superior fibbers of the trapezious and levator scapulae muscle using a strip in a 'Y' shape. The individuals were asked to remain in an upright sitting position and the base of the strip was attached to the skin beyond the acromion without any tension. Later, we placed the two straps of the bandage with a range of tension from 15 to 25%. The main goal of this shape is achieve muscular relaxation of the trapezius, scapula levator and supraspinatus. |
| Global trunk group (GTG) | Active comparator | Other: Global trunk group (GTG)In the GTG the bandage was applied parallel to the paravertebral muscles in a 'C' shape. The individuals were sit in the same position with the head in the neutral position. The strip was pasted with approximately 25% of tension all over the paravertebral musculature. The main goal was procuring a global mechanical correction of the superior part of the trunk. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age between 18 and 70 years old and diagnosis of fibromyalgia based on the American College of Rheumatology (ACR) diagnostic criteria (Wolfe et al., 2011). Once they expressed their interest in taking part of the study, potential participants underwent an examination by a rheumatologist of the association to confirm the diagnosis of fibromyalgia.
Key exclusion criteria (1 listed)
- People with other different diagnosis, musculoskeletal or neurological disorders that prevented the follow-up study, infections, whiplash, migraine, skin hypersensitivity or heart devices were excluded.
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 |
|---|---|---|
| Upper trunk group (UTG)Also: Upper trunkThis bandage was placed over the upper trapezius muscle. | Other | Upper trunk group (UTG) |
| Global trunk group (GTG)Also: Global trunkThis bandage was placed globally along the back | Other | Global trunk group (GTG) |
Primary outcome
Pain intensity
Time frame: three weeks
The pain intensity was recorded by a visual analogue scale (VAS) of pain. The pain was expressed on a scale of 0-10, with 0 being "no pain" and 10 "maximum tolerable pain."
5 secondary outcomes
Comfort.
Time frame: three weeks
Impact on quality of life.
Time frame: three weeks
Physical well-being
Time frame: three weeks
Trunk posture.
Time frame: three weeks
Perception of change
Time frame: three weeks
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 28 Jun 2016.
- Results publication: PubMed 25595290Lim EC, Tay MG. Kinesio taping in musculoskeletal pain and disability that lasts for more than 4 weeks: is it time to peel off the tape and throw it out with the sweat? A systematic review with meta-analysis focused on pain and also methods of tape application. Br J Sports Med. 2015 Dec;49(24):1558-66. doi: 10.1136/bjsports-2014-094151. Epub 2015 Jan 16.
- Results publication: PubMed 23306413Mostafavifar M, Wertz J, Borchers J. A systematic review of the effectiveness of kinesio taping for musculoskeletal injury. Phys Sportsmed. 2012 Nov;40(4):33-40. doi: 10.3810/psm.2012.11.1986.
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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.
Gemma Espí-López, PhD principal investigator
Faculty of Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper trunk group (UTG) and Global trunk group (GTG) in people with Fibromyalgia, run by University of Valencia 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 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 28 Jun 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. 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?
Pain intensity (time frame: three weeks). 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 NCT02763332, which also lists 2 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 28 Jun 2016.