ClinicalTrials.gg
RecruitingNCT07119255Updated Apr 16, 2026

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

An interventional study of PRP Pharmacopuncture and Placebo Pharmacopuncture in Neck Pain and Myofascial Pain Syndrome, sponsored by Indonesia University. Recruiting at 1 site in Indonesia. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Indonesia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Sep 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Neck Pain
  • Myofascial Pain Syndrome
03

In context

Neck Pain

1,360 studies on the registry are indexed under Neck Pain; 299 are open to participants now.

This study's planned enrollment of 72 is above the median of 50 across 1,116 interventional studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

Exclusion Criteria:

  • level \<13 g/dL for males or \<12 g/dL for females.
  • 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 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    PRP 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.

    Procedure: PRP Pharmacopuncture

  • Placebo comparator
    Placebo 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.

    Procedure: Placebo Pharmacopuncture

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.

06

What researchers measure

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 treatment

Secondary 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 treatment

  2. 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 treatment

  3. 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 treatment

  4. 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 treatment

  5. 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.

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

  6. Short-Form 12 Health Survey

    designed to assess health-related quality of life (HRQoL) across two main domains: physical and mental health.

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

  7. Cervical Range of Motion

    To evaluate the degree of movement in cervical flexion, extension, lateral flexion, and rotation using a goniometer or inclinometer.

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

  8. Craniovertebral Angle

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

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

  9. 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.

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

  10. 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.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Aug 2026, 11 months after the start.

Of 763 non-industry interventional studies with no phase under Neck Pain, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 11 months is above that.

Counting every sponsor, half of 772 studies reached it within 7 months; a quarter within 3 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2025
First posted
Aug 13, 2025
StartActual
Sep 1, 2025
Primary completionEst.
Aug 2026
CompletionEst.
Aug 2026
Last update
Apr 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07119255
Responsible party
Irma Nareswari, MD (Principal Investigator, Indonesia University) — Principal investigator
First posted
Aug 13, 2025
Start date
Sep 1, 2025
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Apr 16, 2026

Study contacts

Irma Nareswari, MD
Contact
i.nareswarifkuirscm@yahoo.com
+6281267793888
KEPK FKUI-RSCM
principal investigator · The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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