Low-level Laser Therapy and Static Stretching in Knee Osteoarthritis.

NCT ID: NCT01738737

Last Updated: 2015-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-12-31

Brief Summary

Osteoarthritis (OA) is a highly prevalent and disabling disease. It is estimated that by 2030 the prevalence of symptomatic OA could reach 30% of the population above 60 years. It is associated with significant morbidity being one of the most common causes of joint pain, functional disability and compromised quality of life. This randomised controlled trial will investigate the effect of low-level laser therapy (LLLT) and static stretching exercises, as monotherapy and in combination, on pain, quality of life, function, mobility, knee range of motion (KROM) and hamstring length in participants with knee OA.

This study will involve 145 people aged 50-75 years with symptomatic radiographic knee OA and will consist of two types of treatments: Low-level laser therapy (LLLT) and stretching exercises. The patients will be randomly allocated to five study groups LLLT active+Stretch, LLLT placebo+Stretch, Stretch, LLLT and Control (with n=29 each). Treatment frequency will be three sessions/week for all active groups. LLLT will involve the use of a Galium-Arsenide laser (904nm, 40 milliwatts, 3 Joules/point, 27 Joules/knee) over 24 sessions for the monotherapy group and 9 sessions for the LLLT+Stretch groups. Stretching will consist of seven exercises completed over 24 sessions. The control group will receive a booklet.

The primary outcome is pain measured by Visual Analogue Scale. Secondary outcomes included quality of life assessed by Western Ontario and McMaster Universities Arthritis Index (WOMAC), function by Lequesne Algofunctional Index, mobility by Timed Up and Go Test (TUG), KROM by goniometry of knee flexion and hamstring shortening by popliteal angle. The statistical method will follow the principles of per-protocol analysis.

Detailed Description

Physical performance as a determinant of disability in osteoarthritis (OA) has been investigated extensively, but research has focused primarily on the effect that the decrease in muscle strength has on the functionality in patients with OA. However, the reduced range of motion in affected joints is also an important risk factor for the occurrence of locomotor disability and other developing disability in patients with OA.

Studies using stretching exercises are scarce in the Reid & Mc Nair (2010) specifically examined the range of motion can be improved in subjects with knee osteoarthritis, although this study did only stretching the hamstrings. The results indicate that there is immediate benefits of stretching in subjects with osteoarthritis of the knee joint, providing evidence for the long term development of stretching programs for this population.

In the literature are observed inconsistent results regarding the benefits of laser treatment in improving pain and function in individuals with knee OA. Also there are few studies that specify which dosage and frequency of laser must be used.

In view of the increasing need to support the role of physiotherapy in evidence-based practice, this study is justified by the need to test the effectiveness of stretching exercises and elucidate the effectiveness of low intensity laser therapy in patients with knee OA.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Stretching

Seven stretching exercises for lower limbs during 24 sessions

Group Type: EXPERIMENTAL

Stretching exercises

Intervention Type: OTHER

7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions

Placebo laser + Stretching

application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions

Group Type: EXPERIMENTAL

Stretching exercises

Intervention Type: OTHER

7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions

placebo laser therapy

Intervention Type: DEVICE

18 points of application of placebo laser in the knee (frontal faces, lateral and medial)

Active laser + Stretching

application of active laser therapy during nine sessions plus stretching exercises during 24 sessions

Group Type: EXPERIMENTAL

Active Laser

Intervention Type: DEVICE

18 points of application of active laser in the knee (frontal faces, lateral and medial)

Stretching exercises

Intervention Type: OTHER

7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions

Active Laser

Application of active laser only during 24 sessions

Group Type: EXPERIMENTAL

Active Laser

Intervention Type: DEVICE

18 points of application of active laser in the knee (frontal faces, lateral and medial)

Control

Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Active Laser

18 points of application of active laser in the knee (frontal faces, lateral and medial)

Intervention Type: DEVICE

Stretching exercises

7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions

Intervention Type: OTHER

placebo laser therapy

18 points of application of placebo laser in the knee (frontal faces, lateral and medial)

Intervention Type: DEVICE

Other Intervention Names

LaserPulse (904nm) class II IBRAMED; LaserPulse class II IBRAMED

Eligibility Criteria

Inclusion Criteria

• radiographic evidence of knee osteoarthritis between 2-4 in Kellgren & Lawrence classification
• pain intensity ≥3 on a 10cm Visual Analogue Scale (VAS)
• knee symptoms for at least 3 months

Exclusion Criteria

• symptomatic hip osteoarthritis
• any disease where laser treatment is contraindicated (cancer and uncontrolled diabetes mellitus)
• continuous use of anti-inflammatory drugs
• other concurrent injury/conditions that will affect their ability to participate in the rehabilitation program and/or assessment procedures.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Rubia F Meneses

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Specialized rehabilitation service

Taboão da Serra, São Paulo, Brazil

Countries

Brazil

References

Ferreira de Meneses SR, Hunter DJ, Young Docko E, Pasqual Marques A. Effect of low-level laser therapy (904 nm) and static stretching in patients with knee osteoarthritis: a protocol of randomised controlled trial. BMC Musculoskelet Disord. 2015 Sep 14;16:252. doi: 10.1186/s12891-015-0709-9.

Reference Type: DERIVED

PMID: 26369333 (View on PubMed)

Other Identifiers

CAPPESQ 455/11

Identifier Type: -

Identifier Source: org_study_id