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OpenTrials
Completed

NCT Number: NCT03718663

Predictors for Analgesic Effect to Standardized Exercise Therapy for Osteoarthritic Pain

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

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Key information

Conditions

Osteoarthritis, Knee Arthritis Healthy Subjects Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Viby Fysioterapi

Viby J, Central Jutland, 8260, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physiotherapy-guided Evidence-based Exercise Therapy

Other

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

Part 2: Military training

Other

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

Primary outcomes

  1. Pain Intensity

    Time frame: 1-2 weeks after last exercise session

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

  2. Part 2: Exercise-induced hypoalgesia (EIH)

    Time frame: 6-8 weeks into standardized pre-planned military training that continues after the tests

    Change in EIH

Sponsors and collaborators

Lead sponsor

Kristian Kjær Petersen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 24, 2018
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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