Clinical trial NCT01791933: The Evaluation of the Effectiveness of CAM Treatments for Lumbar and Cervical Spine Pain Patients Due to Spinal Disease
Official title: The Evaluation of the Effectiveness of CAM Treatments for Lumbar and Cervical Spine Pain Patients Due to Spinal Disease : Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar and Cervical Pain
Keywords: LBP
Neck pain
Integrative package
CAM
Lead sponsor: Jaseng Hospital of Korean Medicine
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 111
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patient sampling within lumbar and cervical spine pain patients due to spinal disease.

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."

Eligibility criteria: 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

Primary outcomes:
measure: NRS of low back pain or neck pain/NRS of radiating pain
timeFrame: Change from Baseline at 3rd month
Secondary outcomes:
measure: ODI (Oswestry Disability Index)
timeFrame: Baseline, 1st month, 2nd month, 3rd month
measure: Patient satisfaction
timeFrame: 3rd month
measure: Job loss
timeFrame: Baseline, 1st month, 2nd month, 3rd month
measure: painkiller intaken of times
timeFrame: Baseline, 3rd month
measure: Adverse reactions
timeFrame: Baseline, 1st month, 2nd month, 3rd month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Oriental Medicine
state: Gangnam-gu
Study officials:
affiliation: Jaseng Hospital of Korean Medicine
name: Jinho LEE, KMD
role: PRINCIPAL_INVESTIGATOR
References: