Clinical trial NCT04390932: The Impact of Therapeutic Alliance in the Rehabilitation of Knee Osteoarthritis.
Official title: The Impact of Therapeutic Alliance on Clinical Outcomes in Patients With Symptomatic Knee Osteoarthritis. A Randomized Clinical Trial Protocol.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Therapeutic Alliance
Professional-Patient Relations
Pain
Osteoarthritis
Exercise Therapy.
Lead sponsor: Universidad Catolica de Temuco
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain intensity
timeFrame: 48 hours post intervention
measure: Pressure pain thresholds
timeFrame: 48 hours post intervention
Secondary outcomes:
Other outcomes:
measure: Lower limb function
timeFrame: Only in the evaluation of the baseline.
measure: Therapeutic alliance
timeFrame: 48 hours post intervention
measure: Expectations level
timeFrame: Only in the evaluation of the baseline.
measure: Conditioned pain modulation
timeFrame: Only in the evaluation of the baseline.
measure: Anxiety and depression
timeFrame: Only in the evaluation of the baseline.
Locations:
city: Temuco
country: Chile
facility: UC Temuco
Study officials:
affiliation: Universidad Catolica de Temuco
name: Iván A Cuyul-Vásquez
role: PRINCIPAL_INVESTIGATOR
References:
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.