NCT06535906

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 23, 2024

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2024

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

2 days

First QC Date

July 30, 2024

Last Update Submit

October 26, 2024

Conditions

Keywords

delayed onset muscle sorenesskinesio tapingmanual lymphatic drainagepressure pain thresholdpain

Outcome Measures

Primary Outcomes (2)

  • 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)

    Three days

  • Pressure pain threshold and tolerance

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

    Three days

Secondary Outcomes (5)

  • Tactile sensation

    Three days

  • Edema

    Three days

  • Tissue tension

    Three days

  • Treatment satisfaction and impact

    One day

  • perceived fatigue

    Three days

Study Arms (4)

kinesio taping

ACTIVE COMPARATOR

Kinesio taping is a widely used physiotherapy application for muscle pain. Kinesio taping will be applied to patients in this group.

Other: kinesio taping

placebo kinesio taping

PLACEBO COMPARATOR

Kinesio taping is a widely used physiotherapy application for muscle pain. In this group, placebo kinesio taping will be applied to the patients.

Other: placebo kinesio taping

manual lymph drainage

ACTIVE COMPARATOR

Manual 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.

Other: manual lymph drainage

placebo manual lymph drainage

PLACEBO COMPARATOR

Manual lymphatic drainage is a method commonly used in cases where lymph flow is impaired. In this group, patients will receive placebo manual lymphatic drainage.

Other: placebo manual lymph drainage

Interventions

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

kinesio taping

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

placebo kinesio taping

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

manual lymph drainage

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.

placebo manual lymph drainage

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, 42140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitation

Study Officials

  • Yavuz Özkan, MSc

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No Masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: We conducted our study as a randomized controlled study. There will be no masking in our study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student Physiotherapist

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 2, 2024

Study Start

September 23, 2024

Primary Completion

September 25, 2024

Study Completion

October 18, 2024

Last Updated

October 29, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations