Xi 'an No.3 Hospital
Xi'an, Shaanxi, 710018, China
Location status: Recruiting
NCT Number: NCT06390761
The purpose of the study is to evaluate the efficacy of acupuncture in treating Parkinson's 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 1:1 ratio: the acupuncture group and the sham acupuncture group. The intervention is going to be executed using the acupoints EX-HN1(Sishencong),LI4 (Hegu),ST25 (Tianshu),ST37(Shangjuxu),ST36(Zusanli),ST44 (Neiting), ST44 (Taichong), SP6 (Sanyinjiao) and CV4 (Shuangyuan).The acupuncture needles will be inserted to a depth of 0.8 to 1 cm in the acupuncture group. The sham acupuncture group's needles will be inserted to a depth of 0.2 to 0.3 cm with nonacupuncture points located 0.5 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, frequency,and bloating), the Patient-Assessment of Constipation Quality of Life questionnaire (PAC-QOL), and the Unified Parkinson's Disease Rating Scale (UPDRS) at baseline (week 0), post-treatment (week 4), and follow-up (week 12).Colonic transit time measurement and conventional anorectal manometry were evaluated at the above time points.
Interested in participating?
Request Info35 year–80 year
All sexes
Interventional
Not applicable
Xi'an, Shaanxi, 710018, China
Location status: Recruiting
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 manufacturer's 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All acupoints were selected based on traditional Chinese medicine theory and previous articles on PD and constipation.
Time frame: 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.
Complete spontaneous bowel movements
Time frame: CSEAS 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.
Including the six dimensions of difficulty, Bristol, time, incompleteness, frequency, and bloating
Time frame: PAC-QOL 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.
To assess quality of life in patients with constipation. It includes questions about the impact of constipation symptoms on the daily life of the patient, such as difficult defecation, bloating, abdominal pain, etc.
Time frame: These were assessed 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.
To assess the severity and symptoms
Time frame: TT was assessed 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.
Colonic transit time
Time frame: AM was assessed 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
Contact information is provided by the study sponsor or research team.
Chengxue Du, Doctor
CONTACT
Gejuan Zhang, Doctor
CONTACT
Xi'an No.3 Hospital
Other Gov
Acupuncture for the Treatment of Parkinson's Disease Related Constipation
Acronym: AFPDC
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