Clinical Trial: Qishe Pill for Cervical Radiculopathy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effectiveness of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy: a Randomized, Double-blind, Placebo-controlled, Multicentre Trial

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 Summary:

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, l
Sponsor: Shanghai University of Traditional Chinese Medicine

Current Primary Outcome:

  • pain severity(measured with a visual analogue scale, VAS) [ Time Frame: changes from baseline at 2 weeks ]
    Operationally, the VAS score display as a horizontal line, 100 mm in length, word descriptors anchored at each end. The patient marks on the line the point that they feel represents their perception of their current pain. The VAS score is then determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
  • pain severity(measured with a visual analogue scale, VAS) [ Time Frame: changes from baseline at 4 weeks ]
    Operationally, the VAS score display as a horizontal line, 100 mm in length, word descriptors anchored at each end. The patient marks on the line the point that they feel represents their perception of their current pain. The VAS score is then determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.


Original Primary Outcome: Neck Disability Index [ Time Frame: changes from baseline at 4 weeks ]

Current Secondary Outcome:

  • SF-36 [ Time Frame: changes from baseline at 2 weeks ]
    a composite of functional status
  • Neck Disability Index（NDI） [ Time Frame: changes from baseline at 2 weeks ]
    a composite of functional status
  • Patient satisfaction degree [ Time Frame: Changes from baseline at 4 weeks ]
    To evaluate satisfaction
  • SF-36 [ Time Frame: changes from baseline at 4 weeks ]
    a composite of functional status
  • Neck Disability Index（NDI） [ Time Frame: changes from baseline at 4 weeks ]
    a composite of functional status
  • Neck Disability Index（NDI） [ Time Frame: changes from baseline at 3 months ]
    a composite of functional status
  • Neck Disability Index（NDI） [ Time Frame: changes from baseline at 6 months ]
    a composite of functional status
  • Safety evaluation [ Time Frame: changes from baseline at 4 weeks ]
    Safety evaluation
  • The medicine issue [ Time Frame: changes from baseline at 2 weeks ]
  • Compliance assessment [ Time Frame: changes from baseline at 2 weeks ]
    To evaluate compliance
  • Compliance assessment [ Time Frame: changes from baseline at 4 weeks ]
    To evaluate compliance
  • Concomitant medication [ Time Frame: changes from baseline at 2 weeks ]
  • Concomitant medication [ Time Frame: changes from baseline at 4 weeks ]
  • X-ray(frontal and lateral) [ Time Frame: changes from baseline at 4 weeks ]
  • Kidney function test [ Time Frame: changes from baseline at 4 weeks ]
  • Liver function test [ Time Frame: changes from baseline at 4 weeks ]
  • ECG [ Time Frame: changes from baseline at 4 weeks ]
  • Occult Blood [ Time Frame: changes from baseline at 4 weeks ]
  • Excrement routine [ Time Frame: changes from baseline at 4 weeks ]
  • Urine routine [ Time Frame: changes from baseline at 4 weeks ]
  • Blood routine [ Time Frame: changes from baseline at 4 weeks ]


Original Secondary Outcome:

  • SF-36 [ Time Frame: 4 weeks ]
  • satisfaction [ Time Frame: 4 weeks ]
  • Sick leave [ Time Frame: 4 weeks ]
  • Alt [ Time Frame: 4 weeks ]
  • Visual Analogue Scale [ Time Frame: 4 weeks ]
  • Neck Disability Index [ Time Frame: changes from baseline at 12 weeks ]
  • Neck Disability Index [ Time Frame: changes from baseline at 24 weeks ]
  • SF 36 [ Time Frame: 12 weeks ]
  • SF 36 [ Time Frame: 24 weeks ]
  • satisfaction [ Time Frame: 24 weeks ]
  • Sick leave [ Time Frame: 12 weeks ]
  • Visual Analogue Scale [ Time Frame: 12 weeks ]
  • Visual Analogue Scale [ Time Frame: 24 weeks ]
  • BUN [ Time Frame: 4 weeks ]
  • Cr [ Time Frame: 4 weeks ]
  • Alt [ Time Frame: 12 weeks ]
  • Bun [ Time Frame: 12 weeks ]
  • Br [ Time Frame: 12 weeks ]


Information By: Shanghai University of Traditional Chinese Medicine

Dates:
Date Received: December 14, 2010
Date Started: March 2012
Date Completion: June 2015
Last Updated: November 11, 2014
Last Verified: November 2014