Percutaneous Electrolysis of the Upper Trapezius in Chronic Neck Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSivas State Hospital
About this trial
In the planned study, we aim to investigate the effectiveness of percutaneous electrolysis treatment applied to myofascial trigger points in the upper trapezius muscle in patients with chronic neck pain. Two different protocols, a low-intensity (0.5 mA × 90 s) and a high-intensity (3 mA × 3 s × 3 repetitions), will be compared in the study.
Patients participating in the research will be randomized into 2 groups using a computer program. Stretching exercises targeting the upper trapezius muscle will be given to both groups as a home exercise program. In both groups, the percutaneous electrolysis treatment protocol will be performed on the active myofascial trigger points in the upper trapezius muscle on the 1st, 8th, and 14th days of treatment, using 0.3-millimeter acupuncture needles and an EPTE® percutaneous electrolysis device (Ionclinics \& A. Deionic SL, Valencia, Spain). The low-intensity (0.5 milliampere × 90 s) treatment protocol will be applied to Group 1, and the high-intensity (3 milliampere × 3 s × 3 repetitions) treatment protocol will be applied to Group 2. In the study, two different protocols, low-intensity (0.5 mA × 90 s) and high-intensity (3 mA × 3 s × 3 repetitions), will be compared. In this way, it is aimed both to obtain information about optimal dosing and to contribute to the literature for a frequently involved muscle such as the upper trapezius.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Low-Intensity Percutaneous Electrolysis of the Upper Trapezius
DeviceUltrasound-guided percutaneous electrolysis applied to the active myofascial trigger points of the upper trapezius muscle using 0.3-mm acupuncture needles and an EPTE® percutaneous electrolysis device. A low-intensity protocol is used (0.5 mA for 90 seconds per session) on days 1, 8, and 14.
High-Intensity Percutaneous Electrolysis of the Upper Trapezius
DeviceUltrasound-guided percutaneous electrolysis applied to the active myofascial trigger points of the upper trapezius muscle using 0.3-mm acupuncture needles and an EPTE® percutaneous electrolysis device. A high-intensity protocol is used (3 mA for 3 seconds, repeated 3 times per session) on days 1, 8, and 14.
Upper Trapezius Stretching Exercise Program
Other interventionHome-based stretching exercise program targeting the upper trapezius muscle throughout the treatment period in both groups.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Low-Intensity Percutaneous Electrolysis of the Upper Trapezius plus ExerciseActive comparator 2 interventions
Group B: High-Intensity Percutaneous Electrolysis of the Upper Trapezius plus ExerciseExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Pain Intensity (VAS)
Pain intensity related to plantar heel pain will be assessed using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain.
Time frame
Baseline (before treatment), immediately after completion of the 3rd treatment session (approximately 2 weeks), and 3 months after treatment initiation.Secondary outcomes
1
Change in Pressure Pain Threshold (Algometry)
Pressure will be applied with an algometer at a right angle to the point on the plantar fascia where tenderness is most pronounced, and the patient will be asked to indicate the level at which discomfort is felt. The pressure value at which pain occurs will be determined as the pain threshold, and the pressure-pain threshold will be objectively assessed and recorded. Measurements will be repeated three times, and the best value will be recorded.
Time frame
Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.2
Change in Functional Disability (Modified Neck Disability Index)
Functional disability related to neck pain will be assessed using the Modified Neck Disability Index (MNDI), a 10-item questionnaire evaluating pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each item is scored from 0 to 5, yielding a total score between 0 and 50; higher scores indicate greater disability. The validated Turkish version of the scale will be used.
Time frame
Baseline (prior to the first treatment session), immediately after completion of treatment (after the third session, approximately 2 weeks from baseline), and 3 months after treatment initiation.Sponsors and contacts
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Source ClinicalTrials.gov