Predictors for Analgesic Effect to Standardized Exercise Therapy for Osteoarthritic Pain

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03718663
• Other study ID #: N-20170070
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: July 2019
• 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 1, 2018
• Est. primary completion date: October 31, 2018
• 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.

Part 2:

Inclusion Criteria

• starting as recruits in Defence Command Denmark

Exclusion Criteria:

• Known factors to influence pain and pain sensitization.

Related Conditions & MeSH terms

• Healthy Subjects
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Physiotherapy-guided Evidence-based Exercise Therapy
Standardized supervised exercise therapy for 6-8 weeks (two times per week).
• Part 2: Military training
Part 2: standardized military training for 6-8 weeks in Defence Command Denmark

Locations

Country	Name	City	State
Denmark	Viby Fysioterapi	Viby	Midtjylland

Sponsors (1)

Lead Sponsor	Collaborator
Kristian Kjær Petersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Part 2: Exercise-induced hypoalgesia (EIH)	Change in EIH	6-8 weeks into standardized pre-planned military training that continues after the tests