NCT03928054

Brief Summary

INTRODUCTION: The Osteoarthritis (OA) is the most common type of joint disease, its features include joint space narrowing, osteophytes formation of the joint margins, motor deficit, reduced strength, and persistent pain. As a treatment option physiotherapy has several resources for the patient approach. However, the effect of treatment is not only the application of therapeutic techniques and resources but also to existing contextual factors such as the therapeutic alliance. OBJECTIVE: To assess the effects of an intervention with the focus on positive therapeutic alliance in subjects OA knee on pain and disability. METHODS: This is a randomized study of two arms with a blind evaluator. 40 subjects were randomized into 2 groups: group 1 "Kinesio Taping® KT" group 2 " Kinesio Taping® with therapeutic alliance KT+AT". Both groups received the application of Kinesio Taping® method as the concepts of the original method. The group "KT+AT" session was conducted in order to increase the relationship between the therapist and the patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2019

Completed
Last Updated

April 25, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

April 23, 2019

Last Update Submit

April 24, 2019

Conditions

ArthritisKnee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Pain intensity: VAS

    Pain intensity was assessed using a visual analogic scale (VAS) of 11 items (0 to 10) (22), in which the patient measured the intensity of pain, with 0 = "no pain" and 10 = "worst possible pain

    12 weeks

Study Arms (2)

group 1 "Kinesio Taping® KT"

EXPERIMENTAL

Kinesio Taping® KT

Other: Kinesio Taping and therapeutic alliance

" Kinesio Taping® with therapeutic alliance KT+AT"

EXPERIMENTAL

Kinesio Taping® with therapeutic alliance

Other: Kinesio Taping and therapeutic alliance

Interventions

Kinesio Taping and therapeutic allianceOTHER

bandage used in the treatment of orthopedic diseases and the technique of therapeutic approach in the known patient with therapeutic alliance

" Kinesio Taping® with therapeutic alliance KT+AT"group 1 "Kinesio Taping® KT"

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with both sexes from 40 to 80 years old
  • who underwent imaging examination evidencing grade II or III knee osteoarthritis according to the Kellgren and Lawrence classification
  • who were referred to the physiotherapy service by a physician.

You may not qualify if:

  • Patients who are unable to walk
  • with a history of cancer
  • associated neurological diseases
  • morbid obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Claudio Cazarini Júnior

São Paulo, São Paulo, 03156001, Brazil

Location

Related Publications (1)

  • Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.

    PMID: 18163497BACKGROUND

MeSH Terms

Conditions

ArthritisOsteoarthritis, Knee

Interventions

Therapeutic Alliance

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapeutic ProcessesPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2019

First Posted

April 25, 2019

Study Start

November 1, 2015

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

April 25, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)