Comparison of therapeutic effects between Limaprost alfadex and Gabapentin in cervical myelopathy patient: Randomized controlled trial

Phase 3

Completed

• Conditions: Cervical spondylosis myelopathy; CSM; Gabapentin; Limaprost alfadex

• Registration Number: TCTR20230603001
• Lead Sponsor: Rajavithi hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-05-31
• Study Start: 2023-06-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. 20-80 years old
2. Patients who meet the diagnostic criteria in the following topics
a. Symptom : Neck pain or aching pain down the arm or have numbness Weakness in arms, hands, abnormal gait
b. physical examination : Intrinsic muscle weakness , Finger escape sign + , Grip and release + , lhermitte test +
c. An MRI or CT scan showed narrowing of the spinal canal in the neck. together with spinal cord compression
d. The diagnosis was confirmed by an Orthopedic spine surgeon.
The diagnosis relies on a, b and d together, with or without c.
3. Cooperate consent to participate in the research project

Exclusion Criteria

1. History of allergy to gabapentin or Pregabalin
2. History of allergies to NSAIDs, Opioids
3. Peripheral nerve entrapment and other pathology such as Tandem stenosis.
4. Take anti-platelet drugs (ASA), anticoagulant drugs
5. Received NSAID and Gabapentin treatment within 1 week prior to study participation.
6. History of end-stage chronic kidney disease
7. History of heart failure, ischemic heart disease
8. History of cirrhosis
9. History of peptic ulcer disease
10. History of all types of cancer
11. Persons diagnosed with cervical spondylosis with severe symptoms requiring surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain score 0 4 8 weeks after treatment Visual analog scale

Secondary Outcome Measures

Name	Time	Method
Quality of life before - after treatment SF-36,Motor power , Sensory , Provocation test Before - After treatment Physical examination,Adverse effect In researching time Patient feed back