Cervical Spondylotic RadiculopathyNCT05587075
Clinical Effect of Long Round Needle
A study testing Filiform needle and Long round needle in people with Cervical Spondylotic Radiculopathy, run by Zhanqing Xie at 1 site in China.
Trial summary
The goal of this clinical trial is to test in the clinical effect of long round needle in the treatment of cervical spondylotic radiculopathy, and analyze its safety and its influence on pain and functional recovery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Spondylotic Radiculopathy
- What is being tested?
- Filiform needle and Long round needle
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Apr 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- meet the efficacy criteria for disease certificate diagnosis of Traditional Chinese medicine[4]In the category of "Arthralgia Syndrome" and "Stiff neck", the main diseases: numbness and pain in the shoulder, neck and upper limbs, secondary diseases: unfavorable neck movement, hard, heavy head, thin coating, reddish tongue; (2) cervical X-ray shows hyperplasia of the vertebral body; (3) the patient or family members are informed and signed consent.
Who cannot join
- patients with severe periarthritis of shoulder and mixed cervical spondylosis; (2) spinal canal space-occupying lesions and cervical spine tumors; (3) serious immune system diseases and infectious diseases; (4) liver and kidney insufficiency; (5) cardiovascular and cerebrovascular diseases; (6) mental diseases or medical history; (6) patients with incomplete clinical data and poor compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effect and Safety Analysis of Liu Yingmin Long Round Needle in the Treatment of Cervical Spondylotic Radiotelegraphy and Its Effect on Pain and Functional Recovery
The goal of this clinical trial is to test in the clinical effect of long round needle in the treatment of cervical spondylotic radiculopathy, and analyze its safety and its influence on pain and functional recovery. The main question it aims to answer is whether long round needle therapy for patients with cervical spondylotic radiculopathy is effective and safe. Participants will be selected as the research objects. They will randomly divided into control group (n = 49) and observation group (n = 49). The control group was treated with filiform needle, and the observation group was treated with long round needle. Researchers will compare the two groups to see the differences on the therapeutic effect, safety, Neck dysfunction index (NDI), pain score (McGill pain questionnaire, MPQ), quality of life (Generic Quality of Life Inventory-74, GQOL-74), and levels of inflammatory factors.
- Conditions
- Cervical Spondylotic Radiculopathy
- Being tested
- Filiform needle, Long round needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filiform needleProcedure or surgery
A needle treatment: guide patients take lying or sitting, keep relaxed, select Jingjiaji Point, Fengchi Point, Jianjing Point, Tianzhu Point, Houxi point, Hegu Point, Waiguan Point, preoperative, marker points, conventional disinfection, application specification of 0.35mmx50mm disposable sterile acupuncture needle, in the marker quick needle subcutaneous, slow needle to feel acid swelling feeling, keep needle 30min, once a day, last 5d for 1 course, a total of 4 courses of treatment.
Long round needleProcedure or surgery
Long round needle treatment: mark tendon lesions, take 3-5 tendon lesion points for needle point, after injection of 0.5% lidocaine 1mL, local anesthesia, to hold long round needle, slowly hierarchical detection to tendon lesion points, patients feel acid, hemp, swelling feeling is appropriate, to close method line knot treatment: straight to tendon lesions point surface, scraping, to remove the surface adhesion. Do not cross the superficial surface of the clavicle, sternocleidomastoid muscle deep surface, gentle action. After the needle was released, the pinhole was covered with a disposable dressing, bandaged for 2d, once a week, once for 1 course, and for a total of 4 courses of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The control group was treated with filiform needle. Receives: Procedure: Filiform needle |
| Observation group | Experimental | The observation group was treated with long round needle. Receives: Procedure: Long round needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck dysfunction index (NDI)
Neck dysfunction index (NDI) was used, with 10 items, 0-5 points for each item, and the total score was 0-50 points. The score value was inversely related to the patient's cervical spine function.
Measured: Before treament
Neck dysfunction index (NDI)
Neck dysfunction index (NDI) was used, with 10 items, 0-5 points for each item, and the total score was 0-50 points. The score value was inversely related to the patient's cervical spine function.
Measured: Through study completion, an average of 1 year and 10 months
McGill pain questionnaire (MPQ) score
Neck dysfunction index (NDI) was used, with 10 items, 0-5 points for each item, and the total score was 0-50 points. The score value was inversely related to the patient's cervical spine function.
Measured: Before treament
McGill pain questionnaire (MPQ) score
Neck dysfunction index (NDI) was used, with 10 items, 0-5 points for each item, and the total score was 0-50 points. The score value was inversely related to the patient's cervical spine function.
Measured: Through study completion, an average of 1 year and 10 months
comprehensive assessment questionnaire (GQOL-74) scale
Using the comprehensive assessment questionnaire (GQOL-74) scale, mainly including psychological function, social function, physical function and other items, the score value is positively correlated with the quality of life of patients.
Measured: Before treament
comprehensive assessment questionnaire (GQOL-74) scale
Using the comprehensive assessment questionnaire (GQOL-74) scale, mainly including psychological function, social function, physical function and other items, the score value is positively correlated with the quality of life of patients.
Measured: Through study completion, an average of 1 year and 10 months
interleukin-8 (IL-8) level
5mL of fasting venous blood was extracted from the two groups before and after treatment, centrifuged at 3000 r/min and 8cm for 10 min.
Measured: Before treament
interleukin-8 (IL-8) level
5mL of fasting venous blood was extracted from the two groups before and after treatment, centrifuged at 3000 r/min and 8cm for 10 min.
Measured: Through study completion, an average of 1 year and 10 months
interleukin-10 (IL-10) level
5mL of fasting venous blood was extracted from the two groups before and after treatment, centrifuged at 3000 r/min and 8cm for 10 min.
Measured: Before treament
interleukin-10 (IL-10) level
5mL of fasting venous blood was extracted from the two groups before and after treatment, centrifuged at 3000 r/min and 8cm for 10 min.
Measured: Through study completion, an average of 1 year and 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Jan 2020
- Primary completion31 Oct 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spondylotic RadiculopathyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhanqing Xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhanqing Xie, The No. 2 Hospital of Baoding
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587075
- Sponsor's protocol ID
- HBaoding
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 19 Oct 2022
- 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 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect and Safety Analysis of Liu Yingmin Long Round Needle in the Treatment of Cervical Spondylotic Radiotelegraphy and Its Effect on Pain and Functional Recovery
- ClinicalTrials.gov ID
- NCT05587075
- Acronym / sponsor ID
- HBaoding
- Conditions
- Cervical Spondylotic Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Zhanqing XieUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 19 Oct 2022 (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 goal of this clinical trial is to test in the clinical effect of long round needle in the treatment of cervical spondylotic radiculopathy, and analyze its safety and its influence on pain and functional recovery. The main question it aims to answer is whether long round needle therapy for patients with cervical spondylotic radiculopathy is effective and safe. Participants will be selected as the research objects. They will randomly divided into control group (n = 49) and observation group (n = 49). The control group was treated with filiform needle, and the observation group was treated with long round needle. Researchers will compare the two groups to see the differences on the therapeutic effect, safety, Neck dysfunction index (NDI), pain score (McGill pain questionnaire, MPQ), quality of life (Generic Quality of Life Inventory-74, GQOL-74), and levels of inflammatory factors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Filiform needleThe control group was treated with filiform needle. |
| Observation group | Experimental | Procedure: Long round needleThe observation group was treated with long round needle. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- meet the efficacy criteria for disease certificate diagnosis of Traditional Chinese medicine[4]In the category of "Arthralgia Syndrome" and "Stiff neck", the main diseases: numbness and pain in the shoulder, neck and upper limbs, secondary diseases: unfavorable neck movement, hard, heavy head, thin coating, reddish tongue; (2) cervical X-ray shows hyperplasia of the vertebral body; (3) the patient or family members are informed and signed consent.
Key exclusion criteria (1 listed)
- patients with severe periarthritis of shoulder and mixed cervical spondylosis; (2) spinal canal space-occupying lesions and cervical spine tumors; (3) serious immune system diseases and infectious diseases; (4) liver and kidney insufficiency; (5) cardiovascular and cerebrovascular diseases; (6) mental diseases or medical history; (6) patients with incomplete clinical data and poor compliance.
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 |
|---|---|---|
| Filiform needleA needle treatment: guide patients take lying or sitting, keep relaxed, select Jingjiaji Point, Fengchi Point, Jianjing Point, Tianzhu Point, Houxi point, Hegu Point, Waiguan Point, preoperative, marker points, conventional disinfection, application specification of 0.35mmx50mm disposable sterile acupuncture needle, in the marker quick needle subcutaneous, slow needle to feel acid swelling feeling, keep needle 30min, once a day, last 5d for 1 course, a total of 4 courses of treatment. | Procedure or surgery | Control group |
| Long round needleLong round needle treatment: mark tendon lesions, take 3-5 tendon lesion points for needle point, after injection of 0.5% lidocaine 1mL, local anesthesia, to hold long round needle, slowly hierarchical detection to tendon lesion points, patients feel acid, hemp, swelling feeling is appropriate, to close method line knot treatment: straight to tendon lesions point surface, scraping, to remove the surface adhesion. Do not cross the superficial surface of the clavicle, sternocleidomastoid muscle deep surface, gentle action. After the needle was released, the pinhole was covered with a disposable dressing, bandaged for 2d, once a week, once for 1 course, and for a total of 4 courses of treatment. | Procedure or surgery | Observation group |
Primary outcome
Neck dysfunction index (NDI)
Time frame: Before treament
Neck dysfunction index (NDI) was used, with 10 items, 0-5 points for each item, and the total score was 0-50 points. The score value was inversely related to the patient's cervical spine function.
Neck dysfunction index (NDI)
Time frame: Through study completion, an average of 1 year and 10 months
Neck dysfunction index (NDI) was used, with 10 items, 0-5 points for each item, and the total score was 0-50 points. The score value was inversely related to the patient's cervical spine function.
McGill pain questionnaire (MPQ) score
Time frame: Before treament
Neck dysfunction index (NDI) was used, with 10 items, 0-5 points for each item, and the total score was 0-50 points. The score value was inversely related to the patient's cervical spine function.
McGill pain questionnaire (MPQ) score
Time frame: Through study completion, an average of 1 year and 10 months
Neck dysfunction index (NDI) was used, with 10 items, 0-5 points for each item, and the total score was 0-50 points. The score value was inversely related to the patient's cervical spine function.
comprehensive assessment questionnaire (GQOL-74) scale
Time frame: Before treament
Using the comprehensive assessment questionnaire (GQOL-74) scale, mainly including psychological function, social function, physical function and other items, the score value is positively correlated with the quality of life of patients.
comprehensive assessment questionnaire (GQOL-74) scale
Time frame: Through study completion, an average of 1 year and 10 months
Using the comprehensive assessment questionnaire (GQOL-74) scale, mainly including psychological function, social function, physical function and other items, the score value is positively correlated with the quality of life of patients.
interleukin-8 (IL-8) level
Time frame: Before treament
5mL of fasting venous blood was extracted from the two groups before and after treatment, centrifuged at 3000 r/min and 8cm for 10 min.
interleukin-8 (IL-8) level
Time frame: Through study completion, an average of 1 year and 10 months
5mL of fasting venous blood was extracted from the two groups before and after treatment, centrifuged at 3000 r/min and 8cm for 10 min.
interleukin-10 (IL-10) level
Time frame: Before treament
5mL of fasting venous blood was extracted from the two groups before and after treatment, centrifuged at 3000 r/min and 8cm for 10 min.
interleukin-10 (IL-10) level
Time frame: Through study completion, an average of 1 year and 10 months
5mL of fasting venous blood was extracted from the two groups before and after treatment, centrifuged at 3000 r/min and 8cm for 10 min.
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 19 Oct 2022.
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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 Filiform needle and Long round needle in people with Cervical Spondylotic Radiculopathy, run by Zhanqing Xie 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 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 19 Oct 2022. 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?
Neck dysfunction index (NDI) (time frame: Before treament). The study lists 10 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 19 Oct 2022.