Immediate Effects Of Alliance Therapy In Modulation Of Pain And Disability In Subjects With Knee Osteoarthritis

Sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT03928054

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis Knee Osteoarthritis	Other: Kinesio Taping and therapeutic alliance	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Immediate Effects Of Alliance Therapy In Modulation Of Pain And Disability In Subjects With Knee Osteoarthritis: A Randomized Clinical Trial

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group 1 "Kinesio Taping® KT" Kinesio Taping® KT	Other: Kinesio Taping and therapeutic alliance bandage used in the treatment of orthopedic diseases and the technique of therapeutic approach in the known patient with therapeutic alliance
Experimental: " Kinesio Taping® with therapeutic alliance KT+AT" Kinesio Taping® with therapeutic alliance	Other: Kinesio Taping and therapeutic alliance bandage used in the treatment of orthopedic diseases and the technique of therapeutic approach in the known patient with therapeutic alliance

Arm

Intervention/Treatment

Experimental: group 1 "Kinesio Taping® KT"

Kinesio Taping® KT

Other: Kinesio Taping and therapeutic alliance

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

Experimental: " Kinesio Taping® with therapeutic alliance KT+AT"

Kinesio Taping® with therapeutic alliance

Other: Kinesio Taping and therapeutic alliance

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

Outcome Measures

Primary Outcome Measures

Pain intensity: VAS [12 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Claudio Cazarini Júnior	Sao Paulo	São Paulo	Brazil	03156001

Sponsors and Collaborators

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Claudio Cazarini Junior, Principal Investigator, Faculdade de Ciências Médicas da Santa Casa de São Paulo

ClinicalTrials.gov Identifier:

NCT03928054

Other Study ID Numbers:

Robson Massi

First Posted:

Apr 25, 2019

Last Update Posted:

Apr 25, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Apr 25, 2019