Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy
NCT ID: NCT06320249
Last Updated: 2024-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
216 participants
INTERVENTIONAL
2024-04-01
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Manual Therapy, Exercise and Traction for Patients With Cervical Radiculopathy: A RCT
NCT00695006
Effect of Cervical Exercise Combined With Nerve Mobilization on Cervical Spondylotic Radiculopathy
NCT06453798
Immediate Effects of Manipulation Versus Stretching on Upper Trapezius Pressure Pain Thresholds
NCT02081430
Thoracic Manipulation in Patients With Cervical Radiculopathy
NCT01495728
A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain
NCT02972710
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
The high-frequency manipulation group
In the high-frequency manipulation group, patients will undergo rotation-traction manipulation three times weekly. A total of 12 treatments for four weeks.
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.
The low-frequency manipulation group
In the low-frequency manipulation group, patients will undergo rotation-traction manipulation once time weekly. A total of 4 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.
The cervical traction group
The cervical traction group will be subjected to cervical traction three times a week. A total of 12 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
40 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
OTHER
Affiliated Hospital of Changchun University of Chinese Medicine
OTHER
Dongzhimen Hospital, Beijing
OTHER
Wangjing Hospital, China Academy of Chinese Medical Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WJYY-XZKT-2023-05
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.