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IRCT20210101049910N1 IRCT 2021-03-12 Semnan University of Medical Sciences Effects of adding Cognitive-Behavioral Therapy (CBT) to stability exercises in low back pain patients Effects of adding Cognitive-Behavioral Therapy (CBT) to stability exercises on Lumbo-Pelvic Rhythm during lifting in non-specific low back pain patients with high fear of movement 2021-04-03 anticipated 51 Complete https://irct.ir/trial/53420 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocks of 3 and 6 are used for randomization. The intervention groups are called A and B; the control group is called C. Different 3 blocks including A, B, C, and 6 different blocks with two A, B, C are defined in different permutations. We will have 3 blocks of 3 and 7 blocks of 6. Each block is assigned a number from 0 to 9. Using a random number generator, the blocks are selected from 10 designated blocks, respectively. Eligible individuals are assigned to one of three groups A, B, or C in each block (from left to right) in a predetermined order. N/A Non-specific low back pain. Intervention 1: First intervention group: Participants in this group will receive stabilization exercises that involve pulling the abdomen in 10 different positions for eight weeks, two days in a week. Patients will be taught how to do the exercises orally and using pictures. The abdominal inhalation practice is held for 10 seconds and is repeated 10 times with a pause of 3 seconds and the time interval of each Practice until the next exercise is 60 seconds. The exercises are progressive and the number of exercises increases over time. Intervention 2: Second intervention group: In addition to trunk stabilization exercises that will be given to the subjects for eight weeks and two sessions per week, cognitive behavioral therapy will also be given to the participants of this group. This treatment is based on problem solving, so in the first stage, the patient is evaluated by the therapist. Evaluation in this treatment aims to collect information that based on the cognitive model, determine how the disorder is formed and its continuation. The psychotherapist examines the patient's mood and asks him or her to make a list of his or her problems, write down his or her thoughts, identify abnormal behaviors, and try to control them. Each week, a treatment session is provided for patients in this group, the first session will be 2 hours and the next sessions will be 30 minutes for 8 weeks. Except for the first session, which is more about introducing the patient to the treatment process, in the next sessions, the therapist and the patient review the previous week and both work together to determine the current agenda. In the treatment sessions, the treatment assignments are reviewed, the current agenda is executed, a new assignment is determined, and at the end of each session, the patient is asked to comment on the session. Intervention 3: Control group: This group will not receive treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There are not more informations.
public Rosita Hedayati
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3365 4180 rosehed@yahoo.com Semnan University of Medical Sciences scientific Rosita Hedayati
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3365 4180 rosehed@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Non-specific low back pain patients with high fear of movement At least 12 weeks have passed since the low back pain Having fear scores greater than 40 on the Tampa scale for kinesiophobia According to VAS on the day of the study the maximum pain intensity of each patient must be 3 20 years 55 years Both Any signs of serious spinal involvement Having symptoms of cauda equina syndrome Having symptoms of sciatica Symptoms of spinal canal stenosis Symptoms of nerve root involvement History of spinal surgery Spinal fracture Structural abnormalities in the spine Swelling, inflammation and dryness of the lumbar joints Having a BMI of more than 25 kg per square meter Report of uncorrected visual impairment Severe cognitive and memory impairment Pregnancy M54.5 Low back pain Rehabilitation Rehabilitation Rehabilitation First intervention group: Participants in this group will receive stabilization exercises that involve pulling the abdomen in 10 different positions for eight weeks, two days in a week. Patients will be taught how to do the exercises orally and using pictures. The abdominal inhalation practice is held for 10 seconds and is repeated 10 times with a pause of 3 seconds and the time interval of each Practice until the next exercise is 60 seconds. The exercises are progressive and the number of exercises increases over time. Second intervention group: In addition to trunk stabilization exercises that will be given to the subjects for eight weeks and two sessions per week, cognitive behavioral therapy will also be given to the participants of this group. This treatment is based on problem solving, so in the first stage, the patient is evaluated by the therapist. Evaluation in this treatment aims to collect information that based on the cognitive model, determine how the disorder is formed and its continuation. The psychotherapist examines the patient's mood and asks him or her to make a list of his or her problems, write down his or her thoughts, identify abnormal behaviors, and try to control them. Each week, a treatment session is provided for patients in this group, the first session will be 2 hours and the next sessions will be 30 minutes for 8 weeks. Except for the first session, which is more about introducing the patient to the treatment process, in the next sessions, the therapist and the patient review the previous week and both work together to determine the current agenda. In the treatment sessions, the treatment assignments are reviewed, the current agenda is executed, a new assignment is determined, and at the end of each session, the patient is asked to comment on the session. Control group: This group will not receive treatment. Lumbo-pelvic rhythm. Timepoint: The first session, last session, and one month after the end of the sessions. Method of measurement: 3D motion analysis system. Fear of movement. Timepoint: The first session, last session and one month after the end of the sessions for the intervention and control groups. Method of measurement: Tampa scale for kinesiophobia. Disability. Timepoint: The first session, last session and one month after the end of the sessions for the intervention and control groups. Method of measurement: Roland Morris disability questionnaire. Pain. Timepoint: The first session, last session and one month after the end of the sessions for the intervention and control groups. Method of measurement: Visual analog scale. Semnan University of Medical Sciences Approved 2020-12-22 Ethics Committee of Semnan University of Medical Sciences Semnan University of Medical Sciences, Basij Blvd, Semnan Semnan Semnan Iran (Islamic Republic of)