PEACE: Comparing Chronic Pain Treatment Options

Not Applicable

Active, not recruiting

• Conditions: Pain Management; Chronic Pain; Fibromyalgia; Musculoskeletal Pain
• Interventions: Procedure: Electro-Acupuncture (EA); Procedure: Battle Field Acupuncture (BFA); Device: Wait List Control (WLC)

• Registration Number: NCT02979574
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 360

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electro-Acupuncture (EA) Procedure	Electro-Acupuncture (EA)	Participants will receive 10 treatment of EA acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week).
Wait List Control (WLC) Usual Care Procedure	Electro-Acupuncture (EA)	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.
Battle Field Acupuncture (BFA) Procedure	Battle Field Acupuncture (BFA)	Participants will receive 10 treatment of BFA acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week).
Wait List Control (WLC) Usual Care Procedure	Battle Field Acupuncture (BFA)	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.
Wait List Control (WLC) Usual Care Procedure	Wait List Control (WLC)	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.

Primary Outcome Measures

Name	Time	Method
Pain intensity and pain interference will be measured by using the Brief Pain Inventory (BPI) measure.	12 weeks

Trial Locations

Locations (7)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Rockville Centre; 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States