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NCT Number: NCT06492213

The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for Infraorbital Neuralgia

This is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of PRP injections combined with PRF treatment with PRF alone in patients with IONa who are responded poorly to conventional therapies and are reluctant to receive destructive therapies for seeking a better minimally invasive treatment strategy.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fang Luo

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Fang Luo

CONTACT

[email protected]

59976661

Lu Liu, M.D.

PRINCIPAL_INVESTIGATOR

About this study

Infraorbital neuralgia (IONa) is one of a rare but devastating type of facial pain and lack of current consensus on the management. Previously, we have proved the efficacy of pulsed radiofrequency (PRF) in treatment of IONa. However, refractory patients have not received more ideal treatment until now. Platelet-rich plasma (PRP), as supraphysiological concentration of platelets, can provide prolonged neuropathic pain relief with almost no complications. To date, the efficacy of PRP combined with PRF in the treatment of IONa has not yet been proved. We will conduct this multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study to evaluate the efficacy and safety of PRP combined with PRF in treating refractory IONa patients who were reluctant to receive destructive therapies.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 to 75 years;
  • Paroxysmal or persistent stabbing pain in the distribution area of the infraorbital nerve and positive response to diagnostic block (1 ml of 2% lidocaine) prior to treatment;
  • NRS score≥7;
  • Scheduled for PRF treatment for IONa;
  • Signed informed consent.

Exclusion criteria

  • Platelet count <105*109/L, ongoing anticoagulation therapy or antiplatelets treatment, coagulation disorders or bleeding disorders;
  • Severe cardiopulmonary or hepatorenal dysfunction;
  • Infection at the puncture site; .
  • Neuralgia secondary to tissue damage around the infraorbital foramen from causes such as maxillary sinusitis or tumor;
  • History of destructive treatments such as radiofrequency thermocoagulation, chemical ablation, infraorbital neurectomy, infraorbital nerve avulsion, etc;
  • History of mental disorders;
  • History of narcotic drug abuse;
  • Unable to cooperation.

Treatment and study plan

No interventions

Other

It is a observational study to investigate the efficacy and safety of PRP combined PRF on IONa compared to PRF alone.

Primary outcomes

  1. The 1-year response rate

    Time frame: 12-month period

    cases responding to treatment/total number of cases*100%

Secondary outcomes

  1. Response rate

    Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation

    cases responding to treatment/total number of cases*100%

  2. Dosage of carbamazepine

    Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation

    dosage of carbamazepine

  3. Numeric rating scale (NRS) score of pain

    Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation

    0 representing no pain and 10 representing the most severe pain imaginable

  4. Patients' quality of life (QOL)

    Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation

    evaluated by 12-item short-form health survey (SF-12) scores,Response categories vary from 2 to 6 and can be transformed to scale scores ranging from 0 ('the worst') to 100 ('the best')

  5. Patient satisfaction scores (PSS)

    Time frame: at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after operation

    0 point indicates unsatisfactory, while 10 points indicate the most satisfactory

  6. Adverse events (AEs)

    Time frame: at 30minutes, 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after treatment.

    such as dizziness, facial swelling, facial ecchymoma, eye injury, infection, etc

Study contacts

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

Lu Liu, M.D.

CONTACT

[email protected]

+8618618418228

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Qinghai People's Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Official study title

Effectiveness and Safety of Platelet-Rich Plasma Combined With Pulsed Radiofrequency to Treat Patients With Infraorbital Neuralgia

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 9, 2024
Registry last updated
Feb 21, 2025

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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