Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000615886
Ethics application status
Approved
Date submitted
1/06/2012
Date registered
8/06/2012
Date last updated
8/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
low level laser and osteoarthritis
Scientific title
Efficacy of Low-Level Laser Therapy in Patient with Knee Osteoarthritis: Randomized Placebo-Controlled Single-Blind Clinical trial
Secondary ID [1] 280606 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
aim of this randomized placebo-controlled single-blind clinical trial was to evaluate the short-term efficacy of LLLT on pain alleviation and functional performance in the patients with chronic knee OA 286619 0
Condition category
Condition code
Physical Medicine / Rehabilitation 286892 286892 0 0
Physiotherapy
Musculoskeletal 286956 286956 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants attended to the physical therapy department two times/ week for the 4-week. Patient assumed supine lying on the treatment bed and wore goggle. The knee(s) underwent laser therapy was slightly flexed and supported with a pillow. During the therapy session, hot packs wrapped in toweling were placed on the target knee(s) for 20minutes followed by laser therapy. The equipment of low level laser was a Gal-Al-As diode laser with a power output of 50 mW and a wavelength of 830 nm. The diameter of the laser beam at the treatment point was 1 mm. Eight points were irradiated with LLLT three on the medial side of the knee, three on the lateral side of the knee, and 2 on the medial edge of the tendon of the biceps femoris muscle and semitendinosus muscle in the popliteal fossa. Each point received energy of 6 J/point for one minute, with a total dose of 48 J/cm2 in each session. the duration of each visit was 20 minutes.
Intervention code [1] 285000 0
Treatment: Other
Intervention code [2] 285045 0
Treatment: Devices
Comparator / control treatment
In the placebo group, procedures were identical but without emission of energy. Because this type of laser presents invisible radiation, the patient was unaware of which group, they belonged to.
Control group
Placebo

Outcomes
Primary outcome [1] 287245 0
The primary outcome measurement was the pain intensity on Visual Analogue Scale(VAS).
Pain Intensity on Visual Analogue Scale: The VAS consists of the 10-cm horizontal line anchored by two extremes of pain: "No pain" at the left and "Worst pain" at the right. The patients were provided with a translated Arabic version of VAS, with "No pain" on the right side and "Worst pain" on the left side. Patients indicated their current level of pain intensity in their knee (s), and marked this with X on the 10-cm line. Then, the therapist measured the distance between the right side anchor" No pain" and the mark on the VAS by lying a transparent 10cm ruler over the line. The pain intensity was recorded in centimeters. Pain intensity was recorded at rest and immediately following a 50-foot walking test.
Timepoint [1] 287245 0
outcome measurements were taken at baseline (W0) and 4-week (W4) after the study was begun.
Secondary outcome [1] 297732 0
The secondary outcomes were knee function in terms of WOMAC scale (WOMAC pain, WOMAC stiffness, WOMAC function).
Timepoint [1] 297732 0
outcome measurements were taken at baseline (W0) and 4-week (W4) after the study was begun.
Secondary outcome [2] 297733 0
the time required to walk distance of 50-feet.The time required to walk a distance of 50-foot "as fast as possible" was measured with stopwatch and recorded in seconds.
Timepoint [2] 297733 0
outcome measurements were taken at baseline (W0) and 4-week (W4) after the study was begun.

Eligibility
Key inclusion criteria
Patients who had knee OA according to American College of Rheumatology criteria were recruited for the study. All patients had knee OA of grade II or III confirmed radiologically according to the Kellgren-Lawrence grading system. All the patients had a minimum score of 25 on the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) total score. All patients had moderate to great knee pain defined as a score of 4 or greater on visual analogue scale (VAS) in the previous three months. They were willingness to participate and follow the treatment schedule.
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patients were excluded from the study if they had concomitant disease affecting the knee, such as rheumatoid arthritis, injury and / or surgery to the knee, had received physical therapy and intra-articular corticosteroid or hyaluronic acid injections during the last six months. Furthermore, patients were also excluded if they had history of cancer, dementia, neurological deficits (sensory or motor), heart pacemaker, diabetes mellitus, uncontrolled hypertension, or morbid obesity (BMI less than 40).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients were randomly assigned into two groups by drawing 1 of 50 identical envelopes labeled A (active laser-group), and B (placebo laser-group).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e., computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment outside Australia
Country [1] 4343 0
Saudi Arabia
State/province [1] 4343 0

Funding & Sponsors
Funding source category [1] 285362 0
Self funded/Unfunded
Name [1] 285362 0
Mohammed taher ahmed Omar
Country [1] 285362 0
Saudi Arabia
Primary sponsor type
Individual
Name
Mohammed taher ahmed omar
Address
Faculty of Physical Therapy, Cairo University, Cairo, Egypt
Rehabilitation Research Chair, King Saud University, Riyadh, Saudi Arabia
10219Riyadh 11433
Country
Saudi Arabia
Secondary sponsor category [1] 284217 0
Individual
Name [1] 284217 0
Ahmed Alghader
Address [1] 284217 0
Rehabilitation Research Chair, King Saud University, Riyadh, Saudi Arabia
Rehabilitation Science Department, Collage of Applied Medical Science, Riyadh

10219Riyadh 11433
Country [1] 284217 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287378 0
reserch eithic committe, King Saud Medical City. Riyadh, Saudi Arabia.
Ethics committee address [1] 287378 0
King Saud Medical City. Riyadh, Saudi Arabia.
Ethics committee country [1] 287378 0
Saudi Arabia
Date submitted for ethics approval [1] 287378 0
01/03/2012
Approval date [1] 287378 0
02/05/2012
Ethics approval number [1] 287378 0
129/18

Summary
Brief summary
The equipment of low level laser was a Gal-Al-As diode laser with a power output of 50 mW and a wavelength of 830 nm. The diameter of the laser beam at the treatment point was 1 mm.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34255 0
Address 34255 0
Country 34255 0
Phone 34255 0
Fax 34255 0
Email 34255 0
Contact person for public queries
Name 17502 0
Mohammed Taher Ahmed Omar
Address 17502 0
Rehabilitation Science Department
Collage of Applied Medical Science
King Saud University
Riyadh
P.O .Box. 10219,Riyadh, 11433
Country 17502 0
Saudi Arabia
Phone 17502 0
+9660542115404
Fax 17502 0
Email 17502 0
[email protected]
Contact person for scientific queries
Name 8430 0
mohammmed Taher Ahmed Omar
Address 8430 0
Rehabilitation Science Department
Collage of Applied Medical Science
King Saud University
Riyadh
P.O .Box. 10219,Riyadh, 11433
Country 8430 0
Saudi Arabia
Phone 8430 0
+9660542115404
Fax 8430 0
Email 8430 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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