Efficacy of Kinesio Taping in Musculoskeletal Neck Pain

NCT04916366 | Unknown

• 1 other identifier: 18/133-E_TFG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Neck Pain

Keywords

Musculoskeletal Neck Pain; Kinesio Taping

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (3)

Kinesio taping

EXPERIMENTAL

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

Other: Kinesio taping

Placebo

PLACEBO COMPARATOR

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

Other: Conventional bandage

Control

NO INTERVENTION

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

Interventions

Kinesio taping OTHER

Kinesio taping in a bandage to treat musculoskeletal pain.

Kinesio taping

Conventional bandage OTHER

It will be used a conventional bandage applicated in the same neck region than kinesio taping intervention.

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Faculty of Nurse, Physiotherapy and Podiatry. University Complutense of Madrid

Madrid, 28040, Spain

RECRUITING

Central Study Contacts

Guillermo Ceniza-Bordallo, PhD Student

CONTACT

+34 91 394 1517; gceniza@ucm.es

Nursery, Physiotherapy and Podiatry Complutense University of Madrid

CONTACT

+34 91 394 1530; webenf@enf.ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A double-blind controlled clinical trial.

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 7, 2021
• Study Start: June 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: July 31, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Locations

ES (1)