- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06398171
Exercise-induced Hypoalgesia in Patients With Knee Osteoarthritis
April 30, 2024 updated by: Luis Suso, Cardenal Herrera University
The main objective of this study is to evaluate the differences in the phenomenon of exercise-induced hypoalgesia in patients with osteoarthritis.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Luis Suso-Martí, PhD
- Phone Number: 627819667
- Email: luis.suso@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- diagnosed with severe knee OA (according to the clinical and radiographic criteria of the American College of Rheumatology Guidelines)
Exclusion Criteria:
- pain in the contralateral (non-studied) limb (maximum ≥80 of 100 mm on a visual analog scale (VAS) during daily activities),
- undergone another hip or knee joint replacement in the previous year
- any medical condition in which exercise was contraindicated
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise
|
Participants will perform 8 sessions of 4 sets of knee extension exercises during 1 month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Algometry
Time Frame: Before and after exercise (1 month)
|
Pressure pain thresholds will be measured at the affected knee, the contralateral knee and the contralateral epicondyle.
|
Before and after exercise (1 month)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 15, 2024
Primary Completion (Estimated)
October 15, 2024
Study Completion (Estimated)
December 15, 2024
Study Registration Dates
First Submitted
April 23, 2024
First Submitted That Met QC Criteria
April 30, 2024
First Posted (Actual)
May 3, 2024
Study Record Updates
Last Update Posted (Actual)
May 3, 2024
Last Update Submitted That Met QC Criteria
April 30, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EIH1
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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