Predictors for Analgesic Effect to Standardized Exercise Therapy for Osteoarthritic Pain

NCT03718663 | Completed

• 1 other identifier: N-20170070
• Study Type: observational
• Target: 28
• 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. 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

Conditions

Osteoarthritis, Knee; Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Knee OA patients (part 1)

Painful knee OA patients signed up for standardized exercise therapy

Other: Physiotherapy-guided Evidence-based Exercise Therapy

Healthy subjects (part 2)

Healthy subjects (age 18-28) signed up military service in Defence Command Denmark

Other: Part 2: Military training

Interventions

Physiotherapy-guided Evidence-based Exercise Therapy OTHER

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

Knee OA patients (part 1)

Part 2: Military training OTHER

Part 2: standardized military training for 6-8 weeks in Defence Command Denmark

Healthy subjects (part 2)

Eligibility Criteria

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

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.
• Part 2:
• starting as recruits in Defence Command Denmark
• Known factors to influence pain and pain sensitization.

Sponsors & Collaborators

• Kristian Kjær Petersen: lead

Study Sites (1)

Viby Fysioterapi

Viby J, Central Jutland, 8260, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Kristian K Petersen, PhD

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 24, 2018
• Study Start: October 1, 2017
• Primary Completion: October 31, 2018
• Study Completion: November 1, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

DK (1)