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Single center, double-blind, placebo-controlled clinical efficacy of amitriptyline spray in patients with neuropathic pain

Single center, double-blind, placebo-controlled clinical efficacy of amitriptyline spray in patients with neuropathic pain - Single center, double-blind, placebo-controlled clinical efficacy of amitriptyline spray in patients with neuropathic pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089746
Enrollment
Unknown
Registered
2024-09-14
Start date
2024-09-20
Completion date
Unknown
Last updated
2026-08-24

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

Conditions

Neurological pain related diseases

Interventions

experimental group:Double blind treatment period: In the test group, according to the pharmacokinetics of amitriptyline tablets, amitriptyline spray was administered for 1 week, 3-4 times, tid
Open treatment period: After completing a one week double-blind treatment, patients in the experimental group entered the open treatment phase. At the second week, subjects with visual analogue pain s
The use of amitriptyline spray will be suspended for subjects with VAS score = 3.
control group:Double blind treatment period: The placebo control group (with the same appearance as the amitriptyline spray) received placebo treatment of external excipients, 3-4 sprays/time, tid, la

Sponsors

Pain Department of Taihe Hospital, Shiyan City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. All patients' pain met the diagnostic criteria for neuropathic pain (i.e. DN4 >= 4). 2. When signing the informed consent form, age >= 18 years old, gender not limited; 3. During screening and baseline examination, the pain area should not exceed the range of two skin segments; 4. For adult participants, fully understand the trial content, voluntarily participate in the trial, and sign an informed consent form; 5. Agree to our department's basic treatment plan (conventional oral medication, nerve block, and radiofrequency basic treatment).

Exclusion criteria

Exclusion criteria: 1. The patient's pain components are complex and do not belong to or completely belong to neuropathic pain patients. 2. Patients who need to transfer due to underlying diseases are no longer suitable for continuing the trial; 3. The patient has mental and psychological disorders and is expected to be unable to cooperate with the experimenter. 4. Individuals with skin infections or potential infection risks at the affected area. 5. Subjects who are pregnant, breastfeeding, or planning to conceive; 6. Asthma and other acute respiratory patients.

Design outcomes

Primary

MeasureTime frame
Visual Analog Pain Rating Scale;Infrared thermal imaging;Somatosensory evoked action potential;

Secondary

MeasureTime frame
McGill Pain Questionnaire;

Countries

China

Contacts

Public ContactLai Jinyu

shiyan taihe hospital

laijinyu668@163.com+86 139 7246 1134

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026