Trial ID: ISRCTN14324113
Other - Phase Unknown - No longer available
Background and study aims Parkinson's disease (PD) is a common chronic progressive neurological disease in middle-aged and elderly people, accompanied by various movement and non-movement symptoms. Gastrointestinal dysfunction is one of the most common PD symptoms, and has often been neglected and has not been properly managed. Acupuncture has received attention as a promising intervention for gastrointestinal dysfunction, and some previous studies have reported that this intervention may be beneficial for treating PD patients with gastrointestinal dysfunction. This study aims to explore how practical and effective acupuncture is for PD patients with gastrointestinal dysfunction. Who can participate? Adults aged between 40 and 80 years with a diagnosis of Parkinson's disease and gastrointestinal dysfunction What does the study involve? Parkinson’s disease patients will be asked to join this study while they visit Beijing TCM Hospital’s acupuncture department. The trial will be explained to participants and will be asked to sign an informed consent form. Participants will be allocated to one of two groups with an equal chance of being in either group (like tossing a coin). One group will receive 12 sessions of acupuncture treatment over 4 weeks. The other group will receive 12 sessions of sham acupuncture treatment over 4 weeks using non-penetrating flat needles. The study lasts 1 month in total. Participants also complete online questionnaires and assessments before receiving treatment and after 4, 12 and 24 weeks. The gastrointestinal dysfunction of participants will be measured using a gastrointestinal electrograph scan before and after the treatment. What are the possible benefits and risks of participating? Relief of gastrointestinal dysfunction in PD patients may be a possible benefit while participating in this study. Improvements to the patient's gastrointestinal function are not guaranteed in the sham acupuncture group. If the symptoms are not improved due to the sham acupuncture treatment, normal acupuncture treatment can be provided after the test is completed. The information obtained from this study could benefit patients with the same condition in the future. The main risk of acupuncture would be temporary pain, a sense of itching or swelling, and other possible side effects such as slight bleeding, bruising, or fainting. Patients with any of these side effects will receive immediate medical care, and the study team will reassess whether they can continue to accept treatment. Where is the study run from? Beijing Traditional Chinese Medicine Hospital (China) When is the study starting and how long is it expected to run for? March 2023 to December 2025 Who is funding the study? Beijing Traditional Chinese Medicine Hospital (China) Who is the main contact? Dr Shaosong Wang, wangssmail@163.com
Beijing Hospital of Traditional Chinese Medicine
Source: https://www.isrctn.com/