Chronic Low-back PainNCT05040633
The ECEALT Chronic Low Back Pain Study
A study testing BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK)) and Standard Exercise Therapy in people with Chronic Low-back Pain, run by Health Rehab and Research Clinic at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK)) and Standard Exercise Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2022to 30 Apr 2024
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Health and Rehab Research Inc.
Mississauga, Ontario, L5A 2G9
Muhammad Wasiuddin Arfi, PhD, 4168417918, healthrehabresearch@gmail.com
About this 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
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.
Read the 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.
- Conditions
- Chronic Low-back Pain
- Being tested
- BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK)), Standard Exercise Therapy
- Keywords
- Laser Therapy, Low Back Pain, Randomized Control Trial
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK))Device
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.
Standard Exercise TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Level Laser Therapy + standard exercise therapy | Experimental | This group of participants will first receive the standard therapy of strengthening and stretching exercises followed by the Low Lever Laser Therapy. Receives: Device: BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK)); Other: Standard Exercise Therapy |
| Sham Low Level Laser Therapy + standard exercise therapy | Sham comparator | 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. Receives: Device: BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK)); Other: Standard Exercise Therapy |
| Standard Exercise Therapy | Active comparator | Trial participants in this group will only receive the standard exercise therapy. The exercise therapy will consist of strengthening and stretching exercises. Receives: Other: Standard Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
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).
Measured: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
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).
Measured: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Secondary outcomes (5)
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).
Measured: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
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).
Measured: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
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).
Measured: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
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.
Measured: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
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.
Measured: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Oct 2022 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Rehab and Research Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hammad Qazi, PhD, Principal investigator, Health and Rehab Research Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040633
- Sponsor's protocol ID
- V2/0518
- Status last verified
- Aug 2022
- First submitted
- 10 Jul 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared externally or with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05040633
- Acronym / sponsor ID
- V2/0518
- Conditions
- Chronic Low-back Pain
- Keywords
- Laser Therapy, Low Back Pain, Randomized Control Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Health Rehab and Research ClinicUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 10 Sep 2021 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Low Level Laser Therapy + standard exercise therapy | Experimental | Device: BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK)), Other: Standard Exercise TherapyThis group of participants will first receive the standard therapy of strengthening and stretching exercises followed by the Low Lever Laser Therapy. |
| Sham Low Level Laser Therapy + standard exercise therapy | Sham comparator | Device: BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK)), Other: Standard Exercise TherapyThis 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. |
| Standard Exercise Therapy | Active comparator | Other: Standard Exercise TherapyTrial participants in this group will only receive the standard exercise therapy. The exercise therapy will consist of strengthening and stretching exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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)
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 |
|---|---|---|
| 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. | Device | Low Level Laser Therapy + standard exercise therapy, Sham Low Level Laser Therapy + standard exercise therapy |
| Standard Exercise TherapyExercise 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. | Other | Low Level Laser Therapy + standard exercise therapy, Sham Low Level Laser Therapy + standard exercise therapy, Standard Exercise Therapy |
Primary outcome
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).
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).
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).
5 secondary outcomes
Reliance on medication for pain management using the Brief Pain Inventory
Time frame: 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
Fear of Pain measured using the McGill Pain Questionnaire
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No. No individual participant data will be shared externally or with other researchers.
Related trials for Chronic Low-back Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
Hybrid mHealth for Low Back Pain
Chronic Low-back Pain (cLBP), Non-specific Low Back Pain (NSLBP)
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.
Hammad Qazi, PhD principal investigator
Health and Rehab Research Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK)) and Standard Exercise Therapy in people with Chronic Low-back Pain, run by Health Rehab and Research Clinic at 1 site in Canada.
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 3 inclusion and 15 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 3 Aug 2022. 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 Canada. 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.
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 Hammad Qazi, PhD (+1 (647)4578908, hammadali400@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain using the Quadruple Visual Analog Scale (time frame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52). The study lists 3 primary outcomes in all. 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 3 Aug 2022.