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

Completed

• Conditions: Lumbar and Cervical Pain
• Interventions: Drug: herbal medicine; Procedure: Chuna manual therapy; Procedure: Acupuncture; Procedure: Bee-venom pharmacoacupuncture/pharmacoacupuncture

• Registration Number: NCT01791933
• Lead Sponsor: Jaseng Hospital of Korean Medicine

Brief Summary

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.

Detailed 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."

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-15
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CAM treatment	Acupuncture	-
CAM treatment	Chuna manual therapy	-
CAM treatment	herbal medicine	-
CAM treatment	Bee-venom pharmacoacupuncture/pharmacoacupuncture	-

Primary Outcome Measures

Name	Time	Method
NRS of low back pain or neck pain/NRS of radiating pain	Change from Baseline at 3rd month

Secondary Outcome Measures

Name	Time	Method
ODI (Oswestry Disability Index)	Baseline, 1st month, 2nd month, 3rd month
Patient satisfaction	3rd month	Patient satisfaction of treatment
Job loss	Baseline, 1st month, 2nd month, 3rd month	Life activity of loss rate
painkiller intaken of times	Baseline, 3rd month
Adverse reactions	Baseline, 1st month, 2nd month, 3rd month

Trial Locations

Locations (1)

Jaseng Hospital of Oriental Medicine; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of