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

U

Universidad Catolica de Temuco

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Other: Enhanced TA
Other: Limited TA
Other: Therapeutic exercise protocol.

Study type

Interventional

Funder types

Other

Identifiers

NCT04390932
RCTKINE2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

45 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

24 participants in 2 patient groups

Enhanced TA
Experimental group
Description:
Therapeutic exercise protocol accompanied by an enhanced TA.
Treatment:
Other: Therapeutic exercise protocol.
Other: Enhanced TA
Neutral therapeutic alliance
Active Comparator group
Description:
Therapeutic exercise protocol accompanied by an limited TA
Treatment:
Other: Therapeutic exercise protocol.
Other: Limited TA

Trial contacts and locations

1

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Central trial contact

Iván A Cuyul-Vásquez

Data sourced from clinicaltrials.gov

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