Kozanoglu, E., Basaran, S., Paydas, S., & Sarpel, T. (2009). Efficacy of pneumatic compression and low-level laser therapy in the treatment of postmastectomy lymphoedema: A randomized controlled trial. Clinical Rehabilitation, 23(2), 117–124.

To compare the long-term efficacy of pneumatic compression and low-level laser therapies in the management of postmastectomy lymphoedema

Sixty-four women who had undergone modified radical mastectomy with complete axillary dissection and radiotherapy were recruited for the study. All patients gave informed consent, and the hospital ethics committee had approved the study protocol. Patients who had a history of arm lymphedema of at least three months were recruited to the study. Fourteen patients were excluded from the study (three had current metastases, five had continuing radiotherapy, one had cellulitis, two had a history of receiving a physical therapy program in the previous six months, one was using diuretic agent for hypertension, and two refused the treatment and did not provide informed consent). Patients were randomized to the pneumatic compression therapy group (group I, n = 25) or the low-level laser therapy group (group II, n = 25) by consecutive alternate allocation according to the admittance to the study clinic. The physician who randomized the patients was blind to the treatment groups. Group I received two hours of therapy with an intermittent pneumatic compression therapy device. A pressure of 60 mmHg, which is generally recommended for the treatment of lymphedema, was used. Total treatment period was four weeks and consisted of 20 sessions. Group II received 20 minutes therapy (2800 Hz, 1.5 J/cm2) with a Ga-As 904 nm laser device three times a week. Total treatment period was four weeks and consisted of 12 sessions. Laser therapy was administered at three points on the antecubital fossa and at seven points on the axilla where the lymph nodes accumulated. All patients were advised to perform daily limb exercises (active range of motion, elevation and pumping exercises), hygiene, and skin care. In addition to pre- and post-treatment evaluation, follow-up measurements were performed at 3, 6 and 12 months by the same physician.

• The study sample (N = 50) was comprised of two groups receiving either pneumatic compression therapy (group I, n = 25) or low-level laser therapy (group II, n = 25). 
• Mean age for group I was 51.2 years and group II was 45.4 years. 
• All patients had breast cancer-related lymphedema. 
• Patients were included in the study if they had a history of arm lymphedema of at least three months. 
• Patients were excluded from the study if they
  • Had current metastases, continuing radiotherapy, cellulitis, venous thrombosis, chronic inflammatory diseases, a history of severe trauma, or photosensitivity
  • Were using any medications that affect body fluid and electrolyte balance
  • Had limitation of the upper-extremity joints
  • Had a history of physical therapy other than skin care and home exercises directed to lymphedema within the previous six months.

The study took place at the Department of Physical Medicine and Rehabilitation of Cukurova University in Turkey.

Patients were undergoing long-term follow-up care. The study has clinical applicability for late effects and survivorship. 

The study used a randomized controlled trial design.

• The affected and unaffected upper limbs of the patients were measured by tape at seven anatomic sites, including the axilla, 10 cm proximal and distal to the antecubital fossa, elbow, 5 cm proximal to the wrist, wrist, and mid-palm. Lymphedema was defined as a difference of more than 2 cm at least three of the seven points. The sum of the circumferences of the affected and unaffected limbs was calculated and the difference between these two values was recorded as delta circumference.
• Pain with motion was measured by a visual analog scale of 0–100 mm, ranging from no pain to very severe pain.
• Range of motion of the upper-extremity joints was measured using a conventional goniometer when patients were lying in the supine position.
• Grip strength was measured by portable hydraulic hand dynamometer. The measurements were performed when patients were seated in straight position, with the shoulder adducted, elbow flexed at 90°, and forearm in neutral rotation. A mean of three attempts was calculated, with a 15-second rest in between each of three contractions.

Delta circumference decreased significantly at one, three, and six months within both groups, and the decrease was still significant at month 12 only in group II (p = 0.004). Improvement of group II was greater than that of group I post-treatment (p = 0.04) and at month 12 after 12 months (p = 0.02). Pain was significantly reduced in group I only at post-treatment evaluation, whereas in group II it was significant post-treatment and at follow-up visits. No significant difference was detected in pain scores between the two groups. Grip strength was improved in both groups, but the differences between groups were not significant.

Patients in both groups improved after the interventions. Group II had better long-term results than group I. Low-level laser might be a useful modality in the treatment of post-mastectomy lymphedema.

• The study sample was small, with less than 30 participants for each group and less than 100 participants in total. 
• The study lacked a sham or control group because of ethical issues.
• Patients were not blinded because of the different types of treatment. 

Prospective randomized controlled studies with a larger sample size are needed to better understand the efficacy of low-level laser therapy and pneumatic compression in the treatment of postmastectomy lymphedema. In addition to these suggested treatment modalities, patients are recommended to perform daily limb exercises and follow skin care instructions throughout their lives.