Low-level Laser Therapy and Static Stretching in Knee Osteoarthritis.
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

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.
    

Intervention name(s): Active Laser; Stretching exercises; placebo laser therapy
Intervention type(s): Device; Other; Device
Intervention description(s): 18 points of application of active laser in the knee (frontal faces, lateral and medial); 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions; 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)
Other intervention name(s): LaserPulse (904nm) class II IBRAMED; LaserPulse class II IBRAMED
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment