Clinical trial NCT01920971: Therapeutic Effects of Monochromatic Infrared Energy Therapy on Patients With Chronic Low Back Pain
Official title: Therapeutic Effects of Monochromatic Infrared Energy Therapy on Patients With Chronic Low Back Pain: A Double-Blind, Randomized, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Low Back Pain
Keywords: chronic low back pain
infrared energy
effects
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2013-08-12
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: changes of pain
timeFrame: participants will be evaluated at before treatment, and followed at treatment for 2 and 4 weeks, and 1 and 3 months after treatment
Secondary outcomes:
measure: changes of Multidimensional Fatigue Inventory
timeFrame: participants will be evaluated at before treatment, and followed at treatment for 2 and 4 weeks, and 1 and 3 months after treatment
measure: changes of postural stability
timeFrame: participants will be evaluated at before treatment, and followed at treatment for 2 and 4 weeks, and 1 and 3 months after treatment
measure: changes of fear avoidance behavior
timeFrame: participants will be evaluated at before treatment, and followed at treatment for 2 and 4 weeks, and 1 and 3 months after treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Ru-Lan Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References: