NCT05898867

Brief Summary

This study aims to understand if certain cognitive biases and heuristics are present in patients with knee osteoarthritis being treated with open label placebo (saline injections in the knee). A predefined survey will investigate the affect heuristic and group interviews patients who have responded well or not so well respectively will be used to examine if other cognitive biases or heuristics are present. Cognitive biases are systematic patterns of deviation from norm or rationality in judgment, while heuristics are tactics, or mental shortcuts to aid in the decision-making process.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

June 7, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2023

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

May 10, 2023

Last Update Submit

March 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Concept maps.

    Using the Group Concept Mapping (GCM) method investigators will generate concept maps from non-responders and responders respectively, from participants from the study "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" (Clinical trial.gov registration: NCT05225480) Responders are defined as the those patients that had the largest change (4th quartile) to the pain Visual Analog Scale (VAS) (0-100mm). Non-responders are defined as the 1st quartile (least change). GCM is a formal group process using a structured approach to identify ideas on a topic of interest and organise them into domains based on a mixed-method participatory design that incorporates group processes and multivariate statistical analyses (multidimensional scaling and hierarchical cluster analysis). Using the concept maps and statements, investigators will assess similarities with known cognitive biases or heuristics.

    The GCM sessions are carried out approximately 1 year and 2 months after baseline.

Secondary Outcomes (1)

  • Strength of the affect heuristic in patients with knee OA

    The questionnaire is administered approximately 1 year and 4 months after baseline.

Study Arms (2)

Responders

Participants from the trial "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" will be defined as responders if they belong to the upper quartile of the change to the pain Visual Analogue Scale (VAS) (those who had the greatest positive changes)

Other: Saline

Non-responders

Participants from the trial "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" will be defined as non-responders if they belong to the lower quartile of the change to the pain Visual Analogue Scale (VAS) (those who had the smallest change).

Other: Saline

Interventions

SalineOTHER

Open label intra-articular injection of isotonic saline.

Non-respondersResponders

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People over 50 years of age with tibiofemoral knee osteoarthritis according to the American College of Rheumatology with an average knee pain in the last week during weight bearing activities of at least 4 on a 0 to 10 points VAS scale (0=no pain; 10=worst possible pain).

You may qualify if:

  • Have participated in the study "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" (Clinical trial.gov registration: NCT05225480)

You may not qualify if:

  • Have not participated in the study "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" (Clinical trial.gov registration: NCT05225480)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg-Frederiksberg Hospital

Copenhagen, 2000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 10, 2023

First Posted

June 12, 2023

Study Start

June 7, 2023

Primary Completion

October 5, 2023

Study Completion

October 5, 2023

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations