Efficacy of Kinesio Taping in Musculoskeletal Neck Pain

Efficacy of Kinesio Taping in Musculoskeletal Neck Pain in Short and Medium Term. A Randomized Control Double Blinded Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Musculoskeletal Neck Pain
• Intervention / Treatment: Other: Kinesio taping; Other: Conventional bandage

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillermo Ceniza-Bordallo, PhD Student; Phone Number: +34 91 394 1517; Email: gceniza@ucm.es
• Study Contact Backup: Name: Nursery, Physiotherapy and Podiatry Complutense University of Madrid; Phone Number: +34 91 394 1530; Email: webenf@enf.ucm.es

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Faculty of Nurse, Physiotherapy and Podiatry. University Complutense of Madrid
    • Contact: Guillermo Ceniza-Bordallo, PhD Student; Phone Number: +34 91 394 1517; Email: gceniza@ucm.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kinesio taping; In this arm, patients will be treated with blue Kinesio taping in a muscle relaxation position during 4 days.	Other: Kinesio taping; Kinesio taping in a bandage to treat musculoskeletal pain.
Placebo Comparator: Placebo; In this arm, patients will be treated with conventional bandage in a muscle relaxation position during 4 days.	Other: Conventional bandage; It will be used a conventional bandage applicated in the same neck region than kinesio taping intervention.
No Intervention: Control; In this arm, patients will be not treated but the outcomes will be measure after 4 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	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.	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.	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.	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	Baseline

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): July 31, 2021

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Musculoskeletal Neck Pain; Kinesio Taping
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 18/133-E_TFG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No