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IRCT20130409012953N5 IRCT 2023-12-18 Iran University of Medical Sciences Effect of cupping therapy in chronic low back pain Effectiveness of cupping therapy in patients with chronic nonspecific low back pain: a randomized sham-controlled trial 2023-12-21 anticipated 48 Complete https://irct.ir/trial/74169 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All Eligible patients with chronic non-specific low back pain will be randomly assigned to either the intervention group (cupping therapy combined with routine physical therapy) or the control group (sham cupping therapy combined with routine physical therapy) in a 1:1 ratio. The randomization process will employ a permuted block method using four-letter blocks made up of letters A and B. Subsequently, the randomized treatment list will be placed in sealed and numbered envelopes, with letters A representing actual cupping therapy and letters B representing sham cupping therapy. Six four-letter blocks comprising letters A and B, with no more than two repetitions of either letter, will be created, including sequences like AABB, ABAB, BBAA, BAAB, ABBA, and BABA. Given that each block represents 4 participants and the study requires 48 participants, 12 sets of four blocks are needed. Selection of 12 random numbers from 1 to 6, representing the blocks created, will be carried out using the Google random number generator. The allocation process will be managed by an individual external to the research team prior to the study. Following the initial patient assessment, sequentially numbered envelopes will be assigned to individuals based on their entrance order into the study. Subsequently, therapists will tailor the treatment interventions based on the letters within the envelopes upon each patient’s entry into the treatment sessions. Patients are instructed not to disclose their group allocation to the assessor to prevent data contamination, Blinding description: Individuals allocated to the control group will assume the same position as those in the intervention group. However, in the control group, two cups with a diameter of 5 cm will be placed solely on the lumbar region, positioned 2-3 cm away from the spinous processes, without being longitudinally moved along the paraspinal regions, and will be placed for only one minute. 3 Low back pain. Intervention 1: Intervention group: The treatment in the main group is as follows: The patient lies prone with body oil applied from the 12th thoracic vertebra to the first sacral vertebra. The therapist places two cups, each with a 5 cm diameter, 2 cm away from the spinous processes on either side of the vertebrae, creating negative pressure manually between the cups and the skin using two to three sections, pulling about 1.5 to 2 cm of skin into the cup. Then, the therapist pulls the cups down the length of the vertebrae at a moderate speed (approximately one centimeter per second). After reaching the alignment of the first sacral vertebra, the therapist moves the cups upwards again. This procedure is performed for three minutes. In addition to cupping therapy, patients in this group receive routine physiotherapy treatment, including 20 minutes of transcutaneous electrical nerve stimulation (frequency: 150 Hz, duration: 250 microseconds) with hot packs, as well as therapeutic exercises to strengthen the abdominal and trunk muscles (including abdominal hollowing and bridging exercises). Patients will undergo treatment for 10 sessions (three sessions per week). Intervention 2: Control group: In the control group, the patients' position will be exactly the same as the intervention group. The area of the lower back will be massaged with oil. Two cups with a diameter of 5 cm will be placed on the lower back, and the physiotherapist will create negative pressure between the skin and the cups by performing a suction. The cups will then be left on the skin without any movement for one minute. Additionally, the routine treatment and number of therapy sessions will be the same as the intervention group. Yes - There is a plan to make this available What will be shared: The raw data of research and its analysis will be available to the researcher if they request it. When: After six months from the date of publication. To whom: The data will be available for physical therapists working in academic institutions and also clinicians working in the field of low back pain. Conditions: The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of low back pain. Where to obtain: Applicants can contact Dr. Mohammadreza Pourahmadi by email. Email address: pourahmadipt@gmail.com How to obtain: Applicants should explain in detail about their project and how the data/documents of this study will be used in their project. Then, the data/documents files will be sent by email to applicants on request. This process may takes 10-12 working days. Comments:
public Mohammadreza Pourahmadi
Madadkaran (Nezam) St., Shahnazari St., Madar Sq., Mirdamad Blvd. Tehran.
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 2059 pourahmadipt@gmail.com Iran University of Medical Sciences scientific Mohammadreza Pourahmadi
Madadkaran (Nezam) St., Shahnazari St., Madar Sq., Mirdamad Blvd. Tehran.
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 2059 pourahmadipt@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Chronic non-specific low back pain lasting for a minimum of 3 months The pain intensity is rated between 3 and 6 on the visual analog scale The body mass index falls between 19 and 23. No restrictions for therapeutic exercise and electrotherapy. 18 years 59 years Both The presence of comorbidities such as diabetes and cardiovascular problems. The presence of spinal column deviations, such as scoliosis, is observed. Signs of serious pathology of the spine (eg, fractures, inflammatory diseases, infection or tumours). Consecutive absence of more than three sessions. Patients' dissatisfaction with their participation in the study Receiving physiotherapy, analgesics, and therapeutic procedures during the past 4 weeks. Individuals who have been treated with cupping in the past. Neurological, vestibular, visual or auditory deficits. M54.5 Low back pain Rehabilitation Placebo Intervention group: The treatment in the main group is as follows: The patient lies prone with body oil applied from the 12th thoracic vertebra to the first sacral vertebra. The therapist places two cups, each with a 5 cm diameter, 2 cm away from the spinous processes on either side of the vertebrae, creating negative pressure manually between the cups and the skin using two to three sections, pulling about 1.5 to 2 cm of skin into the cup. Then, the therapist pulls the cups down the length of the vertebrae at a moderate speed (approximately one centimeter per second). After reaching the alignment of the first sacral vertebra, the therapist moves the cups upwards again. This procedure is performed for three minutes. In addition to cupping therapy, patients in this group receive routine physiotherapy treatment, including 20 minutes of transcutaneous electrical nerve stimulation (frequency: 150 Hz, duration: 250 microseconds) with hot packs, as well as therapeutic exercises to strengthen the abdominal and trunk muscles (including abdominal hollowing and bridging exercises). Patients will undergo treatment for 10 sessions (three sessions per week). Control group: In the control group, the patients' position will be exactly the same as the intervention group. The area of the lower back will be massaged with oil. Two cups with a diameter of 5 cm will be placed on the lower back, and the physiotherapist will create negative pressure between the skin and the cups by performing a suction. The cups will then be left on the skin without any movement for one minute. Additionally, the routine treatment and number of therapy sessions will be the same as the intervention group. Pain Intensity: It is an unpleasant sensory and emotional experience that occurs with real or potential tissue damage or is expressed as such damage. Therefore, pain is more than a signal for tissue damage. Timepoint: At the start of the study, at the end of the study (session 10), and two weeks post-study completion. Method of measurement: Numeric pain rating scale. Functional Disability: The effects and consequences of chronic or acute conditions are said to affect various body systems and cause limitation or lack of people's ability to perform basic and functional activities, such as standing, sitting, dressing and walking in a natural range. Timepoint: At the start of the study, at the end of the study (session 10), and two weeks post-study completion. Method of measurement: In this research the Persian version of the Oswestry Questionnaire is used to evaluate the level of functional disability of the patients. The total score of the items of this scale is considered as the functional disability level of the people, which is zero without disability and 100 as maximum disability. This questionnaire has ten parts, each part has six sub-parts, which are graded from 0 to 5. The individual's disability score is calculated by multiplying the total points obtained by 2 and then dividing by 100 and is displayed as a percentage. Quality of life: Quality of life is the perception of each person of their health status and the degree of satisfaction with this situation. Timepoint: At the start of the study, at the end of the study (session 10), and two weeks post-study completion. Method of measurement: Persian version of the 36-item SF-36 questionnaire. Iran University of Medical Sciences Approved 2022-08-27 Ethics committee of Iran University of Medical Sciences Shahnazari St., Madar Sq., Mirdamad Biv., Tehran 1545913187, Iran Tehran Tehran Iran (Islamic Republic of)