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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04146311
Other study ID # N-20170080
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 30, 2019
Est. completion date December 20, 2020

Study information

Verified date January 2021
Source Aalborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objects of this research are to investigate the ability of the motor learning and test the possible differences between younger and older healthy human, and between non-pain and acute experimental pain and chronic clinical pain conditions.


Description:

The project consists of four experimental studies. In the first experiment, younger and older healthy human subjects are involved in a short-term neuromuscular training on the accuracy and precision of knee movement to investigate the possible age effect of the motor learning. The second experiment focuses on the experimental pain on the learning effect of the younger subjects. The third experiment will investigate a group of knee osteoarthritis patients to show the influence of chronic pain on the motor training compared with age-, gender-matched pain free subjects. 3D camera tracking system will be used to record the knee movements at the baseline and after 6-day motor task training. The variability in amplitude of the values of knee movements was transformed to percentage in relation to the target position (accuracy) or to the mean position (precision). The results of the study will contribute to both basic and clinical understanding of the mechanisms related to knee movement control and influences of varies painful conditions.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 20, 2020
Est. primary completion date November 28, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - • Aged 18-30 or 50-65 years - Free from ongoing or chronic pain - Right dominant leg - Speak and understand English - Aged 50-65 years. - Diagnosed with knee OA (according to American College of Rheumatology classification) with pain in left or both knees for more than six months - Have ongoing pain rated above 2 on a 0-10 Visual Analogues Scale (VAS) in the previous week. - Right dominant leg - Speak and understand English - Aged 50-65 years - Diagnosed with knee OA - Have had total knee arthroplasty on left or both knees - Right dominant leg - Speak and understand English Exclusion Criteria: - • Pregnancy or intent to become pregnant, breast feeding - Regular use of analgesics, including simple analgesia and NSAIDs - Frequent recreational drug or alcohol use - History of knee joint pathology or injury - Previous neurologic, musculoskeletal or mental illnesses - Practicing sport activities on a regular basis - Lack of ability to cooperate - Regular use of analgesics, including analgesia and NSAIDs for the last 24 hours - Frequent recreational drug or alcohol use - Previous neurologic, musculoskeletal or mental illnesses - Practicing sports activities on a regular basis - Lack of ability to cooperate - Regular use of analgesics, including analgesia and NSAIDs for the last 24 hours - Frequent recreational drug or alcohol use - Other disorders or injuries in the knee joints - Previous neurologic, musculoskeletal or mental illnesses - Practicing sports activities on a regular basis - Lack of ability to cooperate

Study Design


Intervention

Drug:
Hypertonic saline
A bolus injection (0.25 ml) of hypertonic saline (5%) into the left infrapatellar fat pad.
isotonic saline
A bolus injection (0.25 ml) of isotonic saline (5%) into the left infrapatellar fat pad.
Other:
Motor training
All the subjects recruited need to have a short-term motor task training at home. 30 times a session, totally 2 sessions a day for 6 days

Locations

Country Name City State
Denmark Aalborg University Aalborg

Sponsors (1)

Lead Sponsor Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary knee movement assessment There are two sessions in total, seperated by a 6 days motor training. Using 3D camera to calculate the accuracy and precision of knee movements at 30, 45, 60 degree respectively both with and without visual feedback (baseline), before and after motor training, also before and after injection. Change from baseline, up to 7 days after the first session
Secondary Assessment of pain Immediately following the injection, participants will be instructed to rate the pain intensity for ten minutes using a digital visual analogue scale (VAS; eVas Software: Aalborg University, Denmark), on a tablet.The scale will be measured from 0 to10, where 0 represents 'no pain' and 10 represents 'worst pain imaginable'. Only on day 7 (second session), up to 24 hours
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