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Therapeutic Effects of Monochromatic Infrared Energy Therapy on Patients With Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT01920971
Recruitment Status : Unknown
Verified August 2013 by Ru-Lan Hsieh, Taipei Medical University.
Recruitment status was:  Recruiting
First Posted : August 12, 2013
Last Update Posted : August 12, 2013
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Ru-Lan Hsieh, Taipei Medical University

Brief Summary:
To investigate the effects of short-term and medium-term monochromatic infrared energy therapy on patients with chronic low back pain (LBP) according to the International Classification of Functioning, Disability and Health.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Radiation: infrared therapy Phase 4

Detailed Description:

Methods:70 participants with chronic LBP will be included. Participants received six 40-min sessions of hot pack therapy combined active or placebo monochromatic infrared energy therapy over the low back (wavelength = 890 nm, radiant power output = 6.24 W, power density = 34.7 milliwatt/cm2 for 40 min, total energy 83.2 J/cm2) followed by 20-min supervised therapeutic exercise, for 3 times per week for a 4-week duration. Patients will be assessed at before treatment and follow-up assessments, including after 2 week of treatment; after 4 weeks of treatment; and 1 and 3 months, respectively, after treatment is terminated.

Main Outcome Measures: Patients will be assessed periodically with pain, Multidimensional Fatigue Inventory, postural stability (using the postural stability evaluation system: Biodex Stability System), and Fear-Avoidance Behavior Questionnaire.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Therapeutic Effects of Monochromatic Infrared Energy Therapy on Patients With Chronic Low Back Pain: A Double-Blind, Randomized, Placebo-Controlled Study
Study Start Date : August 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: inferared therapy
hot pack therapy combined active infrared therapy over the low back (wavelength = 890 nm, radiant power output = 6.24 W, power density = 34.7 milliWatts/cm2 for 40 min, total energy 83.2 J/cm2) followed by 20-min supervised therapeutic exercise, for 3 times per week for a 4-week duration. Patients will be assessed at before treatment and follow-up assessments, including after 2 week of treatment; after 4 weeks of treatment; and 1 and 3 months, respectively, after treatment is terminated.
Radiation: infrared therapy
wavelength = 890 nm, radiant power output = 6.24 W, power density = 34.7 milliWatts/cm2 for 40 min, total energy 83.2 J/cm2
Other Name: monochromatic infrared energy therapy

Placebo Comparator: placebo infrared therapy
hot pack therapy combined placebo infrared therapy over the low back (wavelength = 890 nm, radiant power output = 6.24 W, power density = 34.7 milliWatts/cm2 for 40 min, total energy 83.2 J/cm2) followed by 20-min supervised therapeutic exercise, for 3 times per week for a 4-week duration. Patients will be assessed at before treatment and follow-up assessments, including after 2 week of treatment; after 4 weeks of treatment; and 1 and 3 months, respectively, after treatment is terminated.
Radiation: infrared therapy
wavelength = 890 nm, radiant power output = 6.24 W, power density = 34.7 milliWatts/cm2 for 40 min, total energy 83.2 J/cm2
Other Name: monochromatic infrared energy therapy




Primary Outcome Measures :
  1. changes of pain [ Time Frame: participants will be evaluated at before treatment, and followed at treatment for 2 and 4 weeks, and 1 and 3 months after treatment ]
    Participants received six 40-min sessions of hot pack therapy combined active or placebo monochromatic infrared energy therapy over the low back (wavelength = 890 nm, radiant power output = 6.24 W, power density = 34.7 milliWatts/cm2 for 40 min, total energy 83.2 J/cm2) followed by 20-min supervised therapeutic exercise, for 3 times per week for a 4-week duration.


Secondary Outcome Measures :
  1. changes of Multidimensional Fatigue Inventory [ Time Frame: participants will be evaluated at before treatment, and followed at treatment for 2 and 4 weeks, and 1 and 3 months after treatment ]
  2. changes of postural stability [ Time Frame: participants will be evaluated at before treatment, and followed at treatment for 2 and 4 weeks, and 1 and 3 months after treatment ]
    using the postural stability evaluation system: Biodex Stability System

  3. changes of fear avoidance behavior [ Time Frame: participants will be evaluated at before treatment, and followed at treatment for 2 and 4 weeks, and 1 and 3 months after treatment ]
    using Fear-Avoidance Behavior Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

participants with chronic low back pain

Exclusion Criteria:

  1. low back pain accompanied by specific pathological conditions, such as an infection,inflammation, rheumatoid arthritis, fracture, or tumor;
  2. a self-reported history of malignancy, vertigo, stroke, or other condition that may impair postural stability;
  3. a history of low back surgery with an implant;
  4. pregnancy or plans to become pregnant during the course of the study;
  5. having received concurrent treatment for low back pain by another health care professional

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920971


Contacts
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Contact: Ru-Lan Hsieh, MD 886-2-28332211 ext 2538 M001052@ms.skh.org.tw

Locations
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Taiwan
Shin Kong Wu Ho-Su Memorial Hospital Recruiting
Taipei, Taiwan, 111-01
Contact: Ru-Lan Hsieh, MD    886-2-28332211 ext 2538    M001052@ms.skh.org.tw   
Principal Investigator: Ru-Lan Hsieh, MD         
Sponsors and Collaborators
Taipei Medical University
National Science Council, Taiwan
Investigators
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Principal Investigator: Ru-Lan Hsieh, MD Shin Kong Wu Ho-Su Memorial Hospital

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Responsible Party: Ru-Lan Hsieh, Associate Professor, Taipei Medical University
ClinicalTrials.gov Identifier: NCT01920971     History of Changes
Other Study ID Numbers: 102-2314-B-341-001
102-2314-B-341-001 ( Other Grant/Funding Number: National Science Council, Taiwan )
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: August 2013

Keywords provided by Ru-Lan Hsieh, Taipei Medical University:
chronic low back pain
infrared energy
effects

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms