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PEACE: Comparing Chronic Pain Treatment Options (PEACE)

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ClinicalTrials.gov Identifier: NCT02979574
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Musculoskeletal Pain Fibromyalgia Pain Management Procedure: Electro-Acupuncture (EA) Procedure: Battle Field Acupuncture (BFA) Device: Wait List Control (WLC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Personalize Electro-acupuncture vs. Auricular-acupuncture Comparative Effectiveness
Actual Study Start Date : November 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Electro-Acupuncture (EA) Procedure
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)
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.

Active Comparator: Battle Field Acupuncture (BFA) Procedure
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)
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.

Active Comparator: Wait List Control (WLC) Usual Care Procedure
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)
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.

Procedure: Battle 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.

Device: Wait 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.




Primary Outcome Measures :
  1. Pain intensity and pain interference will be measured by using the Brief Pain Inventory (BPI) measure. [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979574


Contacts
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Contact: Jun Mao, MD, MSCE 646-888-0808
Contact: Ting Bao, MD 646-888-0865

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Jun Mao, MD, MSCE    646-888-0808      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Jun Mao, MD, MSCE    646-888-0808      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Jun Mao, MD, MSCE    646-888-0866      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Jun Mao, MD, MSCE    646-888-0866      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Jun Mao, MD, MSCE    646-888-0866      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jun Mao, MD,MSCE    646-888-0808      
Contact: Bao Ting, MD    646-888-0865      
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: Jun Mao, MD, MSCE    646-888-0808      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Jun Mao, MD, MSCE Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02979574     History of Changes
Other Study ID Numbers: 16-1579
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Memorial Sloan Kettering Cancer Center:
acupuncture
pain
chronic pain
pain management
16-1579

Additional relevant MeSH terms:
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Chronic Pain
Fibromyalgia
Musculoskeletal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases