Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2010
INTERVENTION: Fifty‐eight women with postmastectomy lymphedema were enrolled in a double‐blind, placebo controlled trial. Patients were randomly assigned to active laser (n=28) and placebo (n=26) groups and received irradiation with Ga–As laser over the axillary and arm areas, for 20 mniutes , 3 times a week for 12 weeks. The total energy applied at each point was 300mJoules over 17 points (5.1 Joules in total), giving a dosage of 1.5 Joules/cm2 in the active group. The placebo group received placebo therapy in which the laser had been disabled without affecting its apparent function. Limb circumference, shoulder mobility, and grip strength were measured before treatment and at 4, 8, and 12 weeks, laser therapy applied only on the affected limb not bilateral. CONDITION: the effect of low level laser therapy (LLLT) on limb volume, shoulder mobility and hand grip strength in patients with breast cancer related lymphedema PRIMARY OUTCOME: Assessment of Lymphedema: Although various methods exist for assessing the quantity and quality of lymphedema, the most commonly used assessment technique involves measuring the circumference of limb at several points along its length. For the arm circumference measurements, subjects lay prone, arms relaxed by their sides and elbows straight. Both arms were measured at each test date. Circumference was measured every 3 cm beginning at the styloid process of the ulna and continuing 45 cm proximally, as well as at the metacarpals and midhand. The measuring tape was placed around the extremity so that there was no slack but also so there was no indentation in the tissue. The sum circumference of the normal side was calculated likewise. The difference between these two was considered as circumference difference. ; CL affected ‐ CL normal = CD ; CD n ‐CD0 =TRC ; Where: ; CL affected Circumference of affected limb for all anatomical points, ; CL normal Circumference of normal limb for all anatomical points, ; CD Circumference difference of two limbs ; CDn Circumference differences at each follow up session, ; CD0 Circumference difference at pretreatment session, ; TRC Total reduction in circumference SECONDARY OUTCOME: Assessment of hand grip strength: Grip strength was measured by portable hydraulic hand Jamar dynamometer (Lafayette Instrument 78010 Hand Dynamometer), the measurements were performed while the patients were seated in back chair, with the shoulder adducted, elbow flexed 90 degrees and forearm in neutral rotation. A mean of three trials was calculated, with a 15 second rest in between each of the three contractions Assessment of the Shoulder Mobility: A standard plastic goniometer was used to measure active range of motion (ROM)for shoulder flexion, abduction, and external rotation. For measurement the patient was placed supine with the thorax firmly strapped to the table to prevent body shift, which would tend to compensate for movement of the shoulder. ; The use of a goniometer to measure range of movement investigated by, Riddle et al. who concluded that measurements were highly reliable when taken by the same therapist, with reliability between measurers being specific to the range of movement. ; For shoulder abduction; the sound arm was moved away from the side of the body in a coronal plane from 0 to 180 degree, but affected was moved to the limit of pain. INCLUSION CRITERIA: women with breast cancer related lymphedema (swelling of more than 2cm and less than 8cm of excess limb circumference at each point compared to controlled non operative limb ; For shoulder flexion; the arm were initially relaxed at the side of the body (Neutral position of 0 degree); the arm under test was raised in a sagittal plane from 0 to 180 degree, but affected arm was raised to the limit of pain . ; For shoulder external rotation; the arm normal was abducted to 90 degree, and the elbow flexed 90 degree, with forearm in pronation , and the palm facing the feet, but the other arm move according to pain.
Epistemonikos ID: 6494a569dcfe7ca3a50b0ba940c20d3196c75107
First added on: Aug 22, 2024