Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy

Cervical Radiculopathy Clinical Trial

Official title:

Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy: A Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06320249
• Other study ID #: WJYY-XZKT-2023-05
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Wangjing Hospital, China Academy of Chinese Medical Sciences
• Contact: Xu Wei, Ph.D
• Phone: 13488716557
• Email: weixu.007[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 multicenter randomized controlled trial.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: June 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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".

2. Aged between 40 and 65 years.

3. VAS score = 4 points.

4. Duration of the condition = 5 years.

5. Voluntary signature of informed consent form.

Exclusion Criteria:

1. Combined with other types of cervical spondylosis.

2. Suspected or confirmed cases of cervical spine or intraspinal tumor, or intracranial tumor.

3. Patients with unclear diagnosis of spinal injury or symptoms of spinal cord injury.

4. Patients with developmental spinal canal stenosis (vertebral canal ratio = sagittal diameter of vertebral canal / sagittal diameter of vertebral body < 0.75).

5. Those suffering from severe heart, lung, brain, liver, kidney, or hematopoietic system diseases.

6. Conditions such as spinal tuberculosis, osteomyelitis, and osteoporosis.

7. Individuals who have undergone cervical spine surgery and those with cervical spine deformities.

8. Pregnant, planning to become pregnant, or breastfeeding women.

9. Participants unable to complete this clinical study due to mental illness, cognitive, or emotional disorders.

10. Those who have participated in other clinical studies in the past 3 months.

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

Other:
• High-frequency rotation-traction manipulation
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 manipulation
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 traction
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.

Locations

Country	Name	City	State
China	Wangjing Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Wangjing Hospital, China Academy of Chinese Medical Sciences	Affiliated Hospital of Changchun University of Chinese Medicine, Dongzhimen Hospital, Beijing University of Chinese Medicine, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	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.	2 weeks
Secondary	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.	8 weeks
Secondary	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.	12 weeks
Secondary	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.	16 weeks
Secondary	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.	20 weeks
Secondary	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.	2 weeks
Secondary	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.	4 weeks
Secondary	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.	8 weeks
Secondary	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.	12 weeks
Secondary	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.	16weeks
Secondary	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.	20 weeks
Secondary	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.	2 weeks
Secondary	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.	4 weeks
Secondary	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.	8 weeks
Secondary	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.	12 weeks
Secondary	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.	16 weeks
Secondary	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.	20 weeks
Secondary	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.	2 weeks
Secondary	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.	4 weeks
Secondary	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.	8 weeks
Secondary	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.	12 weeks
Secondary	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.	16 weeks
Secondary	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.	20 weeks
Secondary	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.	4 weeks
Secondary	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.	20 weeks
Secondary	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.	1 day
Secondary	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.	4 weeks
Secondary	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.	Up to 20 weeks