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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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This study will evaluate the impact of a novel non-pharmacological multimodal therapy, a type of approach known to improve pain outcomes and recommended by the Institute of Medicine report for chronic pain management. This study design will also allow the investigators to evaluate a neural model supporting therapeutic alliance for pain outcomes for fibromyalgia.
The patient-clinician interaction is central to most therapies and is supported by key interpersonal mechanisms of action such as clinician empathy, therapeutic alliance, and trust. However, the neural underpinnings of this effect are mostly unknown. The investigators' recently published study applied functional MRI (fMRI) hyperscanning (i.e. simultaneously neuroimaging chronic pain patients and clinicians in synchronized MRI scanners) demonstrated that brain-to-brain concordance in the temporoparietal junction (TPJ) is up-regulated following a clinical interaction and associated with patient analgesia. Fibromyalgia is a chronic pain disorder in great need of novel therapies. This study will evaluate the impact of a novel multimodal therapy, a type of approach known to improve pain outcomes and recommended by the Institute of Medicine report for chronic pain management. The study design will also allow the investigators to evaluate a neural model supporting therapeutic alliance for pain outcomes for fibromyalgia wherein training and acupuncture will synergistically target a critical therapeutic pathway - i.e., patient-provider alliance, instantiated by TPJ concordance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Training | Experimental | Participants will meet with a pain specialist who will conduct a specific form of cognitive training targeting fibromyalgia. |
|
| Education Training | Active Comparator | Participants will meet with a pain specialist to receive education training related to fibromyalgia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture | Other | During the treatment sessions the acupuncturist will insert needles in several locations aimed to reduce the patient's fibromyalgia pain. A low-amplitude, sub-sensory electrical current will be activated by the acupuncturist. |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Imaging-fMRI | Hyperscan fMRI assessing brain-to-brain concordance between the patient and the clinician. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Imaging-EEG | Hyperscan EEG assessing brain-to-brain concordance between the patient and the clinician. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory (BPI) - Pain Interference | Brief Pain Inventory (BPI) is a validated 16 item questionnaire designed to assess the severity and interference of pain experienced. Pain interference is assessed on a scale from 0 (no interference) to 10 (severe interference). | Up to 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seneca Ellis | Contact | 617-952-6484 | sellis11@mgb.org | |
| Arvina Grahl, PhD | Contact | agrahl@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vitaly Napadow, PhD | Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Charlestown | Massachusetts | 02129 | United States |
Per NIH guidelines
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| D000091942 | Cognitive Training |
| D012736 | Sex Education |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
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| Cognitive Training | Behavioral | Cognitive training with a pain specialist. |
|
| Education Training | Behavioral | Education training with a pain specialist. |
|
| Spaulding Rehabilitation Hospital | Recruiting | Charlestown | Massachusetts | 02129 | United States |
|
| Brigham and Women's Hospital | Recruiting | Chestnut Hill | Massachusetts | 02467 | United States |
|
| D009422 |
| Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
| D000066530 | Neurological Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D044347 | Sexology |
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |