Personalized Electroacupuncture Therapy or Battle Field Acupuncture Therapy in Reducing Musculoskeletal Pain in Patients with Non-metastatic Cancer

Status: Active

Description

This randomized clinical trial studies how well personalized electroacupuncture therapy or battle field acupuncture therapy works in reducing pain that originates in the bones, muscles, tendons, or ligaments in patients with cancer that has not spread to other parts of the body. Electroacupuncture therapy or battle field acupuncture therapy may help relieve chronic pain caused by cancer and may help guide the personalized delivery of acupuncture for patients with chronic pain.

Eligibility Criteria

Inclusion Criteria

  • English speaking
  • 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 0-10 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 Memorial Sloan Kettering (MSK) confirmed biopsy/diagnosis; participating institution's testing is sufficient for other study sites
  • Completed 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 as above
  • Inflammatory arthritis that requires disease modifying drugs (e.g. rheumatoid arthritis)
  • Phantom limb pain
  • Patients with a history of metastatic cancer who are not currently no evidence of disease (NED)
  • Have a pending pain-related Veterans Administration (VA) or social security or worker's compensation (comp) disability claim by self-report
  • Have an implanted electronically charged medical device

Locations & Contacts

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Jun J Mao
Phone: 646-888-0866
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Jun J Mao
Phone: 646-888-0866
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Jun J. Mao
Phone: 646-888-0866

New York

Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Jun J Mao
Phone: 646-888-0866
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Jun J Mao
Phone: 646-888-0866
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Jun J Mao
Phone: 646-888-0866
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Jun James Mao
Phone: 646-888-0866

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To compare the effects of electroacupuncture therapy (electro-acupuncture [EA]) versus (vs.) battle field acupuncture (BFA) vs. waitlist control usual care (WLC) on patient-reported pain (primary outcome), physical functions, and co-morbid symptoms (fatigue, sleep disturbance, anxiety, depression, and post-traumatic stress disorder [PTSD]) among patients experiencing chronic musculoskeletal pain for three months or greater.

II. To determine the interaction between outcome expectancy and type of needling delivery (EA vs. BFA) on pain reduction.

III. To evaluate the association between specific genetic polymorphisms and patients' responses to acupuncture.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients undergo 10 EA sessions for 30 minutes each over 10 weeks. Patients may receive at most 2 sessions per week.

ARM II: Patients undergo 10 BFA sessions for 10-20 minutes each over 10 weeks. Patients may receive at most 2 sessions per week.

ARM III: Patients are placed on WLC and undergo standard medical care and pain management. After 12 weeks, patients may undergo EA as in Arm I or BFA as in Arm II based on personal preference.

After completion of study treatment, patients are followed up at 2, 6, and 14 weeks.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Supportive care

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Jun J Mao

Trial IDs

Primary ID 16-1579
Secondary IDs NCI-2016-01959
Clinicaltrials.gov ID NCT02979574