CClinicalTrials.gg
CompletedNCT04390932ALLIANCEUpdated Apr 2, 2025

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Therapeutic Alliance
  • Professional-Patient Relations
  • Pain
  • Osteoarthritis
  • Exercise Therapy.
03

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Enhanced TA

    Therapeutic exercise protocol accompanied by an enhanced TA.

    Other: Enhanced TA · Other: Therapeutic exercise protocol.

  • Active comparator
    Neutral therapeutic alliance

    Therapeutic exercise protocol accompanied by an limited TA

    Other: Limited TA · Other: Therapeutic exercise protocol.

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.

05

What researchers measure

Primary outcomes

  1. Pain intensity

    Change in numerical pain rating scale (PI-NRS)

    Time frame: 48 hours post intervention

  2. Pressure pain thresholds

    Change in pressure algometry

    Time frame: 48 hours post intervention

Other outcomes

  1. Lower limb function

    WOMAC physical function section

    Time frame: Only in the evaluation of the baseline.

  2. Therapeutic alliance

    Work Alliance Sub-scale of the Rehabilitation Expectations Scale (PRES)

    Time frame: 48 hours post intervention

  3. Expectations level

    Credibility and Expectations Questionnaire

    Time frame: Only in the evaluation of the baseline.

  4. Conditioned pain modulation

    Change in pressure algometry after application of cold inmmersion test

    Time frame: Only in the evaluation of the baseline.

  5. Anxiety and depression

    Hospital Anxiety and Depression Scale (HADS)

    Time frame: Only in the evaluation of the baseline.

06

Study locations

1 site
  • UC Temuco
    Temuco, Chile
07

References and documents

Publications

  • 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. PubMed 33956775 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04390932
Lead sponsor
Universidad Catolica de Temuco
Responsible party
Iván Alejandro Cuyul Vásquez (Associate Professor, Universidad Catolica de Temuco) — Principal investigator
First posted
May 18, 2020
Start date
Dec 1, 2023
Primary completion
Mar 28, 2025
Completion
Mar 28, 2025
Last update
Apr 2, 2025

Study contacts

Iván A Cuyul-Vásquez
principal investigator · Universidad Catolica de Temuco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion