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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

Tracking Information
First Submitted Date  ICMJE August 6, 2013
First Posted Date  ICMJE August 12, 2013
Last Update Posted Date August 12, 2013
Study Start Date  ICMJE August 2013
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
  • 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 ]
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Effects of Monochromatic Infrared Energy Therapy on Patients With Chronic Low Back Pain
Official Title  ICMJE Therapeutic Effects of Monochromatic Infrared Energy Therapy on Patients With Chronic Low Back Pain: A Double-Blind, Randomized, Placebo-Controlled Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low Back Pain
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Radiation: infrared 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.
    Intervention: Radiation: infrared therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 8, 2013)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2014
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01920971
Other Study ID Numbers  ICMJE 102-2314-B-341-001
102-2314-B-341-001 ( Other Grant/Funding Number: National Science Council, Taiwan )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ru-Lan Hsieh, Taipei Medical University
Study Sponsor  ICMJE Taipei Medical University
Collaborators  ICMJE National Science Council, Taiwan
Investigators  ICMJE
Principal Investigator: Ru-Lan Hsieh, MD Shin Kong Wu Ho-Su Memorial Hospital
PRS Account Taipei Medical University
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP