Effectiveness of cupping therapy in patients with chronic nonspecific low back pain: a randomized sham-controlled trial

Investigating the effect of cupping therapy in patients with CNLBP

This study is a two-arm, double-blind, randomized controlled trial with parallel groups. Patients are allocated to the intervention or control group randomly utilizing the permuted block randomization method.

Participants will be randomly assigned to intervention or control groups using permuted randomization. A third-party will create a random treatment list and place it in sequentially numbered envelopes. The envelopes will be given to participants after their primary assessment. The study will take place at IUMS.

Inclusion criteria: CNLBP for at least three months, pain intensity between 3 to 6 based on the numeric pain rating scale, body mass index between 19 to 23, no contraindications for therapeutic exercise and electrotherapy Exclusion criteria: Comorbidities, spinal deformities, serious pathological symptoms, patient dissatisfaction, absence from more than three consecutive sessions, receiving physiotherapy, analgesics, or procedural interventions in the past 4 weeks, prior use of cupping therapy, neurological, vestibular, visual, or auditory disorders

In the intervention group, the patient lies in a supine position, and the entire lumbar area is covered with body oil. Then, two 5 cm diameter cups are placed on both sides of the spinal column. Moderate negative pressure is manually generated between the cups and the skin, following which the cups are moved along the spine. This process lasts for three minutes. In the control group, patients also lie in a supine position, and two 5 cm diameter cups are placed on the lumbar area and kept stationary for one minute. Additionally, both groups undergo routine physiotherapy, including electrotherapy and stability exercises.

Pain and functional disability

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.

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.

The raw data of research and its analysis will be available to the researcher if they request it.

After six months from the date of publication.

The data will be available for physical therapists working in academic institutions and also clinicians working in the field of low back pain.

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.

Applicants can contact Dr. Mohammadreza Pourahmadi by email. Email address: pourahmadipt@gmail.com

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.