NCT04146311

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2020

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

October 25, 2019

Last Update Submit

January 12, 2021

Conditions

Isotonic SalineHypertonic SalineHealthy Eld HumanKnee Pain Chronic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Assessment of pain

    Only on day 7 (second session), up to 24 hours

Study Arms (3)

Hypertonic saline

ACTIVE COMPARATOR

A bolus injection (0.25 ml) of hypertonic saline (5%) is injected into the left infrapatellar fat pad.

Drug: Hypertonic salineOther: Motor training

Isotonic saline

PLACEBO COMPARATOR

A bolus injection (0.25 ml) of isotonic saline (0.9 %) is injected into the left infrapatellar fat pad.

Drug: isotonic salineOther: Motor training

Motor training

EXPERIMENTAL

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

Other: Motor training

Interventions

Hypertonic salineDRUG

A bolus injection (0.25 ml) of hypertonic saline (5%) into the left infrapatellar fat pad.

Hypertonic saline
isotonic salineDRUG

A bolus injection (0.25 ml) of isotonic saline (5%) into the left infrapatellar fat pad.

Isotonic saline
Motor trainingOTHER

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

Hypertonic salineIsotonic salineMotor training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University

Aalborg, 9220, Denmark

Location

Related Publications (1)

  • Liao S, Arendt-Nielsen L, Wang K, Hirata RP. Effect of Experimental Pain and Visual Feedback on the Accuracy and Precision of Knee Joint Position Sense. Pain Res Manag. 2025 Apr 10;2025:9328803. doi: 10.1155/prm/9328803. eCollection 2025.

    PMID: 40255927DERIVED

MeSH Terms

Interventions

Saline Solution, HypertonicSodium Chloride

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 31, 2019

Study Start

October 30, 2019

Primary Completion

November 28, 2020

Study Completion

December 20, 2020

Last Updated

January 13, 2021

Record last verified: 2021-01

Locations

DK(1)