Chronic Low Back PainPhase 4NCT01920971
Therapeutic Effects of Monochromatic Infrared Energy Therapy on Patients With Chronic Low Back Pain
A Phase 4 study testing infrared therapy in people with Chronic Low Back Pain, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- infrared therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2013to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants with chronic low back pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111-01
Ru-Lan Hsieh, MD, 886-2-28332211 ext. 2538, M001052@ms.skh.org.tw
Ru-Lan Hsieh, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- infrared therapy
- Keywords
- chronic low back pain, infrared energy, effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infrared therapyRadiation
Also called monochromatic infrared energy 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
| Study group | Role | What they receive |
|---|---|---|
| inferared therapy | Active comparator | 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. Receives: Radiation: infrared therapy |
| placebo infrared therapy | Placebo comparator | 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. Receives: Radiation: infrared therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (3)
changes of Multidimensional Fatigue Inventory
Measured: 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
Measured: 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
Measured: participants will be evaluated at before treatment, and followed at treatment for 2 and 4 weeks, and 1 and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Ru-Lan Hsieh, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920971
- Sponsor's protocol ID
- 102-2314-B-341-001
- Other IDs
- 102-2314-B-341-001
- Status last verified
- Aug 2013
- First submitted
- 6 Aug 2013
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Monochromatic Infrared Energy Therapy on Patients With Chronic Low Back Pain: A Double-Blind, Randomized, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT01920971
- Acronym / sponsor ID
- 102-2314-B-341-001
- Conditions
- Chronic Low Back Pain
- Keywords
- chronic low back pain, infrared energy, effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 12 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inferared therapy | Active comparator | Radiation: infrared therapyhot 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 | Placebo comparator | Radiation: infrared therapyhot 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants with chronic low back pain
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infrared therapyAlso: monochromatic infrared energy therapywavelength = 890 nm, radiant power output = 6.24 W, power density = 34.7 milliWatts/cm2 for 40 min, total energy 83.2 J/cm2 | Radiation | inferared therapy, placebo infrared therapy |
Primary outcome
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.
3 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ru-Lan Hsieh, MD principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing infrared therapy in people with Chronic Low Back Pain, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ru-Lan Hsieh, MD (886-2-28332211 ext. 2538, M001052@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.