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

Phase 4

• Conditions: Chronic Low Back Pain
• Interventions: Radiation: infrared therapy

• Registration Number: NCT01920971
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2013-08
• Study Start: 2013-08
• Study First Submitted: 2013-08-06
• Study First Submitted QC: 2013-08-08
• Last Update Submitted: 2013-08-08
• Study First Posted: 2013-08-12
• Last Update Posted: 2013-08-12
• Primary Completion: 2014-04
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
inferared therapy	infrared 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.
placebo infrared therapy	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.

Primary Outcome Measures

Name	Time	Method
changes of pain	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

Name	Time	Method
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	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	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

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan