Cervical Spine DegenerationNCT06428981
Surgical Intervention on the Body-mind-spirit of Patients With Cervical Spine Surgery
A study testing degenerative cervical diseases in people with Cervical Spine Degeneration, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Cervical Spine Degeneration
- What is being tested?
- degenerative cervical diseases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Aug 2022to 26 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: (Holistic Health Care) Influence of Surgical Intervention on the Body-mind-spirit of Patients Undergoing Cervical Spine Surgery
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.
Read the detailed 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.
- Conditions
- Cervical Spine Degeneration
- Being tested
- degenerative cervical diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: degenerative cervical diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start2 Aug 2022
- Primary completion30 Dec 2023
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spine DegenerationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428981
- Sponsor's protocol ID
- 202200381B0
- Status last verified
- Apr 2022
- First submitted
- 15 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Holistic Health Care) Influence of Surgical Intervention on the Body-mind-spirit of Patients Undergoing Cervical Spine Surgery
- ClinicalTrials.gov ID
- NCT06428981
- Acronym / sponsor ID
- 202200381B0
- Conditions
- Cervical Spine Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spine surgery | Other | Other: degenerative cervical diseasesThe 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. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| degenerative cervical diseasesIncluding 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 | spine surgery |
Primary outcome
Quality of life, mental health, pain relief, and spiritual health before surgery
Time frame: Before surgery
The outcomes were assessed using the 36-item Short Form Health Survey Quality of Life Scale (SF-36) before surgery.
Quality of life, mental health, pain relief, and spiritual health before surgery
Time frame: Before surgery
The outcomes were assessed using the Patient Health Questionnaire-9 (PHQ9) scale before surgery.
Quality of life, mental health, pain relief, and spiritual health before surgery
Time frame: Before surgery
The outcomes were assessed using the Pain Disability Questionnaire (PDQ) scale before surgery.
Quality of life, mental health, pain relief, and spiritual health before surgery
Time frame: Before surgery
The outcomes were assessed using the Holistic Well-being Scale (HWS) scale before surgery.
Quality of life, mental health, pain relief, and spiritual health after surgery
Time frame: six months after surgery
The outcomes were assessed using the 36-item Short Form Health Survey Quality of Life Scale (SF-36) six months after surgery.
Quality of life, mental health, pain relief, and spiritual health after surgery
Time frame: six months after surgery
The outcomes were assessed using the Patient Health Questionnaire-9 (PHQ9) scale six months after surgery.
Quality of life, mental health, pain relief, and spiritual health after surgery
Time frame: six months after surgery
The outcomes were assessed using the Pain Disability Questionnaire (PDQ) scale six months after surgery.
Quality of life, mental health, pain relief, and spiritual health after surgery
Time frame: six months after surgery
The outcomes were assessed using the Holistic Well-being Scale (HWS) scale six months after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing degenerative cervical diseases in people with Cervical Spine Degeneration, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life, mental health, pain relief, and spiritual health before surgery (time frame: Before surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.