Chronic Pain, Fibromyalgia, Musculoskeletal Pain, Pain Management
Conditions
Keywords
acupuncture, pain, chronic pain, pain management, 16-1579
Brief summary
The purpose of this study is to compare two types of acupuncture with usual care on treating chronic pain. This study has three groups. Two groups will received acupuncture. One group will receive usual standard of care for 12 weeks and then will receive acupuncture. Acupuncture is an ancient Chinese technique of using very thin needles inserted in the skin to treat different symptoms and illness, and to promote healing. Each group will undergo a different method of needle administration.
Interventions
PROCEDUREElectro-Acupuncture (EA)
Participants will receive 10 treatment of Electro-Acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week). The acupuncturist will insert acupuncture needles in at least 4 local points around the body with the most pain and at least 4 distant points to address the patient's baseline constitution. The needles will be electrically stimulate at 2 Hz by connecting to a TENS unit. The needles will be in place for 30 minutes.
PROCEDUREBattle Field Acupuncture (BFA)
Participants will receive 10 treatment of Battle Field Acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week). Acupuncture needles will be placed in the participants' ears. The total duration of BFA delivery is about 10 to 20 minutes depending on how many needles are used in the procedure.
DEVICEWait List Control (WLC)
After the waiting period (12 weeks from randomization), participants in the WLC will receive up to ten treatments of either EA or BFA based on their personal preference.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* English speaking * Age \>/= 18 years or older * Having musculoskeletal pain, defined as regional (joints, extremities, back, neck) or more generalized (fibromyalgia or chronic widespread pain) * Having a pain rating of 4 or greater in worst pain on a 1-10 numerical rating scale in the preceding week (Patients with a neuropathic component to their pain that involves the extremities or back will be eligible) * Having had pain for at least 3 months and at least 15 days with pain in the preceding 30 days * A diagnosis of cancer with no restrictions placed on type of cancer, other than that patients with metastatic disease will be excluded. Eligibility criteria are not restricted to MSK confirmed biopsy/diagnosis. Participating institution's testing is sufficient for other study sites. * Complete active treatment (surgery, chemotherapy, and/or radiotherapy) at least one month prior to study initiation (patients on continued hormone treatment will not be excluded).
Exclusion criteria
* Have non-musculoskeletal pain syndromes (headache, facial pain, chest pain, visceral abdominal pain) if these are the sole source of pain, but can be present as co-morbid conditions as long as a patient has a primary musculoskeletal pain condition defined s above. * Inflammatory arthritis that require disease modifying drugs (e.g. rheumatoid arthritis) * Phantom limb pain * Patients with a history of metastatic cancer who are not currently NED * Have a pending pain-related VA or social security or worker's comp disability claim by self-report * Have an implanted electronically charged medical device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity and pain interference will be measured by using the Brief Pain Inventory (BPI) measure. | 12 weeks |
Countries
United States
Outcome results
None listed