Clinical trial NCT01875562: A Post-marketing Evaluation of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy
Official title: A Post-marketing Evaluation of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cervical Radiculopathy
Keywords: Neck pain
Cervical radiculopathy
Qishe Pill
Traditional Chinese Medicine
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Huadong Hospital
name: Shanghai East Hospital
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Shanghai No.1 Hospital
name: Shanghai No.6 Hospital
name: Changhai Hospital
First posted: 2013-06-12
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. Many patients use complementary and alternative medicine, including Traditional Chinese Medicine, to address their symptoms. The purpose of the present study is to examine effectiveness and safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in patients with 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 spondylopathic radiculopathy is nearly the same as that of nonspecific neck or back pain that can be found in most 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 is generally no randomized, placebo-controlled trial available comparing standard nonsurgical treatment. 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.According to the basic theory of traditional Chinese medicine (TCM), the obstruction of Qi flow and blood circulation in the neck area caused by 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, TCM doctors can analyze the specific pathogenic factors which cause neck pain. Accordingly they can then prescribe herbal formulae based on the effect and the main indications according to the principles of Chinese medicine. Natural substances, including herbal medicines, have been 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.

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: SF-36
timeFrame: changes from baseline at 4 weeks
measure: Neck Disability Index（NDI）
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: Urine routine
timeFrame: changes from baseline at 4 weeks
measure: Blood routine
timeFrame: changes from baseline at 4 weeks
measure: Number of participants with Concomitant medication
timeFrame: 4 weeks
measure: Number of participants with Adverse Events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital, Shanghai University of TCM
state: Shanghai
Study officials:
affiliation: Longhua Hospital
name: Yongjun Wang, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cui XJ, Sun YL, Zhang CQ, Wu T, Tan J, Zhu ZA, Chen YQ, Wang QG, Li M, Wang YJ. Post-Marketing Surveillance of Qishe Pill () Use for Management of Neck Pain in a Chinese Patient Cohort to Determine its Safety, Tolerability and Effectiveness. Chin J Integr Med. 2021 Jun;27(6):408-416. doi: 10.1007/s11655-021-2868-x. Epub 2021 Apr 21.