NCT06428981

Brief Summary

The study aimed to evaluate if surgical intervention in patients with degenerative cervical diseases improves quality of life (QOL), lowers pain-induced mental impairment, improves psychologic health, and promotes spiritual well-being.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
Last Updated

May 24, 2024

Status Verified

April 1, 2022

Enrollment Period

1.4 years

First QC Date

May 15, 2024

Last Update Submit

May 20, 2024

Conditions

Cervical Spine Degeneration

Outcome Measures

Primary Outcomes (8)

  • Quality of life, mental health, pain relief, and spiritual health before surgery

    The outcomes were assessed using the 36-item Short Form Health Survey Quality of Life Scale (SF-36) before surgery.

    Before surgery

  • Quality of life, mental health, pain relief, and spiritual health before surgery

    The outcomes were assessed using the Patient Health Questionnaire-9 (PHQ9) scale before surgery.

    Before surgery

  • Quality of life, mental health, pain relief, and spiritual health before surgery

    The outcomes were assessed using the Pain Disability Questionnaire (PDQ) scale before surgery.

    Before surgery

  • Quality of life, mental health, pain relief, and spiritual health before surgery

    The outcomes were assessed using the Holistic Well-being Scale (HWS) scale before surgery.

    Before surgery

  • Quality of life, mental health, pain relief, and spiritual health after surgery

    The outcomes were assessed using the 36-item Short Form Health Survey Quality of Life Scale (SF-36) six months after surgery.

    six months after surgery

  • Quality of life, mental health, pain relief, and spiritual health after surgery

    The outcomes were assessed using the Patient Health Questionnaire-9 (PHQ9) scale six months after surgery.

    six months after surgery

  • Quality of life, mental health, pain relief, and spiritual health after surgery

    The outcomes were assessed using the Pain Disability Questionnaire (PDQ) scale six months after surgery.

    six months after surgery

  • Quality of life, mental health, pain relief, and spiritual health after surgery

    The outcomes were assessed using the Holistic Well-being Scale (HWS) scale six months after surgery.

    six months after surgery

Study Arms (1)

spine surgery

OTHER

The inclusion criteria consisted of patients over the age of 20 who were diagnosed with degenerative cervical diseases, including herniation of the intervertebral disc, ossification of the posterior longitudinal ligament, and spinal stenosis, resulting in cervical radiculopathy, or degenerative cervical myelopathy, and were scheduled to undergo anterior discectomy with fusion surgery.

Other: degenerative cervical diseases

Interventions

degenerative cervical diseasesOTHER

Including herniation of the intervertebral disc, ossification of the posterior longitudinal ligament, and spinal stenosis, resulting in cervical radiculopathy, or degenerative cervical myelopathy, and were scheduled to undergo anterior discectomy with fusion surgery.

spine surgery

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over the age of 20 who were diagnosed with degenerative cervical diseases, including herniation of the intervertebral disc, ossification of the posterior longitudinal ligament, and spinal stenosis, resulting in cervical radiculopathy, or degenerative cervical myelopathy, and were scheduled to undergo anterior discectomy with fusion surgery.

You may not qualify if:

  • Patients who were unable to attend follow-up visits or complete the questionnaires, and those patients who expressed doubts or were unable to provide satisfactory responses regarding the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 24, 2024

Study Start

August 2, 2022

Primary Completion

December 30, 2023

Study Completion

February 26, 2024

Last Updated

May 24, 2024

Record last verified: 2022-04

Locations

TW(1)