PainNCT06559358
Subthreshold Stimulation Versus Suprathreshold Stimulation in People With Chronic Low Neck Pain
A study testing electrical stimulation in people with Pain and Trigger Point Pain, Myofascial, run by Beni-Suef University.
Trial summary
this trial will involve three groups. Group 1 will receive subthreshold stimulation. Group 2 will receive suprathreshold stimulation. Group 3 will receive shame treatment. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Pain, Trigger Point Pain, Myofascial
- What is being tested?
- electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 30 Dec 2024
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 40 to 65 years old participated in this study, 2
- Having neck pain for more than 6 months with a grade five or greater on the visual analog scale
- Having one or more trigger points in the upper trapezius muscle,
- A significant increase in neck muscle EMG activity indicates the presence of tender points.
Who cannot join
- Taking non-pharmacological therapies (e.g., acupuncture, physical therapy, osteopathy)
- Taking oral or intravenous pain therapy, intramuscular or subcutaneous injection of cortisone, or local anesthetics during the study period,
- Presence of any contraindication to electrical current including pregnancy, epilepsy, cardiac arrhythmia, cardiac surgery, implanted pacemaker or defibrillator, previous surgery in the spinal cord, infectious diseases of the spinal cord, malignant tumors with or without secondary blastomas in the spinal cord, severe radicular pain with acute paralysis in the extremities
About this study
this trial will involve three groups. Group 1 will receive subthreshold stimulation. Group 2 will receive suprathreshold stimulation. Group 3 will receive shame treatment.
- Conditions
- Pain, Trigger Point Pain, Myofascial
- Being tested
- electrical stimulation
- Medical subject headings
- Pain, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical stimulationDevice
A two-channel portable electrical stimulation unit (BTL-4620, Czech Republic).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | This group will receive subthreshold stimulation Receives: Device: electrical stimulation |
| Group 2 | Experimental | This group will receive suprathreshold stimulation Receives: Device: electrical stimulation |
| Group 3 | Sham comparator | This group will receive no stimulation Receives: Device: electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Neck pain intensity will be assessed by the visual analog scale (VAS). Participants will be asked to explain their present pain by putting a mark on a 10 mm horizontal line with 0 degrees indicating "no pain" and 10 indicating the "worst possible pain"
Measured: 2-3 months
Pressure threshold
Myofascial trigger points' sensitivity will be measured by a pressure-pain algometer from upper trapezius muscle.
Measured: 2-3 months
Electromyography
The EMG activity from the upper trapezius muscle will be recorded during rest and voluntary maximum contraction.
Measured: 2-3 months
Range of motion
Flexion, lateral rotation to both sides, lateral flexion to both sides
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
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 PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Mohamed, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559358
- Sponsor's protocol ID
- Beni-Suef University2
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mohamed AA, Hamed RH, Mohamed DA, Hussien OA. Effect of Nociceptors Hypostimulation Versus Nociceptors Hyperstimulation on Electromyography of Cervical Muscles, Myofascial Trigger Points Sensitivity, Pain, and Disability in Patients With Chronic Cervical Pain: A Randomized Double-Blinded Controlled Trial. Physiother Res Int. 2026 Apr;31(2):e70192. doi: 10.1002/pri.70192.
PubMed 41831217
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subthreshold Stimulation Versus Suprathreshold Stimulation in People With Chronic Low Neck Pain
- ClinicalTrials.gov ID
- NCT06559358
- Acronym / sponsor ID
- Beni-Suef University2
- Conditions
- Pain, Trigger Point Pain, Myofascial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 19 Aug 2024 (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.
this trial will involve three groups. Group 1 will receive subthreshold stimulation. Group 2 will receive suprathreshold stimulation. Group 3 will receive shame treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: electrical stimulationThis group will receive subthreshold stimulation |
| Group 2 | Experimental | Device: electrical stimulationThis group will receive suprathreshold stimulation |
| Group 3 | Sham comparator | Device: electrical stimulationThis group will receive no stimulation |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 40 to 65 years old participated in this study, 2
- Having neck pain for more than 6 months with a grade five or greater on the visual analog scale
- Having one or more trigger points in the upper trapezius muscle,
- A significant increase in neck muscle EMG activity indicates the presence of tender points.
Key exclusion criteria (3 listed)
- Taking non-pharmacological therapies (e.g., acupuncture, physical therapy, osteopathy)
- Taking oral or intravenous pain therapy, intramuscular or subcutaneous injection of cortisone, or local anesthetics during the study period,
- Presence of any contraindication to electrical current including pregnancy, epilepsy, cardiac arrhythmia, cardiac surgery, implanted pacemaker or defibrillator, previous surgery in the spinal cord, infectious diseases of the spinal cord, malignant tumors with or without secondary blastomas in the spinal cord, severe radicular pain with acute paralysis in the extremities
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 |
|---|---|---|
| electrical stimulationA two-channel portable electrical stimulation unit (BTL-4620, Czech Republic). | Device | Group 1, Group 2, Group 3 |
Primary outcome
Pain intensity
Time frame: 2-3 months
Neck pain intensity will be assessed by the visual analog scale (VAS). Participants will be asked to explain their present pain by putting a mark on a 10 mm horizontal line with 0 degrees indicating "no pain" and 10 indicating the "worst possible pain"
Pressure threshold
Time frame: 2-3 months
Myofascial trigger points' sensitivity will be measured by a pressure-pain algometer from upper trapezius muscle.
Electromyography
Time frame: 2-3 months
The EMG activity from the upper trapezius muscle will be recorded during rest and voluntary maximum contraction.
Range of motion
Time frame: 2-3 months
Flexion, lateral rotation to both sides, lateral flexion to both sides
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Derived from this study: PubMed 41831217Mohamed AA, Hamed RH, Mohamed DA, Hussien OA. Effect of Nociceptors Hypostimulation Versus Nociceptors Hyperstimulation on Electromyography of Cervical Muscles, Myofascial Trigger Points Sensitivity, Pain, and Disability in Patients With Chronic Cervical Pain: A Randomized Double-Blinded Controlled Trial. Physiother Res Int. 2026 Apr;31(2):e70192. doi: 10.1002/pri.70192.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing electrical stimulation in people with Pain and Trigger Point Pain, Myofascial, run by Beni-Suef University.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Pain intensity (time frame: 2-3 months). The study lists 4 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 NCT06559358, 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 19 Aug 2024.