This study was a Double-blinded Randomized Clinical Trial in which the effectiveness of MT in reducing pain and disability in patients with SIS was investigated. To this end, people with the primary and external SIS diagnosed by specialists and referring to physiotherapy clinics were identified. The qualified subjects were first informed of the study purposes and the treatment methods. Then written informed consent was obtained from all subjects, and the protocol was approved by the Tabriz University of Medical Sciences Ethics Committee with an approval ID of
IR.TBZMED.REC.1400.055. Personal information such as age, sex, weight, and height were recorded prior to the intervention. The patients were evaluated for inclusion criteria as follows:
(1) Having pain in the shoulder joint lasted more than 1 month (
11)
(2) Diagnosis of the primary and external SIS by specialist mainly based on medical history and clinical findings such as a positive Hawkins Kennedy test and Neer test.
(3) Being subject to restriction of at least one of the active movements of flexion, abduction, external, and internal rotation of the shoulder (
10)
(4) Age above 40 years (
21)
(5) DASH criteria more than 40
The patients were excluded from the study based on the following criteria:
(1) Receiving any rehabilitation treatment in the past
(2) Having neurological disorder
(3) Suffering from injury to the neck, elbow, or hand
(4) Having rheumatoid arthritis
(5) Having heart disease
(6) Having undergone an upper limb surgery
(7) Being pregnant
(8) Receiving intra-articular anti-inflammatory drug in the last 60 days (
22)
(9) Having other pathological shoulder disorders such as fake acromion, osteoarthritis, adhesive capsulitis, or traumatic ruptures of labrum (
19)
Randomization was performed by extracting 60 codes (20 codes for each group) from the Excel program, each of which was placed inside a sealed envelope. Then an envelope was randomly selected for each patient.
The total number of 60 patients were randomly divided into three groups: The first group received routine physiotherapy including electrotherapy and exercise therapy, and MT with a frequency of 18 Hz (MT 18 Hz group); the second group received routine physiotherapy and MT with a frequency of 100 Hz (MT 100 Hz group); and the third group received routine physiotherapy and Sham magnet therapy (MT Sham group).
All participants were informed about the devices used, the safety and harmlessness of the interventions, the way to perform the exercises correctly, as well as the proper posture of the body during the interventions and exercises, so that no error would occur due to unfamiliarity with the type of test.
in this study, PMT-Q Magnet therapy device, a product of ASA company from Italy with solenoid applicator of 36 × 21 cm2, was applied 12 sessions, three times a week for four weeks. The frequencies of MT used for the first and second groups were 18 Hz and 100 Hz, respectively. Other parameters of MT were the same for both groups with an intensity of 100 mT and a duration of 30 minutes in each treatment session. In the Sham MT group, MT was used as a placebo using a switched-off device for 30 minutes in each treatment session. As for the simulations with the first and second groups, the device light was on.
In our study, the VAS scale was used to measure pain intensity, the DASH questionnaire was used to assess the amount of upper limb disability, and the goniometer was used to measure the active range of motion of the shoulder (including flexion, abduction, external rotation, and internal rotation).
Routine physiotherapy included the application of high TENS (80 Hz and 60 µs) and hot pack (for 30 minutes), US (Continues, 1 MHz, 1 W/cm
2, 5 Min) which was performed in all three groups three sessions per week for four weeks (
13). Exercise therapy ranged from motion to stretching which were performed daily along with strengthening exercises three times a week (
23).
At the end of the treatment sessions, the pain intensity was measured again by VAS scale, the amount of disability was assessed using the DASH questionnaire, and the amount of shoulder range of motion (including flexion, abduction, internal rotation, and external rotation) was evaluated by a goniometer. The changes in each group before and after the treatment, as well as the number of changes, observes in all groups were compared and analyzed.
It should be noted that the evaluator and the patients were not aware of the type of groups, as this study was a double-blind study.
3.1. Statistical Analysis
The statistical analysis was performed using SPSS 26. Concordance of the data to normal distribution was tested performing Kolmogorov-Smirnov test. The intragroup comparison (i.e., within the groups) before and after the interventions was performed by using the Paired Sample t-test, whereas the intergroup comparisons (i.e., among the groups) were performed by using statistical method of analysis of variance (ANOVA) and Duncan's multi-range test. Statistical significance was set at P < 0.05 for all tests.