Myofascial Pain Syndrome, Neck Pain
Conditions
Brief summary
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
Detailed description
This is a clinical trial study to evaluate the effectiveness of PRP pharmacopuncture in patients with chronic neck pain in cervical myofascial syndrome related to the upper trapezius muscle. Participants are 60 males/females aged 18-59 years. They will be divided into two groups: (1) PRP pharmacopuncture and (2) Normal saline (placebo) pharmacopuncture. Each participant will receive a single pharmacopuncture treatment. Therapy efficacy will be assessed at week 2, week 4, and week 8 after the intervention.
Interventions
PROCEDUREPRP Pharmacopuncture
Participants 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.
PROCEDUREPlacebo Pharmacopuncture
Participants 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.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Visual Analogue Scale (VAS) score between 30 and 70 mm (out of 100 mm) during activity (e.g., daily activities or light exercise). * Willing to participate in the study until completion and has signed the informed consent form.
Exclusion criteria
* 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. * Structural abnormalities of the cervical spine other than degenerative changes, such as fractures, cervical spine injuries, space-occupying lesions (SOL), infections, neoplasms, or systemic diseases confirmed by radiographic imaging. * History of cervical spine surgery. * Presence of tumors, wounds, or skin infections at the needle insertion site. * Diagnosed with blood disorders or currently taking anticoagulant or antiplatelet medications. * History of hypersensitivity reactions to acupuncture (e.g., metal allergy, severe atopy, keloids, or other skin hypersensitivities). * Uncontrolled cardiovascular disease or diabetes mellitus. * History of pharmacopuncture therapy to the upper trapezius muscle within the past 6 months. * Use of anti-inflammatory medication within the past 2 weeks. * Currently pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker parameters | before treatment (baseline) and 4 weeks after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment | 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. |
| Pressure Pain Threshold | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment | Using the minimum force applied which induces pain, measured with algometer |
| Neck Disability Index | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment | A questionnaire for measuring self-rated disability due to neck pain |
| Perceived Stress Scale | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment | 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. |
| Pain Catastrophizing Scale | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment | a validated self-report questionnaire designed to assess catastrophic thinking related to pain. It consists of 13 items divided into three subscales: rumination, magnification, and helplessness. Each item is rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("all the time"), with total scores ranging from 0 to 52. Higher scores reflect greater levels of pain catastrophizing. |
| Short-Form 12 Health Survey | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment | designed to assess health-related quality of life (HRQoL) across two main domains: physical and mental health. |
| Cervical Range of Motion | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment | To evaluate the degree of movement in cervical flexion, extension, lateral flexion, and rotation using a goniometer or inclinometer. |
| Craniovertebral Angle | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment | To assess head and neck posture, measured from lateral photographic analysis. |
| Size of Myofascial Trigger Point Nodules | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment | The diameter (in millimeters) of hypoechoic nodules identified at active trigger point sites will be measured using B-mode ultrasound. Measurements will be taken in both longitudinal and transverse planes. |
| Resistive Index | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment | The resistive index of the local blood flow surrounding the trigger point area will be assessed using color Doppler and spectral Doppler ultrasound. |
Countries
Indonesia
Contacts
CONTACTIrma Nareswari, MD
PRINCIPAL_INVESTIGATORKEPK FKUI-RSCM
The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM
Outcome results
None listed