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The Impact of Therapeutic Alliance in the Rehabilitation of Knee Osteoarthritis. (ALLIANCE)

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhanced TA
Limited TA
Therapeutic exercise protocol.
Sponsored by
Universidad Catolica de Temuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Therapeutic Alliance, Professional-Patient Relations, Pain, Osteoarthritis, Exercise Therapy.

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- People aged 45 to 65 years with a clinical and radiographic diagnosis of knee osteoarthritis (grade I-III according to Kellgren and Lawrance), symptomatic with pain intensity between 3 and 8 points in the PI-NRS with at least 3 months duration, resulting in a mild to moderate level of disability (WOMAC).

Exclusion Criteria:

- People with other musculoskeletal, neurological, or immune conditions that cause pain or functional limitation in the lower extremities (hip osteoarthritis, patellar tendinopathy, sprains, radiculopathies, rheumatoid arthritis, systemic lupus erythematosus), history of trauma less than a year ago ( knee fractures, meniscal or ligament tears) or surgery of any kind on the lower extremity. Knee mobility less than 90º flexion. People in treatment with oral or intra-articular corticosteroids, antibiotics or exogenous opioids of any kind, with unstable cardiovascular, respiratory, systemic or metabolic conditions that do not allow physical exercise.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Enhanced TA

    Neutral therapeutic alliance

    Arm Description

    Therapeutic exercise protocol accompanied by an enhanced TA.

    Therapeutic exercise protocol accompanied by an limited TA

    Outcomes

    Primary Outcome Measures

    Pain intensity
    Change in numerical pain rating scale (PI-NRS)
    Pressure pain thresholds
    Change in pressure algometry

    Secondary Outcome Measures

    Full Information

    First Posted
    May 12, 2020
    Last Updated
    May 12, 2020
    Sponsor
    Universidad Catolica de Temuco
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04390932
    Brief Title
    The Impact of Therapeutic Alliance in the Rehabilitation of Knee Osteoarthritis.
    Acronym
    ALLIANCE
    Official Title
    The Impact of Therapeutic Alliance on Clinical Outcomes in Patients With Symptomatic Knee Osteoarthritis. A Randomized Clinical Trial Protocol.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    January 30, 2021 (Anticipated)
    Study Completion Date
    March 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Catolica de Temuco

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The therapeutic alliance (TA) is the working relationship or positive social bond between the patient and the therapist. TA is based on collaboration, communication, empathy of the therapist and mutual respect. Fostering an enhanced therapeutic alliance is a low-cost, therapist-dependent strategy that can accompany any clinical intervention. Growing evidence suggests that the TA plays a pivotal role in clinical outcomes in psychotherapy, medicine and physiotherapy interventions for chronic low back pain. On the other hand, therapeutic exercise is an economic, accessible and simple intervention strategy that has proven to be effective and safe to decrease pain and improve physical function in people with knee osteoarthritis (OA). To date, the role of TA in the management of knee OA is unknown. We hypothesized that a therapeutic exercise protocol accompanied by an enhanced TA could reduce the severity of symptoms and improve function in patients with symptomatic knee OA.
    Detailed Description
    The objective of this randomized clinical trial will be to determine the effects of different levels of TA during the application of a therapeutic exercise program on pain intensity, pressure pain thresholds and function in patients with symptomatic knee OA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    Therapeutic Alliance, Professional-Patient Relations, Pain, Osteoarthritis, Exercise Therapy.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    Opaque sealed envelopes.
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Enhanced TA
    Arm Type
    Experimental
    Arm Description
    Therapeutic exercise protocol accompanied by an enhanced TA.
    Arm Title
    Neutral therapeutic alliance
    Arm Type
    Active Comparator
    Arm Description
    Therapeutic exercise protocol accompanied by an limited TA
    Intervention Type
    Other
    Intervention Name(s)
    Enhanced TA
    Intervention Description
    The enhanced TA is characterized by the personalization of the conversation, the verbalization of a joint participation in the process, the full presence of the therapist in the development of the exercise protocol, and the inclusion of behaviors such as active listening, empathy, and encouragement. In addition, therapist's body language transmits confidence, security, and attention.
    Intervention Type
    Other
    Intervention Name(s)
    Limited TA
    Intervention Description
    The limited TA does not consider the personalization of the conversation, uses a unidirectional verbalization and is imperative about the instructions provided to the participant, the therapist is intermittently absent during the therapeutic exercise sessions and uses a neutral or negative nonverbal language cues.
    Intervention Type
    Other
    Intervention Name(s)
    Therapeutic exercise protocol.
    Intervention Description
    Three 45-60 minute sessions of supervised therapeutic exercise (combination of aerobic, isometric, and isotonic exercise) delivered within a one-week period.
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    Change in numerical pain rating scale (PI-NRS)
    Time Frame
    48 hours post intervention
    Title
    Pressure pain thresholds
    Description
    Change in pressure algometry
    Time Frame
    48 hours post intervention
    Other Pre-specified Outcome Measures:
    Title
    Lower limb function
    Description
    WOMAC physical function section
    Time Frame
    Only in the evaluation of the baseline.
    Title
    Therapeutic alliance
    Description
    Work Alliance Sub-scale of the Rehabilitation Expectations Scale (PRES)
    Time Frame
    48 hours post intervention
    Title
    Expectations level
    Description
    Credibility and Expectations Questionnaire
    Time Frame
    Only in the evaluation of the baseline.
    Title
    Conditioned pain modulation
    Description
    Change in pressure algometry after application of cold inmmersion test
    Time Frame
    Only in the evaluation of the baseline.
    Title
    Anxiety and depression
    Description
    Hospital Anxiety and Depression Scale (HADS)
    Time Frame
    Only in the evaluation of the baseline.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - People aged 45 to 65 years with a clinical and radiographic diagnosis of knee osteoarthritis (grade I-III according to Kellgren and Lawrance), symptomatic with pain intensity between 3 and 8 points in the PI-NRS with at least 3 months duration, resulting in a mild to moderate level of disability (WOMAC). Exclusion Criteria: - People with other musculoskeletal, neurological, or immune conditions that cause pain or functional limitation in the lower extremities (hip osteoarthritis, patellar tendinopathy, sprains, radiculopathies, rheumatoid arthritis, systemic lupus erythematosus), history of trauma less than a year ago ( knee fractures, meniscal or ligament tears) or surgery of any kind on the lower extremity. Knee mobility less than 90º flexion. People in treatment with oral or intra-articular corticosteroids, antibiotics or exogenous opioids of any kind, with unstable cardiovascular, respiratory, systemic or metabolic conditions that do not allow physical exercise.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Iván A Cuyul-Vásquez
    Phone
    +56990914987
    Email
    ivancuyul@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Iván A Cuyul-Vásquez
    Organizational Affiliation
    Universidad Catolica de Temuco
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33956775
    Citation
    Cuyul-Vasquez I, Fuentes C J. Effects of therapeutic alliance on clinical outcomes in patients with symptomatic knee osteoarthritis undergoing an exercise program: A randomized clinical trial protocol. Medwave. 2021 Apr 16;21(3):e8160. doi: 10.5867/medwave.2021.03.8159.
    Results Reference
    derived

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