Research Page 2 - Methods
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Methods
The study was conducted at the Phototherapy Clinic of "Shmuel Harofe" Geriatric Medical Center from October 1989 to March 1990.

Subjects: We recruited 50 patients (34 women, 16 men) aged 55 to 86 years (mean age 68 8.7 years). All patients fulfilled criteria for the diagnosis of DOA of both knees and had suffered from pain for at least 3 months. All patients signed an informed consent approving the procedures applied in this study. The following patients were excluded: patients with cancer, any acute disease, uncontrolled diabetes mellitus, untreated hypertension, neurological deficits (motor or sensory), psychotic disorders, dementia, mental retardation or other organic mental disorders. Patients already on treatment for more than 6 weeks continued their medication with drugs that could interfere with the intensity of pain, such as antidepressants, minor tranquilizers, or analgesics.

Study Design: Three types of light emitters were used: red, infrared, and placebo. The placebo emitter was like the infrared emitter in appearance bit did not emit light. The study was conducted in double-blinded fashion for the infrared and placebo emitters but not for the red emitter where light is visible and produces a different treatment experience. All light emitters were supplied by AMCOR LTD. (Table 1). The emitters used in the double-blinded groups had code numbers, and their characteristics were unknown to the patients and medical staff. The patients were randomly divided into red, infrared, and placebo treatment groups.
TABLE 1. LIGHT EMITTERS SPECIFICATION
  Red
CW
Red
Pulse
IR
CW
IR
Pulse
Output power (mW) 18 75 25 270
Illuminated area (cm2) 2 2 2 2
Power density (mW/cm2) 8 34 11 122
Pulses per second   100   100
Duty ratio (%)   10   1
Pulse time (ms)   1   0.1
Delivery energy (J/min) 1.08 0.45 1.5 0.16
CW = Continuous Wave; IR = Infrared

Pain was evaluated by Short-Form McGill Pain Questionnaire (SF-MPQ), by Present Pain Intensity (PPI) Questionnaire, and by Visual Analogue Scale (VAS).15 The main component of the SF-MPQ has 15 descriptors (11 sensory and four affective) that are scored from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The data obtained provide information on the sensory, affective, and total intensity of pain. PPI and VAS provide indices of total intensity of pain. PPI is scored form 0 to 5 (0 = no pain, 1 = mild, 2 = discomforting, 3 = distressing, 4 = horrible, 5 = excruciating). VAS is scored from 0 to 10 (0 = no pain, 10 = worst possible pain), and the patients are requested to record the impact of pain on this scale.

Patients’ functional ability was measured by the Disability Index Questionnaire (DIQ).16 DIQ has nine general components (dressing and grooming, arising, walking, hygiene, reach, grip, outside activity, and sex activity), each of which has one or more specifications. Each question is scored from 0 to 3 (0 = without difficulty, 1 = with difficulty, 2 = with some help from another person, 3 = unable to do). The index is calculated by adding the scores of the components and dividing it by the total number of components answered.

Treatment: The treatment was applied at both sides of the knee for 15 minutes twice a day. Every treatment was composed of 7.5 minutes of continuous wave (CW) application and 7.5 minutes of pulse treatment. Total delivered energy was similar for the red emitters (10.3 joules) and the infrared emitters (11.1 joules). Energy density calculated as J/cm2 was 5.1 for the red emitters and 5.6 for the infrared emitters.

At follow-up in May 1991 we summed up the interval that elapsed from the end of the study until the patient’s request to be retreated because of pain.

Data Analysis: Baseline characteristics of the groups were compared by one-way analysis of variance and unpaired t test. The data obtained from DIQ, SF-MPQ, PPI, and VAS before treatment, and the data obtained from the same tests after treatment, were evaluated using paired t tests.