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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Kinesio taping in a bandage to treat musculoskeletal pain.
It will be used a conventional bandage applicated in the same neck region than kinesio taping intervention.
Faculty of Nurse, Physiotherapy and Podiatry. University Complutense of Madrid
Madrid, Spain
RECRUITINGBaseline 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
Time frame: Baseline
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
Time frame: 4 days after treatment
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
Time frame: 30 days after treatment
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
Time frame: Baseline
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
Nursery, Physiotherapy and Podiatry Complutense University of Madrid
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Time frame: 4 days after treatment
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
Time frame: 30 days after treatment
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
Time frame: Baseline
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
Time frame: 4 days after treatment
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
Time frame: 30 days after treatment
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.
Time frame: Baseline
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.
Time frame: 4 days after treatment
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.
Time frame: 30 days after treatment
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
Time frame: Baseline