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

Lumbar and Cervical Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791933
• Other study ID #: JS-CT-2013-01
• Status: Completed
• Start date: February 2013
• Est. completion date: October 2013

Study information

• Verified date: November 2018
• Source: Jaseng Hospital of Korean Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lumbar and Cervical Pain
• Neck Pain
• Spinal Diseases

Intervention

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.
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Jaseng Hospital of Oriental Medicine	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Hospital of Korean Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS of low back pain or neck pain/NRS of radiating pain		Change from Baseline at 3rd month
Secondary	ODI (Oswestry Disability Index)		Baseline, 1st month, 2nd month, 3rd month
Secondary	Patient satisfaction	Patient satisfaction of treatment	3rd month
Secondary	Job loss	Life activity of loss rate	Baseline, 1st month, 2nd month, 3rd month
Secondary	painkiller intaken of times		Baseline, 3rd month
Secondary	Adverse reactions		Baseline, 1st month, 2nd month, 3rd month