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IRCT20241029063539N1 IRCT 2024-12-02 Tehran University of Medical Sciences Effects of cupping therapy with movement in athletes with non-specific chronic low back pain Effects of cupping therapy with movement compared to cupping therapy on pain, lumbar range of motion, physical performance, and functional mobility in athletes with non-specific chronic low back pain 2024-12-09 anticipated 24 Complete https://irct.ir/trial/79867 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be grouped using a random allocation method with blocks of four (www.Randomization.com). This allocation will be performed by an individual outside the research team prior to the start of the study to prevent bias. Participants will be divided into two groups: 1. Group 1: Static cupping therapy (without active movements) 2. Group 2: Cupping therapy with active movements Based on the sample size, a number of opaque envelopes will be prepared. Each generated random sequence will be recorded on a card, and the cards will be sequentially placed inside the envelopes. To maintain the random sequence, the envelopes will be numbered externally in the same order. Finally, the envelopes will be sealed and placed in a box in sequence. At the time of participant enrollment, one envelope will be opened in order based on the sequence of eligible participants entering the study, revealing the assigned group for that participant, Blinding description: Participants: Patients are randomly assigned to one of two intervention groups: the static cupping therapy group or the cupping therapy group with active movements. However, they are informed that they will only undergo cupping therapy. Participants are not made aware of the specific type of intervention they receive, and no explanation is provided regarding the differences between the two treatments (static and with active movements). This approach aims to prevent bias in patients' expectations and experiences. Evaluator: In addition to the participants, the evaluator is also blinded to the group to which each participant is assigned. This means the evaluator only conducts assessments and evaluates the tests included in the study, without any knowledge of the participant's group allocation. This process helps to prevent bias in the evaluation results. By employing these blinding methods, the validity and accuracy of the study's results are enhanced, allowing for a better assessment of the actual effects of the interventions. N/A Non-specific chronic low back pain. Intervention 1: Intervention Group 1: Static Cupping Therapy. In the static cupping therapy treatment method, participants in the first group receive treatment individually while lying prone (on their stomachs). The cups are placed on the lower back, parallel to the spine, covering the area from L1 to L5, with a distance of 3 to 5 centimeters between them. The negative pressure inside the cups is approximately 300 millibar. In the cupping therapy with active movement technique, oil or gel is used to reduce friction and facilitate the movement of the cups on the skin. The treatment in the first group lasts for 15 minutes and is combined with standard exercises for chronic non-specific low back pain. Intervention 2: Intervention Group 2: Cupping Therapy with Active Movements. This intervention is similar to the previous one in terms of duration and method, but it is combined with additional active exercises. Participants in this group receive 15 minutes of cupping therapy and, in addition, perform other active exercises. These exercises include seated forward bends, cat-camel movement, seated side bends, seated spinal twists, and child pose. 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 Confidentiality
public Dr. Noureddin Nakhostin Ansari
Tehran, Enghelab Street, Shamiaran Intersection, corner of Safi Ali Shah Street, School of Rehabilitation
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 Nakhostin@sina.tums.ac.ir Tehran University of Medical Sciences scientific Arezoo taheri
Tehran, Enghelab Street, Shamiaran Intersection, corner of Safi Ali Shah Street, School of Rehabilitation
Tehran Iran (Islamic Republic of) 1148965111 +98 921 179 9132 Arezoo.t2019@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Athletes with non-specific chronic low back pain Confirmation of low back pain diagnosis by a specialist physician Age between 18 and 40 years Both male and female genders Pain does not radiate to the lower limbs Duration of low back pain exceeds 3 months No contraindications for cupping therapy (e.g., blood clotting disorders, any skin issues, fractured areas, etc.) Engaging in regular exercise at least three days per week, totaling 6 hours per week The average pain intensity, based on the Numeric Rating Scale (NRS), must be equal to or greater than 30 millimeters. No lower limb injuries or surgeries in the past 6 months 18 years 40 years Both Absence from more than one session in the therapy sessions Pregnancy M54.5 Low back pain Rehabilitation Rehabilitation Intervention Group 1: Static Cupping Therapy. In the static cupping therapy treatment method, participants in the first group receive treatment individually while lying prone (on their stomachs). The cups are placed on the lower back, parallel to the spine, covering the area from L1 to L5, with a distance of 3 to 5 centimeters between them. The negative pressure inside the cups is approximately 300 millibar. In the cupping therapy with active movement technique, oil or gel is used to reduce friction and facilitate the movement of the cups on the skin. The treatment in the first group lasts for 15 minutes and is combined with standard exercises for chronic non-specific low back pain. Intervention Group 2: Cupping Therapy with Active Movements. This intervention is similar to the previous one in terms of duration and method, but it is combined with additional active exercises. Participants in this group receive 15 minutes of cupping therapy and, in addition, perform other active exercises. These exercises include seated forward bends, cat-camel movement, seated side bends, seated spinal twists, and child pose. Intensity of Pain: Pain is an unpleasant sensory experience that occurs in association with actual or potential tissue damage. The level of this unpleasant experience is considered the intensity of pain. In this study, pain intensity refers to the average score obtained from the Visual Analog Scale (VAS) for pain over the past 24 hours. Timepoint: Measuring pain intensity was conducted in the first session, the last session, and one week after the end of the intervention in each group: active movement cupping therapy and cupping therapy without active movement. Method of measurement: Visual Analog Scale (VAS). Lumbar Range of Motion: This refers to the extent of movement at each joint, which depends on the bony structure and the physiological characteristics of the surrounding connective tissue. The range of motion in the lumbar spine for forward flexion, backward extension, and lateral bending is typically 40-50, 15-20, and 20 degrees, respectively. Timepoint: Measurement of trunk range of motion was conducted in the first session, the last session, and one week after the end of the intervention in each group: active movement cupping therapy and cupping therapy without active movement. Method of measurement: Inclinometer device. Physical Function: The ability to perform activities requiring physical effort, ranging from self-care (activities of daily living) to more complex tasks that require a combination of skills, is often defined by social aspects or participation in a social environment. Timepoint: The time points for measuring physical function can be the first session, the last session, and one week after the end of the intervention in each group: active movement cupping therapy and cupping therapy without active movement. Method of measurement: The Athlete Disability Index (ADI) questionnaire. Functional Mobility: This refers to an individual’s physiological ability to move independently and safely in various environments in order to perform functional activities or tasks and to participate in daily activities at home, in the workplace, and in the community. Timepoint: The time points for measuring functional mobility can be the first session, the last session, and one week after the end of the intervention in each group: active movement cupping therapy and cupping therapy without active movement. Method of measurement: Single-legged hop Test. Overall Effect Perception Scale:This is a direct scale that addresses the patient’s personal perception since the intervention was performed. Timepoint: The time point for measuring the Overall Effect Perception Scale can be one week after the end of the intervention in each group: active movement cupping therapy and cupping therapy without active movement. Method of measurement: In this study, the individual's perception of the treatment effect is assessed using an 11-point scale, scoring from -5 (much worse than at the start of treatment), through a neutral score of 0, to +5, which indicates significant improvement compared to the start of treatment. Tehran University of Medical Sciences Approved 2024-10-29 Ethics committee of Tehran University of Medical Sciences Tehran, Enghelab St., Shemiran Intersection, Corner of Safi Alishah St., Faculty of Rehabilitation تهران Tehran Iran (Islamic Republic of)