NCT02979574

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
6mo left

Started Nov 2016

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Nov 2016Nov 2026

Study Start

First participant enrolled

November 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

December 4, 2025

Status Verified

December 1, 2025

Enrollment Period

10 years

First QC Date

November 28, 2016

Last Update Submit

December 2, 2025

Conditions

Keywords

acupuncturepainchronic painpain management16-1579

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Study Arms (3)

Electro-Acupuncture (EA) Procedure

ACTIVE COMPARATOR

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

Procedure: Electro-Acupuncture (EA)

Battle Field Acupuncture (BFA) Procedure

ACTIVE COMPARATOR

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

Procedure: Battle Field Acupuncture (BFA)

Wait List Control (WLC) Usual Care Procedure

ACTIVE COMPARATOR

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.

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

Interventions

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.

Electro-Acupuncture (EA) ProcedureWait List Control (WLC) Usual Care Procedure

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.

Battle Field Acupuncture (BFA) ProcedureWait List Control (WLC) Usual Care Procedure

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.

Wait List Control (WLC) Usual Care Procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Related Publications (5)

  • Li X, Lampson K, Rosa WE, Li QS, Ramalingam MB, Epstein AS, Mao JJ. Effect of acupuncture on fatigue in cancer survivors with chronic pain: a secondary analysis. Support Care Cancer. 2025 Dec 13;34(1):31. doi: 10.1007/s00520-025-10219-z.

  • Booher A, Mao JJ, Muniz RC, Romero SAD, Li SQ, Lopez AM, Liou KT. Association between Hispanic Ethnicity and Greater Expectation of Benefit from Acupuncture or Massage for Pain in Cancer. J Immigr Minor Health. 2024 Oct;26(5):953-957. doi: 10.1007/s10903-024-01611-8. Epub 2024 Jul 8.

  • Bao T, Zhi WI, Baser RE, Li QS, Weitzman M, Gillespie EF, Robson M, Mao JJ. Electro-acupuncture versus battle field auricular acupuncture in breast cancer survivors with chronic musculoskeletal pain: subgroup analysis of a randomized clinical trial. Breast Cancer Res Treat. 2023 Nov;202(2):287-295. doi: 10.1007/s10549-023-07072-1. Epub 2023 Aug 24.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Chronic PainMusculoskeletal PainFibromyalgiaAgnosiaPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPerceptual DisordersNeurobehavioral Manifestations

Study Officials

  • Jun Mao, MD, MSCE

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2016

First Posted

December 1, 2016

Study Start

November 1, 2016

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

December 4, 2025

Record last verified: 2025-12

Locations