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IRCT20220403054393N1 IRCT 2022-05-09 University of social welfare and rehabilitation sciences Effect of lumbar belt and custom-made insoles on low back pain and functional disability in pronated foot patients. Effect of altered lumbar belt, with and without custom-made insoles, and comparison of it with common prefabricated belts on low back pain and functional disability in pronated foot patients. 2022-05-28 anticipated 40 Complete https://irct.ir/trial/62753 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of each person to four groups with conventional belt, modified belt, custom insole and modified belt with custom insole will be done according to Appendix 3 block arrangement. For example, according to this list, the first participant will be set in the control group. The second participant in firs intervention group , the third participan in third intervention, the fourth participant in second intervention, and so on as the participants include.That is, the allocation sequence will be completely random and based on the randomized block method (arrangement available as a proposal attachment). N/A chronic low back pain. Intervention 1: Control group: common prefabricated belt. The belt from Tavanmehr Company is considered for each patient based on the recorded size of the pelvic environment in the area between the anterior superior iliac spine and the trochanter and will be closed above the pubice. The force applied by the belt will be 50 Newtons, which is measured by a tensile dynamometer. Then, based on this force, the correct closing place is marked and determined for the patient on the belt, and we ask him to fasten the belt in the same place, and in case of noticeable size or weight change, inform us to adjust the belt. Intervention 2: first Intervention group: altered belt. It is the same as prefabricated belt in which a textured pad is embedded. This pad has a triangular pattern in the shape of a sacrum that covers the lumbar and sacral areas and will be made of silicone, which by installing small cylindrical villi with a height of one centimeter and a diameter of half a centimeter increases the sense of touch and thus proprioception in the lumbar region. Each of the villi will be placed at equal distances of two centimeters from each other. The pad will be attached to the prefabricated belts with Velcro double-sided adhesive. The force applied by the belt will be equal to 50 Newtons, which is measured by a tensile dynamometer. Intervention 3: second Intervention group: custom made insole. Insole fabrication for each patient will be done exclusively by CAD-CAM method. For this purpose, using pressure scan PT-SCAN model 4452F40 of Payafnavaran Ferdowsi Company, made in Iran, pressure scan will be obtained from the participants. The obtained computer scan is evaluated separately for each patient and a special insole is designed for them using PT insole design computer software. The medial edge is 4 degrees from the midline to the inner edge of the insole and is based on the size of the patient foot will be 6 to 8 mm long. The length of the medial longitudinal arch, depending on the size of the patient's foot and the size recorded for him from the talus bone to the head of the first metatarsus and its height will be 15 mm. The metatarsal pad will be located 5 mm behind the second to fourth metatarsals. The size of the metatarsal pad will be such that it covers the three central metatarsals. The height of the metatarsal pad gradually increases from the edges to the middle up to 6 mm at the midpoint. At the end, information is given through G-codes to the device related to Paya Fanavaran Company made in Iran, which cuts the insoles on the foam block with a thickness of 2/3 with the shore of 35 to 40. Intervention 4: third Intervention group: altered belt and custom made insole. Both of these interventions are used simultaneously. Yes - There is a plan to make this available What will be shared: Total potential data after unidentifiable individuals according to the patient information form and file created for them. When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions and people working in the profession Conditions: To do research work and in coordination with the researcher Where to obtain: Bahareh Delshad, E-mail b.delshad20@gmail.com How to obtain: After consulting with other design partners and approving them, the data will be provided to the applicant Comments: The applicant needs to clearly explain why the data is needed
public Bahareh Delshad
Unit 3, in front of Alborz Taxi, Valiasr St., Qasr Al-Dasht St.
شیراز Iran (Islamic Republic of) 7183813455 +98 71 3627 4458 b.delshad20@gmail.com University of social welfare and rehabilitation sciences scientific Bahareh Delshad
Unit 3, in front of Alborz Taxi, Valiasr St., Qasr Al-Dasht St.
Shiraz Iran (Islamic Republic of) 7183813455 +98 71 3627 4458 b.delshad20@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) nonspecific low back pain diagnosed by medical profession and checked by questionnaire 1 pronation in one or both feet(more than +6 score in FPI test age between 30 and 50 having at least score 3 for low back pain in VAS at the beginning of treatment BMI between 18.5 to 30 30 years 50 years Both History of injury or surgery on the foot or back Concomitant use of other treatments such as physiotherapy or injections to reduce pain and increase ability Positive answer to each of the questions in Appendix 1 Any progressive or non-progressive mobility impairment with psychological, neurological, rheumatological and orthopedic reasons that overshadow the ability to participate and be effective in the study Specific lameness or asymmetry in walking Pregnancy or delivery history in the last six months anisomelia more than 5 mm history of ankle sprain rigid pronation in ankle genuvarum M54.5 Low back pain Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Control group: common prefabricated belt. The belt from Tavanmehr Company is considered for each patient based on the recorded size of the pelvic environment in the area between the anterior superior iliac spine and the trochanter and will be closed above the pubice. The force applied by the belt will be 50 Newtons, which is measured by a tensile dynamometer. Then, based on this force, the correct closing place is marked and determined for the patient on the belt, and we ask him to fasten the belt in the same place, and in case of noticeable size or weight change, inform us to adjust the belt. first Intervention group: altered belt. It is the same as prefabricated belt in which a textured pad is embedded. This pad has a triangular pattern in the shape of a sacrum that covers the lumbar and sacral areas and will be made of silicone, which by installing small cylindrical villi with a height of one centimeter and a diameter of half a centimeter increases the sense of touch and thus proprioception in the lumbar region. Each of the villi will be placed at equal distances of two centimeters from each other. The pad will be attached to the prefabricated belts with Velcro double-sided adhesive. The force applied by the belt will be equal to 50 Newtons, which is measured by a tensile dynamometer. second Intervention group: custom made insole. Insole fabrication for each patient will be done exclusively by CAD-CAM method. For this purpose, using pressure scan PT-SCAN model 4452F40 of Payafnavaran Ferdowsi Company, made in Iran, pressure scan will be obtained from the participants. The obtained computer scan is evaluated separately for each patient and a special insole is designed for them using PT insole design computer software. The medial edge is 4 degrees from the midline to the inner edge of the insole and is based on the size of the patient foot will be 6 to 8 mm long. The length of the medial longitudinal arch, depending on the size of the patient's foot and the size recorded for him from the talus bone to the head of the first metatarsus and its height will be 15 mm. The metatarsal pad will be located 5 mm behind the second to fourth metatarsals. The size of the metatarsal pad will be such that it covers the three central metatarsals. The height of the metatarsal pad gradually increases from the edges to the middle up to 6 mm at the midpoint. At the end, information is given through G-codes to the device related to Paya Fanavaran Company made in Iran, which cuts the insoles on the foam block with a thickness of 2/3 with the shore of 35 to 40. third Intervention group: altered belt and custom made insole. Both of these interventions are used simultaneously. Low back pain. Timepoint: at the begining of study and 6 week later. Method of measurement: visual analog scale. Disability. Timepoint: at the begining of study and 6 week later. Method of measurement: oswestry questionnaire. University of social welfare and rehabilitation sciences Approved 2022-02-16 Ethics Committees of University of Social Welfare and Rehabilitation Sciences Evin Daneshjoo Blvd., Koodkiar St., University of Social Welfare and Rehabilitation Sciences Tehran Tehran Iran (Islamic Republic of)