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IRCT20220203053925N1 IRCT 2022-03-14 Esfahan University of Medical Sciences The immediate effects of the orthosis on the tennis elbow syndrome The immediate effects of the clasp elbow orthosis with a textured pad on the pain intensity, hand grip strength, hand function and elbow 2022-04-21 anticipated 48 Complete https://irct.ir/trial/61955 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Used, Assignment: Other, Purpose: Supportive. N/A tennis elbow. Intervention 1: Intervention group:the clasp elbow splint is made with hourse-shoe rigid thermoplastic material which covers two-third of forearm circumferential at the dorsal surface. This splint is fitted on the forarm using a velcro strp. The inner surface of the splint is covered with a soft foam material. At the lateral aspect of the splint, a textured silicon pad with semicirculare projections is placed to provide skin stimulation at the lesion site. Intervention 2: Intervention group: elbow strap is an 8-cm-wide neoprene band fitted 2.5 cm below the elbow. A double layered neoprene pad was incorporated in the forearm band to apply a direct pressure to the origin of the extensor muscles. The elbow strap had a 5-cm-wide non-elastic strap to adjust the pressure on the pad. Intervention 3: Intervention group: placebo orthosis which is an 5 cmwide elastice neoperene band and is fitted 10 cm above the elbow using a velcro strap. Fitting the strap above the elbow is to prevent any effect that this splint might have on the lesion. Intervention 4: Control group: No orthosis, without wearing any splint. Yes - There is a plan to make this available What will be shared: The study data (excluding the personal details) can be shared with other researchers or systematic reviewers. When: Data will be shared once findings are come up or summary date is published. To whom: Data will be shared once findings are come up or summary date is published. Conditions: Data will be shared personally and for academic purposes only. Where to obtain: Data will be shared for teaching or research. Dr Sadeghi (correspondence) will review the requests. How to obtain: People can sent their request to the correspondence and obtain the data. Comments: Request should be sent through an email (sadeghi@rehab.mui.ac.ir).
public dr Ebrahim sadeghi demneh
Hezar jerib Ave
esfahan Iran (Islamic Republic of) 7346181746 +98 31 3792 5219 sadeghi@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific Ebrahim Sadeghi-Demneh
Hezar Jerib
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3792 5219 sadeghi@rehab.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) the age range of 30 to 55 years The report of diffuse and increasing pain in the external epicondyle of the humerus with active wrist and third finger extension movement, supination, and strong hand grip Ability to give an informed consent and participation in the study 30 years 55 years Both Any abnormality or deformity in the hands, forearms, shoulders and neck area A history of fractures, dislocations, surgery on the elbow joint A history of corticosteroid injection in the period of six months before the participation Having a زervical radiculopathy, pathology or an involvement of the peripheral nerves of the elbow joint M77.1 Lateral epicondylitis Rehabilitation Rehabilitation Rehabilitation N/A Intervention group:the clasp elbow splint is made with hourse-shoe rigid thermoplastic material which covers two-third of forearm circumferential at the dorsal surface. This splint is fitted on the forarm using a velcro strp. The inner surface of the splint is covered with a soft foam material. At the lateral aspect of the splint, a textured silicon pad with semicirculare projections is placed to provide skin stimulation at the lesion site. Intervention group: elbow strap is an 8-cm-wide neoprene band fitted 2.5 cm below the elbow. A double layered neoprene pad was incorporated in the forearm band to apply a direct pressure to the origin of the extensor muscles. The elbow strap had a 5-cm-wide non-elastic strap to adjust the pressure on the pad. Intervention group: placebo orthosis which is an 5 cmwide elastice neoperene band and is fitted 10 cm above the elbow using a velcro strap. Fitting the strap above the elbow is to prevent any effect that this splint might have on the lesion. Control group: No orthosis, without wearing any splint Pain score on the visual analoge scale. Timepoint: At the beginning of the study and after wearing each orthosis. Method of measurement: visual analoge scale. The amount of angle recorded to measure the sense of depth by a digital goniometer. Timepoint: At the beginning of the study and after wearing each orthosis. Method of measurement: digital goniometer. Painless grip strength. Timepoint: At the beginning of the study and after wearing each orthosis. Method of measurement: Digital dynamometer. Recorded number for hand function with minnessotta manual test. Timepoint: 5 minutes after intervention. Method of measurement: Hand function is assessed using the Minnesota manual test. Esfahan University of Medical Sciences Approved 2022-01-29 IR.MUI.NUREMA.REC Hezar Jerib Isfahan Isfehan Iran (Islamic Republic of)