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NCT Number: NCT07119255

Effectiveness of PRP Pharmacopuncture for Chronic Neck Pain in Cervical Myofascial Syndrome of the Upper Trapezius

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

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Key information

Conditions

Neck Pain Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndrome Myofascial Pain Syndromes Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fakultas Kedokteran Universitas Indonesia

Jakarta, Indonesia

Location status: Recruiting

Location contact

Irma Nareswari, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Biomarker parameters

    Time frame: 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 outcomes

  1. Visual Analogue Scale

    Time frame: 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.

  2. Pressure Pain Threshold

    Time frame: before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment

    Using the minimum force applied which induces pain, measured with algometer

  3. Neck Disability Index

    Time frame: before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment

    A questionnaire for measuring self-rated disability due to neck pain

  4. Perceived Stress Scale

    Time frame: 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.

  5. Pain Catastrophizing Scale

    Time frame: 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.

  6. Short-Form 12 Health Survey

    Time frame: 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.

  7. Cervical Range of Motion

    Time frame: 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.

  8. Craniovertebral Angle

    Time frame: before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment

    To assess head and neck posture, measured from lateral photographic analysis.

  9. Size of Myofascial Trigger Point Nodules

    Time frame: 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.

  10. Resistive Index

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Irma Nareswari, MD

CONTACT

[email protected]

+6281267793888

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

The Effectiveness of Pharmacopuncture With Platelet-Rich Plasma (PRP) as a Treatment for Chronic Neck Pain in Cervical Myofascial Syndrome Related to the Upper Trapezius Muscle

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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