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IRCT20150210021034N5 IRCT 2020-02-06 Esfahan University of Medical Sciences Orthotic effects on the symptoms of plantar fasciitis The effects of two night splints on the pain and quality of life of people with plantar faciitis 2017-02-19 anticipated 30 Complete https://irct.ir/trial/42789 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization was stratified by gender to pursue equal distribution of the gender for all intervention and control groups. Randomization in each stratum was carried out by having a piece of paper that has the phrase "intervention 1 (heel stretching splint+heel pad)", "intervention 2 (toe stretching splint+heel pad)"and "control (heel pad only)" placed inside an envelope. The outside of the envelops were sequentially numbered. After participants have been enrolled in the study and consented, a sequence number envelope on the stack will be randomly drawn and opened to determine the study group that the participant will enter. N/A Plantar Fasciitis. Intervention 1: First intervention group: an ankle-foot splint was used for night-time stretching of the plantar fascia and a pair of silicone heel pad for day-time use. The ankle-foot splint is a plastic-made device that extends from the dorsal aspect of the leg to the toes. This device is used during resting or sleeping time and fitted on the limb with three straps. This device maintains the ankle in the dorsiflexion position and thereby exerts a stretching force on the plantar fascia. The silicone heel pad is used to reduce the local pressure on the lesion area. Intervention 2: Second intervention group: a neoprene ankle-foot support was used for night-time stretching the plantar fascia and a pair of silicone heel pad for day-time use. The ankle-foot support is made of a neoprene rubber that is put on like a sock. This device is used during resting or sleeping time and pulls the toes toward the shank using an adjustable strap. This device extends the toes and thereby exerts a stretching force on the plantar fascia. The silicone heel pad is used to reduce the local pressure on the lesion area. Intervention 3: Control group: the use of silicone heel pad during day. A pair of silicone heel pad was used to reduce the pressure on the lesion area. Yes - There is a plan to make this available What will be shared: The study data (excluding the personal details) can be shred with other researchers or systematic reviewers. When: No specific limitation is considered. To whom: No limit was set. Conditions: No terms and conditions is considered for sharing the data. Where to obtain: People can sent their request to the correspondence and obtain the data. How to obtain: Request can be sent through an email. Comments:
public Ebrahim Sadeghi-Demneh
Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5235 sadeghi@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific Ebrahim Sadeghi-Demneh
Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5235 sadeghi@rehab.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Pain complain at the heel ( score 3 and more based on visual analogue scale) Stiffness and pain at the heel in morning 18 years no limit Both History of surgery and fracture in the foot and leg Sensory loss in the foot M72.2 Plantar fascial fibromatosis Treatment - Devices Treatment - Devices Treatment - Devices First intervention group: an ankle-foot splint was used for night-time stretching of the plantar fascia and a pair of silicone heel pad for day-time use. The ankle-foot splint is a plastic-made device that extends from the dorsal aspect of the leg to the toes. This device is used during resting or sleeping time and fitted on the limb with three straps. This device maintains the ankle in the dorsiflexion position and thereby exerts a stretching force on the plantar fascia. The silicone heel pad is used to reduce the local pressure on the lesion area. Second intervention group: a neoprene ankle-foot support was used for night-time stretching the plantar fascia and a pair of silicone heel pad for day-time use. The ankle-foot support is made of a neoprene rubber that is put on like a sock. This device is used during resting or sleeping time and pulls the toes toward the shank using an adjustable strap. This device extends the toes and thereby exerts a stretching force on the plantar fascia. The silicone heel pad is used to reduce the local pressure on the lesion area. Control group: the use of silicone heel pad during day. A pair of silicone heel pad was used to reduce the pressure on the lesion area. Pain intensity. Timepoint: The measurement was carried out before intervention and 4 weeks after intervention. Method of measurement: Pain intensity was measured using visual analogue scale. Range of motion at the heel and metatarsophalengeal joints. Timepoint: The measurement was carried out before intervention and 4 weeks after intervention. Method of measurement: The passive range of motion was measured using a digital goniometer. Quality of life. Timepoint: The measurement was carried out before intervention and 4 weeks after intervention. Method of measurement: The quality of life was measured using the Persian version of SF-36 questionnaire. Esfahan University of Medical Sciences Approved 2017-01-22 ُthical committee of Isfahan University of Medical Sciences, Isfahan, Iran Hezar Jerib St. Isfahan Isfehan Iran (Islamic Republic of)