Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390761
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-23
Brief Title:
Efficacy of Acupuncture for the Treatment of Parkinsons Disease Related Constipation
Sponsor:
Xian No3 Hospital
Organization:
Xian No3 Hospital
Study Overview
Official Title:
Acupuncture for the Treatment of Parkinsons Disease Related Constipation
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AFPDC
Brief Summary:
The purpose of the study is to evaluate the efficacy of acupuncture in treating Parkinsons disease related constipation PDC In the randomized controlled clinical trial study patients meeting the criteria for inclusion will be randomly enrolled and divided into two groups in a 11 ratio the acupuncture group and the sham acupuncture group The intervention is going to be executed using the acupoints EX-HN1SishencongLI4 HeguST25 TianshuST37ShangjuxuST36ZusanliST44 Neiting ST44 Taichong SP6 Sanyinjiao and CV4 ShuangyuanThe acupuncture needles will be inserted to a depth of 08 to 1 cm in the acupuncture group The sham acupuncture groups needles will be inserted to a depth of 02 to 03 cm with nonacupuncture points located 05 cm in lateral to the real acupoint or to the right for midline points During the study researchers will observe changes in complete spontaneous bowel movements CSBMs Constipation Symptom and Efficacy Assessment Scale CSEAS including the six dimensions of difficulty Bristol time incompleteness frequencyand bloating the Patient-Assessment of Constipation Quality of Life questionnaire PAC-QOL and the Unified Parkinsons Disease Rating Scale UPDRS at baseline week 0 post-treatment week 4 and follow-up week 12Colonic transit time measurement and conventional anorectal manometry were evaluated at the above time points
Detailed Description:
Age sex duration of disease and equivalent daily dose of levodopa were assessed at baseline From the beginning of the baseline phase to the end of the follow-up phase patients were requested to complete an electronic bowel diary which was supervised by an independent outcome assessor The primary outcome in this study was the number of weekly CSBMs Weekly CSBMs were collected at baseline week 0 post-treatment week 4 and follow-up week 12 and differences from baseline levels were compared at week 4 and week 12 Anorectal manometry AM and colonic transit time TT were assessed in the two groups using standardized procedures In brief for TT evaluation patients swallowed a capsule containing 24 radiopaque markers Abdominal radiographs from patients in the erect posture were acquired 5 days after markers intake During the test period patients were instructed to maintain their habitual diet and to avoid laxatives enema and suppositories According to manufacturers indications the TT was described as normal if at least 19 markers 80 were expelled at day 5 The AM was performed using the stationed pull-through technique with a 4-channel water-perfused catheter linked to an electronic manometer The catheter was inserted via the anal canal and positioned in the rectum with the patient in a left-lateral decubitus position Functional parameters included the resting and squeeze pressures the ability of the anal sphincter to relax with straining the recto-anal inhibitory reflex RAIR and the rectal sensation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020qn06 | OTHER_GRANT | Xian Health Commission Research Project | None |