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Status:

UNKNOWN

True Functional Restoration and Analgesia in Non-Radicular Low Back Pain

Lead Sponsor:

Carolinas Pain Institute

Collaborating Sponsors:

BioDelivery Sciences International

Conditions:

Back Pain Lower Back Chronic

Chronic Pain

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

Brief Summary

To study the response of objective and quasi-objective 'True' functional outcomes, analgesia and safety in chronic non-radicular back pain to buprenorphine buccal film (BBF) using a small 'n' phase IV...

Detailed Description

Scientific/Medical Rationale: Improved function is a high yield goal in back pain in specific, and pain in general. There are a number of self-report scales measuring 'physical functioning', 'quality...

Eligibility Criteria

Inclusion

  • Meets our criteria for CNRBP:
  • Pain of 3 months or more duration
  • non-radiating (below buttocks or above lower back pain)
  • no decreased sensation or allodynia/hyperalgesia in a radicular pattern
  • no reflex asymmetry
  • no frank weakness or atrophy
  • no non-pain sensory or reflex changes
  • If female, not pregnant or breast feeding, and not currently attempting to conceive; if of childbearing potential, use of a highly effective method of birth control (as determined by Pl).
  • Able to read and speak English and provide informed consent.
  • Age 18-65.
  • Able to understand and comply with all data collection methodology, and demonstrated ability to manage the electronic diary system (as tested in 'detox' and baseline/SBPLI period).
  • Subjects may continue any non-opioid stable scheduled drug regimen with no changes during the course of study, hydrocodone/acetaminophen 5/325 up to two doses per day along with Tylenol 2g/day are the only allowed rescue medications. Subjects are asked not to use the rescue medication 12 hours or less before testing.
  • Subjects taking opioids must agree to 'detoxify' for the protocol under the supervision of the study medical personnel. Subjects may use hydrocodone/acetaminophen 5/325 twice daily for breakthrough pain, as provided to them during the study, and must use only the hydrocodone/acetaminophen provided (with a pill count is a secondary outcome)
  • Subjects must agree to try to stay as functional as possible (defined by only tolerable increase in pain with function or function testing)
  • Must have 'average' pain greater than or equal to 4 and no greater that 9 on a 10-point NRS scale at phone screening and first visit
  • Subjects must have and maintain a working phone
  • CMP, CBC, UDS, EKG within normal limits at the discretion of the PI.
  • \-

Exclusion

  • Subjects with hypersensitivity to Opioids, Acetaminophen, buprenorphine or Belbuca®
  • Subjects taking equal to or more than 100 morphine milliequivalents,
  • Subjects with severe or untreated psychiatric disturbance (e.g. mania, depression \[esp suicidality\], anxiety, substance use disorder etc). This exclusion at the discretion of the PI.
  • A known or admitted history of opioid abuse, diversion or addiction.
  • Subjects with severe, ongoing or unaddressed medical conditions (e.g. Renal or Hepatic disease i. \[creatinine\>1.5 ml/dl; AST or ALT\> 2x normal limit\], severe or uncontrolled hypertension, pulmonary ii. disease, seizure disorder or gastroparesis or urinary retention.
  • Subjects with a clinical diagnosis of fibromyalgia, polymyalgia rheumatica, spinal stenosis or non-osteoarthritis i. rheumatologic disease or severe chronic pain disorder of other body regions.
  • Subjects who are currently talking MAO inhibitors (must have been off for \> 14 days)
  • Subjects with planned surgery or invasive/interventional procedures.
  • Subjects must be willing to comply with visit and phone contact schedule, and try to stay as active and 'functional' as they can.
  • Subjects cannot be involved in any litigation concerning Workers Compensation or lawsuit concerning injury.
  • \-

Key Trial Info

Start Date :

August 3 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2023

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT05419297

Start Date

August 3 2022

End Date

July 1 2023

Last Update

February 8 2023

Active Locations (1)

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1

Carolinas Pain Institute

Winston-Salem, North Carolina, United States, 27103