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PEACE: Comparing Chronic Pain Treatment Options (PEACE)

Primary Purpose

Chronic Pain, Musculoskeletal Pain, Fibromyalgia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electro-Acupuncture (EA)
Battle Field Acupuncture (BFA)
Wait List Control (WLC)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring acupuncture, pain, chronic pain, pain management, 16-1579

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge
  • Memorial Sloan Kettering Monmouth
  • Memorial Sloan Kettering Bergen
  • Memorial Sloan Kettering Commack
  • Memorial Sloan Kettering Westchester
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Rockville Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Electro-Acupuncture (EA) Procedure

Battle Field Acupuncture (BFA) Procedure

Wait List Control (WLC) Usual Care Procedure

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Pain intensity and pain interference will be measured by using the Brief Pain Inventory (BPI) measure.

Secondary Outcome Measures

Full Information

First Posted
November 28, 2016
Last Updated
December 1, 2022
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02979574
Brief Title
PEACE: Comparing Chronic Pain Treatment Options
Acronym
PEACE
Official Title
Personalize Electro-acupuncture vs. Auricular-acupuncture Comparative Effectiveness
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2016 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Musculoskeletal Pain, Fibromyalgia, Pain Management
Keywords
acupuncture, pain, chronic pain, pain management, 16-1579

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electro-Acupuncture (EA) Procedure
Arm Type
Active Comparator
Arm Description
Participants will receive 10 treatment of EA acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week).
Arm Title
Battle Field Acupuncture (BFA) Procedure
Arm Type
Active Comparator
Arm Description
Participants will receive 10 treatment of BFA acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week).
Arm Title
Wait List Control (WLC) Usual Care Procedure
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Electro-Acupuncture (EA)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Battle Field Acupuncture (BFA)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Wait List Control (WLC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity and pain interference will be measured by using the Brief Pain Inventory (BPI) measure.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Rockville Centre
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33734288
Citation
Mao JJ, Liou KT, Baser RE, Bao T, Panageas KS, Romero SAD, Li QS, Gallagher RM, Kantoff PW. Effectiveness of Electroacupuncture or Auricular Acupuncture vs Usual Care for Chronic Musculoskeletal Pain Among Cancer Survivors: The PEACE Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):720-727. doi: 10.1001/jamaoncol.2021.0310.
Results Reference
derived
PubMed Identifier
32481275
Citation
Liou KT, Baser R, Romero SAD, Green J, Li QS, Orlow I, Panageas KS, Mao JJ. Personalized electro-acupuncture versus auricular-acupuncture comparative effectiveness (PEACE): A protocol of a randomized controlled trial for chronic musculoskeletal pain in cancer survivors. Medicine (Baltimore). 2020 May 22;99(21):e20085. doi: 10.1097/MD.0000000000020085.
Results Reference
derived
Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

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PEACE: Comparing Chronic Pain Treatment Options

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