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IRCT20200318046813N1 IRCT 2021-08-21 Esfahan University of Medical Sciences evaluation of the effect of ankle and foot mobilization on low back pain Evaluation of the effect of multi segmental foot and ankle mobilization on pain, disability and lumbar and ankle flexion range of motion on patient with chronic mechanical low back pain (Randomized controlled trial) 2021-01-04 anticipated 56 Complete https://irct.ir/trial/49037 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, we use random block method to assign patients to two control and experimental groups. In this method, blocks of 4, 6 and 8 or blocks that have an even number can be used. In this study, we will use quadruple blocks in which two people will be assigned to the experimental group and two to the control group. A quadruple block can be formed into 6 possible states according to the laws of probability. First, we identify these 6 possible cases and assign them the number one to six. In the next step, we determine the required number of blocks, which because the number of samples is 56 people, it is necessary to define this number in the form of 14 blocks of 4 people.In other words, in order to assign patients to two groups of 28 people, 14 times must be selected from codes 1 to 6, which is for possible cases of block formation. To do this, with the eyes closed and the tip of the pencil in the table of random numbers, we select a one-digit number and move in one of four directions, and We will select only numbers from one to six. We will continue this process until we randomly select 14 times from the numbers 1 to 6. Next, we write the blocks on a piece of paper, and select them in order of selection, depending on which of the modes constitutes the 4-person block. For example, if the first selected number is code 5 and the fifth mode of formation of 4 blocks is ABBA mode, it means that the first person will be assigned to group A, the second to B, the third to B and the fourth to A. As patients enter the study, the selected blocks will determine which of the two experimental or control groups each individual should be placed in. Finally, 56 patients will be assigned to one of the two groups of intervention (n = 28) and control (n = 28) during the study according to 14 blocks of 4, Blinding description: Subjects are randomly assigned to treatment and control groups by researchers and are aware of the study and the type of treatment they receive. However, the evaluator is unaware of the groups being treated and the type of treatment in each group. Therefore, the study is a single-blind type. The tests are then taken and recorded by the evaluator unaware to the groups and treatment. After treatment, the tests are repeated by the same evaluator and the results are recorded. N/A chronic mechanical low back pain. Intervention 1: Intervention group: Ten sessions of physiotherapy including 30 minutes of electrotherapy using TENS acupuncture wave with a frequency of 10 Hz and a wavelength of 200 microseconds, 15 minutes of hot packs, exercises includes: abdominal muscle strengthening, iliopsoas, back and gastrosoleous muscle stretching . Each exercise should be repeated in 3 sets, each set has 3 repetition, each repetition should be holded 30 seconds . In each session, the experimental group, after training and electrotherapy, received the mobilization treatment as 4 sets of two-minute Maitland Grade III techniques (1 minute break between each set) for each part of the foot. It includes the ankle, first tarsometamatars, the calcaneutalus or sublatar and the first metatarsophalangeal joint.Ankle joint mobilization: The tibia and fibula are fixed with one hand and the talus is moved anteroposterior with the other hand. First tarsometatarsal joint: by grasping the first Quneiform bone with the index finger and thumb of the proximal hand and with the other hand moving the base of the first metatarsus towards the dorsal with high amplitude and frequency once per second. Calcanotealus or subtalar joint: As the patient lies on his side, the talus is fixed with one hand and the calcaneus is inverted with the other hand. First metatarsophalangeal joint: The person lies on his back and a pillow is placed under the knee that is flexing, then with one hand hold the first metatarsal fixed and with the other hand move the first thumb in the posteroanterior direction with the same criteria as We were told to move for the ankle. Intervention 2: Control group: Ten sessions of physiotherapy including 30 minutes of electrotherapy using TENS acupuncture wave with a frequency of 10 Hz and a wavelength of 200 microseconds, 15 minutes of hot packs, exercises includes: abdominal muscle strengthening, iliopsoas, back and gastrosoleous muscle stretching . Each exercise should be repeated in 3 sets, each set has 3 repetition, each repetition should be holded 30 seconds. 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 is no further information
public Nafiseh Ghanbari Riseh
Unit 117,Eram building, Eram dead end (19)., Asgarieh St., Parvin St
Isfahan Iran (Islamic Republic of) 8199783146 +98 31 3567 9547 n.ghanbari@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific Mojtaba Heshmatipour
Hezar Jerib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5040 heshmatipour@rehab.mi.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Sex: female Age: 30-60 years old Participants must be based on the Force Quebec Task classification in the chronic course. (At least 12 weeks have passed since the onset of symptoms.) VAS > 3 Navicular drop > 10 mm based on navicular drop test Ankle dorsiflexion range of motion must be less than 20 degrees and Metatarsophalyngeal (MTP) extension range of motion must be less than 65 degrees Females with BMI less than 30 30 years 60 years Female Past surgical history of trunk and lower extremity, malignancy, infection, pregnancy, systemic disorder like diabetes and rheumatoid arthritis People who are currently using medical insoles People who underwent physiotherapy, massage therapy and manipulation a month before the study People with nervous system disorders and disc herniation with radicular pain. For example, if a person has persistent pain in the lower limbs, especially below the knee, and has a positive SLR and well-SLR test. All pathological disorders of the ankle and sole of the foot, such as acute ankle sprains in the last 6 weeks, ankle ankylosis, open sores on the feet and ankles M54.5 Low back pain Rehabilitation Rehabilitation Intervention group: Ten sessions of physiotherapy including 30 minutes of electrotherapy using TENS acupuncture wave with a frequency of 10 Hz and a wavelength of 200 microseconds, 15 minutes of hot packs, exercises includes: abdominal muscle strengthening, iliopsoas, back and gastrosoleous muscle stretching . Each exercise should be repeated in 3 sets, each set has 3 repetition, each repetition should be holded 30 seconds . In each session, the experimental group, after training and electrotherapy, received the mobilization treatment as 4 sets of two-minute Maitland Grade III techniques (1 minute break between each set) for each part of the foot. It includes the ankle, first tarsometamatars, the calcaneutalus or sublatar and the first metatarsophalangeal joint.Ankle joint mobilization: The tibia and fibula are fixed with one hand and the talus is moved anteroposterior with the other hand. First tarsometatarsal joint: by grasping the first Quneiform bone with the index finger and thumb of the proximal hand and with the other hand moving the base of the first metatarsus towards the dorsal with high amplitude and frequency once per second. Calcanotealus or subtalar joint: As the patient lies on his side, the talus is fixed with one hand and the calcaneus is inverted with the other hand. First metatarsophalangeal joint: The person lies on his back and a pillow is placed under the knee that is flexing, then with one hand hold the first metatarsal fixed and with the other hand move the first thumb in the posteroanterior direction with the same criteria as We were told to move for the ankle. Control group: Ten sessions of physiotherapy including 30 minutes of electrotherapy using TENS acupuncture wave with a frequency of 10 Hz and a wavelength of 200 microseconds, 15 minutes of hot packs, exercises includes: abdominal muscle strengthening, iliopsoas, back and gastrosoleous muscle stretching . Each exercise should be repeated in 3 sets, each set has 3 repetition, each repetition should be holded 30 seconds. Pain score on Visual analog scale. Timepoint: Measurement of pain is performed at the beginning of the study (before the intervention) and 4 weeks after the start of physiotherapy treatment. Method of measurement: Visual analog scale. Disability score on Oswestry questionnaire. Timepoint: At the beginning of the study (before the start of the intervention) and 4 weeks after the start of physiotherapy treatment. Method of measurement: Oswestry questionnaire. Measure lumbar flexion range of motion using a tape measure. Timepoint: At the beginning of the study (before the start of the intervention) and 4 weeks after the start of physiotherapy treatment. Method of measurement: tape measurement. Measurement of the ankle dorsiflexion range of motion using a goniometer. Timepoint: At the beginning of the study (before the start of the intervention) and 4 weeks after the start of physiotherapy treatment. Method of measurement: Goniometer. Esfahan University of Medical Sciences Approved 2019-08-26 Vice-Chancellor in Research Affairs -Medical University of Isfahan Hezar Jerib street ّّIsfahan Isfehan Iran (Islamic Republic of)