Cervical RadiculopathyNCT06320249
Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy
A study testing High-frequency rotation-traction manipulation, Low-frequency rotation-traction manipulation and Cervical traction in people with Cervical Radiculopathy, run by Wangjing Hospital, China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The evidence for different frequencies of rotation-traction manipulation treatment in cervical radiculopathy is insufficient. This study determined whether 3 sessions per week of rotation-traction manipulation treatment are superior to 1 session per week for symptomatic outcomes in cervical radiculopathy based on a… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- High-frequency rotation-traction manipulation, Low-frequency rotation-traction manipulation and Cervical traction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 30 Jun 2025
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Conforming to the diagnostic criteria outlined in the 2010 North American Spine Society "An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders".
- Aged between 40 and 65 years.
- VAS score ≥ 4 points.
- Duration of the condition ≤ 5 years.
- Voluntary signature of informed consent form.
Who cannot join
- Combined with other types of cervical spondylosis.
- Suspected or confirmed cases of cervical spine or intraspinal tumor, or intracranial tumor.
- Patients with unclear diagnosis of spinal injury or symptoms of spinal cord injury.
- Patients with developmental spinal canal stenosis (vertebral canal ratio = sagittal diameter of vertebral canal / sagittal diameter of vertebral body < 0.75).
- Those suffering from severe heart, lung, brain, liver, kidney, or hematopoietic system diseases.
- Conditions such as spinal tuberculosis, osteomyelitis, and osteoporosis.
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- Individuals who have undergone cervical spine surgery and those with cervical spine deformities.
- Pregnant, planning to become pregnant, or breastfeeding women.
- Participants unable to complete this clinical study due to mental illness, cognitive, or emotional disorders.
- Those who have participated in other clinical studies in the past 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100102
Xu Wei, Ph.D, 13488716557, weixu.007@163.com
Tianxiao Feng, Ph.D, 15733196045, fengtianxiao96@163.com
About this study
Official title: Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy: A Multicenter Randomized Controlled Trial
The evidence for different frequencies of rotation-traction manipulation treatment in cervical radiculopathy is insufficient. This study determined whether 3 sessions per week of rotation-traction manipulation treatment are superior to 1 session per week for symptomatic outcomes in cervical radiculopathy based on a multicenter randomized controlled trial.
Read the detailed description
This study, slated to be conducted across four sub-centers, including the Wangjing Hospital of the China Academy of Chinese Medical Sciences, aims to recruit 216 patients diagnosed with cervical radiculopathy. Employing a central randomization method, participants will be stratified into three groups: high-frequency manipulation, low-frequency manipulation, and cervical traction.
In the high-frequency manipulation group, patients will undergo rotation-traction manipulation three times weekly, while the low-frequency manipulation group will receive the same intervention once a week. The cervical traction group will be subjected to cervical traction three times a week. Each group will undergo 4-week treatment with a subsequent 16-week follow-up, resulting in a total study duration of 20 weeks.
Outcomes' assessments will be conducted at seven specific time points: baseline, 2 weeks after treatment, 4 weeks after treatment, and during follow-up at weeks 4, 8, 12, and 16. Outcomes include scores from the Visual Analog Scale (VAS) for pain, VAS for numbness, Neck Disability Index (NDI), Short Form-12 (SF-12) health survey, and monitoring of adverse reactions. Following the first treatment session and 4 weeks after treatment, Expectation Treatment Credibility Scale (ETCS) will be appraised. Furthermore, the study will record the overall cost incurred by each group after 4 weeks of treatment and the recurrence rates during the follow-up period.
- Conditions
- Cervical Radiculopathy
- Being tested
- High-frequency rotation-traction manipulation, Low-frequency rotation-traction manipulation, Cervical traction
- Keywords
- Rotation-traction manipulation, Cervical radiculopathy, Treatment frequency, Dose effect, Randomized controlled trial
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency rotation-traction manipulationOther
The procedure for rotation-traction manipulation is as follows: The patient is seated, and their neck is allowed to relax. The physician applies massage techniques to relax the muscles around the neck area for approximately 5 to 10 minutes. The patient is then instructed to rotate their head horizontally, flex it, and then rotate it again to its maximum limit while maintaining a sense of fixation. The physician supports the patient's chin with their elbow and gently pulls upward for 3 to 5 seconds. The patient is then asked to fully relax, and the physician applies a quick, short upward traction with the elbow, which may result in audible sounds. Subsequently, massage techniques are applied to further relax the muscles around the neck and shoulders, with each session lasting approximately 10 to 15 minutes. In the high-frequency manipulation group, patients will undergo rotation-traction manipulation three times weekly. A total of 12 treatments for four weeks.
Low-frequency rotation-traction manipulationOther
The procedure for rotation-traction manipulation is as follows: The patient is seated, and their neck is allowed to relax. The physician applies massage techniques to relax the muscles around the neck area for approximately 5 to 10 minutes. The patient is then instructed to rotate their head horizontally, flex it, and then rotate it again to its maximum limit while maintaining a sense of fixation. The physician supports the patient's chin with their elbow and gently pulls upward for 3 to 5 seconds. The patient is then asked to fully relax, and the physician applies a quick, short upward traction with the elbow, which may result in audible sounds. Subsequently, massage techniques are applied to further relax the muscles around the neck and shoulders, with each session lasting approximately 10 to 15 minutes. In the low-frequency manipulation group, patients will undergo rotation-traction manipulation once time weekly. A total of 4 treatments for four weeks.
Cervical tractionOther
The procedure for cervical traction is as follows: The patient assumes a sitting position, and a cervical traction device with a chin strap is applied. The patient is instructed to slightly flex their head forward, approximately 10-15 degrees, based on their comfort level and symptom relief. Traction force starts at 3 kg and increases gradually in increments of 0.5 kg, with a maximum weight not exceeding 6 kg. The cervical traction group will be subjected to cervical traction three times a week. A total of 12 treatments for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| The high-frequency manipulation group | Experimental | In the high-frequency manipulation group, patients will undergo rotation-traction manipulation three times weekly. A total of 12 treatments for four weeks. Receives: Other: High-frequency rotation-traction manipulation |
| The low-frequency manipulation group | Experimental | In the low-frequency manipulation group, patients will undergo rotation-traction manipulation once time weekly. A total of 4 treatments for four weeks. Receives: Other: Low-frequency rotation-traction manipulation |
| The cervical traction group | Active comparator | The cervical traction group will be subjected to cervical traction three times a week. A total of 12 treatments for four weeks. Receives: Other: Cervical traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Visual Analog Scale for Pain
The Visual Analog Scale for Pain is a tool used to assess the intensity of pain experienced by an individual. It consists of a straight line with "painless" marked at one end and "severe pain" at the other. The individual is asked to mark on the line the point that represents their current level of pain. Painless is represented by 0; 1-3 points represent mild pain; 4-6 points represent moderate pain, which is strong but tolerable; 7-10 points represent severe pain, gradually reaching intolerable level, which is severe pain. The higher score indicates more severe pain.
Measured: 4 weeks
Secondary outcomes (28)
The Visual Analog Scale for Pain
The Visual Analog Scale for Pain is a tool used to assess the intensity of pain experienced by an individual. It consists of a straight line with "painless" marked at one end and "severe pain" at the other. The individual is asked to mark on the line the point that represents their current level of pain. Painless is represented by 0; 1-3 points represent mild pain; 4-6 points represent moderate pain, which is strong but tolerable; 7-10 points represent severe pain, gradually reaching intolerable level, which is severe pain. The higher score indicates more severe pain.
Measured: 2 weeks
The Visual Analog Scale for Pain
The Visual Analog Scale for Pain is a tool used to assess the intensity of pain experienced by an individual. It consists of a straight line with "painless" marked at one end and "severe pain" at the other. The individual is asked to mark on the line the point that represents their current level of pain. Painless is represented by 0; 1-3 points represent mild pain; 4-6 points represent moderate pain, which is strong but tolerable; 7-10 points represent severe pain, gradually reaching intolerable level, which is severe pain. The higher score indicates more severe pain.
Measured: 8 weeks
The Visual Analog Scale for Pain
The Visual Analog Scale for Pain is a tool used to assess the intensity of pain experienced by an individual. It consists of a straight line with "painless" marked at one end and "severe pain" at the other. The individual is asked to mark on the line the point that represents their current level of pain. Painless is represented by 0; 1-3 points represent mild pain; 4-6 points represent moderate pain, which is strong but tolerable; 7-10 points represent severe pain, gradually reaching intolerable level, which is severe pain. The higher score indicates more severe pain.
Measured: 12 weeks
The Visual Analog Scale for Pain
The Visual Analog Scale for Pain is a tool used to assess the intensity of pain experienced by an individual. It consists of a straight line with "painless" marked at one end and "severe pain" at the other. The individual is asked to mark on the line the point that represents their current level of pain. Painless is represented by 0; 1-3 points represent mild pain; 4-6 points represent moderate pain, which is strong but tolerable; 7-10 points represent severe pain, gradually reaching intolerable level, which is severe pain. The higher score indicates more severe pain.
Measured: 16 weeks
The Visual Analog Scale for Pain
The Visual Analog Scale for Pain is a tool used to assess the intensity of pain experienced by an individual. It consists of a straight line with "painless" marked at one end and "severe pain" at the other. The individual is asked to mark on the line the point that represents their current level of pain. Painless is represented by 0; 1-3 points represent mild pain; 4-6 points represent moderate pain, which is strong but tolerable; 7-10 points represent severe pain, gradually reaching intolerable level, which is severe pain. The higher score indicates more severe pain.
Measured: 20 weeks
The Visual Analog Scale for Numbness
The Visual Analog Scale for Numbness is a tool used to assess the intensity of numbness experienced by an individual. It consists of a straight line with "unnumbness" marked at one end and "severe numbness" at the other. The individual is asked to mark on the line the point that represents their current level of numbness. Unnumbness is represented by 0; 1-3 points represent mild numbness; 4-6 points represent moderate numbness, which is strong but tolerable; 7-10 points represent severe numbness, gradually reaching intolerable level, which is severe numbness. The higher score indicates more severe numbness.
Measured: 2 weeks
The Visual Analog Scale for Numbness
The Visual Analog Scale for Numbness is a tool used to assess the intensity of numbness experienced by an individual. It consists of a straight line with "unnumbness" marked at one end and "severe numbness" at the other. The individual is asked to mark on the line the point that represents their current level of numbness. Unnumbness is represented by 0; 1-3 points represent mild numbness; 4-6 points represent moderate numbness, which is strong but tolerable; 7-10 points represent severe numbness, gradually reaching intolerable level, which is severe numbness. The higher score indicates more severe numbness.
Measured: 4 weeks
The Visual Analog Scale for Numbness
The Visual Analog Scale for Numbness is a tool used to assess the intensity of numbness experienced by an individual. It consists of a straight line with "unnumbness" marked at one end and "severe numbness" at the other. The individual is asked to mark on the line the point that represents their current level of numbness. Unnumbness is represented by 0; 1-3 points represent mild numbness; 4-6 points represent moderate numbness, which is strong but tolerable; 7-10 points represent severe numbness, gradually reaching intolerable level, which is severe numbness. The higher score indicates more severe numbness.
Measured: 8 weeks
The Visual Analog Scale for Numbness
The Visual Analog Scale for Numbness is a tool used to assess the intensity of numbness experienced by an individual. It consists of a straight line with "unnumbness" marked at one end and "severe numbness" at the other. The individual is asked to mark on the line the point that represents their current level of numbness. Unnumbness is represented by 0; 1-3 points represent mild numbness; 4-6 points represent moderate numbness, which is strong but tolerable; 7-10 points represent severe numbness, gradually reaching intolerable level, which is severe numbness. The higher score indicates more severe numbness.
Measured: 12 weeks
The Visual Analog Scale for Numbness
The Visual Analog Scale for Numbness is a tool used to assess the intensity of numbness experienced by an individual. It consists of a straight line with "unnumbness" marked at one end and "severe numbness" at the other. The individual is asked to mark on the line the point that represents their current level of numbness. Unnumbness is represented by 0; 1-3 points represent mild numbness; 4-6 points represent moderate numbness, which is strong but tolerable; 7-10 points represent severe numbness, gradually reaching intolerable level, which is severe numbness. The higher score indicates more severe numbness.
Measured: 16weeks
The Visual Analog Scale for Numbness
The Visual Analog Scale for Numbness is a tool used to assess the intensity of numbness experienced by an individual. It consists of a straight line with "unnumbness" marked at one end and "severe numbness" at the other. The individual is asked to mark on the line the point that represents their current level of numbness. Unnumbness is represented by 0; 1-3 points represent mild numbness; 4-6 points represent moderate numbness, which is strong but tolerable; 7-10 points represent severe numbness, gradually reaching intolerable level, which is severe numbness. The higher score indicates more severe numbness.
Measured: 20 weeks
The Neck Disability Index
The Neck Disability Index (NDI) is a widely used questionnaire designed to assess disability related to neck pain. It consists of ten items that evaluate different aspects of a person's daily activities and the impact of neck pain on their functionality. The NDI covers areas such as pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping, and recreation. Each item is scored on a scale from 0 to 5, with 0 indicating no disability and 5 indicating complete disability. The total score is then calculated by summing up the individual scores for each item, resulting in a possible range from 0 to 50. Higher scores on the NDI indicate greater disability and impairment due to neck pain.
Measured: 2 weeks
The Neck Disability Index
The Neck Disability Index (NDI) is a widely used questionnaire designed to assess disability related to neck pain. It consists of ten items that evaluate different aspects of a person's daily activities and the impact of neck pain on their functionality. The NDI covers areas such as pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping, and recreation. Each item is scored on a scale from 0 to 5, with 0 indicating no disability and 5 indicating complete disability. The total score is then calculated by summing up the individual scores for each item, resulting in a possible range from 0 to 50. Higher scores on the NDI indicate greater disability and impairment due to neck pain.
Measured: 4 weeks
The Neck Disability Index
The Neck Disability Index (NDI) is a widely used questionnaire designed to assess disability related to neck pain. It consists of ten items that evaluate different aspects of a person's daily activities and the impact of neck pain on their functionality. The NDI covers areas such as pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping, and recreation. Each item is scored on a scale from 0 to 5, with 0 indicating no disability and 5 indicating complete disability. The total score is then calculated by summing up the individual scores for each item, resulting in a possible range from 0 to 50. Higher scores on the NDI indicate greater disability and impairment due to neck pain.
Measured: 8 weeks
The Neck Disability Index
The Neck Disability Index (NDI) is a widely used questionnaire designed to assess disability related to neck pain. It consists of ten items that evaluate different aspects of a person's daily activities and the impact of neck pain on their functionality. The NDI covers areas such as pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping, and recreation. Each item is scored on a scale from 0 to 5, with 0 indicating no disability and 5 indicating complete disability. The total score is then calculated by summing up the individual scores for each item, resulting in a possible range from 0 to 50. Higher scores on the NDI indicate greater disability and impairment due to neck pain.
Measured: 12 weeks
The Neck Disability Index
The Neck Disability Index (NDI) is a widely used questionnaire designed to assess disability related to neck pain. It consists of ten items that evaluate different aspects of a person's daily activities and the impact of neck pain on their functionality. The NDI covers areas such as pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping, and recreation. Each item is scored on a scale from 0 to 5, with 0 indicating no disability and 5 indicating complete disability. The total score is then calculated by summing up the individual scores for each item, resulting in a possible range from 0 to 50. Higher scores on the NDI indicate greater disability and impairment due to neck pain.
Measured: 16 weeks
The Neck Disability Index
The Neck Disability Index (NDI) is a widely used questionnaire designed to assess disability related to neck pain. It consists of ten items that evaluate different aspects of a person's daily activities and the impact of neck pain on their functionality. The NDI covers areas such as pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping, and recreation. Each item is scored on a scale from 0 to 5, with 0 indicating no disability and 5 indicating complete disability. The total score is then calculated by summing up the individual scores for each item, resulting in a possible range from 0 to 50. Higher scores on the NDI indicate greater disability and impairment due to neck pain.
Measured: 20 weeks
The Short Form 12
The Short Form 12 (SF-12) consists of 12 questions that cover various aspects of physical and mental health. It is designed to be a concise yet comprehensive measure of health status. The SF-12 questionnaire includes questions related to physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health. Each question has multiple response options, and the responses are scored and aggregated to produce summary scores for physical health and mental health components. The SF-12 provides two main summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The total scores vary based on individual responses and can range from 0 to 100, with 100 representing the best possible health status and 0 representing the worst.
Measured: 2 weeks
The Short Form 12
The Short Form 12 (SF-12) consists of 12 questions that cover various aspects of physical and mental health. It is designed to be a concise yet comprehensive measure of health status. The SF-12 questionnaire includes questions related to physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health. Each question has multiple response options, and the responses are scored and aggregated to produce summary scores for physical health and mental health components. The SF-12 provides two main summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The total scores vary based on individual responses and can range from 0 to 100, with 100 representing the best possible health status and 0 representing the worst.
Measured: 4 weeks
The Short Form 12
The Short Form 12 (SF-12) consists of 12 questions that cover various aspects of physical and mental health. It is designed to be a concise yet comprehensive measure of health status. The SF-12 questionnaire includes questions related to physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health. Each question has multiple response options, and the responses are scored and aggregated to produce summary scores for physical health and mental health components. The SF-12 provides two main summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The total scores vary based on individual responses and can range from 0 to 100, with 100 representing the best possible health status and 0 representing the worst.
Measured: 8 weeks
The Short Form 12
The Short Form 12 (SF-12) consists of 12 questions that cover various aspects of physical and mental health. It is designed to be a concise yet comprehensive measure of health status. The SF-12 questionnaire includes questions related to physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health. Each question has multiple response options, and the responses are scored and aggregated to produce summary scores for physical health and mental health components. The SF-12 provides two main summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The total scores vary based on individual responses and can range from 0 to 100, with 100 representing the best possible health status and 0 representing the worst.
Measured: 12 weeks
The Short Form 12
The Short Form 12 (SF-12) consists of 12 questions that cover various aspects of physical and mental health. It is designed to be a concise yet comprehensive measure of health status. The SF-12 questionnaire includes questions related to physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health. Each question has multiple response options, and the responses are scored and aggregated to produce summary scores for physical health and mental health components. The SF-12 provides two main summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The total scores vary based on individual responses and can range from 0 to 100, with 100 representing the best possible health status and 0 representing the worst.
Measured: 16 weeks
The Short Form 12
The Short Form 12 (SF-12) consists of 12 questions that cover various aspects of physical and mental health. It is designed to be a concise yet comprehensive measure of health status. The SF-12 questionnaire includes questions related to physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health. Each question has multiple response options, and the responses are scored and aggregated to produce summary scores for physical health and mental health components. The SF-12 provides two main summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The total scores vary based on individual responses and can range from 0 to 100, with 100 representing the best possible health status and 0 representing the worst.
Measured: 20 weeks
The total cost
The total cost includes registration fees, treatment fees, examination fees, loss of income, transportation expenses, and so on. Record the total costs for each group of patients over a 4-week treatment period.
Measured: 4 weeks
The recurrence rate
The recurrence rate is defined as the percentage of individuals experiencing a reappearance of symptoms and signs similar to those before treatment during the follow-up period, among the total number of revisit cases.
Measured: 20 weeks
Expectation of Treatment and Credibility Scale
The Expectation of Treatment and Credibility Scale (ETCS) is a questionnaire commonly used in clinical practice to assess patients' expectations of treatment outcomes and their perceived credibility of the treatment. Responses on the ETCS are usually rated on a Likert 9-point scale (from 0 to 9), with options ranging from "strongly disagree" to "strongly agree" or "not at all credible" to "extremely credible." Scores are then calculated to provide quantitative measures of patients' expectations and perceived credibility of the treatment. Overall, higher ETCS scores generally indicate higher patient expectations for treatment options and greater trust in treatment. This may help improve the effectiveness of treatment and patient satisfaction. Evaluation was performed after the first treatment and at 4 weeks of treatment.
Measured: 1 day
Expectation of Treatment and Credibility Scale
The Expectation of Treatment and Credibility Scale (ETCS) is a questionnaire commonly used in clinical practice to assess patients' expectations of treatment outcomes and their perceived credibility of the treatment. Responses on the ETCS are usually rated on a Likert 9-point scale (from 0 to 9), with options ranging from "strongly disagree" to "strongly agree" or "not at all credible" to "extremely credible." Scores are then calculated to provide quantitative measures of patients' expectations and perceived credibility of the treatment. Overall, higher ETCS scores generally indicate higher patient expectations for treatment options and greater trust in treatment. This may help improve the effectiveness of treatment and patient satisfaction. Evaluation was performed after the first treatment and at 4 weeks of treatment.
Measured: 4 weeks
Adverse reactions
Recording whether patients experience adverse reactions such as progressive worsening of neck pain, upper limb pain, and restricted neck movement, dizziness, chest tightness, palpitations, etc., during the treatment and follow-up.
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wangjing Hospital, China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Affiliated Hospital of Changchun University of Chinese Medicine, Dongzhimen Hospital, Beijing
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320249
- Sponsor's protocol ID
- WJYY-XZKT-2023-05
- Status last verified
- Mar 2024
- First submitted
- 24 Feb 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The researchers do not currently plan to share IPD. Our team is also conducting some other studies on the rotation-traction manipulation. We will consider disseminating our data more openly after the results of these studies are published. However, if other researchers are interested in our research, they can contact the author team to obtain relevant information. Let's work together to contribute to the international dissemination of traditional Chinese medical manipulations.
Publications
Bono CM, Ghiselli G, Gilbert TJ, Kreiner DS, Reitman C, Summers JT, Baisden JL, Easa J, Fernand R, Lamer T, Matz PG, Mazanec DJ, Resnick DK, Shaffer WO, Sharma AK, Timmons RB, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders. Spine J. 2011 Jan;11(1):64-72. doi: 10.1016/j.spinee.2010.10.023.
PubMed 21168100Feng T, Wang X, Sun K, Yin H, Liu A, Li Z, Li J, Zhu L, Wei X. Cervical Rotation-Traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy: Study Protocol for a Randomized Controlled Trial. J Pain Res. 2026 Feb 24;19:547284. doi: 10.2147/JPR.S547284. eCollection 2026.
PubMed 41768107
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06320249
- Acronym / sponsor ID
- WJYY-XZKT-2023-05
- Conditions
- Cervical Radiculopathy
- Keywords
- Rotation-traction manipulation, Cervical radiculopathy, Treatment frequency, Dose effect, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Wangjing Hospital, China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Affiliated Hospital of Changchun University of Chinese Medicine, Dongzhimen Hospital, Beijing
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 20 Mar 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 evidence for different frequencies of rotation-traction manipulation treatment in cervical radiculopathy is insufficient. This study determined whether 3 sessions per week of rotation-traction manipulation treatment are superior to 1 session per week for symptomatic outcomes in cervical radiculopathy based on a multicenter randomized controlled trial.
Detailed description
This study, slated to be conducted across four sub-centers, including the Wangjing Hospital of the China Academy of Chinese Medical Sciences, aims to recruit 216 patients diagnosed with cervical radiculopathy. Employing a central randomization method, participants will be stratified into three groups: high-frequency manipulation, low-frequency manipulation, and cervical traction.
In the high-frequency manipulation group, patients will undergo rotation-traction manipulation three times weekly, while the low-frequency manipulation group will receive the same intervention once a week. The cervical traction group will be subjected to cervical traction three times a week. Each group will undergo 4-week treatment with a subsequent 16-week follow-up, resulting in a total study duration of 20 weeks.
Outcomes' assessments will be conducted at seven specific time points: baseline, 2 weeks after treatment, 4 weeks after treatment, and during follow-up at weeks 4, 8, 12, and 16. Outcomes include scores from the Visual Analog Scale (VAS) for pain, VAS for numbness, Neck Disability Index (NDI), Short Form-12 (SF-12) health survey, and monitoring of adverse reactions. Following the first treatment session and 4 weeks after treatment, Expectation Treatment Credibility Scale (ETCS) will be appraised. Furthermore, the study will record the overall cost incurred by each group after 4 weeks of treatment and the recurrence rates during the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The high-frequency manipulation group | Experimental | Other: High-frequency rotation-traction manipulationIn the high-frequency manipulation group, patients will undergo rotation-traction manipulation three times weekly. A total of 12 treatments for four weeks. |
| The low-frequency manipulation group | Experimental | Other: Low-frequency rotation-traction manipulationIn the low-frequency manipulation group, patients will undergo rotation-traction manipulation once time weekly. A total of 4 treatments for four weeks. |
| The cervical traction group | Active comparator | Other: Cervical tractionThe cervical traction group will be subjected to cervical traction three times a week. A total of 12 treatments for four weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Conforming to the diagnostic criteria outlined in the 2010 North American Spine Society "An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders".
- Aged between 40 and 65 years.
- VAS score ≥ 4 points.
- Duration of the condition ≤ 5 years.
- Voluntary signature of informed consent form.
Key exclusion criteria (10 listed)
- Combined with other types of cervical spondylosis.
- Suspected or confirmed cases of cervical spine or intraspinal tumor, or intracranial tumor.
- Patients with unclear diagnosis of spinal injury or symptoms of spinal cord injury.
- Patients with developmental spinal canal stenosis (vertebral canal ratio = sagittal diameter of vertebral canal / sagittal diameter of vertebral body < 0.75).
- Those suffering from severe heart, lung, brain, liver, kidney, or hematopoietic system diseases.
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 |
|---|---|---|
| High-frequency rotation-traction manipulationThe procedure for rotation-traction manipulation is as follows: The patient is seated, and their neck is allowed to relax. The physician applies massage techniques to relax the muscles around the neck area for approximately 5 to 10 minutes. The patient is then instructed to rotate their head horizontally, flex it, and then rotate it again to its maximum limit while maintaining a sense of fixation. The physician supports the patient's chin with their elbow and gently pulls upward for 3 to 5 seconds. The patient is then asked to fully relax, and the physician applies a quick, short upward traction with the elbow, which may result in audible sounds. Subsequently, massage techniques are applied to further relax the muscles around the neck and shoulders, with each session lasting approximately 10 to 15 minutes. In the high-frequency manipulation group, patients will undergo rotation-traction manipulation three times weekly. A total of 12 treatments for four weeks. | Other | The high-frequency manipulation group |
| Low-frequency rotation-traction manipulationThe procedure for rotation-traction manipulation is as follows: The patient is seated, and their neck is allowed to relax. The physician applies massage techniques to relax the muscles around the neck area for approximately 5 to 10 minutes. The patient is then instructed to rotate their head horizontally, flex it, and then rotate it again to its maximum limit while maintaining a sense of fixation. The physician supports the patient's chin with their elbow and gently pulls upward for 3 to 5 seconds. The patient is then asked to fully relax, and the physician applies a quick, short upward traction with the elbow, which may result in audible sounds. Subsequently, massage techniques are applied to further relax the muscles around the neck and shoulders, with each session lasting approximately 10 to 15 minutes. In the low-frequency manipulation group, patients will undergo rotation-traction manipulation once time weekly. A total of 4 treatments for four weeks. | Other | The low-frequency manipulation group |
| Cervical tractionThe procedure for cervical traction is as follows: The patient assumes a sitting position, and a cervical traction device with a chin strap is applied. The patient is instructed to slightly flex their head forward, approximately 10-15 degrees, based on their comfort level and symptom relief. Traction force starts at 3 kg and increases gradually in increments of 0.5 kg, with a maximum weight not exceeding 6 kg. The cervical traction group will be subjected to cervical traction three times a week. A total of 12 treatments for four weeks. | Other | The cervical traction group |
Primary outcome
The Visual Analog Scale for Pain
Time frame: 4 weeks
The Visual Analog Scale for Pain is a tool used to assess the intensity of pain experienced by an individual. It consists of a straight line with "painless" marked at one end and "severe pain" at the other. The individual is asked to mark on the line the point that represents their current level of pain. Painless is represented by 0; 1-3 points represent mild pain; 4-6 points represent moderate pain, which is strong but tolerable; 7-10 points represent severe pain, gradually reaching intolerable level, which is severe pain. The higher score indicates more severe pain.
28 secondary outcomes
The Visual Analog Scale for Pain
Time frame: 2 weeks
The Visual Analog Scale for Pain
Time frame: 8 weeks
The Visual Analog Scale for Pain
Time frame: 12 weeks
The Visual Analog Scale for Pain
Time frame: 16 weeks
The Visual Analog Scale for Pain
Time frame: 20 weeks
The Visual Analog Scale for Numbness
Time frame: 2 weeks
The Visual Analog Scale for Numbness
Time frame: 4 weeks
The Visual Analog Scale for Numbness
Time frame: 8 weeks
The Visual Analog Scale for Numbness
Time frame: 12 weeks
The Visual Analog Scale for Numbness
Time frame: 16weeks
The Visual Analog Scale for Numbness
Time frame: 20 weeks
The Neck Disability Index
Time frame: 2 weeks
The Neck Disability Index
Time frame: 4 weeks
The Neck Disability Index
Time frame: 8 weeks
The Neck Disability Index
Time frame: 12 weeks
The Neck Disability Index
Time frame: 16 weeks
The Neck Disability Index
Time frame: 20 weeks
The Short Form 12
Time frame: 2 weeks
The Short Form 12
Time frame: 4 weeks
The Short Form 12
Time frame: 8 weeks
The Short Form 12
Time frame: 12 weeks
The Short Form 12
Time frame: 16 weeks
The Short Form 12
Time frame: 20 weeks
The total cost
Time frame: 4 weeks
The recurrence rate
Time frame: 20 weeks
Expectation of Treatment and Credibility Scale
Time frame: 1 day
Expectation of Treatment and Credibility Scale
Time frame: 4 weeks
Adverse reactions
Time frame: Up to 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Background: PubMed 21168100Bono CM, Ghiselli G, Gilbert TJ, Kreiner DS, Reitman C, Summers JT, Baisden JL, Easa J, Fernand R, Lamer T, Matz PG, Mazanec DJ, Resnick DK, Shaffer WO, Sharma AK, Timmons RB, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders. Spine J. 2011 Jan;11(1):64-72. doi: 10.1016/j.spinee.2010.10.023.
- Derived from this study: PubMed 41768107Feng T, Wang X, Sun K, Yin H, Liu A, Li Z, Li J, Zhu L, Wei X. Cervical Rotation-Traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy: Study Protocol for a Randomized Controlled Trial. J Pain Res. 2026 Feb 24;19:547284. doi: 10.2147/JPR.S547284. eCollection 2026.
- Individual participant dataSharing planned: No. The researchers do not currently plan to share IPD. Our team is also conducting some other studies on the rotation-traction manipulation. We will consider disseminating our data more openly after the results of these studies are published. However, if other researchers are interested in our research, they can contact the author team to obtain relevant information. Let's work together to contribute to the international dissemination of traditional Chinese medical manipulations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-frequency rotation-traction manipulation, Low-frequency rotation-traction manipulation and Cervical traction in people with Cervical Radiculopathy, run by Wangjing Hospital, China Academy of Chinese Medical Sciences 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Wei, Ph.D (13488716557, weixu.007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Visual Analog Scale for Pain (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06320249, which also lists 2 linked publications.
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 20 Mar 2024.