Qishe Pill for Cervical Radiculopathy

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Changchun University of Chinese Medicine; Fudan University; Lanzhou Hospital of Traditional Chinese Medicine; Suzhou Hospital of Traditional Chinese Medicine

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