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Short-term spinal cord stimulation and immune ozonated autohemotheapy in the treatment of postherpetic neuralgia in middle-aged and elderly people:a prospective, randomized controlled study

Short-term spinal cord stimulation and immune ozonated autohemotheapy in the treatment of postherpetic neuralgia in middle-aged and elderly people:a prospective, randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073542
Enrollment
Unknown
Registered
2023-07-13
Start date
2023-07-15
Completion date
Unknown
Last updated
2023-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postherpetic neuralgia

Interventions

tSCS group:short-term spinal cord stimulation
tSCS and immune ozonated autohemotheapy group:short-term spinal cord stimulation and immune ozonated autohemotheapy

Sponsors

The First Affiliated Hospital of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. The included patients meet the diagnostic criteria of Chinese expert consensus on diagnosis and treatment of PHN, and break out in a rash between 1 and 6 months; 2. Aged 50 to 90 years, male or female; 3. The area of the rash is thoracolumbar spinal nerve innervation(T1-L5); 4. Patients whose pain intensity VAS >= 7 points or more or still = 5 points after oral pregabalin (150mg/d), or hospitalized patients with burst pain more than 3 times a day; 5. Neuropathic Pain assessment scales ID Pain and DN-4 were completed, and then the nature of pain was considered as neuropathic pain; 6. The subjects are able to follow the doctor's advice on drug and surgical treatment and receive the visit plan; Understand the contents of the questionnaire, or be able to complete the questionnaire with the assistance of the visitor; 7. No contraindications of immune ozonated autohemotheapy.

Exclusion criteria

Exclusion criteria: 1. Poor general condition, or Severe systemic infection or HIV infection, unable to actively cooperate with respiratory insufficiency, etc; 2. Those who suffer from allergic diseases and have allergic constitution 3. have a history of allergy to drugs with similar structure (pregabalin, tramadol); 4. Epilepsy patients and those with a family history of epilepsy; Patients with severe peptic ulcer, pancreatitis, intestinal obstruction, asthma and other contraindications related to experimental drug surgery; 5. Patients with suspected or real history of drug abuse 6. Patients who participated in medical trials within 3 months before the trials (including the drug in the trials); 7. Patients with other diseases of the nervous system need to take analgesic drugs; 8. There are contraindications to spinal cord stimulation or pulsed radiofrequency surgery; 9. Patients can not tolerate placement of electrodes; 10. Patients with serious mental or other illness can not complete pain scores correctly or describe symptoms objectively; 11. Unable to follow-up punctually; 12. There are contraindications to immune ozonated autohemotheapy, such as favism; Hyperthyroidism; abnormal coagulation function; Severe unstable cardiovascular disease; anemia; Pregnant women, especially those in early pregnancy; Other diseases of unknown cause such as psychoneurosis; Patients using angiotensin-converting enzyme inhibitors; allergic to medical ozone.

Design outcomes

Primary

MeasureTime frame
visual analogue scale;

Secondary

MeasureTime frame
daily sleep interference score;Times of burst pain;Dosage of analgesics during hospitalization and follow-up;patient health questionnaire;generalised anxiety disorder assessment;the MOS item short from health survey,SF-36;T lymphocyte subtypes in peripheral blood;Immunoglobulin (IgA, IgG, IgM), complement (C3,C4);Efficiency of postoperative analgesia ;Complete remission rate;

Countries

China

Contacts

Public ContactXiaoping Wang

The First Affiliated Hospital of Jinan University

txp2938@jun.edu.cn+86 137 1057 5060

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026