PEACE: Comparing Chronic Pain Treatment Options

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Musculoskeletal Pain; Fibromyalgia; Pain Management; Chronic Pain

Treatments: Device: Wait List Control (WLC); Procedure: Electro-Acupuncture (EA); Procedure: Battle Field Acupuncture (BFA)

Study type: Interventional

Funder types: Other

Identifiers

NCT02979574

16-1579

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 3 patient groups

Electro-Acupuncture (EA) Procedure

Active Comparator group

Description:

Participants will receive 10 treatment of EA acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week).

Treatment:

Procedure: Electro-Acupuncture (EA)

Battle Field Acupuncture (BFA) Procedure

Active Comparator group

Description:

Participants will receive 10 treatment of BFA acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week).

Treatment:

Procedure: Battle Field Acupuncture (BFA)

Wait List Control (WLC) Usual Care Procedure

Active Comparator group

Description:

Subjects in the WLC group continue to receive their standard medical care and pain management as prescribed by their physicians or other health care providers, including analgesic medications. After the 12 week follow up period, patients in the WLC will receive up to ten treatments of either EA or BFA based on their personal preference.

Treatment:

Procedure: Battle Field Acupuncture (BFA)

Procedure: Electro-Acupuncture (EA)

Device: Wait List Control (WLC)