The Effectiveness of Kinesio Taping Method for Knee Osteoarthritis.
1 other identifier
interventional
187
1 country
1
Brief Summary
Purpose of our study is to evaluate effectiveness of Kinesio Taping method for knee osteoarthritis. Using simple concealed randomization procedure to form two groups (kinesio taping and control-nonspecific taping) of 100 knee osteoarthritis patients in each. 1 month all patients (depending on the group they will be allocated to) will receive either kinesio taping applications or non-specific taping: 4 applications per subject. Three times: before taping, after a month with tapes, and after 1 month without tapes evaluation of knee function, mobility, quality of life will be evaluated, including clinical examination of knee joint, measurements of knee flexion and extension by goniometer, circumference of leg over the knee, in ½ of thigh and in ½ of calf (to evaluate edema); pain will be evaluated by questionnaire, patella tendon algometry; force of calf flexors and extensors will be evaluated using Lovett manual muscle testing scale, goniometry for knee flexion/extension; for mobility, knee function, life quality evaluations - 10 Meter Walk , Five Times Sit to Stand Tests will be performed, Knee injury and Osteoarthritis Outcome Score (KOOS) and Medical Outcomes Study Short Form 36 2 version (SF-36 2v) questionnaires will be used. Also data about the need of analgesic medicament will be collected from subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Oct 2014
Longer than P75 for not_applicable knee-osteoarthritis
1 active site
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 Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 12, 2016
CompletedFirst Posted
Study publicly available on registry
March 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedDecember 19, 2018
December 1, 2018
3.8 years
September 12, 2016
December 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in knee pain intensity from baseline at 4 weeks
Numeric Pain Rating Scale (an 11-point scale from 0-10. "0" = no pain, "10" = the most intense pain imaginable)
4 weeks
Secondary Outcomes (21)
Change in knee pain intensity from baseline at 8 weeks
8 weeks
Change in patella tendon pain threshold from baseline at 4 weeks
4 weeks
Change in patella tendon pain threshold from baseline at 8 weeks
8 weeks
Change in knee function at 4 weeks from baseline
after 4weeks
Change in knee function at 8 weeks from baseline
after 8 weeks
- +16 more secondary outcomes
Study Arms (2)
Kinesio taping group
EXPERIMENTALParticipants receiving kinesio taping application
Non specific taping
SHAM COMPARATORParticipants receiving non specific taping application
Interventions
Kinesio taping application will be applied for experimental group; non specific taping application for control
Eligibility Criteria
You may not qualify if:
- Rheumatoid arthritis or other systemic rheumatoid disease (LE, sclerodermia,.. etc)
- Fragile, very sensitive skin or it's lesions in areas where tapes are to be applied
- Inability to do functional tests according study protocol due to very impaired knee function or severe comorbidities.
- Diagnosed or suspected cancer in areas where tapes to be applied
- \< than 6 months after intra-articular injections in knee joint
- Constant usage of analgesic medicament due to comorbidities
- Pregnancy
- History of Kinesio Taping method applications in the past
- Need for orthotics
- Unwillingness not to use local ointments in knee region during participation in study period (i.e. 2 months)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
LithuanianUHS
Kaunas, LT-50009, Lithuania
Related Publications (1)
Donec V, Kubilius R. The effectiveness of Kinesio Taping(R) for pain management in knee osteoarthritis: a randomized, double-blind, controlled clinical trial. Ther Adv Musculoskelet Dis. 2019 Aug 29;11:1759720X19869135. doi: 10.1177/1759720X19869135. eCollection 2019.
PMID: 31497072DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raimondas Kubilius, PhD
Lithuanian University of Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Venta Donec, MD
Study Record Dates
First Submitted
September 12, 2016
First Posted
March 10, 2017
Study Start
October 1, 2014
Primary Completion
July 1, 2018
Study Completion
August 1, 2018
Last Updated
December 19, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share