Knee OsteoarthritisNCT05387135
Transcutaneous Vagus Nerve Stimulation As a Pain Modulator in Knee Osteoarthritis
A study testing Transcutaneous Vagus Nerve Stimulation in people with Knee Osteoarthritis, run by Suez Canal University at 1 site in Egypt.
Trial summary
a single-blinded, randomized clinical trial, 68 patients divided into 2 groups: active and sham treatment. Afferents of the Auricular branch of vagus nerve are stimulated using a transcutaneous Vagus Nerve Stimulation device (TENS 7000TM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Transcutaneous Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2019to 5 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders.
- Adult over 18 years.
- People who were diagnosed.
- Reported pain on visual analogue scale (VAS)>4/10.
- Able to understand the informed consent.
Who cannot join
- Peptic ulcer
- Pace maker
- Asthma or severe chronic obstructive pulmonary disease
- Pregnancy.
- Cellulites, skin ulceration at area of therapy application.
- Inability to fulfill follow-up criteria.
Trial locations and contacts
1 site in 1 country.
About this study
a single-blinded, randomized clinical trial, 68 patients divided into 2 groups: active and sham treatment. Afferents of the Auricular branch of vagus nerve are stimulated using a transcutaneous Vagus Nerve Stimulation device (TENS 7000TM). The electrode was placed in the left cymba concha with direct contact on the skin. The stimulation for both groups will last for 30 minutes once a day for 3 days per week for 12 weeks. The amplitude of the output current was between 0.25-2.0 mA as tolerated and 250 µs width at 25 Hz. All participants initially will be evaluated before and after intervention and 3 months after the end of the sessions.
Read the detailed description
The included study population is 68.
- Group (1): (tVNS group): This group of study subjects will include 34 patients of knee osteoarthritis and will be subjected to tVNS.
- Group (2): (sham group): This group of study subjects will include 34 patients of knee osteoarthritis and will be subjected to sham treatment.
DESCRIPTION OF THE TECHNIQUE
Active treatment:
Afferents of the Auricular branch of vagus nerve were stimulated using a t-VNS device (TENS 7000TM made by Roscoe Medical Inc., will be used. TENS 7000TM device was labeled as nerve stimulator and low-risk medical device (Instruction manual for TENS 7000). The electrode was placed in the left cymba concha with direct contact on the skin after cleaning with an alcohol swab. The stimulation for both groups will last for 30 minutes once a day for 3 days per week for 12 weeks. The amplitude of the output current was between 0.25-2.0 mA as tolerated and 250 µs width at 10 Hz.
Sham procedure:
For sham-t-VNS device was turned 180°, stimulating the outer earlobe which does not contain fibers of the ABVN. A similar protocol as for active stimulation was used.
All participants initially will be evaluated before and after intervention and 3 months after the end of the sessions by the following:
OUTCOME MEASURES AND ASSESSMENT QUESTIONNAIRES
- Visual analogue scale (VAS)
- PainDETECT questionnaire
- DN4 questionnaire
- Radiological Imaging
- Knee injury and Osteoarthritis Outcome Score
- Hospital Anxiety Depression Scale
- Physical Function Tests
- Quantitative sensory testing
- The Central Sensitization Inventory
- Conditions
- Knee Osteoarthritis
- Being tested
- Transcutaneous Vagus Nerve Stimulation
- Keywords
- Vagus nerve stimulation, knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Vagus Nerve StimulationDevice
Afferents of the Auricular branch of vagus nerve (ABVN) were stimulated using a t-VNS device (TENS 7000TM made by Roscoe Medical Inc., will be used. TENS 7000TM device was labeled as nerve stimulator and low-risk medical device (Instruction manual for TENS 7000).
| Study group | Role | What they receive |
|---|---|---|
| sham Transcutaneous Vagus Nerve Stimulation | Sham comparator | For sham-t-VNS device was turned 180°, stimulating the outer earlobe which does not contain fibers of the ABVN. A similar protocol as for active stimulation was used. Receives: Device: Transcutaneous Vagus Nerve Stimulation |
| Transcutaneous Vagus Nerve Stimulation | Active comparator | Afferents of the Auricular branch of vagus nerve (ABVN) were stimulated using a t-VNS device (TENS 7000TM) made by Roscoe Medical Inc., will be used. TENS 7000TM device was labeled as nerve stimulator and low-risk medical device (Instruction manual for TENS 7000). The electrode was placed in the left cymba concha with direct contact on the skin after cleaning with an alcohol swab. The stimulation for both groups will last for 30 minutes once a day for 3 days per week for 12 weeks. The amplitude of the output current was between 0.25-2.0 mA as tolerated and 250 µs width at 10 Hz. Receives: Device: Transcutaneous Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
to describe pain on 0 to 10 scale
Measured: 3 months
Secondary outcomes (1)
Knee injury and Osteoarthritis Outcome Score (KOOS)
for function and activity assessment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start5 Aug 2019
- Primary completion5 Jul 2021
- Study completion5 May 2022
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 Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Gamal Elsehrawy, Suez Canal University
- Investigators
- Mohammed A Hefny, MD, Study director, professor of physical medicine, rheumatology and rehabilitationNashwa K Elshaarawy, MD, Study director, Assisstant professor of physical medicine, rheumatology and rehabilitationNermeen H Abdelmoneam, Ph.D, Study director, lecturer of physical medicine, rheumatology and rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387135
- Sponsor's protocol ID
- 3905
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elsehrawy GG, Ibrahim ME, A Moneim NH, Hefny MA, El Shaarawy NK. Transcutaneous vagus nerve stimulation as a pain modulator in knee osteoarthritis: a randomized controlled clinical trial. BMC Musculoskelet Disord. 2025 Jan 20;26(1):68. doi: 10.1186/s12891-025-08288-6.
PubMed 39828740
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Vagus Nerve Stimulation As a Pain Modulator in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05387135
- Acronym / sponsor ID
- 3905
- Conditions
- Knee Osteoarthritis
- Keywords
- Vagus nerve stimulation, knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 24 May 2022 (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.
a single-blinded, randomized clinical trial, 68 patients divided into 2 groups: active and sham treatment. Afferents of the Auricular branch of vagus nerve are stimulated using a transcutaneous Vagus Nerve Stimulation device (TENS 7000TM). The electrode was placed in the left cymba concha with direct contact on the skin. The stimulation for both groups will last for 30 minutes once a day for 3 days per week for 12 weeks. The amplitude of the output current was between 0.25-2.0 mA as tolerated and 250 µs width at 25 Hz. All participants initially will be evaluated before and after intervention and 3 months after the end of the sessions.
Detailed description
The included study population is 68.
- Group (1): (tVNS group): This group of study subjects will include 34 patients of knee osteoarthritis and will be subjected to tVNS.
- Group (2): (sham group): This group of study subjects will include 34 patients of knee osteoarthritis and will be subjected to sham treatment.
DESCRIPTION OF THE TECHNIQUE
Active treatment:
Afferents of the Auricular branch of vagus nerve were stimulated using a t-VNS device (TENS 7000TM made by Roscoe Medical Inc., will be used. TENS 7000TM device was labeled as nerve stimulator and low-risk medical device (Instruction manual for TENS 7000). The electrode was placed in the left cymba concha with direct contact on the skin after cleaning with an alcohol swab. The stimulation for both groups will last for 30 minutes once a day for 3 days per week for 12 weeks. The amplitude of the output current was between 0.25-2.0 mA as tolerated and 250 µs width at 10 Hz.
Sham procedure:
For sham-t-VNS device was turned 180°, stimulating the outer earlobe which does not contain fibers of the ABVN. A similar protocol as for active stimulation was used.
All participants initially will be evaluated before and after intervention and 3 months after the end of the sessions by the following:
OUTCOME MEASURES AND ASSESSMENT QUESTIONNAIRES
- Visual analogue scale (VAS)
- PainDETECT questionnaire
- DN4 questionnaire
- Radiological Imaging
- Knee injury and Osteoarthritis Outcome Score
- Hospital Anxiety Depression Scale
- Physical Function Tests
- Quantitative sensory testing
- The Central Sensitization Inventory
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham Transcutaneous Vagus Nerve Stimulation | Sham comparator | Device: Transcutaneous Vagus Nerve StimulationFor sham-t-VNS device was turned 180°, stimulating the outer earlobe which does not contain fibers of the ABVN. A similar protocol as for active stimulation was used. |
| Transcutaneous Vagus Nerve Stimulation | Active comparator | Device: Transcutaneous Vagus Nerve StimulationAfferents of the Auricular branch of vagus nerve (ABVN) were stimulated using a t-VNS device (TENS 7000TM) made by Roscoe Medical Inc., will be used. TENS 7000TM device was labeled as nerve stimulator and low-risk medical device (Instruction manual for TENS 7000). The electrode was placed in the left cymba concha with direct contact on the skin after cleaning with an alcohol swab. The stimulation for both groups will last for 30 minutes once a day for 3 days per week for 12 weeks. The amplitude of the output current was between 0.25-2.0 mA as tolerated and 250 µs width at 10 Hz. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both genders.
- Adult over 18 years.
- People who were diagnosed.
- Reported pain on visual analogue scale (VAS)>4/10.
- Able to understand the informed consent.
Key exclusion criteria (6 listed)
- Peptic ulcer
- Pace maker
- Asthma or severe chronic obstructive pulmonary disease
- Pregnancy.
- Cellulites, skin ulceration at area of therapy application.
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 |
|---|---|---|
| Transcutaneous Vagus Nerve StimulationAfferents of the Auricular branch of vagus nerve (ABVN) were stimulated using a t-VNS device (TENS 7000TM made by Roscoe Medical Inc., will be used. TENS 7000TM device was labeled as nerve stimulator and low-risk medical device (Instruction manual for TENS 7000). | Device | Transcutaneous Vagus Nerve Stimulation, sham Transcutaneous Vagus Nerve Stimulation |
Primary outcome
visual analogue scale
Time frame: 3 months
to describe pain on 0 to 10 scale
1 secondary outcome
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 3 months
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 24 May 2022.
- Derived from this study: PubMed 39828740Elsehrawy GG, Ibrahim ME, A Moneim NH, Hefny MA, El Shaarawy NK. Transcutaneous vagus nerve stimulation as a pain modulator in knee osteoarthritis: a randomized controlled clinical trial. BMC Musculoskelet Disord. 2025 Jan 20;26(1):68. doi: 10.1186/s12891-025-08288-6.
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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.
Mohammed A Hefny, MD study director
professor of physical medicine, rheumatology and rehabilitation
Nashwa K Elshaarawy, MD study director
Assisstant professor of physical medicine, rheumatology and rehabilitation
Nermeen H Abdelmoneam, Ph.D study director
lecturer of physical medicine, rheumatology and rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Vagus Nerve Stimulation in people with Knee Osteoarthritis, run by Suez Canal University at 1 site in Egypt.
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 5 inclusion and 6 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 24 May 2022. 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 Egypt. 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?
visual analogue scale (time frame: 3 months). 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 NCT05387135, 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 24 May 2022.