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

NCT07119255 | Recruiting

• 1 other identifier: 25-05-0695
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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:

• Receive a single session of pharmacopuncture therapy
• Undergo evaluations at week 2, week 4, and week 8 after the intervention

Conditions

Neck Pain; Myofascial Pain Syndrome

Outcome Measures

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.

  before treatment (baseline) and 4 weeks after treatment

Secondary Outcomes (10)

• Visual Analogue Scale

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

• Pressure Pain Threshold

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

• Neck Disability Index

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

• Perceived Stress Scale

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

• Pain Catastrophizing Scale

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

Study Arms (2)

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.

Procedure: PRP Pharmacopuncture

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.

Procedure: Placebo Pharmacopuncture

Interventions

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.

PRP Pharmacopuncture

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.

Placebo Pharmacopuncture

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Fakultas Kedokteran Universitas Indonesia

Jakarta, Indonesia

RECRUITING

MeSH Terms

Conditions

Neck Pain; Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• KEPK FKUI-RSCM

  The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irma Nareswari, MD

CONTACT

+6281267793888; i.nareswarifkuirscm@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)