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IRCT20240608062042N1 IRCT 2024-07-09 Tehran University of Medical Sciences Teleexercise for failed back surgery syndrome Tele exercise for patients with failed back surgery syndrome: Randomized clinical trial 2024-07-09 anticipated 164 Complete https://irct.ir/trial/77258 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization: Using random numbers generated by Google, subjects will be divided into intervention group (doing researcher-made exercises) and control group (doing Williams exercises) with equal numbers and subjects have equal chance to choose. It was agreed from the beginning that the intervention group will be given odd numbers and the control group will be given even numbers. In the random numbers generated by Google, the minimum defined number is 1 and the maximum is set to 164. At the time of using this program, the person who is going to do this process is not aware of the distribution of subjects in these two groups and will not participate in any other phase of the research, Blinding description: Investigator is blind about the randomization. N/A Failed back surgery syndrome. Intervention 1: Intervention group: distance exercises. After 1-2 face-to-face training sessions, a face-to-face visit is performed, ideally with the patient's caregiver or companion, who may later assist the patient with FBSS at home. Then an educational video and poster is sent electronically to the patient and his companion can assist in viewing. After this, remote exercise sessions will begin. The participation of the therapist during the video therapy sessions allows for appropriate intervention and feedback to ensure that the patient performs the exercises safely and effectively. Then the online sessions can continue, focusing on the gradual transition of the patient to perform the exercises alone or with the help of a companion at home. In the intervention group, each exercise should be performed 3 times a day for 4 weeks for 20 sets with a set duration of 10 seconds. (for each leg/hand) The intervention group will perform three exercises defined by the pain specialist, including Hip abduction exercise, Shoulder abduction exercise, and Hip and shoulder abduction exercise. Intervention 2: The control group will only do Williams exercises. The first session, with movement training, will be attended at the pain clinic of Khatam Hospital in Tehran, and pamphlets and videos on the correct way to perform movements will be provided to the patients. Movements are performed at home for 4 weeks, and after 4 weeks, re-evaluations will be done in person, then to monitor the patient, the patient will perform the movements at home for another 4 weeks (according to the previous instructions) and will be re-evaluated. While a companion is essential for these exercises, we will demonstrate these routines through an online consultation. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more data.
public Ardalan Shariat
Tehran University Of Medical Sciences
Tehran Iran (Islamic Republic of) 1936893813 +98 939 861 4772 ardalansh2002@gmail.com Tehran University of Medical Sciences scientific Ardalan Shariat
Tehran University Of Medical Sciences
Tehran Iran (Islamic Republic of) 1936893813 +98 939 861 4772 ardalansh2002@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age: <65 years old Patients with failed back surgery syndrome They have been referred by a surgeon to a pain specialist in Khatam al-Anbia Hospital. no limit 65 years Both Lack of ability to do the exercises. Lack of intention for participation. Having red flags. M54.5 Low back pain Treatment - Other Treatment - Other Intervention group: distance exercises. After 1-2 face-to-face training sessions, a face-to-face visit is performed, ideally with the patient's caregiver or companion, who may later assist the patient with FBSS at home. Then an educational video and poster is sent electronically to the patient and his companion can assist in viewing. After this, remote exercise sessions will begin. The participation of the therapist during the video therapy sessions allows for appropriate intervention and feedback to ensure that the patient performs the exercises safely and effectively. Then the online sessions can continue, focusing on the gradual transition of the patient to perform the exercises alone or with the help of a companion at home. In the intervention group, each exercise should be performed 3 times a day for 4 weeks for 20 sets with a set duration of 10 seconds. (for each leg/hand) The intervention group will perform three exercises defined by the pain specialist, including Hip abduction exercise, Shoulder abduction exercise, and Hip and shoulder abduction exercise. The control group will only do Williams exercises. The first session, with movement training, will be attended at the pain clinic of Khatam Hospital in Tehran, and pamphlets and videos on the correct way to perform movements will be provided to the patients. Movements are performed at home for 4 weeks, and after 4 weeks, re-evaluations will be done in person, then to monitor the patient, the patient will perform the movements at home for another 4 weeks (according to the previous instructions) and will be re-evaluated. While a companion is essential for these exercises, we will demonstrate these routines through an online consultation. Range of motion. Timepoint: Before intervention and 1, 2 months after intervention. Method of measurement: Modified-modified Schober Test. Pain intensity. Timepoint: Before intervention and 1, 2 months after intervention. Method of measurement: Numeric Pain Rating Scale. Quality of life. Timepoint: Before intervention and 1, 2 months after intervention. Method of measurement: Health-related quality of life. Clinical changes. Timepoint: Before intervention and after 1 and 2 month. Method of measurement: MRI. Tehran University of Medical Sciences Approved 2024-05-28 Ethics committee of Tehran University of Medical Sciences Tehran University Of Medical Sciences Tehran Tehran Iran (Islamic Republic of)