The ECEALT Chronic Low Back Pain Study

August 2, 2022 updated by: Health Rehab and Research Clinic

Evaluating the Clinical Effectiveness of Adjunct Low-level Laser Therapy (ECEALT) in the Management of Chronic Low-Back Pain: A Long-Term, Double-Blind, Randomized Control Trial in Physiotherapy Clinics in Ontario, Canada

The primary objective of this double-blind randomized control trial (RCT) is to evaluate the clinical effectiveness of LLLT as adjunctive therapy to standard exercise treatment in patients with non-specific chronic LBP. Specifically, the study will aim to evaluate the effectiveness of adjunct LLLT in the reduction of pain in patients as well as determine its long-term functional outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Low back pain (LBP) is one of the most common musculoskeletal disorders and the leading cause of years lived with disability worldwide with significant socioeconomic impacts. Around 10-15 % of LBP patients develop chronic symptoms lasting more than 3 months, and this is considered chronic, with the causes often being "non-specific" with no identifiable causes. Despite the availability of medication-based protocols, the management of non-specific chronic LBP (NSCLBP) is an increasing challenge to clinicians and their patients. Adjunctive therapy can play an important role in the treatment of NSCLBP. In recent decades, low-level laser therapy (LLLT) has been widely used to relieve pain caused by different musculoskeletal disorders. Though widely used and reported as a safe, non-invasive treatment with minimal side effects; reported therapeutic outcomes of LLLT are varied and conflicting, due in part to methodological concerns, lack of data and unclear results.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L5A 2G9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • are 18-65 years with the ability to give informed consent
  • report with non - specific chronic low back pain, which is defined as pain of >3 months duration that occurs in the lumbosacral area of the spine, which may or not have the characteristics of limiting the patient's range of movements, and is not attributable to a recognizable, known pathology (e.g., infection, tumor, osteoporosis, lumbar spine fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome).
  • are experiencing pain measured using the Quadruple Visual Analogue Scale between 4 and 7 at the time of assessment will be included to keep homogeneity of pain.

Exclusion Criteria:

  • are under 18 years, and those over 65 years of age
  • have had past fractures of the bone structures of the spine
  • have had previous surgery of the spine
  • have a history of previous surgery of the spine or vertebra; spondylosis, spinal stenosis, lumbar disc herniation
  • use pacemakers (cardiac or brain)
  • are pregnant, or those who plan to become pregnant during the course of the study
  • have acute and/or chronic cardiovascular diseases
  • have dermatological conditions in the area of irradiation and/or inflammatory skin lesions
  • have tattoo/tattoos around the area of irradiation
  • have any sensory deficits as defined by the World Health Organization's working definition
  • are sensitive/allergic to phototherapy
  • have neurological disorders as defined by the World Health Organization's working definition
  • are taking anti-inflammatories or analgesic or psychotropic medications
  • have any current infections
  • have a history of drug abuse, either recreational, over the counter or prescription over the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Level Laser Therapy + standard exercise therapy
This group of participants will first receive the standard therapy of strengthening and stretching exercises followed by the Low Lever Laser Therapy.
Device: BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK))
Participants will receive 12 LLLT sessions during the course of the trial, thrice weekly for 4 consecutive weeks. Doses will be as per the recommendations of the Wold Association of Laser Therapy.
Other: Standard Exercise Therapy
Exercise therapy will consist of strengthening and stretching exercises. At each visit, participants will perform each of the exercises under the supervision of a licensed physiotherapist.
Sham Comparator: Sham Low Level Laser Therapy + standard exercise therapy
This group of participants will first receive the standard therapy of strengthening and stretching exercises followed by a sham Low Level Laser Therapy (LLLT). The laser equipment will be deactivated and not switched on.
Device: BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK))
Participants will receive 12 LLLT sessions during the course of the trial, thrice weekly for 4 consecutive weeks. Doses will be as per the recommendations of the Wold Association of Laser Therapy.
Other: Standard Exercise Therapy
Exercise therapy will consist of strengthening and stretching exercises. At each visit, participants will perform each of the exercises under the supervision of a licensed physiotherapist.
Active Comparator: Standard Exercise Therapy
Trial participants in this group will only receive the standard exercise therapy. The exercise therapy will consist of strengthening and stretching exercises.
Other: Standard Exercise Therapy
Exercise therapy will consist of strengthening and stretching exercises. At each visit, participants will perform each of the exercises under the supervision of a licensed physiotherapist.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pain using the Quadruple Visual Analog Scale
Time Frame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
The change in Pain measured using the Quadruple Visual Analog Scale (QVAS) measured at weeks 1, 2, 3, 6, 8, 12, 26 and 52. Pain reduction measured on a 10-point Likert scale from 0 (no pain) to 10 (worst possible pain). Overall score interpreted based on QVAS scoring manual of <50(Low intensity) and >50 (high intensity).
Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Change in Pain using the McGill Pain Questionnaire
Time Frame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
The change in Pain measured using the McGill Pain Questionnaire measured at weeks 1, 2, 3, 6, 8, 12, 26 and 52. Pain reduction assessed based on an overall score ranging from 0 (would not be seen in a person with true pain) to 78(seen in a person with the greatest pain).
Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Change in Pain using the Brief Pain Inventory
Time Frame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
The change in Pain measured using the Brief Pain Inventory measured at weeks 6, 8, 12, 26 and 52. Pain reduction assessed based on an overall score ranging from 0 (no pain or does not interfere) to 10(pain as bad as be imagined or completely interferes).
Weeks 1, 2, 3, 6, 8, 12, 26 and 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reliance on medication for pain management using the Brief Pain Inventory
Time Frame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Reliance on medication for pain management measured using the Brief Pain Inventory (short form) measured at weeks 6, 8, 12, 26 and 52. Pain reduction assessed based on an overall score ranging from 0% (no relief) to 100% (complete relief).
Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Mean Pain Free Days/Months using the Brief Pain Inventory
Time Frame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Mean Pain Free Days measured using the Brief Pain Inventory measured at weeks 6, 8, 12, 26 and 52. Pain reduction assessed based on an overall score ranging from 0 (no pain or does not interfere) to 10(pain as bad as can be imagined or completely interferes).
Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Fear of Pain measured using the McGill Pain Questionnaire
Time Frame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Fear of pain measured using the McGill Pain Questionnaire at weeks 1, 2, 3, 6, 8, 12, 26 and 52. Fear of Pain assessed on a 3-point scale from 1(fearful), 2 (frightful) or 3 (terrifying).
Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Frequency of Low Back Pain Episodes assessed using patients personal daily pain records
Time Frame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Frequency of LBP episodes during trial measured using patients personal daily pain records at weeks 1, 2, 3, 4, 6, 8, 12, 26 and 52. Each episode of pain recorded as a single occurrence.
Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Mean number of days absent from work measured using patients personal daily pain record
Time Frame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Mean number of days absent from work measured using patients personal daily pain records at weeks 1, 2, 3, 4, 6, 8, 12, 26 and 52. Not being able to work completely due to pain within a work day recorded as a single day, while working for less than 4 hours due to pain recorded as partial work day.
Weeks 1, 2, 3, 6, 8, 12, 26 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Health Rehab and Research Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hammad Qazi, PhD, Health and Rehab Research Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V2/0518

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No individual participant data will be shared externally or with other researchers.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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