None listed
Conditions
Brief summary
The purpose of this study is to find out how effective and safe acupuncture is in treating cancer related pain. Who is it for? You may be eligible for this study if you are aged 18 or older, and have documented cancer related pain due to cancer of any type. Study details Participants in this study will be randomised by chance (like flipping a coin) into two groups. One groups will start acupuncture at enrolment. This will involve two sessions of acupuncture per week (approx. 40min per session) for 4 weeks, in addition to their prescribed pain medication. The other group will continue their prescribed medication for 4 weeks after enrolment, then receive the same acupuncture as the first group. As part of this study, all participants will complete questionnaires, have an interview. It is hoped this research will demonstrate acupuncture can be used with western medicine to relieve the pain that cancer can cause.
Interventions
BRIEF NAME Acupuncture WHY Acupuncture has been widely used for many conditions including pain. In China, in which use of acupuncture originated, it has been widely used for cancer treatment for many years. It is now recommended in the National Comprehensive Cancer Network (NCCN) guidelines for cancer pain in adults as part of integrative interventions in the United States. Acupuncture is also recommended by the American Society of Clinical Oncology (ASCO) practice guidelines specifically for chronic pain in cancer survivors. Implementation of acupuncture within hospitals as a prominent therapy offered as part of integrative oncology programs is an increasing trend in cancer care in developed Western countries worldwide. In a 2013 European survey of integrative oncology, acupuncture (55%) was most commonly provided in integrative oncology centres in Europe for supportive care. In the USA, acupuncture is a standard therapy commonly offered as part of integrative oncology programs in major hospitals alongside conventional medicine. A recent systematic review has found that in the United States, more than 80% of National Cancer Institute (NCI) designated cancer centres governed by the National Institute of Health (NIH) recommend acupuncture for symptom management and a majority (73%) provide acupuncture as part of integrative oncology programs to treat a variety of symptoms and conditions associated with cancer and the side effects of cancer treatments. Leading NCI designated cancer centres, including Dana-Farber Cancer Institute (DFCI), the premier academic medical and research hospital of Harvard Medical School in Boston, Memorial Sloan- Kettering Cancer Centre in New York, and M.D. Anderson Cancer Centre in Houston, have nearly 20 years of history in developing and implementing clinical models of acupuncture within integrative oncology programs to address patients’ unmet needs. WHAT Acupuncture is a Chinese medicine therapy that involves the use of needles inserted into specific points on the skin. There are several different forms of acupuncture, including traditional body acupuncture, electroacupuncture, microsystem acupuncture (such as auricular acupuncture and scalp acupuncture), acupressure and moxibustion. Based on Chinese Medicine theories and clinical evidence, 4 points in the limbs and several points in the back will be selected for acupuncture. The auricular acupressure, which involves pressing ear seeds against auricular points,will used to ensure prolonged effects of pain management. The auricular points are all located on the ear. The participant will be asked to lie down on a massage table with the needling area exposed. The body acupuncture points will be punctured with 0.25*40 mm stainless steel, single used needles manufactured by Helio USA (https://www.heliousa.com/products/acupuncture-needles.html). Insertion technique will be one-hand insertion method. Lifting and twisting techniques will be used for each points until the participant can feel the needling sensation commonly known as “deqi”, with a series of soreness, numbness, distention or heaviness around the needle site. The needles will be retained for 30 min without manipulation. After the body acupuncture, ear seeds manufactured by Earseed USA (https://www.earseeds.com/shop-by-condition-2/) will be applied to the auricular acupuncture points and pressed until the pressure sites reacted with hot sensation. The pressure seeds sit on a sticky bandage and will be remain on the ear for 3 days. The participant will be asked to massage the pressure seeds three time a day as directed in the protocol. WHO PROVIDED Acupuncture will be given by Dr Qi Zhao, who came from a family of traditional Chinese medicine and was influenced by it from a young age. He was majored in acupuncture and massage therapy at Beijing University of Chinese Medicine and also received a Doctor degree of medicine. He has been working in the field for over 17 years and is skilful at treating diseases through acupuncture and herbs. Dr Zhao is experienced in treating some of the common conditions including cervical spondylosis, protrusion of lumbar intervertebral discs, lumbar muscle strain, shoulder stiffness, knee pain, ischialgia, headache, sequela of stroke, rheumatoid arthritis, insomnia, herpes zoster, allergic disorders, depression, acne, eczema and chronic gastritis. The researcher has over 17 years of clinical experiences in treatment using Acupuncture, in Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine. He has previously conducted clinical in Beijing investigating the effects of Acupuncture in pain related conditions. The researcher has a PhD degree in clinical medicine, and a master degree in clinical science with Acupuncture and Tuina (Chinese Massage Therapy), also a Bachelor degree in Medicine and Chinese Medicine. All degree were obtained in China under Beijing University of Chinese Medicine. HOW Acupuncture will be delivered face to face individually. WHERE The intervention will be given in Liverpool Hospital, the leading hospital in the South Western Sydney Local Health District (SWSLHD). The hospital has provided a fully comprehensive range of cancer services since 1995. There has been a strong trend for integrating allied health services for improving cancer survivorship. The construction of a facility, Oncology Alliance for the Science of Integrative Survivorship (OASIS) is supported by the Australian Cancer Research Foundation (ACRF) since 2017. The facility is located at the Wellness Centre at the hospital, annual visits were 1,098 in 2017 with 11,138 occasions of services provided by allied health staff. Acupuncture is one of the most popular services at the Centre. WHEN and HOW MUCH This study is a pragmatic randomised controlled trial with two groups, an intervention group (acupuncture plus standard analgesic medication) and a control group in a setting as wait-list (standard analgesic medication). The participants are randomly assigned into the two groups by computer with a 1:1 allocation ratio. Intervention group: a total of 8-week will be involved which includes 4-week acupuncture intervention and 4-week follow-up. Participants will receive a 40-minutes acupuncture intervention twice per week over 4 weeks in addition to continuing their prescribed analgesic medication for CRP. On completion of the final intervention, participants will complete a 4-week follow-up, during which they will continue to take their prescribed analgesic medication for CRP. Control group: a total of 12-week will be involved which includes 4-week on wait-list, 4-week on acupuncture and 4-week follow-up.From week-1 to week-4, participants will wait to receive the intervention whilst continuing prescribed analgesic medication for CRP. From week-5 to week-8 participants will receive a 40-minutes acupuncture intervention twice per week for a total of eight interventions over 4 weeks in addition to continuing their prescribed analgesic medication for CRP. On completion of the final intervention, participants will complete a 4-week follow-up, during which they will continue to take their prescribed analgesic medication for CRP. During each intervention session, each participant will also be asked questions about the pain, medication and side effects, which will take around 5 minutes. During the first and the eighth intervention session, each participant will be asked to complete a survey, which will take around 10 minutes. During the last session, participants will not receive an intervention but report pain level and analgesic use, which will take around 5 minutes. TAILORING The points used will include body acupuncture points and auricular points, both of which were planned to be personalised during each session. According to Traditional Chinese Medicine theory, back-shu points and auricular points will be selected by cancer type and pain location. The customized point selection will be done by Dr Qi Zhao based on the Traditional Chinese Medicine theories. MODIFICATIONS N/A HOW WELL Each eligible participant will receive a timetable for the study. A message will be sent to the participant as a reminder of each coming session. The principal investigator will explain why and how to massage the sear seeds. Timed messages will work as the reminders of massaging the ear seeds three times a day. The participants are encouraged to contact the research assistant or the principal investigator to ask questions relevant with the trial.
Sponsors
Study design
Eligibility
Inclusion criteria
• Age 18 years old or older. • A diagnostic certificate of CRP provided by an oncologist of Liverpool hospital, regardless of the cancer type, stage or the presence of metastasis. • Included types of pain: somatic nociceptive pain, visceral nociceptive pain, neuropathic pain and mixed types of pain. • Numerical Rating Scale (NRS) score > 3. • Cognitive ability to give consent.
Exclusion criteria
• Presence of skin infection that potentially interferes with the needling (intervention) area. • Presence of thrombocytopenia, fever or active infection. • Inability to remain supine position for 40 minutes continuously, given the nature of the acupuncture intervention. • Estimated survival time less than or equal to 12 weeks. • Numerical Rating Scale (NRS) score less than or equal to 3. • Pregnant woman.