Clinical trial NCT01500967: Shi-style Cervical Manipulations for Cervical Radiculopathy
Official title: Shi-style Cervical Manipulations for Cervical Radiculopathy-A Randomized Single Blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Radiculopathy
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Tianjin University of Traditional Chinese Medicine
First posted: 2011-12-29
Enrollment: 648
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neck pain and related problems occur frequently in modern societies and have a considerable impact on individuals and the society. Cervical radiculopathy (CR) generally presents with pain, numbness, or weakness in a dermatomal distribution. CR results from impingement on a nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation. Various studies have shown that nonoperative management for CR is effective, such as medications, physical therapy, Spinal manipulation, traction, acupuncture, collar immobilization and epidural steroid injections. Spinal manipulation is one of the manual techniques for treating mechanical neck pain. No high-quality evidence has proved the effectiveness of manipulative therapy in the treatment of cervical radiculopathy. However, limited evidence suggests that manipulation may provide short-term benefit in the treatment of neck pain, cervicogenic headaches and radicular symptoms. Few complications, such as worsening radiculopathy, myelopathy, and spinal cord injury, may occur. Spinal massage manipulation is used for centuries in China. Many patients with cervical disc disease are increasingly turning to manipulations to alleviate their symptoms and reduce the side effects of medications. The goal of this study is to determine the efficacy of a spinal manipulation, three steps and nine manipulations, on treating with the cervical radiculopathy.

Detailed description: Radiculopathy generally presents with pain, numbness, or weakness in a dermatomal distribution. Causative factors include an acute nucleus pulposus herniation, spondylitic changes around the foramen causing nerve compression, or a combination of these.

Cervical radiculopathy results from impingement on a nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation. Frequent complaints include painful neck movements, radicular pain, paraspinal muscle spasm, muscle weakness, and diminished deep tendon reflexes (Radhakrishnan K, 1994). Radiculopathy tends to produce substantial limitation of movement of the head and neck.

The goals of any treatment plan should be well defined. Specifically, it should be the goal of the treating physician to relieve pain, improve function, and prevent recurrence. Although some symptomatic patients meet surgical criteria, most patients are clearly candidates for nonoperative treatment. Treatment modalities for radiculopathy include rest, medications, physical therapy, manipulation, injections, and patient education.

Various studies have shown that nonoperative management of cervical radiculopathy leaves a substantial minority of patients with persistently troublesome symptoms (Lees F, 1963,41, 42). Lees and Turner found that in two thirds of patients, symptoms tend to persist in the absence of surgical treatment (Lees F, 1963). DePalma and Subin found that of 255 patients treated nonoperatively, only 29% experienced complete symptom relief (Radhakrishnan K, 1994,41). Better outcomes with nonoperative management, however, have been observed in studies that were based in physiotherapy centers than those from surgical series (Radhakrishnan K, 1994).

Spinal balance is the way Professor Shi Qi " Arthralgia theory" and " The theory of muscle imbalance " theory under the guidance of mix martial arts, Wang Shi expertise and Traumatology, combined with clinical experience and experimental research. Rub, take, roll, put, loose, pull, friction, shaking, pinching, so called "nine manipulations." It can adjust qi and blood, phlegm stasis, Dredge meridians, spasm pain, support organs, alleviate, correct cervical dynamic and static imbalance. Three steps and nine manipulations is the common method of treatment of Professor Shi Qi for cervical disease .

Eligibility criteria: Inclusion Criteria:

* Informed consent and signed an informed consent;
* aged 18 to 65 year-old male or female ;
* appear cervical nerve root symptoms typical of 3 months to 5 years;
* VAS pain greater than 30 mm.
* positive for one of the following :Brachial plexus traction test, Foraminal compression test, Neck rotation test is less than 60 degrees, Foraminal separation test, Decreased muscle strength.

Exclusion Criteria:

* nerve root in the past received surgical treatment of cervical or neck trauma;
* with obvious symptoms of vertigo, TCD examination there was abnormal;
* signs and symptoms of spinal cord compression, MRI found that spinal cord oppressors\[e\];
* pregnant women, lactating women;
* can not attend follow-up (such as six months or less distance of immigrant relocation plan, no mobile phones and other communication tools, etc.), and no ability to participate in six months follow-up of patients;
* currently participating in cervical spondylosis associated with other clinical trials;
* hepatic, renal, hematopoietic system, endocrine system, cardiovascular, nervous system, primary and other serious diseases, tuberculosis, vertebral deformities, cancer and mental illness;
* There are opioid analgesics, sedative hypnotics and alcohol abuse history;
* those who can not read and write Chinese.
* the past two weeks received RF, minimally invasive , ozone , a small knife , or other manual therapy and Closed injection treatment.
* vertebral displacement, forward, backward or lateral horizontal displacement \> 3 mm, the angulation between adjacent intervertebral \> 11 °.

Primary outcomes:
measure: Neck Disability Index
timeFrame: changes from baseline at 2 weeks
Secondary outcomes:
measure: SF 36
timeFrame: changes from baseline at 2 weeks
measure: Visual Analogue Scale
timeFrame: changes from baseline at 2 weeks
measure: Neck Disability Index
timeFrame: changes from baseline at 4 weeks
measure: SF 36
timeFrame: 4 weeks
measure: Visual Analogue Scale
timeFrame: 4 weeks
measure: Neck Disability Index
timeFrame: changes from baseline at 3 months
measure: SF 36
timeFrame: changes from baseline at 3 months
measure: Visual Analogue Scale
timeFrame: changes from baseline at 3 months
measure: Neck Disability Index
timeFrame: changes from baseline at 6 months
measure: SF 36
timeFrame: changes from baseline at 6 months
measure: Visual Analogue Scale
timeFrame: changes from baseline at 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Yongjun Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: