Isotonic SalineNCT04146311
Effect of Short-term Motor Training on Accuracy and Precision of Knee Movement in Human With and Without Knee Pain
A study testing Hypertonic saline, isotonic saline and Motor training in people with Isotonic Saline and Hypertonic Saline, run by Aalborg University at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Isotonic Saline, Hypertonic Saline, Healthy Eld Human
- What is being tested?
- Hypertonic saline, isotonic saline and Motor training
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Oct 2019to 20 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
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- 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
Who cannot join
- • 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Being tested
- Hypertonic saline, isotonic saline, Motor training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic salineDrug
A bolus injection (0.25 ml) of hypertonic saline (5%) into the left infrapatellar fat pad.
isotonic salineDrug
A bolus injection (0.25 ml) of isotonic saline (5%) into the left infrapatellar fat pad.
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
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic saline | Active comparator | A bolus injection (0.25 ml) of hypertonic saline (5%) is injected into the left infrapatellar fat pad. Receives: Drug: Hypertonic saline; Other: 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. Receives: Drug: isotonic saline; Other: 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 Receives: Other: Motor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline, up to 7 days after the first session
Secondary outcomes (1)
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'.
Measured: Only on day 7 (second session), up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start30 Oct 2019
- Primary completion28 Nov 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Isotonic SalineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelun Wang, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146311
- Sponsor's protocol ID
- N-20170080
- Status last verified
- Jan 2021
- First submitted
- 25 Oct 2019
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40255927
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-term Motor Training on Accuracy and Precision of Knee Movement in Human With and Without Knee Pain
- ClinicalTrials.gov ID
- NCT04146311
- Acronym / sponsor ID
- N-20170080
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 28 Nov 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypertonic saline | Active comparator | Drug: Hypertonic saline, Other: Motor trainingA bolus injection (0.25 ml) of hypertonic saline (5%) is injected into the left infrapatellar fat pad. |
| Isotonic saline | Placebo comparator | Drug: isotonic saline, Other: Motor trainingA bolus injection (0.25 ml) of isotonic saline (0.9 %) is injected into the left infrapatellar fat pad. |
| Motor training | Experimental | Other: Motor trainingAll 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- • Aged 18-30 or 50-65 years
Key exclusion criteria (18 listed)
- • Pregnancy or intent to become pregnant, breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertonic salineA bolus injection (0.25 ml) of hypertonic saline (5%) into the left infrapatellar fat pad. | Drug | Hypertonic saline |
| isotonic salineA bolus injection (0.25 ml) of isotonic saline (5%) into the left infrapatellar fat pad. | Drug | Isotonic saline |
| Motor trainingAll 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 | Hypertonic saline, Isotonic saline, Motor training |
Primary outcome
knee movement assessment
Time frame: Change from baseline, up to 7 days after the first session
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.
1 secondary outcome
Assessment of pain
Time frame: Only on day 7 (second session), up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Derived from this study: PubMed 40255927Liao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertonic saline, isotonic saline and Motor training in people with Isotonic Saline and Hypertonic Saline, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee movement assessment (time frame: Change from baseline, up to 7 days after the first session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04146311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.