Neck PainNCT07119255
Effectiveness of PRP Pharmacopuncture for Chronic Neck Pain in Cervical Myofascial Syndrome of the Upper Trapezius
A study testing PRP Pharmacopuncture in people with Neck Pain and Myofascial Pain Syndrome, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Neck Pain, Myofascial Pain Syndrome
- What is being tested?
- PRP Pharmacopuncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Fakultas Kedokteran Universitas Indonesia
Jakarta
Irma Nareswari, MD
About this study
Official 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
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:
- 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?
- Does PRP pharmacopuncture improve functional outcomes and quality of life in these patients?
- Are there any adverse effects associated with PRP pharmacopuncture in this context?
Read more
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.
- Conditions
- Neck Pain, Myofascial Pain Syndrome
- Being tested
- PRP Pharmacopuncture, Placebo Pharmacopuncture
- Medical subject headings
- Neck Pain, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP PharmacopunctureProcedure or surgery
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 PharmacopunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Placebo Pharmacopuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before treatment (baseline) and 4 weeks after treatment
Secondary outcomes (10)
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.
Measured: before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment
Pressure Pain Threshold
Using the minimum force applied which induces pain, measured with algometer
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Sep 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irma Nareswari, MD, Universitas Indonesia
- Investigators
- KEPK FKUI-RSCM, Principal investigator, The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119255
- Sponsor's protocol ID
- 25-05-0695
- Status last verified
- Apr 2026
- First submitted
- 28 Jul 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07119255
- Acronym / sponsor ID
- 25-05-0695
- Conditions
- Neck Pain, Myofascial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- Does PRP pharmacopuncture improve functional outcomes and quality of life in these patients?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP Pharmacopuncture | Experimental | Procedure: PRP PharmacopunctureParticipants 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 | Placebo comparator | Procedure: Placebo PharmacopunctureParticipants 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP PharmacopunctureParticipants 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 or surgery | PRP Pharmacopuncture |
| Placebo PharmacopunctureParticipants 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 or surgery | Placebo Pharmacopuncture |
Primary outcome
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.
10 secondary outcomes
Visual Analogue Scale
Time frame: before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment
Pressure Pain Threshold
Time frame: before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment
Neck Disability Index
Time frame: before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment
Perceived Stress Scale
Time frame: before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment
Pain Catastrophizing Scale
Time frame: before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment
Short-Form 12 Health Survey
Time frame: before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment
Cervical Range of Motion
Time frame: before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment
Craniovertebral Angle
Time frame: before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment
Size of Myofascial Trigger Point Nodules
Time frame: before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment
Resistive Index
Time frame: before treatment (baseline), 2 weeks, 4 weeks, and 8 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
KEPK FKUI-RSCM principal investigator
The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP Pharmacopuncture in people with Neck Pain and Myofascial Pain Syndrome, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irma Nareswari, MD (+6281267793888, i.nareswarifkuirscm@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker parameters (time frame: before treatment (baseline) and 4 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.