Qishe Pill for Cervical Radiculopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Shanghai University of Traditional Chinese Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01274936
First received: December 14, 2010
Last updated: January 11, 2011
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Cervical Radiculopathy
Drug: Qishe Pill
Drug: Qishe Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Qishe Pill for Cervical Radiculopathy: a Randomized, Double-blind, Placebo-controlled Trail

Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Neck Disability Index [ Time Frame: changes from baseline at 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF 36 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Sick leave [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Alt [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Visual Analogue Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Neck Disability Index [ Time Frame: changes from baseline at 12 weeks ] [ Designated as safety issue: No ]
  • Neck Disability Index [ Time Frame: changes from baseline at 24 weeks ] [ Designated as safety issue: No ]
  • SF 36 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • SF 36 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • satisfaction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Sick leave [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Visual Analogue Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Visual Analogue Scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • BUN [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Cr [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Alt [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Bun [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Br [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: April 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Qishe Drug: Qishe Pill
Pill, 25, twice a day, four weeks
Other Name: Qishe Pill
Placebo Comparator: Control
Qishe Placebo
Drug: Qishe Placebo
Pill, 25, twice a day, four weeks
Other Name: Qishe Placebo

Detailed Description:

Radiculopathy generally presents with pain, numbness, or weakness in a dermatomal distribution. Causative factors include an acute nucleus pulposus herniation, spondylitic changes around the foramen causing nerve compression, or a combination of these.

Cervical radiculopathy results from impingement on a nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation. Frequent complaints include painful neck movements, radicular pain, paraspinal muscle spasm, muscle weakness, and diminished deep tendon reflexes (Radhakrishnan K, 1994). Radiculopathy tends to produce substantial limitation of movement of the head and neck.

The goals of any treatment plan should be well defined. Specifically, it should be the goal of the treating physician to relieve pain, improve function, and prevent recurrence. Although some symptomatic patients meet surgical criteria, most patients are clearly candidates for nonoperative treatment. Treatment modalities for radiculopathy include rest, medications, physical therapy, manipulation, injections, and patient education.

Various studies have shown that nonoperative management of cervical radiculopathy leaves a substantial minority of patients with persistently troublesome symptoms (Lees F, 1963,41, 42). Lees and Turner found that in two thirds of patients, symptoms tend to persist in the absence of surgical treatment (Lees F, 1963). DePalma and Subin found that of 255 patients treated nonoperatively, only 29% experienced complete symptom relief (Radhakrishnan K, 1994,41). Better outcomes with nonoperative management, however, have been observed in studies that were based in physiotherapy centers than those from surgical series (Radhakrishnan K, 1994).

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 (Dillin W, 1992).

Herbal medicines have been used for centuries in China. As a complementary and alternative medicine (CAM), herbal medicines have the potential to avoid the harshness of drugs and surgery (Bensoussan 1996). In China, many patients with cervical disc disease are increasingly turning to CAM, including herbal medicines, to alleviate their symptoms and reduce the side effects of medications. However, Chinese herbal medicines are not totally without side effects and some patients who take them might experience nausea, vomiting, or dizziness.

The goal of this study is to determine the efficacy and efficacy of an herbal medicine, Qishe Pill, to treat cervical radiculopathy.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 40 mm measured by a visual analogue scale (VAS 0-100 mm).
  • normal mobility of the cervical spine.
  • intellectual and physical ability to participate in the study.
  • informed consent.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274936

Contacts
Contact: Xuejun Cui, Dr 13917715524@139.com

Locations
China
Longhua Hospital Not yet recruiting
Shanghai, China, 200032
Contact: Xuejun Cui       13917715524@139.com   
Principal Investigator: Wen Mo, Dr         
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
Principal Investigator: Yongjun Wang, Dr Longhua Hospital
  More Information

No publications provided by Shanghai University of Traditional Chinese Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yongjun Wang, Longhua Hospital
ClinicalTrials.gov Identifier: NCT01274936     History of Changes
Other Study ID Numbers: Qishe
Study First Received: December 14, 2010
Last Updated: January 11, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014