Immediate Effects Of Alliance Therapy In Modulation Of Pain And Disability In Subjects With Knee Osteoarthritis
Primary Purpose
Arthritis, Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Kinesio Taping and therapeutic alliance
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis
Eligibility Criteria
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
Sites / Locations
- Claudio Cazarini Júnior
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group 1 "Kinesio Taping® KT"
" Kinesio Taping® with therapeutic alliance KT+AT"
Arm Description
Kinesio Taping® KT
Kinesio Taping® with therapeutic alliance
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03928054
First Posted
April 23, 2019
Last Updated
April 24, 2019
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03928054
Brief Title
Immediate Effects Of Alliance Therapy In Modulation Of Pain And Disability In Subjects With Knee Osteoarthritis
Official Title
Immediate Effects Of Alliance Therapy In Modulation Of Pain And Disability In Subjects With Knee Osteoarthritis: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
January 1, 2016 (Actual)
Study Completion Date
July 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1 "Kinesio Taping® KT"
Arm Type
Experimental
Arm Description
Kinesio Taping® KT
Arm Title
" Kinesio Taping® with therapeutic alliance KT+AT"
Arm Type
Experimental
Arm Description
Kinesio Taping® with therapeutic alliance
Intervention Type
Other
Intervention Name(s)
Kinesio Taping and therapeutic alliance
Intervention Description
bandage used in the treatment of orthopedic diseases and the technique of therapeutic approach in the known patient with therapeutic alliance
Primary Outcome Measure Information:
Title
Pain intensity: VAS
Description
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
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Claudio Cazarini Júnior
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
03156001
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18163497
Citation
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.
Results Reference
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Immediate Effects Of Alliance Therapy In Modulation Of Pain And Disability In Subjects With Knee Osteoarthritis
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