ISRCTN - ISRCTN24010862: The efficacy of Low Level Laser Therapy (LLLT) in knee osteoarthritis

Plain English Summary

Background and study aims
Osteoarthritis (OA) is the most common type of arthritis and is a major cause of disability and impaired quality of life in the elderly. In recent years, this problem extended to affecteven younger people. Currently, no disease modifying treatments (DMT) are approved by the Food and Drug Administration or European Medicines Agency for OA. However, large number of treatments is available such as non-steroidal anti-inflammatory drugs, despite its high risks of side-effects in addition to relatively high cost. Low level laser therapy (LLLT) is an intervention (treatment) which is increasingly recognised as a
non-invasive and safe treatment for numerous chronic conditions including OA. Results of using LLLT on patients with knee OA are conflicting. Thus, the purpose of this study was to determine the efficacy of LLLT when applied on specific acupuncture points.

Who can participate?
Any patient with knee OA and diagnosed by his physician and then was referred to physiotherapy department was eligible for the study. Participants were both male and female aged 35 and over.

What does the study involve?
Forty nine participants were randomly assigned to one of the two study groups, group 1 (experimental) received active laser therapy (n= 26) or group 2 (control) received placebo (dummy) laser therapy (n=23). Participants in group 1 received active laser group on five acupuncture points at the affected knee. The same procedures were applied to patients in the placebo
group but rather this time the device was inactive, only producing visible red light. both the investigator and the patient were unaware of whether placebo or active treatment were utilized, only the research assistant had the identifying code to determine which treatment was given.

What are the possible benefits and risks of participating?
One of the most important benefits is finding out alternative, non-invasive, and safe treatment for patients with knee OA, especially relevant for patients who do not respond to medical therapy or those who suffer adverse side-effects to drug therapy and for patients who are not candidates for surgery.
Despite using LLLT is safe, direct laser on eye can cause damage, thus, in the current study the investigator, research assistant and patients wore protective goggles to guard their eyes from active laser radiation.

Where is the study run from?
The study was carried out at Physiotherapy Department of Security Forces Hospital in Riyadh, Saudi Arabia

When is the study starting and how long is it expected to run for?
Patient recruitment started in September 2010, and last follow-up assessment was done in February 2011.

Who is funding the study?
The project was funded by general administration for medical services of Ministry of Interior, Security Forces Hospital; Riyadh, Saudi Arabia.

Who is the main contact?
Abdullah Al Rashoud
Joud55@yahoo.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Abdullah Al Rashoud

ORCID ID

Contact details

Department of Orthopaedic and Trauma Surgery
College of Medicine
Dentistry and Nursing
University of Dundee
TORT Centre
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
ortho@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The efficacy of Low Level Laser Therapy (LLLT) in knee osteoarthritis: A randomized double-blind controlled trial

Acronym

Study hypothesis

We hypothesized that when low level laser is administrating on specific acupuncture points on patients with knee osteoarthritis for nine treatment sessions over three weeks will be effective in relief their pain and improve quality of the life.

Ethics approval

The Research Committee of the Security Forces Hospital, March 8, 2010

Study design

Randomized double blinded placebo controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Knee osteoarthritis

Intervention

On the affected knee, the laser probe was sequentially and perpendicularly placed in a full contact with the skin at five acupuncture points on and around the affected knee. In the active laser group, each point was irradiated by an active and continuous laser beam for 40 seconds (energy density of 4 J/ cm2 per point, total of 20 J/cm2 per session) for each patient. This dose was in accordance with World Association for Laser Therapy recommendations. The same procedures were applied to patients in the placebo group but rather this time the device was inactive, only producing visible red light.

In both groups, patients were given a straight leg raising (SLR) exercise to perform after each treatment session and they were advised to repeat it at home five times daily, minimally. Patients in both groups were given helpful advice and instructions regarding their problem and how they should be managing and coping with Knee OA.

Each participant received 9 treatment sessions over 3 weeks and they were evaluated at baseline, at the 5th treatment session, at the 9th treatment session (last treatment session), after 6 weeks, and after 6 months of the last treatment session.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

The change in the VAS scores for pain during movement. It consists of a 10 cm line anchored at each end (0 = no pain, 10 = unbearable
pain). All evaluations for both primary and secondary outcomes were administrated at the 5th treatment session, at the 9th treatment session, after 6 weeks, and after 6 months of the last treatment session. All evaluations were performed by the investigator.

Secondary outcome measures

1. The Saudi knee functional scale (SKFS): It is a multidimensional self-administered, and Arabic language instrument that emphasises pain (8 items), stiffness (2 items), physical function activities (12 items), social activities (3 items), and psychological activities (3 items) related to KOA.
2. The degree of active knee angle flexion: measured by goniometer
3. Knee circumference (KC): was measured using a standard tape measure at the middle of the patella with the knee extended.
4. Patient satisfaction: each participant was asked to rate his satisfied about the intervention that has been received, if he has gotten any benefit. The assessment was performed using a verbal numeric scale (end-points 0% no improvement or benefit to 100% full improvement or benefit; in blocks of 5%). Evaluation started at the 5th session as a baseline, then at , at the 9th treatment session, after 6 weeks, and after 6 months of the last treatment session.

Overall trial start date

18/09/2010

Overall trial end date

01/07/2011

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients who had knee OA (both male and female aged 35 and over) according to the American College of Rheumatology criteria
2. Had an average pain intensity of 3 or more on a 10 cm visual analogue scale (VAS)
3. Had an ability to practice all movements included in the evaluation forms
4. Had the ability to read or understand the patient information sheets and the ability to sign a consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

21 participants for each arm of the study

Participant exclusion criteria

1. Patients with previous knee surgery, serious valgus or varus deformity and any disease where laser treatment is contraindicated, such as cancer, uncontrolled diabetes mellitus and hypertension
2. Patients already using medications that may interfere with LLLT treatment for less than six weeks, such as corticosteroid injections

Recruitment start date

18/09/2010

Recruitment end date

01/07/2011

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

Department of Orthopaedic and Trauma Surgery
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

Security Forces Hospital (Saudi Arabia)

Sponsor details

General administration for medical services of Ministry of Interior
Riyadh
3643
Saudi Arabia
joud55@yahoo.com

Sponsor type

Hospital/treatment centre

Website

http://www.sfh.med.sa/English/Pages/Security%20Forces%20Hospital%20Program.aspx

Funders

Funder type

Government

Funder name

General administration for medical services of Ministry of Interior, Security Forces Hospital; Riyadh (Saudi Arabia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data