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

NCT01791933 | Completed DMC

• 1 other identifier: JS-CT-2013-01
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar and Cervical Pain

Keywords

LBP; Neck pain; Integrative package; CAM

Outcome Measures

Primary Outcomes (1)

• NRS of low back pain or neck pain/NRS of radiating pain

  Change from Baseline at 3rd month

Secondary Outcomes (5)

• ODI (Oswestry Disability Index)

  Baseline, 1st month, 2nd month, 3rd month

• Patient satisfaction

  3rd month

• Job loss

  Baseline, 1st month, 2nd month, 3rd month

• painkiller intaken of times

  Baseline, 3rd month

• Adverse reactions

  Baseline, 1st month, 2nd month, 3rd month

Study Arms (1)

CAM treatment

Drug: herbal medicine; Procedure: Chuna manual therapy; Procedure: Acupuncture; Procedure: Bee-venom pharmacoacupuncture/pharmacoacupuncture

Interventions

herbal medicine DRUG

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

CAM treatment

Chuna manual therapy PROCEDURE

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.

Also known as: Chuna manipulation

CAM treatment

Acupuncture PROCEDURE

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

CAM treatment

Bee-venom pharmacoacupuncture/pharmacoacupuncture PROCEDURE

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

Also known as: BV, Bee-venom therapy

CAM treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Hospital of Korean Medicine: lead

Study Sites (1)

Jaseng Hospital of Oriental Medicine

Seoul, Gangnam-gu, South Korea

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Phytotherapy; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jinho LEE, KMD

  Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 15, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

KR (1)