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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP Pharmacopuncture | Experimental | 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. |
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| Placebo Pharmacopuncture | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP Pharmacopuncture | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | before treatment (baseline) and 4 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irma Nareswari, MD | Contact | +6281267793888 | i.nareswarifkuirscm@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| KEPK FKUI-RSCM | The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakultas Kedokteran Universitas Indonesia | Recruiting | Jakarta | Indonesia |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D009209 | Myofascial Pain Syndromes |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo Pharmacopuncture | Procedure | 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. |
|
| Pressure Pain Threshold | Using the minimum force applied which induces pain, measured with algometer | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment |
| Neck Disability Index | A questionnaire for measuring self-rated disability due to neck pain | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment |
| 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. | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment |
| Pain Catastrophizing Scale | 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. | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment |
| Short-Form 12 Health Survey | designed to assess health-related quality of life (HRQoL) across two main domains: physical and mental health. | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment |
| Cervical Range of Motion | To evaluate the degree of movement in cervical flexion, extension, lateral flexion, and rotation using a goniometer or inclinometer. | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment |
| Craniovertebral Angle | To assess head and neck posture, measured from lateral photographic analysis. | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment |
| Size of Myofascial Trigger Point Nodules | 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. | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment |
| Resistive Index | The resistive index of the local blood flow surrounding the trigger point area will be assessed using color Doppler and spectral Doppler ultrasound. | before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |