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Efficacy of addition of transcutaneous electrical nerve stimulation to standardized physical therapy in subacute spinal spasticity: a randomized control trial
Oo WM
Archives of Physical Medicine and Rehabilitation 2014 Nov;95(11):2013-2020
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To study the immediate and short-term efficacy of adding transcutaneous electrical nerve stimulation (TENS) to standardized physical therapy on subacute spasticity within 6 months post-spinal cord injury. DESIGN: Randomized controlled trial for 3 weeks. SETTING: University hospital of Mandalay. SUBJECTS AND INTERVENTION: Sixteen subjects with clinically determined spasticity were randomly assigned to experimental group (n = 8, 60 minute sessions of TENS over the bilateral common peroneal nerves before 30 minutes of physical therapy) or control group (n = 8, 30 minutes of physical therapy alone). All patients in both groups had access to standardized rehabilitation care. OUTCOME MEASURES: Composite spasticity score as primary end point to assess plantar flexor spasticity which included three sub-scores: ankle jerk, muscle tone and ankle clonus scores. These sub-scores were designated as secondary end points. Serial evaluations were made at baseline before study entry, immediately after the first and last sessions in both groups. RESULTS: On analysis for immediate effects, there was significant reduction only in composite spasticity score (mean difference 1.75 (99% confidence interval (CI) 0.47 to 3.03), p = 0.002) in the experimental group but no significant reduction was observed in all outcome variables in the control group. The significant difference of composite spasticity score (1.63 (99% CI 0.14 to 3.11), p = 0.006) was observed between the two groups. After 15 sessions of treatment, significant reduction was determined in composite spasticity score (2.75 (99% CI 1.31 to 4.19), p < 0.001), muscle tone score (1.75 (99% CI 0.16 to 3.34), p = 0.006) and ankle clonus score (0.75 (99% CI 0.18 to 1.32), p = 0.003) in the experimental group while none of outcome variables revealed significant reduction in control group. The between-group difference was significant only in composite spasticity score (2.13 (99% CI 0.59 to 3.66), p = 0.001) and muscle tone score (1.50 (99% CI 0.15 to 2.85), p = 0.005) after 15 intervention sessions. CONCLUSION: Addition of TENS to standardized physical therapy had synergistically anti-spastic action, providing more effective reduction of clinical spasticity.

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