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Efficacy of Kinesio Taping in Musculoskeletal Neck Pain

Primary Purpose

Musculoskeletal Neck Pain

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Kinesio taping
Conventional bandage
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Neck Pain focused on measuring Musculoskeletal Neck Pain; Kinesio Taping

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presence of myofascial pain syndrome (MPS) and myofascial trigger point (MTP) in the upper trapezius muscle, according to the diagnostic criteria proposed by the American Academy of Pain Medicine(2) and the scientific community (3) a) tender point on palpation, with or without referred pain b) patient recognizes pain during tender point palpation c) at least three of the following: muscle stiffness or muscle spasm, limited range of motion in an associated joint, increase of pain with stress, palpation of tight band and / or nodule, associated with a tender point
  • understand written Spanish.

Exclusion Criteria:

  • Neck pain of traumatic origin, due to recent surgery or causing radiculopathy
  • Have been diagnosed with chronic pathology, as well as neoplastic or suspicion of it
  • Have received some type of pharmacological or non-pharmacological analgesic treatment in the last 30 days.
  • Pregnant or menstrual women

Sites / Locations

  • Faculty of Nurse, Physiotherapy and Podiatry. University Complutense of MadridRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Kinesio taping

Placebo

Control

Arm Description

In this arm, patients will be treated with blue Kinesio taping in a muscle relaxation position during 4 days.

In this arm, patients will be treated with conventional bandage in a muscle relaxation position during 4 days.

In this arm, patients will be not treated but the outcomes will be measure after 4 days.

Outcomes

Primary Outcome Measures

Baseline Pain intensity
assessed by numerical rating scale (NRS) (5). Self-evaluation system of a scale with scores from "0" to "10", where "0" = absence of pain and "10" = maximum pain tolerable by the patient. A value lower than 4 means "mild pain, a value between 4-6 moderate pain, and values of 6-10 implies the presence of intense pain
Post-treatment Pain intensity
assessed by numerical rating scale (NRS) (5). Self-evaluation system of a scale with scores from "0" to "10", where "0" = absence of pain and "10" = maximum pain tolerable by the patient. A value lower than 4 means "mild pain, a value between 4-6 moderate pain, and values of 6-10 implies the presence of intense pain
Follow-up Pain intensity
assessed by numerical rating scale (NRS) (5). Self-evaluation system of a scale with scores from "0" to "10", where "0" = absence of pain and "10" = maximum pain tolerable by the patient. A value lower than 4 means "mild pain, a value between 4-6 moderate pain, and values of 6-10 implies the presence of intense pain
Baseline Health-related quality of life
assessed using the Short Form-36 (SF-36) questionnaire (6). This is a 36-item self-evaluating instrument where the perception of physical and emotional health is assessed in the 4 weeks before taking the questionnaire. The score ranges from "0" to "100", where a higher score implies a higher grade in health-related quality of life. This questionnaire has been shown to have adequate psychometric quality
Post-treatment Health-related quality of life
assessed using the SF-36 questionnaire (6). This is a 36-item self-evaluating instrument where the perception of physical and emotional health is assessed in the 4 weeks before taking the questionnaire. The score ranges from "0" to "100", where a higher score implies a higher grade in health-related quality of life. This questionnaire has been shown to have adequate psychometric quality
Follow-up Health-related quality of life
assessed using the SF-36 questionnaire (6). This is a 36-item self-evaluating instrument where the perception of physical and emotional health is assessed in the 4 weeks before taking the questionnaire. The score ranges from "0" to "100", where a higher score implies a higher grade in health-related quality of life. This questionnaire has been shown to have adequate psychometric quality
Baseline Impact of neck pain on daily life
assessed using the Neck Pain Questionnaire (NPQ)(7). It is made up of 9 items, which can be answered using a 5-response Likert scale. The result is represented in percentage values, where higher percentage means/shows more significant and negative impact on the patient's daily actions. The questionnaire has been validated in the Spanish language and population, showing adequate validity and reliability
Post-treatment Impact of neck pain on daily life
assessed using the Neck Pain Questionnaire (NPQ)(7). It is made up of 9 items, which can be answered using a 5-response Likert scale. The result is represented in percentage values, where higher percentage means/shows more significant and negative impact on the patient's daily actions. The questionnaire has been validated in the Spanish language and population, showing adequate validity and reliability
Follow-up Impact of neck pain on daily life
assessed using the Neck Pain Questionnaire (NPQ)(7). It is made up of 9 items, which can be answered using a 5-response Likert scale. The result is represented in percentage values, where higher percentage means/shows more significant and negative impact on the patient's daily actions. The questionnaire has been validated in the Spanish language and population, showing adequate validity and reliability
Baseline Pressure pain threshold (PPT)
Assessed by pressure algometry. Assesses the minimum pressure necessary to trigger an uncomfortable sensation associated with pain(8). This method is valid and reliable to measure the sensitivity of an MTP if three consecutive measurements are made and allowing a rest time between 30 seconds to 1 minute between measurements.Algometer has demonstrated an inter-examiner reliability range of 0.91(95% Interval coefficient CI)), showing adequate reliability for research if performed by inexperienced evaluators (9). The PPT is expressed in kPa (kilopascal), for an accurate evaluation, the force to be applied with algometer must be perpendicular to the point to be measured, without the skin sliding over the subcutaneous tissue. And a constant force must be applied, currently the application of a constant force with an acceleration of 5kPa is advocated (8). The PPT was measured in the MTP 2 of the upper trapezius, taking three measurements and taking the arithmetic mean of the three.
Post-treatment Pressure pain threshold (PPT)
Assessed by pressure algometry. Assesses the minimum pressure necessary to trigger an uncomfortable sensation associated with pain(8). This method is valid and reliable to measure the sensitivity of a MTP if three consecutive measurements are made and allowing a rest time between 30 seconds to 1 minute between measurements. Algometer has demonstrated an inter-examiner reliability range of 0.91 (95% CI, 0.82-0.97), showing adequate reliability for research if performed by inexperienced evaluators (9). The PPT is expressed in kPa (1kg / cm2 = 98.0665 kPa), for an accurate evaluation, the force to be applied with the algometer must be perpendicular to the point to be measured, without the skin sliding over the subcutaneous tissue. and a constant force must be applied, currently the application of a constant force with an acceleration of 5kPa is advocated (8). The PPT was measured in the MTP 2 of the upper trapezius, taking three measurements and taking the arithmetic mean of the three.
Follow-up Pressure pain threshold (PPT)
Assessed by pressure algometry. Assesses the minimum pressure necessary to trigger an uncomfortable sensation associated with pain(8). This method is valid and reliable to measure the sensitivity of a MTP if three consecutive measurements are made and allowing a rest time between 30 seconds to 1 minute between measurements. Algometer has demonstrated an inter-examiner reliability range of 0.91 (95% CI, 0.82-0.97), showing adequate reliability for research if performed by inexperienced evaluators (9). The PPT is expressed in kPa (1kg / cm2 = 98.0665 kPa), for an accurate evaluation, the force to be applied with the algometer must be perpendicular to the point to be measured, without the skin sliding over the subcutaneous tissue. and a constant force must be applied, currently the application of a constant force with an acceleration of 5kPa is advocated (8). The PPT was measured in the MTP 2 of the upper trapezius, taking three measurements and taking the arithmetic mean of the three.
Suggestibility
measured by the Inventor of Suggestibility questionnaire (IS) (10). It is made up of 22 items and 4 subconstructs: fantasizing, concentration, emotional involvement and influencing. It consists of 22 items with five-point Likert-type scalar response options ("0" = "almost never"; to "4" = "almost always"), where patients must respond about the frequency with which certain reactions appear in their daily life, with a high score being an indicator of greater suggestibility

Secondary Outcome Measures

Full Information

First Posted
June 2, 2021
Last Updated
June 7, 2021
Sponsor
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT04916366
Brief Title
Efficacy of Kinesio Taping in Musculoskeletal Neck Pain
Official Title
Efficacy of Kinesio Taping in Musculoskeletal Neck Pain in Short and Medium Term. A Randomized Control Double Blinded Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare efficacy of Kinesio taping against a conventional tape in a patient with cervical musculoskeletal pain. For this, a double-blind controlled clinical trial be carried out in patients with musculoskeletal neck pain.
Detailed Description
During the months of May to July 2021, a research assistant will contact potential participants who will be invited to participate in this study. Once they agree to participate, it will schedule for a face-to-face consultation at the university, where the main researcher will inform the study participants. Once the information sheet and informed consent will be a sign, an investigator will carry out the measurements of the variables for initial data collection in the first session. In another room, an expertise physiotherapist with experience in applying Kinesio taping will perform interventions on patients on the same day as the initial evaluation. It this way, the investigator that will assess outcomes will be blind to the treatment that each patient will receive. At the second consultation, 4 days after the first, the same physiotherapist who applied the bandage will remove it from the patients who received it and any remains of the bandage on the skin were cleaned. For patients in the control group (nothing apply), it will be the same protocol to alter, not the double-blind. The principal investigator will perform the evaluations and data collection without knowing the intervention the patient will receive. In a third consultation, as a follow-up (30 days after the second consultation), the collection of the same measurements and clinical variables from the patients who completed the process will repeat by the same investigator that did the outcomes' assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Neck Pain
Keywords
Musculoskeletal Neck Pain; Kinesio Taping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A double-blind controlled clinical trial.
Masking
ParticipantCare ProviderInvestigator
Masking Description
An investigator will carried out the measurement of the baseline variables. An expertise physiotherapy with experience in kinesio taping application, will performed the intervention with Kinesio taping in neck. All patients will be told that they are going to undergo a kinesio taping treatment, except for the control group, which will be given the option of being included in the experimental group once the follow-up process is over.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kinesio taping
Arm Type
Experimental
Arm Description
In this arm, patients will be treated with blue Kinesio taping in a muscle relaxation position during 4 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In this arm, patients will be treated with conventional bandage in a muscle relaxation position during 4 days.
Arm Title
Control
Arm Type
No Intervention
Arm Description
In this arm, patients will be not treated but the outcomes will be measure after 4 days.
Intervention Type
Other
Intervention Name(s)
Kinesio taping
Intervention Description
Kinesio taping in a bandage to treat musculoskeletal pain.
Intervention Type
Other
Intervention Name(s)
Conventional bandage
Intervention Description
It will be used a conventional bandage applicated in the same neck region than kinesio taping intervention.
Primary Outcome Measure Information:
Title
Baseline Pain intensity
Description
assessed by numerical rating scale (NRS) (5). Self-evaluation system of a scale with scores from "0" to "10", where "0" = absence of pain and "10" = maximum pain tolerable by the patient. A value lower than 4 means "mild pain, a value between 4-6 moderate pain, and values of 6-10 implies the presence of intense pain
Time Frame
Baseline
Title
Post-treatment Pain intensity
Description
assessed by numerical rating scale (NRS) (5). Self-evaluation system of a scale with scores from "0" to "10", where "0" = absence of pain and "10" = maximum pain tolerable by the patient. A value lower than 4 means "mild pain, a value between 4-6 moderate pain, and values of 6-10 implies the presence of intense pain
Time Frame
4 days after treatment
Title
Follow-up Pain intensity
Description
assessed by numerical rating scale (NRS) (5). Self-evaluation system of a scale with scores from "0" to "10", where "0" = absence of pain and "10" = maximum pain tolerable by the patient. A value lower than 4 means "mild pain, a value between 4-6 moderate pain, and values of 6-10 implies the presence of intense pain
Time Frame
30 days after treatment
Title
Baseline Health-related quality of life
Description
assessed using the Short Form-36 (SF-36) questionnaire (6). This is a 36-item self-evaluating instrument where the perception of physical and emotional health is assessed in the 4 weeks before taking the questionnaire. The score ranges from "0" to "100", where a higher score implies a higher grade in health-related quality of life. This questionnaire has been shown to have adequate psychometric quality
Time Frame
Baseline
Title
Post-treatment Health-related quality of life
Description
assessed using the SF-36 questionnaire (6). This is a 36-item self-evaluating instrument where the perception of physical and emotional health is assessed in the 4 weeks before taking the questionnaire. The score ranges from "0" to "100", where a higher score implies a higher grade in health-related quality of life. This questionnaire has been shown to have adequate psychometric quality
Time Frame
4 days after treatment
Title
Follow-up Health-related quality of life
Description
assessed using the SF-36 questionnaire (6). This is a 36-item self-evaluating instrument where the perception of physical and emotional health is assessed in the 4 weeks before taking the questionnaire. The score ranges from "0" to "100", where a higher score implies a higher grade in health-related quality of life. This questionnaire has been shown to have adequate psychometric quality
Time Frame
30 days after treatment
Title
Baseline Impact of neck pain on daily life
Description
assessed using the Neck Pain Questionnaire (NPQ)(7). It is made up of 9 items, which can be answered using a 5-response Likert scale. The result is represented in percentage values, where higher percentage means/shows more significant and negative impact on the patient's daily actions. The questionnaire has been validated in the Spanish language and population, showing adequate validity and reliability
Time Frame
Baseline
Title
Post-treatment Impact of neck pain on daily life
Description
assessed using the Neck Pain Questionnaire (NPQ)(7). It is made up of 9 items, which can be answered using a 5-response Likert scale. The result is represented in percentage values, where higher percentage means/shows more significant and negative impact on the patient's daily actions. The questionnaire has been validated in the Spanish language and population, showing adequate validity and reliability
Time Frame
4 days after treatment
Title
Follow-up Impact of neck pain on daily life
Description
assessed using the Neck Pain Questionnaire (NPQ)(7). It is made up of 9 items, which can be answered using a 5-response Likert scale. The result is represented in percentage values, where higher percentage means/shows more significant and negative impact on the patient's daily actions. The questionnaire has been validated in the Spanish language and population, showing adequate validity and reliability
Time Frame
30 days after treatment
Title
Baseline Pressure pain threshold (PPT)
Description
Assessed by pressure algometry. Assesses the minimum pressure necessary to trigger an uncomfortable sensation associated with pain(8). This method is valid and reliable to measure the sensitivity of an MTP if three consecutive measurements are made and allowing a rest time between 30 seconds to 1 minute between measurements.Algometer has demonstrated an inter-examiner reliability range of 0.91(95% Interval coefficient CI)), showing adequate reliability for research if performed by inexperienced evaluators (9). The PPT is expressed in kPa (kilopascal), for an accurate evaluation, the force to be applied with algometer must be perpendicular to the point to be measured, without the skin sliding over the subcutaneous tissue. And a constant force must be applied, currently the application of a constant force with an acceleration of 5kPa is advocated (8). The PPT was measured in the MTP 2 of the upper trapezius, taking three measurements and taking the arithmetic mean of the three.
Time Frame
Baseline
Title
Post-treatment Pressure pain threshold (PPT)
Description
Assessed by pressure algometry. Assesses the minimum pressure necessary to trigger an uncomfortable sensation associated with pain(8). This method is valid and reliable to measure the sensitivity of a MTP if three consecutive measurements are made and allowing a rest time between 30 seconds to 1 minute between measurements. Algometer has demonstrated an inter-examiner reliability range of 0.91 (95% CI, 0.82-0.97), showing adequate reliability for research if performed by inexperienced evaluators (9). The PPT is expressed in kPa (1kg / cm2 = 98.0665 kPa), for an accurate evaluation, the force to be applied with the algometer must be perpendicular to the point to be measured, without the skin sliding over the subcutaneous tissue. and a constant force must be applied, currently the application of a constant force with an acceleration of 5kPa is advocated (8). The PPT was measured in the MTP 2 of the upper trapezius, taking three measurements and taking the arithmetic mean of the three.
Time Frame
4 days after treatment
Title
Follow-up Pressure pain threshold (PPT)
Description
Assessed by pressure algometry. Assesses the minimum pressure necessary to trigger an uncomfortable sensation associated with pain(8). This method is valid and reliable to measure the sensitivity of a MTP if three consecutive measurements are made and allowing a rest time between 30 seconds to 1 minute between measurements. Algometer has demonstrated an inter-examiner reliability range of 0.91 (95% CI, 0.82-0.97), showing adequate reliability for research if performed by inexperienced evaluators (9). The PPT is expressed in kPa (1kg / cm2 = 98.0665 kPa), for an accurate evaluation, the force to be applied with the algometer must be perpendicular to the point to be measured, without the skin sliding over the subcutaneous tissue. and a constant force must be applied, currently the application of a constant force with an acceleration of 5kPa is advocated (8). The PPT was measured in the MTP 2 of the upper trapezius, taking three measurements and taking the arithmetic mean of the three.
Time Frame
30 days after treatment
Title
Suggestibility
Description
measured by the Inventor of Suggestibility questionnaire (IS) (10). It is made up of 22 items and 4 subconstructs: fantasizing, concentration, emotional involvement and influencing. It consists of 22 items with five-point Likert-type scalar response options ("0" = "almost never"; to "4" = "almost always"), where patients must respond about the frequency with which certain reactions appear in their daily life, with a high score being an indicator of greater suggestibility
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of myofascial pain syndrome (MPS) and myofascial trigger point (MTP) in the upper trapezius muscle, according to the diagnostic criteria proposed by the American Academy of Pain Medicine(2) and the scientific community (3) a) tender point on palpation, with or without referred pain b) patient recognizes pain during tender point palpation c) at least three of the following: muscle stiffness or muscle spasm, limited range of motion in an associated joint, increase of pain with stress, palpation of tight band and / or nodule, associated with a tender point understand written Spanish. Exclusion Criteria: Neck pain of traumatic origin, due to recent surgery or causing radiculopathy Have been diagnosed with chronic pathology, as well as neoplastic or suspicion of it Have received some type of pharmacological or non-pharmacological analgesic treatment in the last 30 days. Pregnant or menstrual women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillermo Ceniza-Bordallo, PhD Student
Phone
+34 91 394 1517
Email
gceniza@ucm.es
First Name & Middle Initial & Last Name or Official Title & Degree
Nursery, Physiotherapy and Podiatry Complutense University of Madrid
Phone
+34 91 394 1530
Email
webenf@enf.ucm.es
Facility Information:
Facility Name
Faculty of Nurse, Physiotherapy and Podiatry. University Complutense of Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillermo Ceniza-Bordallo, PhD Student
Phone
+34 91 394 1517
Email
gceniza@ucm.es

12. IPD Sharing Statement

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Efficacy of Kinesio Taping in Musculoskeletal Neck Pain

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