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RecruitingNCT06393231

Clinical Study on the End Time of Acupuncture and Moxibustion Therapy for Peripheral Facial Paralysis

Clinical Study on the End Time of Acupuncture and Moxibustion Therapy for Peripheral Facial Paralysis: Randomized Controlled Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
Nanjing First Hospital, Nanjing Medical University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

Bell's palsy itself has a certain self-healing tendency. Therefore, it is recommended to leave a bit of Bell's palsy for self-recovery without treatment. If complete recovery is achieved after treatment, complications such as stiffness, contracture and even hemifacial inversion may occur as time moves. Therefore, this study aims to evaluate the optimal end time of acupuncture for facial paralysis.

Detailed description

This is a randomized, double-blind, controlled study, with a total of 120 eligible patients randomly divided into an observation group (n=60) and a control group (n=60). Both groups received facial acupuncture combined with infrared irradiation treatment, once a day,10 times as a course, and the next course of treatment will be carried out after a 5-day rest.The treatment duration for both groups will not exceed three months, with the observation group aiming for a Sunnybrook score of ≥83 and the control group aiming for a score≥95. The primary outcome measure is Sunnybrook scores at 6 months after onset compared with baseline. Secondary outcome measures included Sunnybrook Scores, electroneurography, blink reflex, Facial Disability Index, Self-Rating Depression Scale and Self-Rating Anxiety Scale.

Conditions

Interventions

TypeNameDescription
OTHERacupunctureAcupuncture is applied to ST8, GB14, BL12, SJ23, ST2, SI18, ST4, ST7, RN24, Ex-HN16, SJ17 and LI4 on the affected side and needles are retained for half an hour.Add infrared irradiation therapy in the same time

Timeline

Start date
2024-05-02
Primary completion
2025-05-01
Completion
2026-05-01
First posted
2024-05-01
Last updated
2024-05-16

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06393231. Inclusion in this directory is not an endorsement.