Predicting Outcome Following Standardized Exercise Therapy in Knee Osteoarthritis Patients

Knee Osteoarthritis Clinical Trial

Official title:

Smerteprofiler Som Redskab Til at prædiktere Effekten af 6-8 Ugers GLA:D®-forløb Hos Patienter Med Smertefuld Slidgigt i knæene

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04123756
• Other study ID #: N-20190045
• Status: Terminated
• Start date: October 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2024
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Known factors to influence pain and pain sensitization

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• standardized exercise therapy for knee OA patients
Standardized exercise therapy for 6-8 weeks (two times per week).

Locations

Country	Name	City	State
Denmark	FysioDanmark Aarhus	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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