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| Name | Class |
|---|---|
| CancerCare Manitoba | OTHER |
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To evaluate the effectiveness of Electro acupuncture (EA) for treatment of persistent painful CIPN symptoms in patients with stages 1-3 breast cancer treated with docetaxel chemotherapy 6 months prior
A double blind prospective randomized controlled pilot study with cross over.
To assess the effectiveness of EA in improving pain and function for chronic chemotherapy Induced Peripheral Neuropathy (CIPN) 30 participants will be recruited 6 months post-completion of chemotherapy. Fifteen participants will be randomized to the true EA group and 15 to the sham EA group. Those participants randomized to the sham group will cross over to receive true EA after the trial is complete.
Treatment consists of EA or sham EA 1 x per week x 6 weeks. Re-assessment visits occur after the 6 week intervention and again 2 months post trial.
Each assessment visit quantifies the sensory experience of CIPN at that moment in time using Quantitative Sensory Testing (QST) which includes; thermal detection and thermal pain thresholds, light touch detection using nylon monofilament hairs (Semmes Weinstein Monofilaments (SWMF)), static 2-point discrimination, pressure algometry and vibration thresholds. Patient reported outcome measures including the Disabilities of the Arm, Shoulder and Hand (DASH), Lower extremity functional score (LEFS), the Self report Leeds Assessment of Neuropathic signs and symptoms (S-LANSS) pain questionaire will also be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | Acupuncture will consist of acupuncture points ST36, LR3, LI4 bilaterally x 30 minutes, once a week over 6 weeks. ST36 will have EA with 2Hz at the maximum tolerated intensity (ES-130 Portable Japanese Electro-Acupuncture Device, UPC Medical Supplies Inc. South El Monte, CA, USA). |
|
| Sham Acupuncture | Sham Comparator | Sham acupuncture (Streitberger Placebo Needles, Asiamed) uses the same points and treatment parameters but the placebo needle does not penetrate the skin and the current for EA is not turned on. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | Acupuncture points selected on the arms and legs using both acupuncture and electroacupuncture to assess effectiveness in alleviating neuropathic pain caused by chemotherapy in breast cancer patients |
| Measure | Description | Time Frame |
|---|---|---|
| S-Lanss (short- Leads assessment of neuropathic symptoms and signs) | 16 point pain questionnaire that differentiates nociceptive from neuropathic pain | 2 years |
| VAS (Visual Analogue Scale) | 10 point verbal rating pain scale to measure participants pain in each assessment | 2 years |
| DASH (Disabilities of the arm, shoulder, hand) | 30 item questionnaire measuring upper limb function | 2 years |
| LEFS (Lower extremity functional scale) | 20 item questionnaire measuring lower limb function | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Hammond, M.Sc. | Contact | 204-451-5702 | umande20@myumanitoba.ca | |
| Barbara Shay, PhD | Contact | 204-977-5636 | barbara.shay@med.umanitoba.ca |
| Name | Affiliation | Role |
|---|---|---|
| Barbara Shay, PhD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manitoba | Recruiting | Winnipeg | Manitoba | R3E 0T6 | Canada |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Sham Acupuncture | Device | Placebo needles appear to penetrate but do not actually penetrate the skin |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |