An interventional study of Enhanced TA and Limited TA in Knee Osteoarthritis, sponsored by Universidad Catolica de Temuco. Completed at 1 site in Chile. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Universidad Catolica de Temuco · Not applicable, Interventional, and Treatment
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.
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 24 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Universidad Catolica de Temuco is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Therapeutic exercise protocol accompanied by an enhanced TA.
Other: Enhanced TA · Other: Therapeutic exercise protocol.
Therapeutic exercise protocol accompanied by an limited TA
Other: Limited TA · Other: Therapeutic exercise protocol.
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.
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.
Three 45-60 minute sessions of supervised therapeutic exercise (combination of aerobic, isometric, and isotonic exercise) delivered within a one-week period.
Pain intensity
Change in numerical pain rating scale (PI-NRS)
Time frame: 48 hours post intervention
Pressure pain thresholds
Change in pressure algometry
Time frame: 48 hours post intervention
Lower limb function
WOMAC physical function section
Time frame: Only in the evaluation of the baseline.
Therapeutic alliance
Work Alliance Sub-scale of the Rehabilitation Expectations Scale (PRES)
Time frame: 48 hours post intervention
Expectations level
Credibility and Expectations Questionnaire
Time frame: Only in the evaluation of the baseline.
Conditioned pain modulation
Change in pressure algometry after application of cold inmmersion test
Time frame: Only in the evaluation of the baseline.
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS)
Time frame: Only in the evaluation of the baseline.
Plan to share: No
Ran from Dec 2023 to primary completion in Mar 2025, 15 months.
Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 15 months is below that.
Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Universidad Catolica de Temuco