Knee OsteoarthritisNCT05870033
Muscle Activation in Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by University of Pecs at 1 site in Hungary.
Trial summary
Muscle activity, as a possible fundamental cause of functional limitation, has been extensively investigated in knee osteoarthritis (KOA). Many trials investigated muscle activity during dynamic movements and functional tasks in KOA. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Electromyography (EMG) measurement
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteHungary
- Study dates
- 30 Apr 2023to 30 Nov 2023
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with radiologically diagnosed KOA
Who may be able to join
- radiologically diagnosed KOA based on the Kellgren-Lawrence grading system 1-3,
- age above 60 years
- at least 60° active knee flexion
- sufficient mental status
Who cannot join
- acute inflammation of the knee
- intraarticular injections within the last 3 months
- total knee replacement in the opposite side
- class II obesity (body mass index, BMI>35kg/m2)
- severe degenerative lumbar spine disease (e.g., spondylolisthesis)
- systemic inflammatory arthritic or neurological condition
Show all 10Show fewer
- conservative intervention attendance within 6 months
- contraindication to conservative therapy and manual therapy
- unstable heart condition
- complex regional pain syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gender Difference of Muscle Activation Amongst Patients With Knee Osteoarthritis
Muscle activity, as a possible fundamental cause of functional limitation, has been extensively investigated in knee osteoarthritis (KOA). Many trials investigated muscle activity during dynamic movements and functional tasks in KOA. In addition, gender-related differences has been also investigated during functional movements in KOA. However, no trial investigated gender-related differences in muscle activation during static movement in KOA.
Read the detailed description
Muscle activity, as a possible fundamental cause of functional limitation, has been extensively investigated in knee osteoarthritis (KOA). Interestingly, studies concentrated mainly on investigation of muscle activity during dynamic movements and different functional tests. Moznuzzaman et al displayed greater muscle activation during sitting to standing test (STS) and standing to sitting test in KOA patients compared to healthy participants. Interestingly, some studies investigated muscle activation standing up from a knee-height seat during STS and illustrated a greater muscle activation amongst KOA patients compared to healthy controls. Moreover, Amer et al found greater muscle activation while performing STS from a lower height seat compared to a knee-height seat amongst women and men patients with uni/bilateral KOA. These findings might be of interest due to compensatory mechanisms observed by female patients during STS transition increases loading on the joint surfaces and consequently leading to progression of KOA. Furthermore, different studies also presented gender-differences of muscle activation during different weight-bearing tasks (gait, STS, stair ascend/descend, and squat) amongst patients with KOA and healthy control. Interestingly, both studies showed women with KOA representing higher muscle activation compared to men. Therefore, an analytical comparative study might be useful for identification of gender-differences in muscle activation amongst patients with KOA.
Investigation of static muscle activity during functional movements is very rare in KOA. Zhang et al investigated muscle activation after single whole body vibration trial in standing position at 0°, 30° and 60° static knee flexion angles amongst women with KOA. Authors found that muscle activation in 60° was greater compared to 30°, and it was also greater in 30° compared to 0°. Based on our literature search, no further study examined muscle activity in static knee flexion in KOA. However, investigating static knee flexion might be useful as it could be related to different knee moments in KOA.
- Conditions
- Knee Osteoarthritis
- Being tested
- Electromyography (EMG) measurement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyography (EMG) measurementDevice
Electromyography (EMG) measurement of m. quadriceps femoris and semitendinosus muscle during static functional tasks
| Study group | Role | What they receive |
|---|---|---|
| Men group | Muscle activity amongst men with KOA Receives: Device: Electromyography (EMG) measurement | |
| Women group | Muscle activity amongst women with KOA Receives: Device: Electromyography (EMG) measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' baseline state
Measurement of patients' pain, stiffness and functional state based on WOMAC
Measured: within 1 day
Patients' baseline pain
Measurement of patients' pain based on Numeric Pain Rating Scale
Measured: within 1 day
Patients' baseline knee flexion
Measurement of patients' active knee flexion in supine
Measured: within 1 day
Patients' baseline knee flexion in standing position
Measurement of patients' active knee flexion during weight-bearing
Measured: within 1 day
Muscle strength of m. quadriceps femoris
Measurement of muscle strength of m. quadriceps femoris in 0, 35 and 60 degree
Measured: within 1 day
Muscle strength of hamstring muscles
Measurement of muscle strength of m. semitendinosus, semimembranosus and biceps femoris in 0, 35 and 60 degree
Measured: within 1 day
Muscle activation in 30 degree static knee flexion
EMG measurement of muscle activation during 2-leg 30 degree static knee flexion
Measured: within 1 day
Muscle activation in 60 degree static knee flexion
EMG measurement of muscle activation during 2-leg 60 degree static knee flexion
Measured: within 1 day
Muscle activation during stepping up a stair
EMG measurement of muscle activation during stepping up on a stair
Measured: within 1 day
Muscle activation during stepping down a stair
EMG measurement of muscle activation during stepping down from a stair
Measured: within 1 day
Muscle activation during stepping down side-ways a stair with affected leg
EMG measurement of muscle activation during stepping down side-ways a stair with affected leg
Measured: within 1 day
Muscle activation during stepping down side-ways a stair with opposite leg
EMG measurement of muscle activation during stepping down side-ways a stair with opposite leg
Measured: within 1 day
Muscle activation in one-leg standing position
EMG measurement of muscle activation in one-leg standing position
Measured: within 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start30 Apr 2023
- Primary completion1 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Csaba Melczer, Physiother., Study director, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870033
- Sponsor's protocol ID
- Muscle activation
- Status last verified
- Nov 2023
- First submitted
- 2 May 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al Amer HS, Sabbahi MA, Alrowayeh HN, Bryan WJ, Olson SL. Electromyographic activity of quadriceps muscle during sit-to-stand in patients with unilateral knee osteoarthritis. BMC Res Notes. 2018 Jun 5;11(1):356. doi: 10.1186/s13104-018-3464-9.
PubMed 29871669Bouchouras G, Sofianidis G, Patsika G, Kellis E, Hatzitaki V. Women with knee osteoarthritis increase knee muscle co-contraction to perform stand to sit. Aging Clin Exp Res. 2020 Apr;32(4):655-662. doi: 10.1007/s40520-019-01245-z. Epub 2019 Jun 15.
PubMed 31203528Smith SL, Woodburn J, Steultjens MPM. Sex- and osteoarthritis-related differences in muscle co-activation during weight-bearing tasks. Gait Posture. 2020 Jun;79:117-125. doi: 10.1016/j.gaitpost.2020.04.019. Epub 2020 Apr 27.
PubMed 32402893
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Difference of Muscle Activation Amongst Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05870033
- Acronym / sponsor ID
- Muscle activation
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 23 May 2023 (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.
Muscle activity, as a possible fundamental cause of functional limitation, has been extensively investigated in knee osteoarthritis (KOA). Many trials investigated muscle activity during dynamic movements and functional tasks in KOA. In addition, gender-related differences has been also investigated during functional movements in KOA. However, no trial investigated gender-related differences in muscle activation during static movement in KOA.
Detailed description
Muscle activity, as a possible fundamental cause of functional limitation, has been extensively investigated in knee osteoarthritis (KOA). Interestingly, studies concentrated mainly on investigation of muscle activity during dynamic movements and different functional tests. Moznuzzaman et al displayed greater muscle activation during sitting to standing test (STS) and standing to sitting test in KOA patients compared to healthy participants. Interestingly, some studies investigated muscle activation standing up from a knee-height seat during STS and illustrated a greater muscle activation amongst KOA patients compared to healthy controls. Moreover, Amer et al found greater muscle activation while performing STS from a lower height seat compared to a knee-height seat amongst women and men patients with uni/bilateral KOA. These findings might be of interest due to compensatory mechanisms observed by female patients during STS transition increases loading on the joint surfaces and consequently leading to progression of KOA. Furthermore, different studies also presented gender-differences of muscle activation during different weight-bearing tasks (gait, STS, stair ascend/descend, and squat) amongst patients with KOA and healthy control. Interestingly, both studies showed women with KOA representing higher muscle activation compared to men. Therefore, an analytical comparative study might be useful for identification of gender-differences in muscle activation amongst patients with KOA.
Investigation of static muscle activity during functional movements is very rare in KOA. Zhang et al investigated muscle activation after single whole body vibration trial in standing position at 0°, 30° and 60° static knee flexion angles amongst women with KOA. Authors found that muscle activation in 60° was greater compared to 30°, and it was also greater in 30° compared to 0°. Based on our literature search, no further study examined muscle activity in static knee flexion in KOA. However, investigating static knee flexion might be useful as it could be related to different knee moments in KOA.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men group | – | Device: Electromyography (EMG) measurementMuscle activity amongst men with KOA |
| Women group | – | Device: Electromyography (EMG) measurementMuscle activity amongst women with KOA |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with radiologically diagnosed KOA
Key inclusion criteria (4 listed)
- radiologically diagnosed KOA based on the Kellgren-Lawrence grading system 1-3,
- age above 60 years
- at least 60° active knee flexion
- sufficient mental status
Key exclusion criteria (10 listed)
- acute inflammation of the knee
- intraarticular injections within the last 3 months
- total knee replacement in the opposite side
- class II obesity (body mass index, BMI>35kg/m2)
- severe degenerative lumbar spine disease (e.g., spondylolisthesis)
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 |
|---|---|---|
| Electromyography (EMG) measurementElectromyography (EMG) measurement of m. quadriceps femoris and semitendinosus muscle during static functional tasks | Device | Men group, Women group |
Primary outcome
Patients' baseline state
Time frame: within 1 day
Measurement of patients' pain, stiffness and functional state based on WOMAC
Patients' baseline pain
Time frame: within 1 day
Measurement of patients' pain based on Numeric Pain Rating Scale
Patients' baseline knee flexion
Time frame: within 1 day
Measurement of patients' active knee flexion in supine
Patients' baseline knee flexion in standing position
Time frame: within 1 day
Measurement of patients' active knee flexion during weight-bearing
Muscle strength of m. quadriceps femoris
Time frame: within 1 day
Measurement of muscle strength of m. quadriceps femoris in 0, 35 and 60 degree
Muscle strength of hamstring muscles
Time frame: within 1 day
Measurement of muscle strength of m. semitendinosus, semimembranosus and biceps femoris in 0, 35 and 60 degree
Muscle activation in 30 degree static knee flexion
Time frame: within 1 day
EMG measurement of muscle activation during 2-leg 30 degree static knee flexion
Muscle activation in 60 degree static knee flexion
Time frame: within 1 day
EMG measurement of muscle activation during 2-leg 60 degree static knee flexion
Muscle activation during stepping up a stair
Time frame: within 1 day
EMG measurement of muscle activation during stepping up on a stair
Muscle activation during stepping down a stair
Time frame: within 1 day
EMG measurement of muscle activation during stepping down from a stair
Muscle activation during stepping down side-ways a stair with affected leg
Time frame: within 1 day
EMG measurement of muscle activation during stepping down side-ways a stair with affected leg
Muscle activation during stepping down side-ways a stair with opposite leg
Time frame: within 1 day
EMG measurement of muscle activation during stepping down side-ways a stair with opposite leg
Muscle activation in one-leg standing position
Time frame: within 1 day
EMG measurement of muscle activation in one-leg standing position
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 1 Dec 2023.
- Background: PubMed 29871669Al Amer HS, Sabbahi MA, Alrowayeh HN, Bryan WJ, Olson SL. Electromyographic activity of quadriceps muscle during sit-to-stand in patients with unilateral knee osteoarthritis. BMC Res Notes. 2018 Jun 5;11(1):356. doi: 10.1186/s13104-018-3464-9.
- Background: PubMed 31203528Bouchouras G, Sofianidis G, Patsika G, Kellis E, Hatzitaki V. Women with knee osteoarthritis increase knee muscle co-contraction to perform stand to sit. Aging Clin Exp Res. 2020 Apr;32(4):655-662. doi: 10.1007/s40520-019-01245-z. Epub 2019 Jun 15.
- Background: PubMed 32402893Smith SL, Woodburn J, Steultjens MPM. Sex- and osteoarthritis-related differences in muscle co-activation during weight-bearing tasks. Gait Posture. 2020 Jun;79:117-125. doi: 10.1016/j.gaitpost.2020.04.019. Epub 2020 Apr 27.
- Individual participant dataSharing planned: Undecided
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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.
Csaba Melczer, Physiother. study director
University of Pecs
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 Knee Osteoarthritis, run by University of Pecs at 1 site in Hungary.
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 4 inclusion and 10 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 1 Dec 2023. 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 Hungary. 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?
Patients' baseline state (time frame: within 1 day). The study lists 13 primary outcomes in all. 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 NCT05870033, which also lists 3 linked publications.
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 1 Dec 2023.