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Abstract
Objective To identify any improvements in pain or function in patients with chronic plantar fasciitis following the use of a tension night splint (TNS).
Methods Single-blinded randomised controlled trial, with participants split evenly between intervention group (TNS + home exercise programme/HEP) and control group (HEP only). Follow-up at 3 months, with interim data at 6 weeks.
Results 40 patients recruited. Mean age 52.1 years, 33% male, mean body mass index 30.8 kg/m2, mean duration of symptoms of 25 months. Improvement in self-reported ‘average pain' in the intervention group from 6.8/10 at baseline to 5.6/10 at 6 weeks, and 5.3/10 at 3 months (both clinically and statistically significant at both time points), compared with control group of 7.1/10 at baseline to 6.2/10 at 6 weeks and 5.6/10 at 3 months (significant only at 3 months). Improvements in self-reported ‘worst pain', ‘pain walking' and ‘pain first thing in the morning' in both groups at all time periods. Improvements were seen in revised Foot Function Index at all time points in both groups, but limited changes seen in flexibility and no significant changes in anxiety or depression Hospital Anxiety and Depression Scale domains or sleep quality in either group. However, no differences were seen between the outcomes seen in the two groups for the majority of the measures studied.
Conclusions Improvements in pain and some functional measures seen in both groups, with few, if any, differences seen in outcomes between the intervention group compared with the control group. However, ongoing pain symptoms were reported in both groups, suggesting that ‘help' rather than ‘cure' was obtained for the majority. There is a possibility of earlier benefit seen in the intervention group compared with the control group, but data are unclear and further work may be needed.
Trial registration number ClinicalTrials.gov: NCT02546115; results.
- Tendinopathy
- Foot
- Randomised controlled trial
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Footnotes
Acknowledgements The author would like to offer his thanks to Chloe Tattersall, the nurse practitioner in the Sports Medicine Department at University Hospitals of Leicester for conducting the study blinding. The author would also like to offer his thanks to Dr Jonathan Folland at Loughborough University for his support during the study, and to the Leicester Arthritis Research Fund for the small charitable grant that allowed the purchase of the tension night splint devices.
Contributors This manuscript has a sole author who was responsible for the design, setting up and analysis of this study.
Competing interests None declared.
Patient consent Not required in this study design fully anonymised data used only no specific individuals can be identified from material used patients consented to enter study, and for anonymised data from this to be used to disseminate in medical journals.
Ethics approval NHS Research Ethics Committee (REC ref 14/WS/1069).
Provenance and peer review Not commissioned; externally peer reviewed.