]>
IRCT20220626055278N2 IRCT 2022-08-25 Tehran University of Medical Sciences Effects of High Intensity Laser and Manual Therapy in Patients with Disk Herniation Effects of High Intensity Laser Plus Manual Therapy versus Manual Therapy alone on Pain and Function in Patients with Cervical Radiculopathy cause by Disk Herniation 2022-08-22 anticipated 48 Complete https://irct.ir/trial/64972 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: In the present study, sampling is non probability and easy or available sampling. Allocation of patients to two groups of manual therapy and laser therapy (experimental group) or manual therapy alone (control group) is done based on random block method (block size of 4 and allocation ratio 1:1). in this way, at the end of all four samplings, the number of samples in both groups is equal, Blinding description: The participant will not know the type of treatment and the number of treatment groups.The researcher will not know which treatment group the patient is in, the high intensity laser will be performed by one therapist and the manual therapy will be performed by another therapist. The evaluator will not know the type of treatment performed on the patient. N/A Disc herniation. Intervention 1: Control group: Treatment protocol for the control group (alone manual therapy ) that will receive three times a week for 6 weeks: 1- myofascial release technique: this technique is one of the manual therapy techniques that is done with the aim of stretching and relaxing the fascia and muscles to reduce pain and improve performance. This technique is applied for 10 minutes by the therapist on the tissues of the neck and shoulder girdle. 2- nerve mobilization: in this study, radial and median nerve mobilization is performed and the range of techniques is increased by the therapist according to the patients condition during the sessions. 3- chin tuck exercise: people are asked to perform head flexion with the aim of stretching the suboccipital muscles and activating the deep flexor muscles 5 times a week, 10-15 repetitions, with 10 second hold and 10 second rest. 4- strengthening and stretching exercises for shoulder girdle muscles: people are taught strengthening exercises for the scapula retractor muscles and stretching of the upper trapezius, scalene and sternocleidomastoid muscles. Intervention 2: Intervention group: Test group (manual therapy and high intensity laser): People in this group, will receive the same protocol of manual therapy and exercise therapy as the control group 3 times a week for 6 weeks. In addition, in this group, people are treated with high- intensity laser. In this study, high- intensity laser device, k-laser series 4, with maximum output of 20 watts, made in Italy, is used. This laser has 4 wavelengths 660, 800, 905, 970 nanometers. To perform the laser, the patient is placed in prone position and the laser application technique is scanning around the cervical vertebrae and the total time of laser treatment is five minutes and eight seconds and the total energy received by the tissue, is 2975 joules. The application program includes 11 phases, the first and last phases are continuous waves and the phases between them are pulses. Befor laser irradiation the treatment area will be completely cleaned with alcohol to minimize the amount of skin resistance caused by fat on the skin and the reflection of laser beams from the skin surface. During the treatment, both the therapist and the patient will use special glasses to prevent eye damage. 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 Namvar hasan
Enghelab Street
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 hassan_753@yahoo.com Tehran University of Medical Sciences scientific Gholamreza Olyaie
Enghelab street
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 olyaeigh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) People with cervical radiculopathy caused by disc herniation in C6 and C7 roots Age between 20 and 55 years The presence of conflict for more than three months 20 years 55 years Both Known history of migraine Presence of thoracic outlet syndrome The presence of fracture in the spine during the last 6 months The presence of tumor in the spine Musculoskeletal disorders of the shoulder area such as tendonitis and bursitis Rheumatoid inflammatory diseases Pregnancy Simultaneous pain in other areas of the spine such as back pain and radiculopathy in the area of the lumbar spine History of whiplash injury History of any shoulder and neck surgery in the past 6 months Peoples unwillingness to participate in the study Receiving any type of physical therapy treatment in the past month Rehabilitation Rehabilitation Control group: Treatment protocol for the control group (alone manual therapy ) that will receive three times a week for 6 weeks: 1- myofascial release technique: this technique is one of the manual therapy techniques that is done with the aim of stretching and relaxing the fascia and muscles to reduce pain and improve performance. This technique is applied for 10 minutes by the therapist on the tissues of the neck and shoulder girdle. 2- nerve mobilization: in this study, radial and median nerve mobilization is performed and the range of techniques is increased by the therapist according to the patients condition during the sessions. 3- chin tuck exercise: people are asked to perform head flexion with the aim of stretching the suboccipital muscles and activating the deep flexor muscles 5 times a week, 10-15 repetitions, with 10 second hold and 10 second rest. 4- strengthening and stretching exercises for shoulder girdle muscles: people are taught strengthening exercises for the scapula retractor muscles and stretching of the upper trapezius, scalene and sternocleidomastoid muscles. Intervention group: Test group (manual therapy and high intensity laser): People in this group, will receive the same protocol of manual therapy and exercise therapy as the control group 3 times a week for 6 weeks. In addition, in this group, people are treated with high- intensity laser. In this study, high- intensity laser device, k-laser series 4, with maximum output of 20 watts, made in Italy, is used. This laser has 4 wavelengths 660, 800, 905, 970 nanometers. To perform the laser, the patient is placed in prone position and the laser application technique is scanning around the cervical vertebrae and the total time of laser treatment is five minutes and eight seconds and the total energy received by the tissue, is 2975 joules. The application program includes 11 phases, the first and last phases are continuous waves and the phases between them are pulses. Befor laser irradiation the treatment area will be completely cleaned with alcohol to minimize the amount of skin resistance caused by fat on the skin and the reflection of laser beams from the skin surface. During the treatment, both the therapist and the patient will use special glasses to prevent eye damage. Pain: according to the definition of the International Pain Association, pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Timepoint: Before the start of the intervention and six weeks after the intervention and two months after the end of treatment. Method of measurement: Visual Analogue Scale. The people participating in the study are asked to determine the level of their neck pain on a chart where the number 0 indicates the lowest level of pain and the number 10 indicates the highest level of pain. Disability: any lack or limitation in the ability to perform activities that are normally expected of any person, is called disability. Timepoint: Before the start of the intervention and six weeks after the intervention and two months after the end of treatment. Method of measurement: Disability is measured by two questionnaires, Neck disability index and Neck pain and disability scale. Imaging the deep flexor muscles of the neck: the images of the deep flexor muscles of the neck, including longus colli and longus capitis, are evaluated both in the transverse view and in the longitudinal view. Timepoint: Before the start of the intervention and six weeks after the intervention and two months after the end of treatment. Method of measurement: Ultrasonography device. Recording the electrical activity of the flexor carpi radialis muscle. Timepoint: Before the start of the intervention and six weeks after the intervention and two months after the end of treatment. Method of measurement: Surface electromyography device. Tehran University of Medical Sciences Approved 2022-07-16 Ethics committee of Tehran University of Medical Sciences Ghods Street, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)