Cervical radiculopathy (CR)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Satisfied the following diagnostic criteria of cervical radiculopathy (CR), which was made according to the Expert Consensus on Cervical Radiculopathy Standardized Diagnosis and Treatment issued in China in 2015, the Diagnosis and Treatment of Cervical Radiculopathy from Degenerative Disorders released by North American Spine Society in 2011, and pertinent literatures about CR diagnostic accuracy: (1) suffering from cervicobrachialgia, accompanying numbness, weakness, and abnormal deep tendon reflexes in the upper limb (2) having positive provocation tests such as spurling test, distraction test, and brachial plexus tension test (3)the symptoms and signs suffering from in line with the impinged cervical nerve roots shown on magnetic resonance imaging (MRI) 2. Being aged >= 45 to <= 75 3. Cervicobrachialgia pain level over the previous 24 hours = 4 on numerical rating scale (NRS) 4. Having not angled manual traction experience 5. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Having co-morbidities that could contribute to cervicobrachialgia (e.g., shoulder bursitis, thoracic outlet syndrome, spinal muscular atrophy, cubital tunnel syndrome, tennis elbow, carpal tunnel syndrome, angina pectoris and pathological changes of cervical vertebrae like tuberculosis, neoplasms) 2.Having congenital spine diseases (scoliosis, abnormalities, etc.), cervical surgery history, spinal cord injuries history, osteomyelitis, severe osteoporosis and other type of cervical spondylosis (cervical myelopathy, mixed-type cervical spondylosis, etc.) 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 within 2 weeks) 4.Having active malignancy 5.Planning surgery during the study period 6.Failing to understand and follow the study protocol due to disabilities (blindness, deafness,dumbness, intellectual disability, mental disability, etc.) 7.Gravida, lactating women, or individuals planning to conceive during the trial 8.Participating who are currently participating or planning to participating in other concurrent clinical studies 9.Having other conditions considered inappropriate by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Enrollment rate (ER);Weekly enrollment rate (WR);Drop-out rate (DR);Retention rate (DR);Adherence rate (AR);Completion rate of intervention effect-related outcome measures;Completion rate of intervention cost-related outcome measures ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cervicobrachial pain;Pain in upper limb ;Pain in neck;Pain in shoulder ;Mumbness in upper limb ;Grip strength;Upper limb disability;Neck disability;Nonsteroidal anti-inflammatory drug (NSAID) consumed per period;Opiates consumed per period;Work-productivity impairment;Quality of life;Depressed status;Anxiety state;Aadverse event rates (AER);Adverse reaction rates (AER);Intervention cost based on a societal perspective (including direct medical costs, direct non-medical costs and direct medical costs); | — |
Countries
China
Contacts
Guangdong Provincial Hospital of Chinese Medicine