Clinical trial NCT04128670: Effects of Kinesio Tape on Delayed Onset Muscle Soreness
Official title: Effects of Kinesio Tape on Delayed Onset Muscle Soreness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delayed Onset Muscle Soreness
Keywords: kinesio tape
muscle soreness
eccentric exercise
muscle pain
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized single-blind controlled trial
Primary purpose: TREATMENT

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.

Detailed description: Participants will complete 4 testing sessions that will be held on 4 separate days (Baseline, Eccentric Exercise day, 48 hours post exercise, and 72 hours post exercise). All sessions will take place in the National Institute of Fitness and Sport, where the Department of Kinesiology laboratories are located.

During the first session (Baseline), the purpose and procedures of the research will be explained by the investigator, co-investigator, or a research assistant in more detail. Participants will read and sign the informed consent form and then undergo an exclusion/inclusion criteria assessment which includes the Physical Activity Readiness Questionnaire (PAR-Q), and brief questionnaire. All study personnel/staff obtaining informed consent will be trained in the responsible conduct of research. All participants will be asked if they have a known allergy to Kinesio Tape (KT) or if they have sensitive skin. Those with sensitive skin will be administered an allergy test. After screening and enrollment, participants will complete baseline assessments of muscle pain and function, pain sensitivity, and psychological risk factors (See outcome measures).

During Session 2, strength of the non-dominant bicep will be measured first. Participants will then perform an eccentric exercise protocol designed to induce delayed onset muscle soreness (DOMS) on the non-dominant arm. Strength of the non-dominant bicep will be measured immediately post the eccentric exercise protocol. At the end of this session, subjects will be randomly assigned to one of two intervention groups (experimental KT group, placebo KT group) or a control group (i.e., no intervention performed). The experimental group will receive KT with proper technique and tension (10-20%), while the placebo group will receive KT without technique and tension.

Sessions 3 and 4 will occur approximately 48 and 72 hours post Session 2, respectively. All the outcome variables will be measured during these sessions. For participants in the KT groups, the tape will be removed at the end of session 4, as described below.

Eligibility criteria: Inclusion Criteria:

* 18 to 30 years old

Exclusion Criteria:

* 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.
* An answer of yes to any of the seven questions on the first page of the 2019 Physical Activity Readiness Questionnaire \[PAR-Q: 16\] indicating that the subject is not physically ready for exercise without a medical exam. These exclusions include the following:

  * 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

Session exclusion criteria:

● 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).

Primary outcomes:
measure: change in worst pain in previous 24 hours
timeFrame: This measure will be assessed at baseline and 48 hours and 72 hours following completion of the eccentric exercise protocol
measure: Change in average pain in previous 24 hours
timeFrame: This measure will be assessed at baseline and 48 hours and 72 hours following completion of the eccentric exercise protocol
measure: Change in pain during elbow extension and elbow flexion
timeFrame: This measure will be assessed at baseline and 48 hours and 72 hours following completion of the eccentric exercise protocol
measure: Change in pressure pain threshold of the affected biceps
timeFrame: This measure will be assessed at baseline and 48 hours and 72 hours following completion of the eccentric exercise protocol
measure: Change in Active Total Elbow Range of Motion (AT-ROM)
timeFrame: This measure will be assessed at baseline and 48 hours and 72 hours following completion of the eccentric exercise protocol
measure: Change in pain during elbow flexion and extension
timeFrame: This measure will be assessed at baseline and 48 hours and 72 hours following completion of the eccentric exercise protocol
measure: Change in Maximal Strength of non-dominant bicep.
timeFrame: This measure will be assessed at baseline and 48 hours and 72 hours following completion of the eccentric exercise protocol
Secondary outcomes:
measure: Change in Self-reported function of the affected arm
timeFrame: This measure will be assessed at baseline and 48 hours and 72 hours following completion of the eccentric exercise protocol
measure: Pain catastrophizing
timeFrame: This instrument will be administered at baseline
measure: Fear of movement or reinjury
timeFrame: This instrument will be administered at baseline
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Purdue University Indianapolis
state: Indiana
Study officials:
References: