NCT04128670

Brief Summary

The purpose of this study is to determine the effect of Kinesio tape on delayed onset muscle soreness of the biceps muscle of your arm following strenuous exercise of the bicep muscle.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Jan 2020May 2026

First Submitted

Initial submission to the registry

October 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 30, 2020

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

6.3 years

First QC Date

October 11, 2019

Last Update Submit

November 6, 2025

Conditions

Keywords

kinesio tapemuscle sorenesseccentric exercisemuscle pain

Outcome Measures

Primary Outcomes (7)

  • change in worst pain in previous 24 hours

    Brief Pain Inventory

    This measure will be assessed at baseline and 48 hours and 72 hours following completion of the eccentric exercise protocol

  • Change in average pain in previous 24 hours

    Brief Pain Inventory

    This measure will be assessed at baseline and 48 hours and 72 hours following completion of the eccentric exercise protocol

  • Change in pain during elbow extension and elbow flexion

    Subjects will perform the following elbow movements: 1) moving from a fully flexed starting position through active range of motion to full extension 2) moving from a fully extended starting position through active range of motion to full flexion. Ratings of muscle pain intensity will be assessed following each contraction using a 0-100 scale, with "0" indicating "no pain" and "100" indicating the "most intense pain imaginable".

    This measure will be assessed at baseline and 48 hours and 72 hours following completion of the eccentric exercise protocol

  • Change in pressure pain threshold of the affected biceps

    Using a hand-held, clinical grade pressure algometer (Wagner Instruments, Greenwich, CT), pressure will be applied to the biceps brachii muscle of the affected (non-dominant) arm while the arm is stationary at approximately 90 degrees of elbow flexion. Pressure will increase at a rate of about 1kg/s until the subject first reports feeling pain.

    This measure will be assessed at baseline and 48 hours and 72 hours following completion of the eccentric exercise protocol

  • Change in Active Total Elbow Range of Motion (AT-ROM)

    AT-ROM in elbow flexion and extension of the elbow joint will be measured with a standard goniometer and the subject in the supine position on a padded table. The subject is instructed to flex and extend the non-dominant arm at the elbow "as far as you can". Elbow flexion and extension is assessed in the sagittal plane with the arm parallel to the trunk and in the anatomic position. The center fulcrum of the goniometer is placed over the lateral epicondyle of the humerus. The stationary arm of the goniometer is fixed along the lateral midline of the humerus in line with the acromion process and the moving arm along the lateral midline of the radius in the line with the styloid. Three measurements of active elbow flexion and extension will be conducted at each assessment time point, with the average of the three measurements used as the outcome measure for each time point.

    This measure will be assessed at baseline and 48 hours and 72 hours following completion of the eccentric exercise protocol

  • Change in pain during elbow flexion and extension

    Subjects will perform the following elbow movements: 1) moving from a fully flexed starting position through active range of motion to full extension 2) moving from a fully extended starting position through active range of motion to full flexion. Ratings of muscle pain intensity will be assessed following each contraction using a 0-100 scale, with "0" indicating "no pain" and "100" indicating the "most intense pain imaginable".

    This measure will be assessed at baseline and 48 hours and 72 hours following completion of the eccentric exercise protocol

  • Change in Maximal Strength of non-dominant bicep.

    Maximal strength will be assessed by performing a maximal contraction with the arm flexed at 90 degrees. The participant will be seated on a Biodex strength testing machine, with both feet on a support and the upper arm supported at 45 degrees of shoulder flexion by a padded support arm, with the forearm flexed at 90 degrees during the contraction. Three maximal contractions will be performed at 60 degrees per second with 60 seconds of rest between trials.

    This measure will be assessed at baseline and 48 hours and 72 hours following completion of the eccentric exercise protocol

Secondary Outcomes (3)

  • Change in Self-reported function of the affected arm

    This measure will be assessed at baseline and 48 hours and 72 hours following completion of the eccentric exercise protocol

  • Pain catastrophizing

    This instrument will be administered at baseline

  • Fear of movement or reinjury

    This instrument will be administered at baseline

Study Arms (3)

Kinesiotape (KT)

EXPERIMENTAL

Tape will be applied to the biceps muscle of the nondominant arm from approximately the shoulder to the elbow for up to 72 hours. For the KT group taping will be applied with a lymphatic application method according to the guidelines recommended by Kenzo Kase. This type of application is known to improve blood and lymphatic circulation which enhances the removal of metabolic products. The tape will be applied with a tension of 10-20%.

Device: Kinesiotape

Placebo Kinesiotape

PLACEBO COMPARATOR

Tape will be applied to the biceps muscle of the nondominant arm from approximately the shoulder to the elbow for up to 72 hours. The placebo KT group will have 0% tension.

Device: Kinesiotape

No Tape

NO INTERVENTION

This group will not receive any intervention.

Interventions

Tape will be applied to the biceps muscle of the nondominant arm from approximately the shoulder to the elbow for up to 72 hours. For the KT group taping will be applied with a lymphatic application method according to the guidelines recommended by Kenzo Kase. This type of application is known to improve blood and lymphatic circulation which enhances the removal of metabolic products. It is recommended that the application of the tape for lymphatic correction be applied for 24-72 hours. The tape will be applied with a tension of 10-20%.

Kinesiotape (KT)Placebo Kinesiotape

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 30 years old

You may not qualify if:

  • Participating in any strengthening exercises or activities of the upper extremities for the past month.
  • Regularly (\~2x per month) participating in strengthening exercises or activities that include lengthening actions of the upper extremity for the past 6 months.
  • If participant's doctor has ever said that he/she has a heart condition or high blood pressure
  • Pain in chest at rest, during daily activities of living, or when doing physical activity
  • If participant has ever lost balance because of dizziness or has lost consciousness in the past 12 months
  • If the participant currently has (or have had within the past 12 months) a bone, joint, or soft tissue (muscle, ligament, or tendon) problem that could be made worse by becoming more physically activity
  • If participant is currently taking prescribed medications for a chronic medical condition
  • If the participant's doctor has ever told them that they should only do medically supervised physical activity.
  • Currently taking nutritional supplements or anti-inflammatory medication on a daily basis
  • Any injury or surgery to the neck or upper extremity in the past 6 months
  • Open or scabbed wounds in the arm area to be taped
  • Known allergies to the tape or medical adhesive bandages
  • If skin irritation develops to the tape
  • ● Taking over-the-counter pain medications on days of testing, prior to testing sessions, including acetaminophen (Tylenol) and nonsteroidal inflammatory drugs (NSAIDs), including ibuprofen (Motrin, Advil) or naproxen (Aleve, Naprosyn).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Purdue University Indianapolis

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Myalgia

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Central Study Contacts

Kelly M Naugle, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant will not know if they are in the experimental taping condition or the placebo taping condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized single-blind controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 16, 2019

Study Start

January 30, 2020

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

November 10, 2025

Record last verified: 2025-11

Locations