The ECEALT Chronic Low Back Pain Study

NCT05040633 | Unknown DMC

• 1 other identifier: V2/0518
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

Laser Therapy; Low Back Pain; Randomized Control Trial

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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).

  Weeks 1, 2, 3, 6, 8, 12, 26 and 52

Secondary Outcomes (5)

• Reliance on medication for pain management using the Brief Pain Inventory

  Weeks 1, 2, 3, 6, 8, 12, 26 and 52

• Mean Pain Free Days/Months using the Brief Pain Inventory

  Weeks 1, 2, 3, 6, 8, 12, 26 and 52

• Fear of Pain measured using the McGill Pain Questionnaire

  Weeks 1, 2, 3, 6, 8, 12, 26 and 52

• Frequency of Low Back Pain Episodes assessed using patients personal daily pain records

  Weeks 1, 2, 3, 6, 8, 12, 26 and 52

• Mean number of days absent from work measured using patients personal daily pain record

  Weeks 1, 2, 3, 6, 8, 12, 26 and 52

Study Arms (3)

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.

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.

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.

Other: Standard Exercise Therapy

Interventions

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.

Low Level Laser Therapy + standard exercise therapy; Sham Low Level Laser Therapy + standard exercise therapy

Standard Exercise Therapy OTHER

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.

Low Level Laser Therapy + standard exercise therapy; Sham Low Level Laser Therapy + standard exercise therapy; Standard Exercise Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Health Rehab and Research Clinic: lead

Study Sites (1)

Health and Rehab Research Inc.

Mississauga, Ontario, L5A 2G9, Canada

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hammad Qazi, PhD

  Health and Rehab Research Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hammad Qazi, PhD

CONTACT

+1 (647)4578908; hammadali400@hotmail.com

Lamin Massaquoi, PhD

CONTACT

+1 (306)5353719; lamindmassaquoi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 10, 2021
• First Posted: September 10, 2021
• Study Start: October 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)