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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Therapeutic Effects of Monochromatic Infrared Energy Therapy on Patients With Chronic Low Back Pain: A Double-Blind, Randomized, Placebo-Controlled Study

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Radiation: infrared therapy


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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: inferared therapy<br>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<br>* wavelength = 890 nm, radiant power output = 6.24 W, power density = 34.7 milliWatts/cm2 for 40 min, total energy 83.2 J/cm2<br>* Other names: monochromatic infrared energy therapy;|
| Placebo Comparator: placebo infrared therapy<br>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<br>* wavelength = 890 nm, radiant power output = 6.24 W, power density = 34.7 milliWatts/cm2 for 40 min, total energy 83.2 J/cm2<br>* Other names: monochromatic infrared energy therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of pain | 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. | participants will be evaluated at before treatment, and followed at treatment for 2 and 4 weeks, and 1 and 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of Multidimensional Fatigue Inventory |  | 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 | using the postural stability evaluation system: Biodex Stability System | 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 fear avoidance behavior | using Fear-Avoidance Behavior Questionnaire | participants will be evaluated at before treatment, and followed at treatment for 2 and 4 weeks, and 1 and 3 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic low back pain, infrared energy, effects