CompletedNot Applicable

Clinical Effect of Long Round Needle

China98 participantsStarted 2020-01-01

Plain-language 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. 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: (1) 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. Exclusion Criteria: (1) 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neck dysfunction index (NDI)

Timeframe: Before treament

Neck dysfunction index (NDI)

Timeframe: Through study completion, an average of 1 year and 10 months

McGill pain questionnaire (MPQ) score

Timeframe: Before treament

McGill pain questionnaire (MPQ) score

Timeframe: Through study completion, an average of 1 year and 10 months

comprehensive assessment questionnaire (GQOL-74) scale

Timeframe: Before treament

comprehensive assessment questionnaire (GQOL-74) scale

Timeframe: Through study completion, an average of 1 year and 10 months

interleukin-8 (IL-8) level

Timeframe: Before treament

Trial details

NCT IDNCT05587075

SponsorZhanqing Xie

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-31

View on ClinicalTrials.gov More Cervical Spondylotic Radiculopathy trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Neck dysfunction index (NDI)

Timeframe: Before treament

Neck dysfunction index (NDI)

Timeframe: Through study completion, an average of 1 year and 10 months

McGill pain questionnaire (MPQ) score

Timeframe: Before treament

McGill pain questionnaire (MPQ) score

Timeframe: Through study completion, an average of 1 year and 10 months

comprehensive assessment questionnaire (GQOL-74) scale

Timeframe: Before treament

comprehensive assessment questionnaire (GQOL-74) scale

Timeframe: Through study completion, an average of 1 year and 10 months

interleukin-8 (IL-8) level

Timeframe: Before treament