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Delayed Onset Muscle SorenessNCT06535906

Effect of Manual Lymphatic Drainage and Kinesio Taping on Delayed Onset Muscle Soreness

A study testing kinesio taping and manual lymph drainage in people with Delayed Onset Muscle Soreness, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Delayed muscle soreness is pain and tenderness that occurs after unusual exercises, most often involving eccentric contraction. This sensitivity, which usually begins in the distal part of the muscle and is intense, spreads progressively throughout the entire muscle 24-48 hours after exercise. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Delayed Onset Muscle Soreness
What is being tested?
kinesio taping and manual lymph drainage
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
23 Sep 2024to 18 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Being between the ages of 18-40
  • Agreeing to participate in the study
  • Being healthy sedentary

Who cannot join

  • Those with neurological or perception problems
  • Having any musculoskeletal injury in the last 6 months
  • Having pain in the upper extremity and a history of surgery
  • Participating in upper extremity weight training in the last 6 months
  • Those taking anti-inflammatory or analgesic medications up to 12 hours before evaluation

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Necmettin Erbakan University

    Konya, Meram, 42140

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Manual Lymphatic Drainage and Kinesio Taping on Delayed Onset Muscle Soreness: Randomized -Controlled Study

Delayed muscle soreness is pain and tenderness that occurs after unusual exercises, most often involving eccentric contraction. This sensitivity, which usually begins in the distal part of the muscle and is intense, spreads progressively throughout the entire muscle 24-48 hours after exercise. The intensity of the discomfort increases within the first 24 hours following cessation of exercise, peaks between 24 and 72 hours, decreases and eventually disappears within 5-7 days after exercise.

Delayed onset muscle soreness is considered one of the most common and recurring forms of sports injuries. The most prominent symptoms and findings are a decrease in joint range of motion and strength, edema, stiffness, pain and tenderness. In the planned study, the investigatorss aimed to compare the effects of kinesio taping, manual drainage, placebo kinesio taping and placebo kinesio taping on pain intensity, pain threshold and tolerance, sensory sensitivity and connective tissue stiffness in individuals with delayed-onset muscle soreness.48 healthy adults will be included in our study. Participants will be divided into four groups of 12 people: kinesio taping, placebo kinesio taping, manual lymph drainage and placebo manual lymph drainage. Our participants will have a maximum repetition weight on their wrist flexor muscles, and a delayed muscle soreness protocol will be applied using 80% of this amount. In our participants, pain at rest and activity (VAS), pressure pain threshold and tolerance (algometer), tactile sense (Semmes-Weinstein Monofilament Test), edema (circumference measurement with tape measure), treatment satisfaction and effect (VAS), tissue tension (skin rolling). and perceived fatigue (VAS) will be evaluated. The researchers plan to conduct 5 assessments: before the delayed-onset muscle soreness protocol, immediately after the protocol, immediately after treatment, and 24 hours and 48 hours after the initial assessment.

Read the detailed description

Volunteers, healthcare students and university employees between the ages of 18-40 who meet the inclusion criteria will be included in our study. All participants meeting the inclusion criteria will be selected and divided into four groups using computer-generated randomization (simple randomization) ( www.randomizer.org ).Participants will be divided into four groups: manual lymph drainage, placebo manual lymph drainage, kinesio taping and placebo kinesio taping.

On the first day, after the volunteers who meet the inclusion criteria are divided into groups, demographic information (gender, age, height, body weight) will be collected. The first evaluation will be made after demographic information is obtained. The evaluation includes pain at rest and activity (VAS), pressure pain threshold and tolerance (algometer), tactile sense (Semmes-Weinstein Monofilament Test), edema (circumference measurement with tape measure), treatment satisfaction and effect (VAS), tissue tension and perceived fatigue. (VAS) will be evaluated. Visual Analog scale will be used to evaluate pain at rest and activity. Visual Analog Scale is a 10 cm long ruler drawn horizontally, starting with "No pain" and ending with "Unbearable pain". Our participants will be asked to mark an "x" in the appropriate area on this ruler for the intensity of pain they feel at rest. In order to determine the intensity of pain during the activity, the patient will be asked to perform wrist flexion and extension and will be asked to mark the pain they feel during the movement on the ruler in the same way. Algometer will be used to evaluate pressure pain threshold and tolerance. As the measurement point, the researcher will mark 5 cm distal to the medial epicondyle of the humerus on the line connecting the midpoint of the wrist joint and the medial epicondyle of the humerus . Two measurements will be made on this point with an interval of 30 seconds and the average will be recorded. Semmes-Weinstein Monofilament Test will be used for tactile sensation. The patient is asked to close his eyes while sitting with his forearm supported. The point where the pressure pain threshold was measured was chosen as the measurement point. Monofilament test is applied to the determined area a maximum of 3 times; Force is applied until the filament becomes slightly curved. The participant is told to say yes as soon as he feels it and the application is stopped at that moment. For each filament that is not felt, the next value, the thicker filament, is tried. Each filament is kept in the applied area for 1-1.5 seconds. The value obtained after the measurement is recorded. Edema measurement will be measured with a non-flexible tape measure at the reference point where the pressure pain threshold is measured, with the participant in a sitting position with forearm supported. Treatment satisfaction and impact will only be questioned at the final evaluation.Researchers will evaluate the patient's treatment satisfaction level with a visual analog scale. The patient will be asked to evaluate his/her satisfaction with the treatment by placing an "x" mark on the ruler, which starts with "I am not at all satisfied" and ends with "I am very satisfied". Tissue tension will be evaluated on the forearm with the skin rolling technique. Visual Analog scale will be used for perceived fatigue. "There is no fatigue at all." The patient will be asked to evaluate the fatigue he/she feels by placing an "x" on the ruler starting with "Severe Fatigue". All evaluations will be applied to the non-dominant upper extremity wrist flexor muscles. Because the researchers recruited healthy volunteers, they do not expect the participants to experience any pain at the start of the study.Researchers will create the muscle soreness they want using free weights. Researchers will find a 1 Maximum Rep Weight to create delayed onset muscle soreness. Researchers will reference previous studies to find a 1 Maximum Rep Weight.1 Maximum Repetition is the weight that can be lifted only once but cannot be lifted a second time. 1 After the Maximum Repetition weight is determined, an eccentric exercise program will be applied to the participants with a free weight of 80% of this weight. After the first evaluation, the 1 Maximum Repetition weight of the non-dominant wrist flexor muscles will be determined. 1 Mayhew et al.'s formula will be used to find Maximum Repetition. Participants will be given an estimated weight for their wrist flexors and counted the number of times they lift that weight. The resulting weight and number of repetitions will be substituted into the formula and 1 Maximum Repetition will be calculated. After 1 Maximum Repetition is determined, a delayed muscle soreness protocol will be applied by performing 10 sets of wrist flexion consisting of 10 repetitions at 80% of 1 Maximum Repetition. There will be a 1 minute rest period between each set. After delayed onset muscle soreness is established, participants will be given a second evaluation and then their treatments will be applied according to the groups they belong to. After the treatment, the third evaluation will be made and the first day applications will end. A fourth assessment will be made 24 hours after the delayed muscle soreness protocol and a fifth assessment will be made 48 hours later.All of the parameters described above will be evaluated in all five planned evaluations. Treatment satisfaction and impact will only be questioned at the final evaluation

Being tested
kinesio taping, placebo kinesio taping, manual lymph drainage, placebo manual lymph drainage
Keywords
delayed onset muscle soreness, kinesio taping, manual lymphatic drainage, pressure pain threshold, pain
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • kinesio tapingOther

    The 5 cm wide Kinesio tape (Kinesio® Tex Gold™, Albuquerque, NM) applied to the participants has the ability to stretch up to 140% of its original length. Moreover, it provides comfortable use for 3 to 5 days thanks to its latex-free, cotton, hypoallergenic and porous features. The skin will be cleaned with alcohol before applying Kinesio tape. To prevent muscle tension, the physiotherapist will apply the kinesio tape inhibition technique to the wrist flexor muscles with light tension (15-25% of the current tension) from the end point to the origin. We will use this inhibition technique to prevent muscle spasm. Kinesio taping will be applied immediately after exercise

  • placebo kinesio tapingOther

    5 cm wide and 0.5 mm thick I-shaped Kinesio tape (Kinesio Tex® Gold) will be used. The tape will be applied in a plus-shaped, tension-free and technical sitting position. Kinesio taping will be applied immediately after exercise

  • manual lymph drainageOther

    Participants will lie in a supine position with their knees bent. Manual lymphatic drainage will begin with abdominal lymph drainage followed by central lymph stimulation. Then, bilateral axillary lymph nodes will be stimulated and the fluid in the exercised arm will be directed to the axillary lymph nodes. While the patients are in the prone position, the axillary lymph nodes will be stimulated in the same way and each manual lymphatic drainage will be performed from the back to the axillary lymph node. Each treatment session will last approximately 30 minutes

  • placebo manual lymph drainageOther

    Participants will lie in a supine position with their knees bent. It will only be moved in a stroking style with hand contact from the fingers towards the armpit.

Study groups in NCT06535906
Study groupRoleWhat they receive
kinesio tapingActive comparatorKinesio taping is a widely used physiotherapy application for muscle pain. Kinesio taping will be applied to patients in this group.
Receives: Other: kinesio taping
placebo kinesio tapingPlacebo comparatorKinesio taping is a widely used physiotherapy application for muscle pain. In this group, placebo kinesio taping will be applied to the patients.
Receives: Other: placebo kinesio taping
manual lymph drainageActive comparatorManual lymphatic drainage is a method commonly used in cases where lymph flow is impaired. Manual lymphatic drainage will be applied to patients in this group.
Receives: Other: manual lymph drainage
placebo manual lymph drainagePlacebo comparatorManual lymphatic drainage is a method commonly used in cases where lymph flow is impaired. In this group, patients will receive placebo manual lymphatic drainage.
Receives: Other: placebo manual lymph drainage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain at rest and activity

    It will be evaluated with a visual analog scale. Possible scores range from 0 (no pain) to 10 (worst possible pain)

    Measured: Three days

  2. Pressure pain threshold and tolerance

    It will be measured with an algometer. The result will be displayed in pounds

    Measured: Three days

Secondary outcomes (5)
  1. Tactile sensation

    Semmes-Weinstein Monofilament Test will be used for tactile sensation.Monofilament sets containing sizes 2.83, 3.61, 4.31, 4.56, 6.65 will be used.

    Measured: Three days

  2. Edema

    Edema measurement will be made with a non-flexible tape measure. Will be recorded in centimeters

    Measured: Three days

  3. Tissue tension

    Tissue tension will be evaluated on the forearm with the skin rolling technique. In all planned evaluations, the tension bands will be evaluated according to the amount of tension (sensitivity) felt by the individual and the amount of tension felt by the therapist as "none (0)", "mild (1)", "moderate (2)" and "severe (3)".

    Measured: Three days

  4. Treatment satisfaction and impact

    It will be evaluated with a visual analog scale. It will be scored between 0 - 10. 0(I am not happy at all)- 10(I am completely satisfied)

    Measured: One day

  5. perceived fatigue

    It will be evaluated with a visual analog scale. It will be scored between 0 - 10. 0(I'm not tired at all) - 10(I'm completely tired).

    Measured: Three days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2024
  2. Study start23 Sep 2024
  3. Primary completion25 Sep 2024
  4. Study completion18 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
We conducted our study as a randomized controlled study. There will be no masking in our study.
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06535906
Sponsor's protocol ID
NEU-FTR-YO-01
Status last verified
Oct 2024
First submitted
30 Jul 2024
Last updated
29 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing kinesio taping and manual lymph drainage in people with Delayed Onset Muscle Soreness, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain at rest and activity (time frame: Three days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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