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Constipation is one of the most common complications in patients with advanced cancer.
The aim of this protocol designed as a double-blind randomized controlled trial is to investigate the efficacy of laser acupuncture (LA) therapy on constipation in patients with advanced cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LA group | Experimental | The subjects in the experimental group will receive 0.375 J of energy at each of the following acupoints: LI4 (Hegu, B3), LI11 (Quchi, B2), PC6 (Neiguan, B3), ST36 (Zusanli, B2), ST37 (Shangjuxu, B2), ST39 (Xiajuxu, B2), SP4 (Gongsun, B3) , SP9 (Yinlingquan, B2). |
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| Control group | Sham Comparator | The subjects in the control group will receive sham LA treatment, without any laser output (no stimulation) at the same acupoints used in experimental group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser acupuncture | Procedure | Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Complete spontaneous bowel movements (CSBM) | CSBM is defined as an spontaneous bowel movements associated with a sensation of complete evacuation. The number of CSBM within one week will be recorded. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort levels during defecation | Estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort). | 1 week |
| Symptoms of constipation | A five-symptoms questionnaire for measuring the severity of constipation including straining during defecation, abdominal pain during defecation, hard stools, sensation of incomplete evacuation, and sensation of anorectal obstruction or blockage. Each item is rated on a four point Likert scale that ranges from severe symptom (4 points) to no symptom (1 point). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun-Ting Liu, MD | Contact | +886-7-7317123 | 2334 | juntin0214@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chun-Ting Liu, MD | Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital | Recruiting | Kaohsiung City | 833 | Taiwan |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The participants in each group will receive real (with energy output) or sham (without energy output) laser acupuncture. The feelings of participants in each group are not different. The care provider and outcomes assessor don't involve the random allocation and don't know if participants receive real laser acupuncture.
| 1 week |
| Colonic motility | Measured by auscultation of the lower right abdomen with a stethoscope. | 1 week |