Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy
1 other identifier
interventional
216
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2024
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedMarch 20, 2024
March 1, 2024
1.1 years
February 24, 2024
March 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (28)
The Visual Analog Scale for Pain
2 weeks
The Visual Analog Scale for Pain
8 weeks
The Visual Analog Scale for Pain
12 weeks
The Visual Analog Scale for Pain
16 weeks
The Visual Analog Scale for Pain
20 weeks
- +23 more secondary outcomes
Study Arms (3)
The high-frequency manipulation group
EXPERIMENTALIn 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
EXPERIMENTALIn 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 COMPARATORThe cervical traction group will be subjected to cervical traction three times a week. A total of 12 treatments for four weeks.
Interventions
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 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 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
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100102, China
Related 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.
PMID: 21168100BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- This study did not implement blinding for the manipulative therapists and participants. However, blinding procedures were employed for the outcome assessors and data analysts, meaning that they remained unaware of the group.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2024
First Posted
March 20, 2024
Study Start
April 1, 2024
Primary Completion
April 30, 2025
Study Completion
June 30, 2025
Last Updated
March 20, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share
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.