cervical radiculopathy (CR)
Conditions
Interventions
the control group (usual care):Usual care with neck immobilization in anterior flexion position at a 10°~20°angle and conventional analgesics.
the intervention group:Angled Manual Traction (AMT) plus Usual Care. AMT consists of pressingkneading manipulation, traction manipulation and mechanical traction. Procedures were performed by a physic
Sponsors
Guangdong Province Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Formulated with reference to the 2015 Expert Consensus on Standardized Diagnosis and Treatment of Cervical Spondylotic Radiculopathy, the 2011 North American Spine Society guideline "An Evidence-based Clinical Guideline for the Diagnosis and Treatment of Cervical Radiculopathy from Degenerative Disorders", and relevant literature. The specific details are as follows: 1) presence of cervicobrachialgia, manifested as pain in the neck, upper extremity, scapula, or periscapular region; accompanied simultaneously by symptoms and signs of cervical nerve root compression such as paresthesia, numbness, weakness, or abnormal deep tendon reflexes in the upper extremity. 2) having positive provocation tests such as spurling test, distraction test, and brachial plexus tension test. 3) pathologic level indicated by symptoms and signs in line with the impinged cervical nerve roots shown on magnetic resonance imaging. (2) Aged =40 to =75. (3) Cervicobrachialgia over the previous 24 h = 4 on numerical rating scale (NRS) (4) No angled manual traction experience. (5) signed informed consent.
Exclusion criteria
Exclusion criteria: (1) presence of other disorders that may cause pain or numbness in the upper extremity, neck, scapula, or periscapular region (e.g., periarthritis of shoulder, thoracic outlet syndrome, progressive muscular atrophy, cubital tunnel syndrome, lateral epicondylitis of humerus, carpal tunnel syndrome, angina pectoris, or cervical bone lesions such as cervical tuberculosis, cervical tumor, etc.). (2) having congenital spine diseases (scoliosis, abnormalities, developmental spinal stenosis, etc.), cervical surgery history, spinal cord injuries history, osteomyelitis, severe osteoporosis and other type of cervical spondylosis. (3) having contraindications against nonsteroidal anti-inflammatory drugs (NSAIDs) or opiates (e.g., hypersensitivity to NSAIDs or opiates, active or relapsing peptic ulcer or gastrointestinal bleeding, NSAIDs-related gastrointestinal bleeding or perforation, gastrointestinal obstruction, hepatic failure, renal failure with GFR<15mL/min/1.73m2, heart failure with New York Heart Association (NYHA) class IV, bronchial asthma, and on prescribed monoamine oxidase (MAO) inhibitors (Isocarboxazid, ,Moclobemide, Phenelzine, etc.) within 2 weeks). (4) having active malignancy. (5) planning surgery during the study period. (6) failing to understand and/or follow the study protocol due to disabilities (blindness, deafness, dumbness, intellectual disability, psychiatric disorder, etc.). (7) gravida, lactating women, or individuals planning to conceive during the trial. (8) participating in other clinical trials or planning to participate in other concurrent clinical studies. (9) having any other conditions investigators deem inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cumulative cervicobrachial pain during the trial; | — |
Secondary
| Measure | Time frame |
|---|---|
| cervicobrachial pain on numeric rating scale (NRS);upper extremity pain on numeric rating scale (NRS);neck pain on numeric rating scale (NRS);shoulder pain on numeric rating scale (NRS);numbness in arms on numeric rating scale (NRS);cervicobrachialgia-related nighttime awakenings;grip strength;quick disabilities of the arm, shoulder, and hand questionnaire (QuickDASH);neck disability index (NDI);NSAID consumption per period;opiate consumption per period;work productivity and activity impairment questionnaire: cervical radiculopathy (WPAI: CR);5-level version of the euroqol 5-dimensional descriptive system (EQ-5D-5L);Zung's self-rating depression scale (SDS);Zung's self-rating anxiety scale (SAS);patient global impression of change (PGIC);adverse event rate (AER);intervention cost based on a societal perspective (including direct costs and indirect costs);cumulative cervicobrachial pain during the trial (effect measure);quality-adjusted life year (QALY) (utility measure); | — |
Countries
China
Contacts
Public ContactDingkun Lin
Guangdong Province Hospital of Chinese Medicine
Outcome results
None listed