Learn about our active and completed clinical studies of pain and pain management.

Clinical Research Areas

  • Pharmacological and interventional management of neuropathic pain: complex regional pain syndrome, post-herpetic neuralgia, diabetic neuropathy, spinal stenosis, low back pain with radiculopathy and chemotherapy-related neuropathy
  • Pharmacological and interventional management of inflammatory and nociceptive pain: osteoarthritis, rheumatoid arthritis, myofascial pain, axial lower back with facet joint disease and fibromyalgia
  • Opioid-induced hyperalgesia: clinical diagnosis and management
  • Quantitative sensory testing in clinical research and clinical practice
  • Depression and chronic pain, chronic pain and opioid addiction and opioid-induced hyperalgesia
  • Alternative medicine and acupuncture for clinical pain management
  • Spinal cord stimulations in pain management

Preclinical Research Areas

  • Cellular and molecular mechanisms of neuropathic pain, opioid tolerance, dependence and addiction, and opioid-induced hyperalgesia
  • Brain mechanisms of interactions between pain and pain-related comorbidities such as depression, anxiety and addiction
  • Role of endogenous cannabinoids in the modulation of neuropathic pain
  • Role of central glucocorticoid receptors and glutamatergic receptors in the mechanisms of pain and opioid tolerance
  • Peripheral and central mechanisms of burn injury-induced pain and radicular back pain
  • New drug development for pain treatment

Currently Enrolling Clinical Research Studies

NOTE: All clinical research studies at our center have received approval by the Institutional Review Board – the Partners Human Research Committee.

FERUMOXYTOL

Exploratory Study on In Vivo Imaging of Spinal Inflammation in Sciatica Patients Using Ferromagnetic Nanoparticles 

IRB Protocol 2015P-001527

The purpose of this study is to see if MRI can identify areas of inflammation in the spine after an injection of ferumoxytol. Ferumoxytol contains iron and is FDA-approved to treat anemia in patients with chronic kidney disease. Using ferumoxytol in this study is experimental. The center is currently recruiting 40 subjects with currently-diagnosed lower extremity radicular pain (sciatica pain) and 20 healthy volunteers between the ages 18-65. Subjects will attend three study visits during a 1-2 week period. Study procedures include a brief physical exam, two urine tests, two MRIs, questionnaires and an IV placement.

For further information, please contact us at 617-724-6102, toll-free at 888-NO-2-OUCH or email MGHPainResearch@partners.org.


GUANFACINE AIM I

Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance I

RB Protocol 2013P-001510

The purpose of this study is to see if the study drug, guanfacine, in combination with an opioid medication (morphine), can help reduce pain felt by people with chronic pain and prevent the development of opioid-induced hyperalgesia (OIH).

Sometimes opioid medications used to treat chronic pain don’t reduce the pain and can make the pain feel worse. This is called OIH. The center is currently recruiting people ages 18-65 with chronic neck or back pain and who have not taken opioids, guanfacine (or other alpha-2AR agonists) for at least 6 months. Compensation will be provided.

If you are interested in participating in this study, please click on the link above or contact us at 617-724-6102, toll-free at 888-NO-2-OUCH or email MGHPainResearch@partners.org.


GUANFACINE AIM II

Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH) and Tolerance

IRB Protocol 2014P-001377

The purpose of this study is to see if the study drug, guanfacine, in combination with an opioid medication (for example, morphine), can help reduce pain felt by people with chronic pain and reverse the symptoms of opioid-induced hyperalgesia (OIH).

Sometimes opioid medications used to treat chronic pain don’t reduce the pain and can make the pain feel worse. This is called OIH. The center is currently recruiting people ages 18-65 with chronic neck or back pain who are currently taking an opioid medication to relieve their pain. Compensation will be provided.

If you are interested in participating in this study, please click on the link above or contact us at 617-724-6102, toll-free at 888-NO-2-OUCH or email MGHPainResearch@partners.org.


HF10 Spinal Cord Stimulator

Effects of HF10 Spinal Cord Stimulation on Pain Intensity, Functional Improvement, Pain Thresholds, and Sensory Perceptions in Chronic Pain Patients

IRB Protocol 2016P-000874

This is a study of a High Frequency 10 kHz Spinal Cord Stimulator (HF10 SCS) for relieving chronic pain. A Spinal Cord Stimulator (SCS) is a device used to treat chronic pain that is difficult to manage with other treatments. An SCS works by sending electric pulses through small flexible wires that are placed under the skin and near the spine. Patients can enroll in this study if they will be or are being treated in the Mass General Pain Clinic with a Spinal Cord Stimulator.

If you are interested in participating in this study, please contact your pain doctor at the Mass General Pain Clinic at 617-726-8810.


Selected Completed Clinical Research Studies

ACUPUNCTURE AIM I

Evaluating the Effect of Acupuncture on Pain Relief Using QST

IRB Protocol 2009P-001551

The purpose of this study is to test a new approach to measuring the effectiveness of acupuncture therapy in chronic pain conditions using a quantitative sensory testing (QST) device. Measurements were taken before, during and after acupuncture treatment. This study is currently undergoing data analysis.


ACUPUNCTURE AIM III

Effect of Acupuncture and Pain Medication on Radicular Pain Using QST

IRB Protocol 2012P-001795

The purpose of this randomized, double blinded, placebo-controlled clinical trial is to compare the clinical effectiveness of acupuncture therapy to a course of pain medication (e.g., Gabapentin) on radicular pain as measured by quantitative sensory testing (QST). The study is currently undergoing data analysis.


Epidural Steroid Injection (ESI)-II 

PET/MRI Imaging of Neuraxial Inflammation in Sciatica Patients

IRB Protocol 2013P-002174

The purpose of this study is to determine if inflammation around the spinal nerves can be identified using a radioactive tracer [11C] PBR28 and integrated PET/MRI scan with the goal of better treating patients who have radicular lumbar pain with epidural steroid injections. Blood samples were collected for genotyping to identify proteins that bind to the radioactive tracer. This study is currently undergoing data analysis.


KETAMINE

Effect of Ketamine on Opioid-induced Hyperalgesia IRB Protocol 2008P-000879

The purpose of this study is to see if a single IV infusion of ketamine can predict response to dextromethorphan (DX). The study compared pain threshold, pain tolerance and wind up as measured by QST, before and after a single dose of ketamine infusion in chronic pain patients on opioid therapy and chronic pain patients without opioid therapy. Findings showed a highly significant correlation (r=0.54, P=0.0001) between response to DX following ketamine infusion. Subgroup analysis showed no significant differences in the response to either ketamine or DX treatment based on pain classification (i.e., nociceptive, neuropathic or mixed) or placebo response. In contrast, a weaker correlation between ketamine and DX response was found in subjects requiring high-dose therapy, rather than low-dose opioid therapy. A significant correlation also was noted between the development of side effects for the two NMDA-R antagonists. Based on these results, we conclude that an i.v. ketamine test may be a valuable tool in predicting subsequent response to DX treatment in opioid-exposed patients with persistent pain.

Publication: Cohen SP, Wang S, Chen L, Kurihara C, McKnight G, Marcuson M, Mao J. An intravenous ketamine test as a predictive response tool in opioid-tolerant patients. J Pain Symp Manage 2009; 37:698-708. 


QUANTITATIVE SENSORY TESTING (QST)
Pain Response in Patients on Long-Term Opioid Therapy for Chronic Pain
IRB Protocol 2003P-000110

The purpose of this study was to compare pain threshold and tolerance using quantitative sensory testing (QST). This study explored the effects of opioids on pain threshold and tolerance.


RADICULAR PAIN
Somatosensory Profiling in Radicular Pain Patients and its Correlation with Treatment Outcome
IRB Protocol 2011P-002234

The aim of this study was to compare the sensitivity to experimental pain in chronic pain patients on opioid therapy versus chronic pain patients not on opioid therapy versus healthy subjects using quantitative sensory testing (QST). Identifying the characteristic changes in thermal pain sensitivity in chronic opioid users will be helpful in diagnosing pain sensitivity alterations associated with chronic opioid use.

Our findings showed that chronic pain subjects on opioid therapy experienced: 1) increased sensitivity to heat pain and significantly lower threshold to heat pain; 2) significantly decreased tolerance to supra-threshold heat pain; and 3) exacerbated temporal pain summation, compared to chronic pain subjects receiving non-opioid therapy. A subgroup of chronic pain subjects on opioids with increased heat pain sensitivity had a significantly higher average opioid dosage than those who had an above-average heat pain threshold. Moreover, a subset of chronic pain subjects on opioid therapy exhibited a significant decrease in diffuse noxious inhibitory control (DNIC) compared with chronic pain subjects on non-opioid therapy. These findings suggest that a subset of QST parameters can reflect opioid-associated thermal pain sensitivity alteration, including decreased heat pain threshold, decreased cold and heat pain tolerance, diminished DNIC, and/or exacerbated temporal summation.

Publication: Maher DP, Ding W, Singh S, Opalacz A, Fishman C, Houghton M, Ahmed S, Chen L, Mao J, Zhang Y. Thermal QST phenotypes associated with the response to lumbar epidural steroid injection: A pilot study. Pain Med. 2017 Mar 13. doi: 10.1093/pm/pnw364. [Epub ahead of print]


Acupuncture and Pain Management—A National Survey

A nationwide survey was conducted to gather information regarding the role of acupuncture in pain management from physicians and referral physicians who manage clinical pain conditions. In recent years, acupuncture has gained popularity in the U.S. as a modality of complementary and alternative medicine for certain disease entities and clinical conditions including pain. Our results indicate that an overwhelming majority of survey responders have a positive attitude toward using acupuncture as an alternative treatment modality for pain management.

Publication: Chen L, Houghton M, Seefeld L, Malarick C, Mao J. A survey of selected physician views on acupuncture in pain management. Pain Med. 2010 Apr;11(4):530-4. doi: 10.1111/j.1526-4637.2010.00815.x. Epub 2010 Mar 1. 


CRPS Nerve Pain—Gralise
Treatment of Complex Regional Pain Syndrome with Once-Daily Gastric-Retentive Gabapentin (Gralise)
IRB Protocol 2012P-000466

This was an open-label study of the drug Gralise (gastric-retentive gabapentin) to treat complex regional pain syndrome type I (CRPS I). CRPS I is a common type of neuropathic pain (pain that results from damage to nerves in the peripheral nervous system). Gralise is approved by the U.S. Food and Drug Administration (FDA) to treat postherpetic neuralgia (neuropathic pain that is a complication of the disease shingles caused by the chickenpox virus), but is not FDA-approved to treat CRPS I.


Opioid Therapy for Chronic Pain: Physicians' Attitude and Current Practice Patterns—A National Survey

The authors conducted a comprehensive practice-oriented survey to examine physicians' attitudes, knowledge, experience and practice patterns regarding opioid therapy for chronic pain management. The survey contained 23 questions divided into six categories:


(1) Physicians' overall view on opioid therapy for chronic pain management
(2) Clinical indications for opioid therapy
(3)Patient-related factors influencing the decision to begin opioid therapy
(4) Effectiveness of opioid therapy
(5) Choice of opioid regimen
(6) Opioid agreement and opioid abuse behavior

The survey results suggest that opioid therapy remains an important treatment option for chronic malignant and nonmalignant pain. However, the survey results should be viewed in the context of a low response rate (18.2 percent). These results also suggest that by improving the clinical knowledge of physicians participating in opioid therapy through education and collaboration, including a team approach with consultation from pain specialists, psychologists and others, a better outcome for opioid therapy in patients with chronic pain conditions could be achieved.

Publication: Chen L, Houghton M, Seefeld L, Malarick C, Mao J. Opioid therapy for chronic pain: physicians' attitude and current practice patterns. J Opioid Manag. 2011 Jul-Aug;7(4):267-76. PubMed PMID: 21957826.


Pennsaid
Effect of Pennsaid on Clinical Neuropathic Pain
IRB Protocol 2011P-000897

This was a randomized, double-blind, placebo-controlled cross-over study of the effectiveness of Pennsaid (diclofenac) lotion as compared to placebo lotion in reducing neuropathic pain. The FDA approved Pennsaid to treat osteoarthritis, but the FDA has not approved Pennsaid to treat neuropathic pain.

Publication: Ahmed S, Zhang Y, Chen, L Cohen AS, Hilaire K, Vo T, Houghton M, Mao J. Effect of 1.5% Topical Diclofenac on Clinical Neuropathic Pain. Anesthesiology, 2015, 123:191-198. 


Spinal Cord Stimulation (SCS)
Effects of Spinal Cord Stimulation on Pain Thresholds and Sensory Perceptions in Chronic Pain Patients
IRB Protocol 2010P-000425

The purpose of this study was to better understand how the spinal cord stimulation (SCS)  works in relieving chronic pain. Quantitative sensory testing (QST) was performed on subjects with an indwelling SCS in an area of pain covered with SCS-induced paresthesia and an area without pain and without paresthesia, while the SCS was turned off and on. The temperature at which the patient detected warm sensation, heat pain and maximal tolerable heat pain was used to define the thresholds. Findings showed that in all three parameters, the detection of warm sensation, heat pain threshold and heat pain tolerance were increased during the period when SCS was on compared with when it was off. This increase was observed in both painful and non-painful sites.

The observed pain relief during SCS therapy seems to be related to its impact on increased sensory threshold as detected in this study. The increased sensory threshold on areas without pain and without the presence of SCS coverage may indicate a central (spinal and/or supra-spinal) influence from SCS.

Publication: Ahmed S.U., Zhang Y., Chen L., St. Hillary K., Cohen A., Vo T., Houghton M., Mao J. Effects of Spinal Cord Stimulation on Pain Thresholds and Sensory Perceptions in Chronic Pain Patients. Neuromodulation. 2015; 18: 355-360