Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07345793
Eligibility Criteria:
INCLUSION CRITERIA Phase 1 - healthy subjects
1. Age between 18 and 65 years.
2. Healthy individuals without any current musculoskeletal or neurological pathology.
3. Presence of a palpable myofascial trigger point in the upper trapezius muscle.
4. No neck or shoulder pain requiring medical treatment in the past three months.
5. Willingness to refrain from other physiotherapy or manual therapy interventions during the study period.
6. Ability to understand and provide written informed consent
Phase 2 - Patients with Chronic Neck Pain
1. Age between 18 and 65 years.
2. Diagnosis of chronic mechanical or tension-type neck pain lasting for at least 3 months.
3. Presence of at least one active myofascial trigger point in the upper trapezius muscle.
4. Pain intensity between 3 and 7 on a 10-cm Visual Analog Scale (VAS) at baseline.
5. No previous invasive physiotherapy treatments (dry needling, electrolysis, or neuromodulation) within the last 4 weeks.
6. Ability and willingness to attend all study sessions and follow-up assessments.
7. Signed informed consent before participation.
EXCLUSION CRITERIA
1. History of cervical or shoulder surgery.
2. Neurological, systemic, or rheumatologic disorders affecting the cervical or upper limb region.
3. Anticoagulant therapy or known bleeding disorders.
4. Pregnancy or suspected pregnancy.
5. Skin infection, wound, or dermatological condition at or near the intervention site.
6. Use of analgesic, anti-inflammatory, or muscle relaxant medications within 48 hours prior to the intervention.
7. Prior invasive physiotherapy (dry needling, PENS, or EPE) in the target area during the past month.
8. Contraindications to electrical stimulation (for PENS or EPE groups), such as implanted pacemaker or metal implants near the treatment area.
9. Fear of needles (trypanophobia) or intolerance to invasive procedures.
10. Participation in another clinical trial within the past 3 months.
11. Refusal or inability to provide informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07345793
Study Brief:
Protocol Section:
NCT07345793