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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Radiation: infrared therapy

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: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 111-01
    • Recruiting
    • Shin Kong Wu Ho-Su Memorial Hospital
    • Contact: Ru-Lan Hsieh, MD; Phone Number: 2538 886-2-28332211; Email: M001052@ms.skh.org.tw
    • Principal Investigator: Ru-Lan Hsieh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: monochromatic infrared energy therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: National Science Council, Taiwan

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): April 1, 2014
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: August 6, 2013
• First Submitted That Met QC Criteria: August 8, 2013
• First Posted (Estimate): August 12, 2013

Study Record Updates

• Last Update Posted (Estimate): August 12, 2013
• Last Update Submitted That Met QC Criteria: August 8, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: chronic low back pain; infrared energy; effects
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 102-2314-B-341-001 (Other Grant/Funding Number: National Science Council, Taiwan)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No