Predictors for Analgesic Effect to Standardized Exercise Therapy for Osteoarthritic Pain

NCT ID: NCT03718663

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-11-01

Brief Summary

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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

Detailed Description

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Conditions

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Osteoarthritis, Knee Healthy Subjects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Knee OA patients (part 1)

Painful knee OA patients signed up for standardized exercise therapy

Physiotherapy-guided Evidence-based Exercise Therapy

Intervention Type OTHER

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

Part 2: Military training

Intervention Type OTHER

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

Interventions

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Physiotherapy-guided Evidence-based Exercise Therapy

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

Intervention Type OTHER

Part 2: Military training

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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


* starting as recruits in Defence Command Denmark

Exclusion Criteria

* Known factors to influence pain and pain sensitization.

Part 2:


* Known factors to influence pain and pain sensitization.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kristian Kjær Petersen

OTHER

Sponsor Role lead

Responsible Party

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Kristian Kjær Petersen

Associated professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kristian K Petersen, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Locations

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Viby Fysioterapi

Viby J, Central Jutland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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N-20170070

Identifier Type: -

Identifier Source: org_study_id

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