LASER THERAPY AND SENSORY RE-EDUCATION THERAPY ON LOWER LIMB SENSORY FUNCTIONS IN DIABETIC NEUROPATHY PATIENTS: A PILOT RANDOMIZED CLINICAL TRIAL

S. Khadayat¹, A.J. Samuel², S. Chatterjee³

Background: Impaired sensory function is associated with loss of sensation and poor quality of life are the hallmarks of the patient with diabetic neuropathy (DN). There is a scarcity of evidence that class IV LASER therapy applied to the lower limb improves the sensory function in patients with DN. The study aimed at investigating whether class IV LASER therapy and sensory re-education treatment would improve the sensory functions of the lower limb in patients with DN.

Purpose: To find out the effectiveness of class IV LASER therapy and sensory re-education training on the sensory functions in patients with DN.

Methods: Twenty patients in the age group, 50 to 70 years were recruited through the convenience sampling method after screening 38 patients with DN and randomly allocated through block randomization method into one of the two groups, LASER therapy group (LTG) and sensory re-education therapy (SRG). LTG received class IV LASER therapy which included 8 minutes of class IV LASER therapy per session with dose delivery rate was set at 7j/cm2 per session/day on each distal lower limb for 5 consecutive days while SRG received sensory re-education treatment which included three types sensory interventions, touch   (light and rough), vibration and temperature (hot and cold). A light touch will be provided with a 30-degree inclination of the ends of the brush and rough touch by sandpaper to the skin surface for 5mins. Vibration sensation was provided by a handheld mechanical vibrator (50 Hz). The hot temperature was provided by heat pack (75°C) and cold by a cold pack (<0°C) wrapped in towels for up to 15 and 30 seconds respectively. The above treatment protocol for both the groups was continued for a period of 5 consecutive days. To evaluate the sensory functions, monofilament (Semmes-Weinstein monofilament - 10grams), and nerve conduction studies using Allergens (Scorpio-2/4 EMG, NCS-EP System) were performed. Baseline and post-intervention treatment effects were compared with monofilament testing, nerve conduction velocity (m/s), latency (ms), and compound muscle action potential amplitude (mV).  

Results: Median (IQR) of age, height, weight, and BMI of patient with DN recruited in the study was 57 (55, 63) years, 170 (163.30, 170.68) height, 68 (61.50, 73.75) weight and 23.74 (21.89, 25.14) Kg/m2. Between-group comparison in estimating the changed score of the post-pre test score of LTG and post-pre score of SRG revealed no significant (p=0.058) result between LTG and STG. Data were analyzed by the intention to treat analysis.

Conclusion(s): There is sufficient evidence to prove that class IV LASER therapy is better in improving sensory functioning when compared to sensory re-education training among patients with DN.  

Implications: Class IV LASER therapy could be safely used alternative to sensory re-education training. Class IV LASER therapy could be administered to the patient with DN who are hypersensitive to the sensory treatment.

Funding, acknowledgements: None
Ethics number: MMDU/IEC/1110 dated 24.03.2018
Clinical Trial Registration: CTRI/2018/08/015561 [Registered on: 31/08/2018].

Keywords: LASER therapy, Diabetic neuropathy, Lower limb

Topic: Neurology

Did this work require ethics approval? Yes

Institution: Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation

Committee: Maharishi Markandeshwar Institute of Medical Sciences and Research

Ethics number: MMDU/2018/1110