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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jaseng Hospital of Korean Medicine
ClinicalTrials.gov Identifier:
NCT01791933
First received: February 7, 2013
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Lumbar and Cervical Pain
Drug: herbal medicine
Procedure: Chuna manual therapy
Procedure: Acupuncture
Procedure: Bee-venom pharmacoacupuncture/pharmacoacupuncture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Evaluation of the Effectiveness of CAM Treatments for Lumbar and Cervical Spine Pain Patients Due to Spinal Disease : Prospective, Observational Study

Resource links provided by NLM:


Further study details as provided by Jaseng Hospital of Korean Medicine:

Primary Outcome Measures:
  • NRS of low back pain or neck pain/NRS of radiating pain [ Time Frame: Change from Baseline at 3rd month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ODI (Oswestry Disability Index) [ Time Frame: Baseline, 1st month, 2nd month, 3rd month ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 3rd month ] [ Designated as safety issue: No ]
    Patient satisfaction of treatment

  • Job loss [ Time Frame: Baseline, 1st month, 2nd month, 3rd month ] [ Designated as safety issue: No ]
    Life activity of loss rate

  • painkiller intaken of times [ Time Frame: Baseline, 3rd month ] [ Designated as safety issue: No ]
  • Adverse reactions [ Time Frame: Baseline, 1st month, 2nd month, 3rd month ] [ Designated as safety issue: Yes ]

Enrollment: 111
Study Start Date: February 2013
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CAM treatment Drug: herbal medicine
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) taken twice a day 30 minutes after meals for more than 2 months
Procedure: Chuna manual therapy
A type of Korean spinal manual therapy administered 5~10 minutes at physician's discretion 1-2times a week for more than 2 months Applies mobilization using High-Velocity, Low-Amplitude thrusts to joints slightly beyond the passive ROM and manual force within the passive ROM without thrusts.
Other Name: Chuna manipulation
Procedure: Acupuncture
Acupuncture using sterilized disposable needles, sized 0.30X40mm. Needles left for 15~20 minutes, selecting 6 acupoints(both BL23, BL24, BL25 ) and other acupoints at physician's discretion, using a total of 10~20 acupoints 1-2times a week for more than 2 months
Procedure: Bee-venom pharmacoacupuncture/pharmacoacupuncture
pharmacoacupuncture using 30G sterilized bee venom. Selecting 6 acupoints(both BL23, BL24, BL25) and other acupoints at physician's discretion, concentration 10,000:1, 0.1 cc per acupoint, total amount injected 1.0 cc/session 1-2times a week for more than 2 months
Other Names:
  • BV
  • Bee-venom therapy

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Consecutive patient sampling within lumbar and cervical spine pain patients due to spinal disease.

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
  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: NCT01791933

Locations
Korea, Republic of
Jaseng Hospital of Oriental Medicine
Seoul, Gangnam-gu, Korea, Republic of
Sponsors and Collaborators
Jaseng Hospital of Korean Medicine
Investigators
Principal Investigator: Jinho LEE, KMD Jaseng Hospital of Korean Medicine
  More Information

No publications provided

Responsible Party: Jaseng Hospital of Korean Medicine
ClinicalTrials.gov Identifier: NCT01791933     History of Changes
Other Study ID Numbers: JS-CT-2013-01
Study First Received: February 7, 2013
Last Updated: October 29, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Jaseng Hospital of Korean Medicine:
LBP
Neck pain
Integrative package
CAM

Additional relevant MeSH terms:
Neck Pain
Spinal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 27, 2014