Clinical trial NCT01274936: Qishe Pill for Cervical Radiculopathy
Official title: Effectiveness of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy: a Randomized, Double-blind, Placebo-controlled, Multicentre Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Radiculopathy
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Fudan University
name: Changchun University of Chinese Medicine
name: Lanzhou Hospital of Traditional Chinese Medicine
name: Suzhou Hospital of Traditional Chinese Medicine
First posted: 2011-01-12
Enrollment: 240
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: Radiculopathy generally presents with pain, numbness, or weakness in a dermatomal distribution. Cervical radiculopathy results from impingement on a nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation. Specifically, it should be the goal of the treating physician to relieve pain, improve function, and prevent recurrence. Various studies have shown that nonoperative management of cervical radiculopathy leaves a substantial minority of patients with persistently troublesome symptoms. Pharmacologic agents treat the underlying condition and provide symptomatic relief. The various classes of medications used to treat radiculopathy include steroids, nonsteroidal antiinflammatory drugs (NSAIDs), muscle relaxants, narcotics, and antidepressants. Herbal medicines have been used for centuries in China. In China, many patients with cervical disc disease are increasingly turning to herbal medicines to alleviate their symptoms and reduce the side effects of medications. The goal of this study is to determine the efficacy and efficacy of an herbal medicine, Qishe Pill, to treat cervical radiculopathy.

Detailed description: Cervical radiculopathy is a distinct consideration in the evaluation of any patients who have neck pain and may be defined simply as an abnormality of a nerve root, which originates in the cervical spine. The initial approach to the management of cervical spondylopathy radiculopathy is nearly the same that the nonspecific neck or back pain can be found in most of patients. Conservative treatments include non-steroidal anti-inflammatory drugs (NSAIDs), narcotics, muscle relaxants, physical therapy and transcutaneous electrical nerve stimulation (TENS). The main objectives of conservative treatments are to relieve pain, improve function and improve health-related quality of life.However, these treatments for cervical radiculopathy are limited by their modest effectiveness. Surgical treatment for cervical disc disease is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. In terms of pharmacotherapy, there generally is no randomized, placebo-controlled trial available comparing the standard nonsurgical treatments. Therefore, care plans should be designed principally based on accumulated experience, the services available locally, and the respective preferences of patients. Treatment plans are developed to alleviate pain, improve function, and prevent recurrences.

As a complementary and alternative medicine (CAM), herbal medicines have the potential to avoid the adverse effects of medications and surgery.In the basic theory of traditional Chinese medicine (TCM), the obstruction of Qi flow and blood circulation in the neck area caused by some pathogenic factors, such as "Feng"(wind), "Han"(cold), "Shi"(dampness), invading the neck, induces cervical degenerative disc diseases which are the cause of cervical radiculopathy. According to the four traditional methods of diagnosis - observation, listening, interrogation, and pulse-taking, on patients, TCM doctors can analyze the certain pathogenic factors which cause neck pain. And then they will prescribe herbal formulae based on the effect and the main indications of Chinese medicine. Natural substances, including herbal medicines, have being used to promote healing and alleviate neck pain in western countries. Previous studies have demonstrated that some active substances in herbal medicine can promote Qi flow and blood circulation to alleviate pain.

A number of studies on the effects of the Chinese herbal medicine on cervical radiculopathy have been proposed, but useful empirical research is insufficiency. For chronic neck pain with or without radicular symptoms, there is low quality evidence that herbal is more effective than placebo for pain relief, which is measured at the end of the treatment. However, the size of the studies was small and the effect was measured in the short-term. Further research is very likely to change both the effect size and our confidence in the results. There is a need for trials with adequate numbers of participants that address long-term efficacy or effectiveness of herbal medicine compared to placebo.

Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, Calculus Bovis Artifactus. Using a well-designed clinical trial, we will survey the effectiveness of concurrent use of this remedy in relieving neck pain. Therefore, the present study is to examine effectiveness and safety of Qishe Pill, a compound traditional Chinese herbal medicine, on neck pain in cervical spondylotic radiculopathy in a randomized, double-blind, placebo-controlled trial. Results of this study will provide evidence regarding the value of the Qishe Pill as an intervention to alleviate neck pain caused by cervical radiculopathy.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of chronic neck pain since at least 3 months and complaints for a maximum duration of 5 years.
* average pain intensity of the last 7 days more or equal to 25 points measured by a Neck Disability Index.
* intellectual and physical ability to participate in the study.
* informed consent.
* One positive result of Brachial Plexus Traction Test, Cervical compression test or Cervical distraction test

Exclusion Criteria:

* cervical pain related to malignancy
* cervical pain due to an accident
* inflammatory joint disorders
* previous spine surgery
* protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology
* actually doing or planning to do other regular physical exercise during the study with possible positive effects on neck pain - such as swimming, yoga, pilates, tai chi, etc.
* use of pain drugs for other diseases (\> 1x/week)
* pregnancy
* severe chronic or acute disease interfering with therapy attendance
* alcohol or substance abuse
* participation in another clinical trial in the last 6 months before study entry

Primary outcomes:
measure: pain severity(measured with a visual analogue scale, VAS)
timeFrame: changes from baseline at 2 weeks
measure: pain severity(measured with a visual analogue scale, VAS)
timeFrame: changes from baseline at 4 weeks
Secondary outcomes:
measure: SF-36
timeFrame: changes from baseline at 2 weeks
measure: Neck Disability Index（NDI）
timeFrame: changes from baseline at 2 weeks
measure: Patient satisfaction degree
timeFrame: Changes from baseline at 4 weeks
measure: SF-36
timeFrame: changes from baseline at 4 weeks
measure: Neck Disability Index（NDI）
timeFrame: changes from baseline at 4 weeks
measure: Neck Disability Index（NDI）
timeFrame: changes from baseline at 3 months
measure: Neck Disability Index（NDI）
timeFrame: changes from baseline at 6 months
measure: Safety evaluation
timeFrame: changes from baseline at 4 weeks
measure: The medicine issue
timeFrame: changes from baseline at 2 weeks
measure: Compliance assessment
timeFrame: changes from baseline at 2 weeks
measure: Compliance assessment
timeFrame: changes from baseline at 4 weeks
measure: Concomitant medication
timeFrame: changes from baseline at 2 weeks
measure: Concomitant medication
timeFrame: changes from baseline at 4 weeks
measure: X-ray(frontal and lateral)
timeFrame: changes from baseline at 4 weeks
measure: Kidney function test
timeFrame: changes from baseline at 4 weeks
measure: Liver function test
timeFrame: changes from baseline at 4 weeks
measure: ECG
timeFrame: changes from baseline at 4 weeks
measure: Occult Blood
timeFrame: changes from baseline at 4 weeks
measure: Excrement routine
timeFrame: changes from baseline at 4 weeks
measure: Urine routine
timeFrame: changes from baseline at 4 weeks
measure: Blood routine
timeFrame: changes from baseline at 4 weeks
Other outcomes:
Locations:
city: Changchun
country: China
facility: No.1 Hospital, Changchun University of TCM
city: Lanzhou
country: China
facility: Gansu Hospital of TCM
city: Shanghai
country: China
facility: Huadong Hospital
city: Shanghai
country: China
facility: Longhua Hospital
city: Suzhou
country: China
facility: Suzhou Hospital of TCM
Study officials:
affiliation: Longhua Hospital
name: Yongjun Wang, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cui XJ, Sun YL, You SF, Mo W, Lu S, Shi Q, Wang YJ. Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: study protocol for a randomized controlled trial. Trials. 2013 Oct 7;14:322. doi: 10.1186/1745-6215-14-322.