Predicting Outcome Following Standardized Exercise Therapy in Knee Osteoarthritis Patients

NCT04123756 | Terminated DMC

• 1 other identifier: N-20190045
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Pain sensitization has been associated with pain severity in people with knee osteoarthritis (KOA) and a neuropathic pain component has been identified in up to 30% of KOA patients. Mechanistic pain profiling aims to identify the underlying mechanisms in the peripheral and central nervous systems, which are associated to the clinical pain. In addition, the mechanisms underlying the pain relieving effect of standardized exercise therapy are largely unknown, but it is hypothesized that they are linked to the patient's ability to activate the descending pain inhibitory pathways (conditioned pain modulation, CPM) in the central nervous system. Mechanistic pain profiling including CPM have been used prognostic to identify responders to treatment, but these measures as a prognostic tool for standardized exercise therapy has not been investigated. The primary aim of this study is to investigate if mechanistic pain profiling alone or in combination with clinical pain measures before standardized exercise therapy can predict the patients' pain reduction following the exercise therapy program

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• pain reduction

  Pain measured on a numerical rating scale from 0 (no pain) to 10 (worst pain imaginable)

  1-2 weeks after last exercise session

Interventions

standardized exercise therapy for knee OA patients BEHAVIORAL

Standardized exercise therapy for 6-8 weeks (two times per week).

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

130 patients with knee osteoarthritis scheduled for standardized exercise therapy

You may qualify if:

• The American College of Rheumatology for clinical knee osteoarthritis (excluding radiological OA assessment)

You may not qualify if:

• Known factors to influence pain and pain sensitization

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

FysioDanmark Aarhus

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, M.Sc., Ph.D.

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 11, 2019
• Study Start: October 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

DK (1)