Hyperbaric Oxygen and Orthopedic Comprehensive Treatment for Traumatic Incomplete Spinal Cord Injury in the Plateau

NCT03112941 | Completed DMC

• 1 other identifier: QinghaiUH_JM
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

Brief Summary

To observe modified Barthel index, American Spinal Injury Association (ASIA) impairment scale grading, sensory score and motor score in patients with incomplete SCI in the plateau using 0.2 MPa HBO combined with pedicle screw fixation and decompressive laminectomy so as to investigate the effect of HBO therapy on incomplete SCI in the plateau.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Modified Barthel index

  To assess the difference before and after treatment

  40 days after treatment

Secondary Outcomes (1)

• American Spinal Injury Association impairment scale grading

  40 days after treatment

Study Arms (2)

control group

EXPERIMENTAL

Patients with traumatic incomplete spinal cord injury (SCI) in the control group are treated with pedicle screw fixation and decompressive laminectomy.

Procedure: control group

hyperbaric oxygen group

EXPERIMENTAL

Patients with traumatic incomplete spinal cord injury (SCI) in the hyperbaric oxygen group are treated with pedicle screw fixation and decompressive laminectomy, and are given 0.2 MPa hyperbaric oxygen (HBO), once a day, 10 times as a course, with 5-7 days of resting between two courses, totally four courses.

Other: hyperbaric oxygen group

Interventions

control group PROCEDURE

Patients with traumatic incomplete spinal cord injury (SCI) in the control group are treated with pedicle screw fixation and decompressive laminectomy.

control group

hyperbaric oxygen group OTHER

Patients with traumatic incomplete spinal cord injury (SCI) in the hyperbaric oxygen group are treated with pedicle screw fixation and decompressive laminectomy, and are given 0.2 MPa hyperbaric oxygen (HBO), once a day, 10 times as a course, with 5-7 days of resting between two courses, totally four courses.

hyperbaric oxygen group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Incomplete spinal cord injury (SCI) (contusion) assessed by rectal examination in accordance with International standards for neurological classification of spinal cord injury (Revised 2011);
• SCI revealed by CT, X-ray or MRI scan;
• Clear trauma in the spine;
• Different degrees of movement, sensation and sphincter dysfunction below spine injury segment;
• Living in the plateau for at least 2 years;
• Age of ≥18 years, irrespective of sex.

You may not qualify if:

• Brain trauma, combined injury of chest and abdominal organs, instable vital signs or disturbance of consciousness;
• Coagulation dysfunction;
• Hypertension, heart disease, diabetes, stroke, brain damage and neurological disease;
• Lumbar surgery, trauma history, lumbar fracture, infection, tumor, severe osteoporosis;
• Nerve pain, limb cramps, periarticular heterotopic ossification;
• Other diseases that may impact neurological examination;
• Participating in other clinical trials.

Sponsors & Collaborators

• Qinghai University: lead

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jun Ma, Ph.D

  Affiliated Hospital of Qinghai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 164 patients with traumatic incomplete spinal cord injury (SCI) were recruited in the plateau from June 2012 to February 2016.

Study Record Dates

• First Submitted: April 8, 2017
• First Posted: April 13, 2017
• Study Start: January 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2017
• Last Updated: February 9, 2018

Record last verified: 2018-02