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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06428981
Other study ID # 202200381B0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2, 2022
Est. completion date February 26, 2024

Study information

Verified date April 2022
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Degenerative cervical disease induces cervical radiculopathy and myelopathy, which have a significant impact on the patients' health. 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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date February 26, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 100 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT04222777 - Cervical Spine Motion in the Elderly N/A
Enrolling by invitation NCT03955705 - Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery N/A
Withdrawn NCT05408923 - Randomized Controlled Trial Comparing Irrisept Versus Normal Saline for Wound Irrigation After Posterior Spine Surgery Phase 4
Withdrawn NCT03312192 - Stand-Alone Cage Verus Anterior Plating for Anterior Cervical Discectomy and Fusion. N/A
Recruiting NCT06202443 - Improving Surgical Outcomes With Early PT After ACDF N/A