Pregabalin add-on for Neuropathic Pain in Cervical Myelopathy

NCT03618589 | Unknown Phase 1

• 1 other identifier: pregabalin & LANSS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

There is no information on the effect of pregabalin in patients with neuropathic pain in cervical myelopathy under routine clinical practice. The investigators will conduct this prospective, randomized trial to determine the efficacy of pregabalin for neuropathic pain in cervical myelopathic patients in order to validate or refute this popular practice. The primary aim of this study was to compare Leeds assessment of neuropathic symptoms and signs scale (LANSS) scores of neuropathic pain in cervical myelopathy patients.

Conditions

Pain, Neuropathic

Outcome Measures

Primary Outcomes (1)

• Leeds assessment of neuropathic symptoms and signs (LANSS) and visual analogue scale (VAS)

  The LANSS pain scales are used globally to screen for the presence of pain of neuropathic origin because they have high sensitivity and specificity compared with other available tools. It rages from 0 to 24. The LANSS scores ≧12 suggest the presence of neuropathic pain. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. It ranges from 0 to 10 (0 means no pain, 10 means worst pain.

  2 months

Secondary Outcomes (1)

• neck disability index (NDI) and EuroQol- 5 Dimension (EQ-5D)

  2 months

Study Arms (2)

opioid only

PLACEBO COMPARATOR

Patients in the opioid group received the only opioid (5mg of oxycodone three times a day) for 8 weeks.

Drug: Opioid

pregabalin add-on

EXPERIMENTAL

Patients in the pregabalin add-on group received 75mg of pregabalin twice a day for the first week (150 mg/day) and 150mg of pregabalin twice a day (300 mg/day) for the second week and 300mg of pregabalin twice a day (600mg/day) for subsequent 6 weeks.

Drug: Pregabalin; Drug: Opioid

Interventions

Pregabalin DRUG

Patients in the pregabalin add-on group received 75mg of pregabalin twice a day for the first week (150 mg/day) and 150mg of pregabalin twice a day (300 mg/day) for the second week and 300mg of pregabalin twice a day (600mg/day) for subsequent 6 weeks.

Also known as: Lyrica

pregabalin add-on

Opioid DRUG

Patients in the opioid group received the only opioid (5mg of oxycodone three times a day) for 8 weeks.

Also known as: IRcordon

opioid only; pregabalin add-on

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between the ages of 18 to 80 years
• Among patients with cervical myelopathy, patients with neuropathic pain (LANSS pain scale ≥ 12)
• Completing 8-week drug trial

You may not qualify if:

• Current or prior gabapentin or pregabalin use
• Chronic use of narcotic pain medications
• Chronic depression or the use of anti-depressants
• History of addiction and/or substance abuse
• Presence of significant motor deficits, and /or bowel and/or bladder dysfunction
• Known renal insufciency, diabetes, congestive heart failure, cardiac conduction abnormalities, and thrombocytopenia

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Neuralgia

Interventions

Pregabalin; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Chun Kee Chung, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun Kee Chung, MD, PhD

CONTACT

+82-2-2072-2352; chungc@snu.ac.kr

Jong-myung Jung, MD

CONTACT

+82-2-2072-2358; beast2625@naver.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 7, 2018
• Study Start: November 26, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)