Chronic Neck PainNCT06054672
Subthreshold Stimulation on Chronic Low Neck Pain Myofascial Trigger Points
A study testing Subthreshold Electrical stimulation in people with Chronic Neck Pain, run by Beni-Suef University.
Trial summary
This study will investigate the effect of subthreshold stimulation on pain and muscle activity in patients with chronic low neck pain and myofascial trigger points. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Subthreshold Electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2023to 30 Nov 2023
- 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
- chronic neck pain
- One or more trigger point
Who cannot join
- any musculoskeletal or neuromuscular diseases
About this study
Official title: Effect of Subthreshold Stimulation on Pain and Muscle Activity in Patients With Chronic Low Neck Pain and Myofascial Trigger Points
This study will investigate the effect of subthreshold stimulation on pain and muscle activity in patients with chronic low neck pain and myofascial trigger points.
Read the detailed description
The study will include 2 groups. One group will receive subthreshold stimulation and other will not receive any treatment. The measurements will include pain and myscle activity.
- Conditions
- Chronic Neck Pain
- Being tested
- Subthreshold Electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subthreshold Electrical stimulationDevice
We will use a electrotherapy device to deliver subthreshold Electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | This group will receive subthreshold stimulation Receives: Device: Subthreshold Electrical stimulation |
| Group II | No intervention | This group will receive no stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyographical signals
We will record the the Trapezius muscle activity of both sides.
Measured: 2 months
Pressure sensitivity using pressure ergometer
We will measure pain threshold produced from Trapezius muscle
Measured: 2 months
Secondary outcomes (2)
Neck pain and disability
We will record the level of pain and disability in neck using neck pain and disability index. standard instrument for measuring self-rated disability due to neck pain and is used by both clinicians and researchers. Each of the 10 items scores from 0 to 5. The maximum score is 50. The obtained score can be multiplied by two to produce a percentage score
Measured: 2 months
Functional ability
We will measure the functional ability. The Copenhagen Neck Functional Disability Scale has been developed for those who have neck pain and disabilities due to the pain. The scale includes questions relating to headache, ability to sleep and to concentrate and activities of daily living.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start30 Sep 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 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
- NCT06054672
- Sponsor's protocol ID
- Beni-Suef University 1
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Subthreshold Stimulation on Pain and Muscle Activity in Patients With Chronic Low Neck Pain and Myofascial Trigger Points
- ClinicalTrials.gov ID
- NCT06054672
- Acronym / sponsor ID
- Beni-Suef University 1
- Conditions
- Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 26 Sep 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.
This study will investigate the effect of subthreshold stimulation on pain and muscle activity in patients with chronic low neck pain and myofascial trigger points.
Detailed description
The study will include 2 groups. One group will receive subthreshold stimulation and other will not receive any treatment. The measurements will include pain and myscle activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Subthreshold Electrical stimulationThis group will receive subthreshold stimulation |
| Group II | No intervention | –This 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 (2 listed)
- chronic neck pain
- One or more trigger point
Key exclusion criteria (1 listed)
- any musculoskeletal or neuromuscular diseases
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 |
|---|---|---|
| Subthreshold Electrical stimulationWe will use a electrotherapy device to deliver subthreshold Electrical stimulation | Device | Group 1 |
Primary outcome
Electromyographical signals
Time frame: 2 months
We will record the the Trapezius muscle activity of both sides.
Pressure sensitivity using pressure ergometer
Time frame: 2 months
We will measure pain threshold produced from Trapezius muscle
2 secondary outcomes
Neck pain and disability
Time frame: 2 months
Functional ability
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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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 Subthreshold Electrical stimulation in people with Chronic Neck Pain, 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 2 inclusion and 1 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 26 Sep 2023. 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. 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?
Electromyographical signals (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2023; AzTrials last refreshed its copy on 1 Nov 2026.