The Evaluation of the Effectiveness of CAM Treatments for Lumbar and Cervical Spine Pain Patients Due to Spinal Disease

Jaseng Hospital of Korean Medicine

Status: Completed

Conditions: Lumbar and Cervical Pain

Treatments: Procedure: Bee-venom pharmacoacupuncture/pharmacoacupuncture; Procedure: Chuna manual therapy; Drug: herbal medicine; Procedure: Acupuncture

Study type: Observational

Funder types: Other

Identifiers

NCT01791933

JS-CT-2013-01

Details and patient eligibility

About

The purpose of this study is to investigate the effect of CAM treatments consisting of herbal medicine, Chuna manual therapy, pharmacoacupuncture, acupuncture on lumbar and cervical spine pain patients due to spinal disease.

Full description

"The purpose of this study is to investigate the effect of CAM treatments on lumbar and cervical spine pain patients due to spinal disease.

After subjects selected by screening, who receive CAM treatments 1-2times a week for more than 2 months and F/U at 1st, 2nd, 3rd month by meeting and F/U at 6nd, 12nd month by calling.

The CAM treatments used in this study consists of 120ml of Chuna herbal medicine(Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, and Cuscuta chinensis) and dried extracts in pill form(Cibotium barometz, Atractylodes japonica) taken twice a day 30 minutes after meals, Chuna manual therapy, intermuscular injections of bee-venom pharmacoacupuncture(Select 6 acupoints, concentration 10,000:1, 0.1 cc per acupoint, total amount injected 1.0 cc/session), acupuncture and allow for NSAID intake during the investigational period. The subject is allowed a maximum of 3 pills/day, taken at a minimum of 8 hrs apart. The number of pills taken will be measured at 4 wks after conclusion of treatment."

Enrollment: 111 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suffering from low back pain or Neck due to spinal disease Agree to the treatment of more than 2 months
• Age all(If under 18yr, Guardian's consent need)
• Volunteers do not have a problem with my speech as those who have signed the consent

Exclusion criteria

• Diagnosis of serious disease(s) which are possible causes of back pain such as malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equina compression, etc.
• Prior diagnosis of other chronic disease(s) which could affect effectiveness or interpretation of treatment results such as cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.
• Progressive neurologic deficit(s) or concurrent severe neurological symptoms Unsuitable for or at risk of complications from acupuncture treatment such as patients with clotting disorders, severe diabetes with risk of infection, serious cardiovascular disease, or undergoing anticoagulant treatment, etc.
• Under prescription of corticosteroids, immuno-suppressant drugs, psychiatric medicine, or other medication considered unsuitable for subjects by the researcher
• Experience of gastroenteric complications after taking NSAIDs or currently undergoing treatment for digestive disorders
• During pregnancy or suspected pregnancy
• Subjects considered unsuitable for clinical trial by the researcher

Trial design

111 participants in 1 patient group

CAM treatment

Treatment:

Procedure: Acupuncture

Drug: herbal medicine

Procedure: Chuna manual therapy

Procedure: Bee-venom pharmacoacupuncture/pharmacoacupuncture