PEACE: Comparing Chronic Pain Treatment Options

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02979574

Collaborator

(none)

360

Enrollment

Locations

Arms

Anticipated Duration (Months)

51.4

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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.

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)	N/A

Study Design

Study Type:

Interventional

Actual 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 :

Nov 1, 2016

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

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.

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)

Procedure: Battle Field Acupuncture (BFA)

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Commack	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
7	Memorial Sloan Kettering Rockville Centre	Rockville Centre	New York	United States	11570