Aktas 2007.
Methods |
Study design: Parallel group RCT Setting: Hospital, Turkey Intervention: Pulsed electromagnetic field plus exercise plus cold pack Control: Sham pulsed electromagnetic field plus exercise plus cold pack Source of Funding: This study was supported by the Department of Physical Medicine and Rehabilitation, Cerrahpasa Medical Faculty, Istanbul University. |
|
Participants |
Diagnostic label used by trialists: Subacromial impingement syndrome Criteria for defining the shoulder condition being treated: Diagnosis of shoulder impingement syndrome by:
Any restriction on duration of symptoms
Inclusion Criteria (not listed above)
Exclusion Criteria (not listed above)
Baseline characteristics Intervention: PEMF Number randomised: 20 Number included in analyses: 20 Age: 48 ± 7.9 years old Sex: F/M 15/5 Duration of symptoms: 4.82 ± 3.75 Control: Sham PEMF Number randomised: 20 Number included in analyses: 20 Age: 53.9 ± 11.12 years old Sex: F/M 15/5 Duration of symptoms: 4.80 ± 3.47 |
|
Interventions |
Intervention: PEMF Description of modality used: Magnetoterapia model MG/3P (Elettromed) Dose: Frequency 50 Hz with a field intensity of 30 G for 25 min per session Method of administration: the switch that allowed the machine to produce waves was set to ‘on' and a U‐shaped applicator 30 x 15 cm in size was used Frequency of administration: 5 sessions per week for 3 weeks Control: Sham PEMF Description of modality used: Magnetoterapia model MG/3P (Elettromed) Dose: none for a 25‐min session Method of administration: the switch that allowed the machine to produce waves was set to ‘off' and a U‐shaped applicator 30 x 15 cm in size was used Frequency: 5 sessions per week for 3 weeks Both Groups Description of modality used
Dose
Method of administration
Frequency
Any additional treatment during trial
|
|
Outcomes | Outcomes assessed at 3 weeks
|
|
Notes |
Conflict of interest: not reported Funding: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomly divided into two equal groups of 23 patients in a simple systematic manner (x + 1) according to the therapeutic PEMF or sham PEMF application." Comment: There was no information on how the allocation sequence was generated |
Allocation concealment (selection bias) | Unclear risk | Quote: "A separate individual was provided the randomization list and informed therapist." Comment: There was no information on how the allocation sequence was concealed |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Patients and physicians remained blind to the group allocation throughout the study." Quote: "One group was given PEMF; the other group was given sham PEMF. A magnetic field treatment unit was used with a concealed switch for either the presence or absence of waves when activated by the patient's attendant." Comment: Participants and personnel were blinded |
Blinding of outcome assessment (detection bias) Self‐reported outcomes | Low risk | Comment: Blinded participants self‐reported some outcomes |
Blinding of outcome assessment (detection bias) Objectively rated outcomes | Low risk | Quotes: "Patients and physicians remained blind to the group allocation throughout the study." Comment: Assessors of objective outcomes were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Forty patients completed the study. Three patients from each group could not continue treatment program. Therefore, six patients dropped out of the study." Comment: The rate and reasons for attrition were equal between groups. Also, analysis was based on all randomised participants |
Selective reporting (reporting bias) | Unclear risk | Comment: Outcome data were fully reported for all outcomes reported in the methods section of the publication, but without a trial protocol it is unclear whether other outcomes were measured but not reported based on the nature of the results |
Other bias | Low risk | Comment: No other sources of bias identified |