The effectiveness of muscle energy techniques on some clinical signs in participants with myofascial trigger points related to chronic non-specific back pain: Study protocol for a double-blind randomized controlled trial

to investigate The effectiveness of muscle energy techniques on some clinical signs in participants with myofascial trigger points related to chronic non-specific back pain

The present study will be a randomized, double-blind, controlled trial.

After selecting people with non-specific chronic back pain using non-probability sampling method, the patients will be randomly divided into two groups of muscle energy techniques (first group) and placebo group of muscle energy techniques (second group). In both treatment groups, participants will undergo routine physical therapy (includes low-power laser and fixed exercises). Both groups will be treated for 9 sessions in 3 days. Also, this study is a double-blind study in which the participants, the one who evaluates the outcomes and the one who analyzes the characteristics of the patients will be treated in two groups. This study will be conducted in the Faculty of Rehabilitation Sciences of Iran University of Medical Sciences.

Patients aged between 20 to 50 years no referral pain to lower extremities Moderate pain intensity (between 3 to 6) based on Numerical Pain Rating Scale. no specific cause for a subject's chronic back pain. Patients with trigger points in the quadratus lumborum and erector spine muscles and gluteus medius muscle

The treatments of the intervention group include muscle energy techniques and routine physiotherapy. The treatment of the control group includes sham muscle energy techniques along with routine physiotherapy.

a)Pain intensity measurement based on Numerical Pain Rating Scale b) functional disability based on oswestry disability index c) lumbar ROM d) pain pressure threshold

The edited items include change the word "clinical signs" to "some clinical signs" due to more explanation in the title. In this study, some clinical symptoms were investigated and not all symptoms. Another case is the change of the word "individuals" to "participants". In the text of the article, an attempt has been made to use the same words for the participants, so this change was made in order to unify the text and the title. The final change is apdate the word "trigger points" to "myofascial trigger points". In other studies , myofascial trigger points were used and the word "myofascial" was added to specify the nature of trigger points. Another apdate is the change of the primary outcomes, which was reduced from two variables "pain intensity" and "functional disability" to one "pain intensity". With the consultation with statistician and methodologist and considering the determination of the sample size based on the variable of pain intensity and also considering the past studies that only considered pain as the primary outcome and also emphasizing the fact that pain is a primary factor that affects othervariables, we decided to mention only "pain intensity" as the primary variable.

All eligible chronic non-specific low back pain patients will be randomized to an intervention group ( muscle energy techniques and routine physical therapy) and a control group (sham muscle energy techniques and routine physical therapy) with a ratio of 1:1. Randomized allocation will be performed by using permuted block randomization method, which consists of four-letter blocks made of letters A and B. Then, the random treatment list that will be obtained at the end of the random allocation task will be placed in letters A and B inside the sealed and numbered envelopes (muscle energy techniques and letter B indicates sham muscle energy techniques). The random assignment process will be performed by someone outside the research team before the study begins. After the initial evaluation of the patient by the examiner, the numbered envelopes will be presented to him/her according to the ordinal number of each person admitted to the study. Finally, after each patient enters the treatment sessions, the therapist will adjust the treatment interventions based on the letters in the envelope. Patients are asked not to provide their grouping information to the assessor to prevent data contamination.

In this study, participants, outcome assessor and data analyzer will be kept blind to being assigned to the study groups. Blinding method: A) Participants: Participants will not have information about which treatment group they have entered, and also in each treatment group, people will receive a real treatment in addition to sham of the real treatment in the other group (the first group includes muscle energy techniques and the second group includes sham muscle energy techniques ) were used so the participants could not guess which treatment group they have entered. B) Outcome assessor: Outcome assessment will be performed by a person who does not know the grouping of the individuals and the treatments performed in each treatment group. C) Data analyzer: Data analysis will be performed by a person who does not know the grouping of individuals and the treatments performed in each treatment group.