VAS and JOA ScoresNCT06995066
Combined Therapy for Cervical Disc Herniation
A study testing collagenase injection into the epidural space in people with VAS and JOA Scores and Adverse Reaction Rates, run by Nanchong Central Hospital at 1 site in China.
Trial summary
This study mainly explores the efficacy and safety of low-temperature plasma radiofrequency ablation combined with ozone injection and collagenase in the treatment of cervical disc herniation.The primary outcomes included the collection of clinical data for all patients, such as gender, age, surgical segment… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- VAS and JOA Scores, Adverse Reaction Rates, Clinical Efficacy at 1 Month and 6 Months
- What is being tested?
- collagenase injection into the epidural space
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Jul 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be diagnosed with cervical disc herniation through MRI or CT, with single-level disc protrusion (C3-C7) that occupies ≤1/3 of the central spinal canal.
- Aged between 30 and 80 years.
- Have suffered from persistent neck/shoulder pain or upper extremity radiating pain for ≥3 months.
- The pain does not respond to conventional treatments, including traction, massage, and oral medications.
- Be willing to undergo surgery therapy.
- Have no prior cervical spine surgery.
Who cannot join
- Cervical instability, myelopathic spondylosis, severe spinal stenosis (canal occupancy >1/3), or ligament calcification.
- Severe osteoporosis (T-score <-2.5).
- Extruded or sequestered disc herniation
- Coagulation disorders or active infections
- Cervical deformities, tumors, or a history of cervical spine surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Treatment of Cervical Disc Herniation by Low-temperature Plasma Radiofrequency Ablation Combined With Ozone Injection and Collagenase
This study mainly explores the efficacy and safety of low-temperature plasma radiofrequency ablation combined with ozone injection and collagenase in the treatment of cervical disc herniation.The primary outcomes included the collection of clinical data for all patients, such as gender, age, surgical segment, preoperative scores, and VAS and JOA scores at 1 week, 1 month, 3 months, and 6 months postoperatively, as well as a comparison of adverse reaction rates between the two groups. The secondary outcomes involved evaluating clinical efficacy at 1 month and 6 months after surgery using the modified Macnab criteria.
Read the detailed description
- Research Objective This study mainly explores the efficacy and safety of low-temperature plasma radiofrequency ablation combined with ozone injection and collagenase in the treatment of cervical disc herniation. By establishing this objective, the study sets the overall direction, aiming to comprehensively evaluate how this combined treatment impacts the therapeutic outcomes and safety profile of patients suffering from cervical disc herniation. This objective serves as the cornerstone, guiding the selection of outcome measures, data collection methods, and the overall research design.
- Primary Outcome Measures The primary outcomes included the collection of clinical data for all patients, such as gender, age, surgical segment, preoperative scores, and VAS and JOA scores at 1 week, 1 month, 3 months, and 6 months postoperatively, as well as a comparison of adverse reaction rates between the two groups. Firstly, the collection of comprehensive clinical data from all participants, including demographic information like gender, age, and the specific surgical segment, provides a detailed characterization of the patient cohort. This baseline data is crucial for understanding the patient population's characteristics, enabling researchers to account for potential confounding factors during data analysis and ensuring the validity of the study results. Secondly, the collection of preoperative scores, along with Visual Analog Scale (VAS) and Japanese Orthopaedic Association (JOA) scores at multiple postoperative time points (1 week, 1 month, 3 months, and 6 months), allows for a dynamic assessment of treatment efficacy. The VAS scores track the evolution of pain levels over time, offering a direct measure of how effectively the treatment alleviates patients' discomfort. Meanwhile, the JOA scores evaluate the recovery of cervical spine function, providing insights into the overall improvement of patients' quality of life and functional ability. By monitoring these scores at different intervals, researchers can observe the treatment's short-term and long-term effects, identify trends in patient recovery, and determine the optimal time frame for achieving the best outcomes. Lastly, the comparison of adverse reaction rates between the two groups is a pivotal component for evaluating treatment safety. By systematically documenting and contrasting the occurrence of adverse events, such as allergic reactions, infections, or neurological complications, researchers can determine whether the combined treatment poses a higher risk to patients. This comparison helps in balancing the potential benefits of the treatment against its associated risks, guiding clinical decision-making and ensuring patient well-being.
- Secondary Outcome Measures The secondary outcomes involved evaluating clinical efficacy at 1 month and 6 months after surgery using the modified Macnab criteria. Utilizing the modified Macnab criteria to evaluate clinical efficacy at 1 month and 6 months post-surgery provides a standardized, comprehensive framework for gauging treatment success. This criteria assesses multiple dimensions of patient recovery, including symptom relief, functional improvement, and patient satisfaction. By incorporating a broader range of factors beyond just pain and function scores, it offers a more holistic understanding of the treatment's impact on patients' overall condition. This secondary evaluation complements the primary outcome measures, providing additional evidence to support the study's findings and enhancing the robustness of the conclusions regarding the combined treatment's efficacy.
- Being tested
- collagenase injection into the epidural space
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagenase injection into the epidural spaceProcedure or surgery
The "Collagenase injection into the epidural space" is a medical procedure for treating cervical disc herniation. Firstly, the patient is positioned, and the specific location of the epidural space at the affected cervical spine segment is accurately identified with the guidance of imaging devices like fluoroscopy or CT. After local anesthesia, a special puncture needle is inserted into the epidural space following the marked path. Once the needle is in the correct position, an appropriate amount of collagenase solution is slowly injected. After the operation, the patient needs to stay in the hospital for observation to monitor vital signs and neurological conditions. The patient should rest in bed for a certain period and then gradually engage in proper activities. Additionally, personalized rehabilitation treatment plans, including physical therapy and exercise, are usually required to help with recovery.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | The study group received low-temperature plasma radiofrequency ablation and ozone injection as the control group, with the addition of collagenase injection into the epidural space. Receives: Procedure: collagenase injection into the epidural space |
| Control Group | Experimental | The control group underwent low-temperature plasma radiofrequency ablation combined with ozone injection. Receives: Procedure: collagenase injection into the epidural space |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) score at 1 week, 1 month, 3 months, and 6 months postoperatively, as well as a comparison of adverse reaction rates between the two groups.
The Visual Analogue Scale (VAS) score is a psychometric tool used to measure subjective experiences such as pain, anxiety, or satisfaction.
The following is a detailed description of the meanings represented by specific numerical values in the VAS score, typically converted to a 0-10 numerical scale for clinical use:
0: Represents the complete absence of the measured sensation (e.g., pain) 1-2: Very mild level. Sensation is barely noticeable and does not interfere with daily activities.
3: Mild but distinct sensation. Noticeable enough to be recognized but still easily ignored or managed.
Moderate level. 4-6: Moderate level. Sensation is clearly present and affects daily activities to some extent, but remains tolerable.
7-9: Severe level. Sensation dominates attention and drastically limits functionality; immediate intervention may be needed.
10: Maximal/intolerable level. Sensation is beyond endurance, rendering the individual unable to perform any normal activities.
Measured: 6 months
Secondary outcomes (1)
evaluating clinical efficacy at 1 month and 6 months after surgery using the modified Macnab criteria
The modified Macnab criteria is a clinical scoring system used to evaluate the outcome of spinal surgeries by assessing patient satisfaction, symptom relief, and functional status. Below is a description of the specific numerical values and their meanings, typically categorized into excellent, good, fair, and poor outcomes:
Excellent: Symptoms: Complete resolution of pain and neurological deficits (e.g., weakness, numbness).
Good: Symptoms: Significant improvement in pain and neurological symptoms, with only mild residual issues.
Fair: Symptoms: Moderate improvement, but persistent pain or neurological deficits that affect quality of life.
Poor: Symptoms: Little to no improvement, or symptoms may have worsened post-surgery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Jun 2023
- Primary completion1 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VAS and JOA ScoresStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995066
- Sponsor's protocol ID
- NanchongCH
- Status last verified
- May 2025
- First submitted
- 10 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical and Legal Constraints Informed Consent Limitations: Participants in prospective studies have not explicitly consented to broader data sharing. Ethical Risks: Even with de-identification, residual identifiability risks (e.g., through rare demographic or clinical data) may raise ethical concerns about re-identification of participants.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Treatment of Cervical Disc Herniation by Low-temperature Plasma Radiofrequency Ablation Combined With Ozone Injection and Collagenase
- ClinicalTrials.gov ID
- NCT06995066
- Acronym / sponsor ID
- NanchongCH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Nanchong Central HospitalOther government
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 29 May 2025 (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.
This study mainly explores the efficacy and safety of low-temperature plasma radiofrequency ablation combined with ozone injection and collagenase in the treatment of cervical disc herniation.The primary outcomes included the collection of clinical data for all patients, such as gender, age, surgical segment, preoperative scores, and VAS and JOA scores at 1 week, 1 month, 3 months, and 6 months postoperatively, as well as a comparison of adverse reaction rates between the two groups. The secondary outcomes involved evaluating clinical efficacy at 1 month and 6 months after surgery using the modified Macnab criteria.
Detailed description
- Research Objective This study mainly explores the efficacy and safety of low-temperature plasma radiofrequency ablation combined with ozone injection and collagenase in the treatment of cervical disc herniation. By establishing this objective, the study sets the overall direction, aiming to comprehensively evaluate how this combined treatment impacts the therapeutic outcomes and safety profile of patients suffering from cervical disc herniation. This objective serves as the cornerstone, guiding the selection of outcome measures, data collection methods, and the overall research design.
- Primary Outcome Measures The primary outcomes included the collection of clinical data for all patients, such as gender, age, surgical segment, preoperative scores, and VAS and JOA scores at 1 week, 1 month, 3 months, and 6 months postoperatively, as well as a comparison of adverse reaction rates between the two groups. Firstly, the collection of comprehensive clinical data from all participants, including demographic information like gender, age, and the specific surgical segment, provides a detailed characterization of the patient cohort. This baseline data is crucial for understanding the patient population's characteristics, enabling researchers to account for potential confounding factors during data analysis and ensuring the validity of the study results. Secondly, the collection of preoperative scores, along with Visual Analog Scale (VAS) and Japanese Orthopaedic Association (JOA) scores at multiple postoperative time points (1 week, 1 month, 3 months, and 6 months), allows for a dynamic assessment of treatment efficacy. The VAS scores track the evolution of pain levels over time, offering a direct measure of how effectively the treatment alleviates patients' discomfort. Meanwhile, the JOA scores evaluate the recovery of cervical spine function, providing insights into the overall improvement of patients' quality of life and functional ability. By monitoring these scores at different intervals, researchers can observe the treatment's short-term and long-term effects, identify trends in patient recovery, and determine the optimal time frame for achieving the best outcomes. Lastly, the comparison of adverse reaction rates between the two groups is a pivotal component for evaluating treatment safety. By systematically documenting and contrasting the occurrence of adverse events, such as allergic reactions, infections, or neurological complications, researchers can determine whether the combined treatment poses a higher risk to patients. This comparison helps in balancing the potential benefits of the treatment against its associated risks, guiding clinical decision-making and ensuring patient well-being.
- Secondary Outcome Measures The secondary outcomes involved evaluating clinical efficacy at 1 month and 6 months after surgery using the modified Macnab criteria. Utilizing the modified Macnab criteria to evaluate clinical efficacy at 1 month and 6 months post-surgery provides a standardized, comprehensive framework for gauging treatment success. This criteria assesses multiple dimensions of patient recovery, including symptom relief, functional improvement, and patient satisfaction. By incorporating a broader range of factors beyond just pain and function scores, it offers a more holistic understanding of the treatment's impact on patients' overall condition. This secondary evaluation complements the primary outcome measures, providing additional evidence to support the study's findings and enhancing the robustness of the conclusions regarding the combined treatment's efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: collagenase injection into the epidural spaceThe study group received low-temperature plasma radiofrequency ablation and ozone injection as the control group, with the addition of collagenase injection into the epidural space. |
| Control Group | Experimental | Procedure: collagenase injection into the epidural spaceThe control group underwent low-temperature plasma radiofrequency ablation combined with ozone injection. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be diagnosed with cervical disc herniation through MRI or CT, with single-level disc protrusion (C3-C7) that occupies ≤1/3 of the central spinal canal.
- Aged between 30 and 80 years.
- Have suffered from persistent neck/shoulder pain or upper extremity radiating pain for ≥3 months.
- The pain does not respond to conventional treatments, including traction, massage, and oral medications.
- Be willing to undergo surgery therapy.
Key exclusion criteria (5 listed)
- Cervical instability, myelopathic spondylosis, severe spinal stenosis (canal occupancy >1/3), or ligament calcification.
- Severe osteoporosis (T-score <-2.5).
- Extruded or sequestered disc herniation
- Coagulation disorders or active infections
- Cervical deformities, tumors, or a history of cervical spine surgery
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 |
|---|---|---|
| collagenase injection into the epidural spaceThe "Collagenase injection into the epidural space" is a medical procedure for treating cervical disc herniation. Firstly, the patient is positioned, and the specific location of the epidural space at the affected cervical spine segment is accurately identified with the guidance of imaging devices like fluoroscopy or CT. After local anesthesia, a special puncture needle is inserted into the epidural space following the marked path. Once the needle is in the correct position, an appropriate amount of collagenase solution is slowly injected. After the operation, the patient needs to stay in the hospital for observation to monitor vital signs and neurological conditions. The patient should rest in bed for a certain period and then gradually engage in proper activities. Additionally, personalized rehabilitation treatment plans, including physical therapy and exercise, are usually required to help with recovery. | Procedure or surgery | Control Group, Study Group |
Primary outcome
Visual Analogue Scale (VAS) score at 1 week, 1 month, 3 months, and 6 months postoperatively, as well as a comparison of adverse reaction rates between the two groups.
Time frame: 6 months
The Visual Analogue Scale (VAS) score is a psychometric tool used to measure subjective experiences such as pain, anxiety, or satisfaction. The following is a detailed description of the meanings represented by specific numerical values in the VAS score, typically converted to a 0-10 numerical scale for clinical use: 0: Represents the complete absence of the measured sensation (e.g., pain) 1-2: Very mild level. Sensation is barely noticeable and does not interfere with daily activities. 3: Mild but distinct sensation. Noticeable enough to be recognized but still easily ignored or managed. Moderate level. 4-6: Moderate level. Sensation is clearly present and affects daily activities to some extent, but remains tolerable. 7-9: Severe level. Sensation dominates attention and drastically limits functionality; immediate intervention may be needed. 10: Maximal/intolerable level. Sensation is beyond endurance, rendering the individual unable to perform any normal activities.
1 secondary outcome
evaluating clinical efficacy at 1 month and 6 months after surgery using the modified Macnab criteria
Time frame: 6 months
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 29 May 2025.
- Individual participant dataSharing planned: No. Ethical and Legal Constraints Informed Consent Limitations: Participants in prospective studies have not explicitly consented to broader data sharing. Ethical Risks: Even with de-identification, residual identifiability risks (e.g., through rare demographic or clinical data) may raise ethical concerns about re-identification of participants.
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 collagenase injection into the epidural space in people with VAS and JOA Scores and Adverse Reaction Rates, run by Nanchong Central Hospital at 1 site in China.
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 6 inclusion and 5 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 29 May 2025. 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 China. 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?
Visual Analogue Scale (VAS) score at 1 week, 1 month, 3 months, and 6 months postoperatively, as well as a comparison of adverse reaction rates between the two groups. (time frame: 6 months). 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 29 May 2025.