Clinical study to evaluate the efficacy and safety of heating and cooling combination therapeutic device in chronic low back pain

A randomized, single-blind, parallel designed Clinical study to evaluate the efficacy and safety of heating and cooling combination therapeutic device in patients with chronic low back pain

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001399

Enrollment

Registered

2015-03-02

Start date

2013-10-01

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : We find the most painful acupuncture point in lower back, then attach the probe of heating machine(maximum to 45?) or cooling machine(minimum to 15?) by turns. The treatment was appli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Low back pain in the last 3 months (12 weeks) or more 2. Low back pain rated over 40 mm on a 100 mm Visual Analog Scale (VAS) 3. Those who are reliable and willing to cooperate in this test, and obey the restrictions for the treatment period 4. An understanding of the objectives, methods and efficacy of the clinical trial, and willingness in completing the consent form

Exclusion criteria

Exclusion criteria: 1. Trauma to or surgery on the lumbar region within 6 months prior to enrollment 2. Patients who have systematic disease (e.g. cancer, infection, etc.) 3. Skin disease in pain area (e.g. burn, ecchymosis, etc.) 4. Psychiatric disease that may affect the collected data 5. A history of medication, oriental medical treatment, physiotherapy for treating low back pain within the last 4 weeks 6. Neurological disease, such as topical or whole body hypoesthesia in temperature sensation (e.g. stroke, peripheral neuropathy, etc.) 7. Hypersensitivity in heating and cooling stimulation 8. History of alcoholic or drug abuse within the last 12 months 9. Pregnant and lactating women 10. Participate in the other clinical trials within the last 3 months or after enroll this trial 11. When researchers evaluate that it is not appropriate to participate in this clinical test 12. Hypertension or participants who equip the electronic medical machine 13. Patients who have an acute disease

Design outcomes

Primary

Measure	Time frame
100mm Visual Analogue Scale (VAS)	—

Secondary

Measure	Time frame
Korean Oswestry disability index;Korean version of the Roland-Morris disability questionnaire;Traditional Medicine Back pain Questionnaire;Modified schöber test;Finger-to-floor distance;Finger-to-floor distance;Adverse event	—

Countries

Korea, Republic of

Contacts

Public ContactYoungdoo Choi

Dongguk University Ilsan Hospital

ydseeker@naver.com

Outcome results