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

The Evaluation of the Effectiveness of CAM Treatments for Lumbar and Cervical Spine Pain Patients Due to Spinal Disease : Prospective, Observational Study

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-gu
    • Seoul, Gangnam-gu, Korea, Republic of
      • Jaseng Hospital of Oriental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
NRS of low back pain or neck pain/NRS of radiating pain	Change from Baseline at 3rd month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jaseng Hospital of Korean Medicine
• Investigators: Principal Investigator: Jinho LEE, KMD, Jaseng Hospital of Korean Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: February 7, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Actual): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: CAM; LBP; Neck pain; Integrative package
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Bone Diseases; Neck Pain; Spinal Diseases
• Other Study ID Numbers: JS-CT-2013-01