Parkinson DiseaseAFPDCNCT06390761
Efficacy of Acupuncture for the Treatment of Parkinson's Disease Related Constipation
A study testing Acupuncture in people with Parkinson Disease and Constipation, run by Xi'an No.3 Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Parkinson Disease, Constipation, Non-motor Symptom
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2024to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of PD (according to the Movement Disorder Society's revised clinical diagnostic criteria for Parkinson's disease in 2015) and functional constipation (according to the Rome IV diagnostic criteria) ;
- Age between 35 and 80 years;
- Hoehn-Yahr grade ≤ 3;
- No medications taken within 2 weeks that may affect gastrointestinal function (such as prucalopride and probiotics);
- No anticipation in other clinical trials within 1 month;
- Voluntary engagement in this study, ability to sign the informed consent, and cooperation in the completion of the bowel diary and scale filling.
Who cannot join
- Organic lesions of the digestive system (such as intestinal adhesions, obstructions, tumors, or malformations in the gastrointestinal tract);
- A history of abdominal or anorectal surgery that may affect intestinal transit, systemic diseases that may affect the dynamics of the digestive tract (such as diabetes and hyperthyroidism);
- Serious life-threatening diseases (such as severe cardiovascular diseases and malignant tumors);
- Skin lesions that were inappropriate for needling, the viscose allergy that prevented acupuncture device attachment;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xi 'an No.3 Hospital
Xi'an, Shaanxi, 710018
Chengxue Du, Doctor, +8615771726803, dcx1014@stu.xjtu.edu.cn
About this study
Official title: Acupuncture for the Treatment of Parkinson's Disease Related Constipation
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.
Read the 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 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.
- Being tested
- Acupuncture
- Medical subject headings
- Parkinson Disease, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
All acupoints were selected based on traditional Chinese medicine theory and previous articles on PD and constipation.
| Study group | Role | What they receive |
|---|---|---|
| The Acupuncture Group | Experimental | 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. Receives: Procedure: Acupuncture |
| The Sham Acupuncture Group | Sham comparator | 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. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of weekly CSBMs
Complete spontaneous bowel movements
Measured: 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.
Secondary outcomes (5)
Constipation Symptom and Efficacy Assessment Scale (CSEAS)
Including the six dimensions of difficulty, Bristol, time, incompleteness, frequency, and bloating
Measured: 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.
Patient-Assessment of Constipation Quality of Life questionnaire (PAC-QOL)
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.
Measured: 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.
The Unified Parkinson's Disease Rating Scale (UPDRS)
To assess the severity and symptoms
Measured: 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.
TT
Colonic transit time
Measured: 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.
AM
Anorectal manometry
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start30 Apr 2024 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an No.3 Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gejuan Zhang, Doctor, Study director, The dean
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390761
- Sponsor's protocol ID
- AFPDC
- Other IDs
- 2020qn06
- Acronym
- AFPDC
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is managed by the project team and can be shared according to individual needs
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for the Treatment of Parkinson's Disease Related Constipation
- ClinicalTrials.gov ID
- NCT06390761
- Acronym / sponsor ID
- AFPDC / AFPDC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xi'an No.3 HospitalOther government
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Acupuncture Group | Experimental | Procedure: AcupunctureThe 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 | Sham comparator | Procedure: AcupunctureThe 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. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A diagnosis of PD (according to the Movement Disorder Society's revised clinical diagnostic criteria for Parkinson's disease in 2015) and functional constipation (according to the Rome IV diagnostic criteria) ;
- Age between 35 and 80 years;
- Hoehn-Yahr grade ≤ 3;
- No medications taken within 2 weeks that may affect gastrointestinal function (such as prucalopride and probiotics);
- No anticipation in other clinical trials within 1 month;
Key exclusion criteria (5 listed)
- Organic lesions of the digestive system (such as intestinal adhesions, obstructions, tumors, or malformations in the gastrointestinal tract);
- A history of abdominal or anorectal surgery that may affect intestinal transit, systemic diseases that may affect the dynamics of the digestive tract (such as diabetes and hyperthyroidism);
- Serious life-threatening diseases (such as severe cardiovascular diseases and malignant tumors);
- Skin lesions that were inappropriate for needling, the viscose allergy that prevented acupuncture device attachment;
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAll acupoints were selected based on traditional Chinese medicine theory and previous articles on PD and constipation. | Procedure or surgery | The Acupuncture Group, The Sham Acupuncture Group |
Primary outcome
The number of weekly CSBMs
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
5 secondary outcomes
Constipation Symptom and Efficacy Assessment Scale (CSEAS)
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.
Patient-Assessment of Constipation Quality of Life questionnaire (PAC-QOL)
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.
The Unified Parkinson's Disease Rating Scale (UPDRS)
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.
TT
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.
AM
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: No. Data is managed by the project team and can be shared according to individual needs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gejuan Zhang, Doctor study director
The dean
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Parkinson Disease and Constipation, run by Xi'an No.3 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gejuan Zhang, Doctor (+8615934875839, zhanggejuan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of weekly CSBMs (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.