Predictors for Analgesic Effect to Standardized Exercise Therapy for Osteoarthritic Pain

Kliniske Smertetests Som prædiktorer for Effekten af GLA:D®-træningsforløb Hos Patienter Med Symptomgivende Slidgigt i knæene

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. In addition, exercise-induced hypoalgesia (EIH), a measure of descending pain control, has previously been found dysfunctional in a subgroup of people with painful KOA and has also been utilized as a predictive factor for pain progression following total knee replacement.

Measures of pain sensitization have been used prognostic to identify responders to treatment but EIH as a prognostic tool for Physiotherapy-guided Evidence-based Exercise Therapy (PEET) has not been investigated. The primary aim of this explorative study is to investigate if EIH assessed pre-PEET was associated with changes in pain, disability and PainDETECT (PDQ) score post-PEET. The secondary aim is to investigate if PEET changes EIH and PDQ score in patients with painful KOA.

Part 2:

Cross-sectional studies indicate, that daily level of activity influence the effectivity of the EIH mechanims, while pain patients (e.g. KOA patients) can have normal of dysfunctional EIH. It has not been investigated if EIH changes after prolonged exercise in healthy subjects. The aim of this secord part of the study, is to investigate if EIH changes after 6-9 weeks of intensive military training in healthy subjects

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee; Healthy Subjects
• Intervention / Treatment: Other: Physiotherapy-guided Evidence-based Exercise Therapy; Other: Part 2: Military training

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Denmark
  • Midtjylland
    • Viby, Midtjylland, Denmark, 8260
      • Viby Fysioterapi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

25 patients with knee osteoarthritis scheduled for PEET.

Part 2 40 healthy subjects (age 18-28) signed up as recruits in Defence Command Denmark

Description

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.

Part 2:

Inclusion Criteria

• starting as recruits in Defence Command Denmark

Exclusion Criteria:

• Known factors to influence pain and pain sensitization.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Knee OA patients (part 1); Painful knee OA patients signed up for standardized exercise therapy	Other: Physiotherapy-guided Evidence-based Exercise Therapy; Standardized supervised exercise therapy for 6-8 weeks (two times per week).
Healthy subjects (part 2); Healthy subjects (age 18-28) signed up military service in Defence Command Denmark	Other: Part 2: Military training; Part 2: standardized military training for 6-8 weeks in Defence Command Denmark

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Pain measured on a numerical analog scale from 0 (no pain) to 10 (worst pain imaginable)	1-2 weeks after last exercise session
Part 2: Exercise-induced hypoalgesia (EIH)	Change in EIH	6-8 weeks into standardized pre-planned military training that continues after the tests

Collaborators and Investigators

• Sponsor: Kristian Kjær Petersen
• Investigators: Principal Investigator: Kristian K Petersen, PhD, Aalborg University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: N-20170070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No