The Impact of Therapeutic Alliance in the Rehabilitation of Knee Osteoarthritis.

Knee Osteoarthritis Clinical Trial

— ALLIANCE  

Official title:

The Impact of Therapeutic Alliance on Clinical Outcomes in Patients With Symptomatic Knee Osteoarthritis. A Randomized Clinical Trial Protocol.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04390932
• Other study ID #: RCTKINE2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: May 2020
• Source: Universidad Catolica de Temuco
• Contact: Iván A Cuyul-Vásquez
• Phone: +56990914987
• Email: ivancuyul[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: March 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Enhanced 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.
• Limited 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.
• Therapeutic exercise protocol.
Three 45-60 minute sessions of supervised therapeutic exercise (combination of aerobic, isometric, and isotonic exercise) delivered within a one-week period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Catolica de Temuco

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lower limb function	WOMAC physical function section	Only in the evaluation of the baseline.
Other	Therapeutic alliance	Work Alliance Sub-scale of the Rehabilitation Expectations Scale (PRES)	48 hours post intervention
Other	Expectations level	Credibility and Expectations Questionnaire	Only in the evaluation of the baseline.
Other	Conditioned pain modulation	Change in pressure algometry after application of cold inmmersion test	Only in the evaluation of the baseline.
Other	Anxiety and depression	Hospital Anxiety and Depression Scale (HADS)	Only in the evaluation of the baseline.
Primary	Pain intensity	Change in numerical pain rating scale (PI-NRS)	48 hours post intervention
Primary	Pressure pain thresholds	Change in pressure algometry	48 hours post intervention