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

NCT01738737 | Completed Results

• 1 other identifier: CAPPESQ 455/11
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Visual Analogue Scale for Pain

  The scale varies from 0 to 10. Higher values represent worse outcomes. The assessment will be done in the patient's first evaluation and after each intervention.

  Baseline and post-intervention, up to 11 weeks

Secondary Outcomes (4)

• Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index

  Baseline and post-intervention, up to 11 weeks

• Change From Baseline in Range of Motion of Flexion of the Knee

  Baseline and post-intervention, up to 11 weeks

• Change From Baseline in Lequesne Functional Questionnaire

  Baseline and post-intervention, up to 11 weeks

• Change From Baseline in Timed Get Up and Go Test

  Baseline and post-intervention, up to 11 weeks

Study Arms (5)

Stretching

EXPERIMENTAL

Seven stretching exercises for lower limbs during 24 sessions

Other: Stretching exercises

Placebo laser + Stretching

EXPERIMENTAL

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

Other: Stretching exercises; Device: placebo laser therapy

Active laser + Stretching

EXPERIMENTAL

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

Device: Active Laser; Other: Stretching exercises

Active Laser

EXPERIMENTAL

Application of active laser only during 24 sessions

Device: Active Laser

Control

NO INTERVENTION

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

Interventions

Active Laser DEVICE

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

Also known as: LaserPulse (904nm) class II IBRAMED

Active Laser; Active laser + Stretching

Stretching exercises OTHER

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

Active laser + Stretching; Placebo laser + Stretching; Stretching

placebo laser therapy DEVICE

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

Also known as: LaserPulse class II IBRAMED

Placebo laser + Stretching

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Specialized rehabilitation service

Taboão da Serra, São Paulo, 06775-005, Brazil

Location

Related Publications (1)

• 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.

  PMID: 26369333 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Sarah Rubia Ferreira de Meneses
• Organization: University of Sao Paulo

sarah.meneses@usp.br

+55(11)470898-71

Study Officials

• Sarah Rubia F Meneses

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: November 30, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 10, 2015
• Results First Posted: December 10, 2015

Record last verified: 2015-09

Locations

BR (1)