Effectiveness of PRP Pharmacopuncture for Chronic Neck Pain in Cervical Myofascial Syndrome of the Upper Trapezius
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-59
SponsorIndonesia University
About this trial
The goal of this clinical trial is to learn whether pharmacopuncture with Platelet-Rich Plasma (PRP) is effective for treating chronic neck pain in cervical myofascial syndrome related to the upper trapezius muscle. The main questions it aims to answer are:
1. Is pharmacopuncture with Platelet-Rich Plasma (PRP) effective in reducing chronic neck pain in patients with cervical myofascial syndrome related to the upper trapezius muscle? 2. Does PRP pharmacopuncture improve functional outcomes and quality of life in these patients? 3. Are there any adverse effects associated with PRP pharmacopuncture in this context?
Researchers will compare PRP pharmacopuncture to normal saline pharmacopuncture (placebo) to evaluate whether PRP provides greater effectiveness in reducing chronic neck pain in cervical myofascial syndrome related to the upper trapezius muscle.
Participants will:
* Receive a single session of pharmacopuncture therapy * Undergo evaluations at week 2, week 4, and week 8 after the intervention
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, aged 18 to 59 years.
Experiencing neck pain for more than 3 months (chronic).
Neck pain classified as Grade I to III according to the Neck Pain Task Force classification.
Presence of referred pain pattern on physical examination consistent with the distribution of the upper trapezius muscle.
Disqualifiers
Hemoglobin level <13 g/dL for males or <12 g/dL for females.
Platelet count <150,000/μL.
Presence of fever (≥37.5°C).
Diagnosis of fibromyalgia.
Trial design
Design model
Parallel
Treatments tested in this trial
PRP Pharmacopuncture
Procedure/SurgeryParticipants in the PRP pharmacopuncture arm will receive a single administration of platelet-rich plasma (PRP) via intramuscular injection at acupuncture points corresponding to chronic neck pain in cervical myofascial syndrome in the upper trapezius muscle.
Placebo Pharmacopuncture
Procedure/SurgeryParticipants in the placebo pharmacopuncture arm will receive a single administration of normal saline via intramuscular injection at acupuncture points corresponding to chronic neck pain in cervical myofascial syndrome in the upper trapezius muscle.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: PRP PharmacopunctureExperimental treatment 1 intervention
Group B: Placebo PharmacopuncturePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Biomarker parameters
The serum concentration of interleukin-1 beta (IL-1β) and vascular endothelial growth factor (VEGF) will be measured as outcome biomarkers to evaluate inflammatory and angiogenic responses following the intervention.
Time frame
before treatment (baseline) and 4 weeks after treatmentSecondary outcomes
1
Visual Analogue Scale
Pain intensity will be assessed using a 100 mm horizontal visual analogue scale, where 0 mm indicates "no pain" and 100 mm indicates "worst imaginable pain." Participants will mark the point on the line that best represents their perceived pain intensity.
Time frame
before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment2
Pressure Pain Threshold
Using the minimum force applied which induces pain, measured with algometer
Time frame
before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment3
Neck Disability Index
A questionnaire for measuring self-rated disability due to neck pain
Time frame
before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment4
Perceived Stress Scale
psychological instrument for measuring the perception of stress. It assesses the degree to which individuals perceive situations in their lives as stressful over the past month. The scale consists of 10 items, each rated on a 5-point Likert scale ranging from 0 ("never") to 4 ("very often"). Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
Time frame
before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatmentSponsors and contacts
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Source ClinicalTrials.gov