Knee Osteoarthritis
Conditions
Keywords
Therapeutic Alliance, Professional-Patient Relations, Pain, Osteoarthritis, Exercise Therapy.
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.
Interventions
OTHEREnhanced TA
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.
OTHERLimited TA
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.
OTHERTherapeutic exercise protocol.
Three 45-60 minute sessions of supervised therapeutic exercise (combination of aerobic, isometric, and isotonic exercise) delivered within a one-week period.
Sponsors
Universidad Catolica de Temuco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Opaque sealed envelopes.
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 48 hours post intervention | Change in numerical pain rating scale (PI-NRS) |
| Pressure pain thresholds | 48 hours post intervention | Change in pressure algometry |
Other
| Measure | Time frame | Description |
|---|---|---|
| Expectations level | Only in the evaluation of the baseline. | Credibility and Expectations Questionnaire |
| Lower limb function | Only in the evaluation of the baseline. | WOMAC physical function section |
| Anxiety and depression | Only in the evaluation of the baseline. | Hospital Anxiety and Depression Scale (HADS) |
| Conditioned pain modulation | Only in the evaluation of the baseline. | Change in pressure algometry after application of cold inmmersion test |
| Therapeutic alliance | 48 hours post intervention | Work Alliance Sub-scale of the Rehabilitation Expectations Scale (PRES) |
Countries
Chile
Outcome results
None listed