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The ECEALT Chronic Low Back Pain Study

Primary Purpose

Chronic Low-back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK))
Standard Exercise Therapy
Sponsored by
Health Rehab and Research Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Laser Therapy, Low Back Pain, Randomized Control Trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Health and Rehab Research Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

Low Level Laser Therapy + standard exercise therapy

Sham Low Level Laser Therapy + standard exercise therapy

Standard Exercise Therapy

Arm Description

This group of participants will first receive the standard therapy of strengthening and stretching exercises followed by the Low Lever Laser 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.

Trial participants in this group will only receive the standard exercise therapy. The exercise therapy will consist of strengthening and stretching exercises.

Outcomes

Primary Outcome Measures

Change in Pain using the Quadruple Visual Analog Scale
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).
Change in Pain using the McGill Pain Questionnaire
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).
Change in Pain using the Brief Pain Inventory
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).

Secondary Outcome Measures

Reliance on medication for pain management using the Brief Pain Inventory
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).
Mean Pain Free Days/Months using the Brief Pain Inventory
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).
Fear of Pain measured using the McGill Pain Questionnaire
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).
Frequency of Low Back Pain Episodes assessed using patients personal daily pain records
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.
Mean number of days absent from work measured using patients personal daily pain record
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.

Full Information

First Posted
July 10, 2021
Last Updated
August 2, 2022
Sponsor
Health Rehab and Research Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05040633
Brief Title
The ECEALT Chronic Low Back Pain Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Health Rehab and Research Clinic

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Laser Therapy, Low Back Pain, Randomized Control Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be allocated to three groups and provided with one of the following interventions: (i) Low Level Laser Therapy (LLLT) therapy in combination with standard exercise therapy (Arm 1), (ii) sham LLLT therapy in combination with standard exercise therapy (Arm 2), or (iii) exercise therapy alone (Arm 3). Participants will receive treatment three times per week for four consecutive weeks (i.e., each participant will receive a total of 12 treatment sessions; see section 2, Trial Design).
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Randomization codes will be generated by a member of the trial team who is not involved in the day-to-day running of the trial, nor will they be involved in future data analysis. Each participant's randomized code will be kept in a sealed envelope to be opened only by the assessor during the first trial visit. The assessor and patients will be blinded to treatment allocation but physiotherapists offering treatment will not be blinded to treatment allocation.
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Level Laser Therapy + standard exercise therapy
Arm Type
Experimental
Arm Description
This group of participants will first receive the standard therapy of strengthening and stretching exercises followed by the Low Lever Laser Therapy.
Arm Title
Sham Low Level Laser Therapy + standard exercise therapy
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Standard Exercise Therapy
Arm Type
Active Comparator
Arm Description
Trial participants in this group will only receive the standard exercise therapy. The exercise therapy will consist of strengthening and stretching exercises.
Intervention Type
Device
Intervention Name(s)
BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK))
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Exercise Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain using the Quadruple Visual Analog Scale
Description
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).
Time Frame
Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Title
Change in Pain using the McGill Pain Questionnaire
Description
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).
Time Frame
Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Title
Change in Pain using the Brief Pain Inventory
Description
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).
Time Frame
Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Secondary Outcome Measure Information:
Title
Reliance on medication for pain management using the Brief Pain Inventory
Description
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).
Time Frame
Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Title
Mean Pain Free Days/Months using the Brief Pain Inventory
Description
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).
Time Frame
Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Title
Fear of Pain measured using the McGill Pain Questionnaire
Description
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).
Time Frame
Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Title
Frequency of Low Back Pain Episodes assessed using patients personal daily pain records
Description
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.
Time Frame
Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Title
Mean number of days absent from work measured using patients personal daily pain record
Description
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.
Time Frame
Weeks 1, 2, 3, 6, 8, 12, 26 and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hammad Qazi, PhD
Phone
+1 (647)4578908
Email
hammadali400@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lamin Massaquoi, PhD
Phone
+1 (306)5353719
Email
lamindmassaquoi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hammad Qazi, PhD
Organizational Affiliation
Health and Rehab Research Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health and Rehab Research Inc.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5A 2G9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Wasiuddin Arfi, PhD
Phone
4168417918
Email
healthrehabresearch@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared externally or with other researchers.

Learn more about this trial

The ECEALT Chronic Low Back Pain Study

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