Osteoarthritis KneeNEKONCT02314715
Neuromuscular Control in Knee Osteoarthritis
An observational study of Osteoarthritis Knee, run by Martijn Steultjens at 1 site in United Kingdom.
Trial summary
Arthritis is one of the most prevailing causes of disability with knee osteoarthritis (KOA) the most common form. The lifetime risk of developing symptomatic KOA by the age of 85 years is 44.7%, where females are at a greater risk (1.8 times) than male counter parts. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis Knee
- How many people
- 95 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Feb 2015
- Phase
- Observational
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary and secondary care clinics, and general community.
Who may be able to join
- Knee osteoarthritis participants only:
- Knee Osteoarthritis confirmed by a physician using the American College of Rheumatology (ACR 1986) Criteria
- Have unilateral or bilateral knee osteoarthritis
- Aged 40 years or over.
- Healthy control participants only:
- Have no history of unilateral/bilateral knee osteoarthritis
- Had no current chronic/stable knee pain in the past 3 months
- Aged 40 years or over.
Who cannot join
- All participants are excluded if they:
- Have neuromuscular skeletal injury/illness (e.g.Multiple Sclerosis, Parkinson's disease, Muscular Dystrophy, Cerebral Palsy)
- Have had knee surgery, knee arthroplastic surgery and arthroscopic debridement or corrective surgery for knee osteoarthritis in the past 12 months
- Have had corticosteroid injections to or around the knee in the past 3 months.
- Have unstable heart disease
- Previously had a stroke
Show all 14Show fewer
- Have insulin-dependent diabetes
- Have osteoporosis
- Have a history of falls and other motor deficits
- Are unable to walk up and down stairs
- Are unable to rise from a chair without the aid of another person
- Have an unstable medication schedule and medication that causes dizziness
- Have Dementia/Alzheimer's/ an inability to comprehend, follow instructions and give informed consent
- Have an inability to lie flat for 60 minutes Have mental in their body.
Trial locations and contacts
1 site in 1 country.
About this study
Arthritis is one of the most prevailing causes of disability with knee osteoarthritis (KOA) the most common form. The lifetime risk of developing symptomatic KOA by the age of 85 years is 44.7%, where females are at a greater risk (1.8 times) than male counter parts. KOA is the leading cause of limitations in activities of daily living such as walking and climbing stairs particularly in the elderly. This is primarily due to pain and instability of the joint resulting in buckling of knees caused by muscle weakness, joint stiffness and damage. Patients with KOA have larger variations in muscle strength and are unable to maintain a target force combined with impaired ability to perceive joint movement and positioning suggests impaired neuromuscular control (NC) may influence KOA. NC refers to the nervous system's control over muscle activation contributing to task performance. This study aims to establish the role of loss of NC in biomechanical determinants and health outcomes of KOA.
- Conditions
- Osteoarthritis Knee
- Keywords
- Osteoarthritis Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Knee Osteoarthritis | Participants with diagnosed knee osteoarthritis | |
| Controls | Participants without knee osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular Control
Neuromuscular control will be assessed through muscle co-activation index from electromyography (EMG) of the hamstrings, quadriceps and gastrocnemius. The electromechanical delay (delay between the onset of EMG and force), active proprioception and force accuracy and steadiness measure determined from submaximal isometric contractions will be used to determine neuromuscular control
Measured: 1 day
Secondary outcomes (1)
Disease Outcome
Joint damage scored using the Boston Leeds Osteoarthritis Knee Score (BLOKS) from 1.5T MRI along with pain and function assessed from knee injury and osteoarthritis score (KOOS) and patient reported outcomes measurement information system (PROMIS) will be used to determine disease outcome.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startNov 2013
- Primary completionFeb 2015
- Study completionFeb 2015
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 Osteoarthritis KneeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martijn Steultjens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Martijn Steultjens, Glasgow Caledonian University
- Investigators
- Stephanie L Smith, MRes, Principal investigator, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314715
- Sponsor's protocol ID
- GCU_MSK_SS_001
- Acronym
- NEKO
- Status last verified
- Mar 2015
- First submitted
- 2 Dec 2014
- Last updated
- 3 Mar 2015
- Results posted
- No
Publications
Smith SL, Allan R, Marreiros SP, Woodburn J, Steultjens MPM. Muscle Co-Activation Across Activities of Daily Living in Individuals With Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2019 May;71(5):651-660. doi: 10.1002/acr.23688.
PubMed 29953745
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Control in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02314715
- Acronym / sponsor ID
- NEKO / GCU_MSK_SS_001
- Conditions
- Osteoarthritis Knee
- Keywords
- Osteoarthritis Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Martijn SteultjensUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 11 Dec 2014 (estimated)
- 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.
Arthritis is one of the most prevailing causes of disability with knee osteoarthritis (KOA) the most common form. The lifetime risk of developing symptomatic KOA by the age of 85 years is 44.7%, where females are at a greater risk (1.8 times) than male counter parts. KOA is the leading cause of limitations in activities of daily living such as walking and climbing stairs particularly in the elderly. This is primarily due to pain and instability of the joint resulting in buckling of knees caused by muscle weakness, joint stiffness and damage. Patients with KOA have larger variations in muscle strength and are unable to maintain a target force combined with impaired ability to perceive joint movement and positioning suggests impaired neuromuscular control (NC) may influence KOA. NC refers to the nervous system's control over muscle activation contributing to task performance. This study aims to establish the role of loss of NC in biomechanical determinants and health outcomes of KOA.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee Osteoarthritis | – | –Participants with diagnosed knee osteoarthritis |
| Controls | – | –Participants without knee osteoarthritis |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary and secondary care clinics, and general community.
Key inclusion criteria (8 listed)
- Knee Osteoarthritis confirmed by a physician using the American College of Rheumatology (ACR 1986) Criteria
- Have unilateral or bilateral knee osteoarthritis
- Aged 40 years or over.
- Have no history of unilateral/bilateral knee osteoarthritis
- Had no current chronic/stable knee pain in the past 3 months
Key exclusion criteria (14 listed)
- Have neuromuscular skeletal injury/illness (e.g.Multiple Sclerosis, Parkinson's disease, Muscular Dystrophy, Cerebral Palsy)
- Have had knee surgery, knee arthroplastic surgery and arthroscopic debridement or corrective surgery for knee osteoarthritis in the past 12 months
- Have had corticosteroid injections to or around the knee in the past 3 months.
- Have unstable heart disease
- Previously had a stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuromuscular Control
Time frame: 1 day
Neuromuscular control will be assessed through muscle co-activation index from electromyography (EMG) of the hamstrings, quadriceps and gastrocnemius. The electromechanical delay (delay between the onset of EMG and force), active proprioception and force accuracy and steadiness measure determined from submaximal isometric contractions will be used to determine neuromuscular control
1 secondary outcome
Disease Outcome
Time frame: 1 day
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 3 Mar 2015.
- Derived from this study: PubMed 29953745Smith SL, Allan R, Marreiros SP, Woodburn J, Steultjens MPM. Muscle Co-Activation Across Activities of Daily Living in Individuals With Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2019 May;71(5):651-660. doi: 10.1002/acr.23688.
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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.
Stephanie L Smith, MRes principal investigator
Glasgow Caledonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis Knee, run by Martijn Steultjens at 1 site in United Kingdom.
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 8 inclusion and 14 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 3 Mar 2015. 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 United Kingdom. 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. 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?
Neuromuscular Control (time frame: 1 day). 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 NCT02314715, 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 3 Mar 2015.