Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
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Plantar fasciitis: a prospective randomized clinical trial of the tension night splint.

OBJECTIVE: The objective of this study was to evaluate the efficacy of a tension night splint (TNS) as part of a treatment regimen for the management of plantar fasciitis.

DESIGN: The design was a randomized clinical trial.

SETTING: The setting was a university-based primary care sports medicine clinic in California.

PATIENTS: Forty patients with plantar fasciitis entered the study (age range, 20-74 years; average age, 45.7 years). Excluded from the study were patients with other concomitant ankle or foot pathology. Thirty-two patients (21 women, 11 men) completed the study with 33 treated feet.

INTERVENTION: The patients were randomized to one of two treatment groups. The control group (n = 17) received standard treatment of antiinflammatory medication (Ibuprofen), a Viscoheel sofspot heel cushion (Bauerfeind USA, Kennesaw, GA, U.S.A.) and a stretching program for the gastrocnemius and soleus muscles. The tension night split group (n = 16) received the same standard treatment protocol and additionally an office manufactured custom fitted posterior splint to be used at night. Those patients in the control group not responding to treatment after 8-12 weeks were crossed over to the tension night splint group. Patients were reviewed every 4 weeks for symptom assessment and compliance.

MAIN OUTCOME MEASURES: The main outcome measures were subjective assessment of pain (Visual analogue scale), plantar fascial tenderness, and ankle range of motion. Patients were discharged from either arm of the trial when they had resumed normal activities with minimal or no discomfort. This end point was recorded as weeks to cure.

MAIN RESULTS: There was no significant difference in the demographics of the two groups (p > 0.05). In the control group, 6 of 17 were cured after an average interval of 8.8 weeks. The remaining 11 of 17 control group patients were crossed over to receive a TNS in addition to control modalities. Following cross over 8 of 11 of this group were cured after an average of 13 weeks. Three of the 11 failed to significantly respond. Of the 15 patients (16 feet) originally randomly assigned to the TNS group 16 of 16 were cured with an average treatment time of 12.5 weeks. The TNS treatment protocol was a significantly more efficacious treatment regime (p < 0.05). Thus, of 33 cases of plantar fasciitis treated in this study three failed treatment.

CONCLUSION: When used in combination with a visco-elastic heel pad, stretching program and nonsteroidal anti-inflammatory drugs, the TNS is an effective treatment of plantar fasciitis.

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