A Post-marketing Evaluation of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy

• Status: Unknown status
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Changhai Hospital; Huadong Hospital; Shanghai 9th People's Hospital; Shanghai East Hospital; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Shanghai No.1 Hospital; Shanghai No.6 Hospital

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