NCT03076177

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

87
On Track

Trial Health Score

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

Enrollment
187

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable knee-osteoarthritis

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

3.8 years

First QC Date

September 12, 2016

Last Update Submit

December 18, 2018

Conditions

Keywords

knee osteoarthritis, kinesio taping, knee function, pain

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

EXPERIMENTAL

Participants receiving kinesio taping application

Other: Taping application

Non specific taping

SHAM COMPARATOR

Participants receiving non specific taping application

Other: Taping application

Interventions

Kinesio taping application will be applied for experimental group; non specific taping application for control

Also known as: Kinesio taping/non specific taping
Kinesio taping groupNon specific taping

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Osteoarthritis, KneePain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Raimondas Kubilius, PhD

    Lithuanian University of Health Sciences

    PRINCIPAL INVESTIGATOR

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

Locations