Battisti 2007.
Methods |
Design: Parallel group, three‐arm, single‐blind randomised controlled trial (Italy) Interventions: Low‐frequency (100 Hz) pulsed electromagnetic field therapy (PEMF) or Therapeutic Application of a Musically Modulated Electromagnetic Field (TAMMEF) or simulated (placebo) electromagnetic field, each while listening to music Sample size calculation: Not reported Analysis: Per protocol analysis Source of funding: Fondazione Monte dei Paschi di Siena (non‐industry) |
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Participants |
Number of participants: 60 (20 per group) Baseline characteristics: Basline characteristics by group were not reported Mean (SD; range) age = 47.6 (7.3; 37‐66) years; Male:Female = 32:28 Mean (SD) duration of symptoms = 1.4 (1.9) months Inclusion criteria: 1. Affected by shoulder periarthritis for less than three months 2. Stopped taking analgesic anti‐inflammatory drugs 15 days prior to electromagnetic therapy 3. Had never had infiltrative steroid therapy Exclusion criteria: Not reported |
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Interventions |
Low‐frequency (100 Hz) pulsed electromagnetic field therapy while listening to music (N=20) Components of intervention: Extremely low‐frequency (100 Hz) electromagnetic field therapy was delivered by applying magnets to the shoulder while the participant listened to music Dosage: 30 minutes Frequency of administration: Daily for 15 days (15 sessions) Provider: Physicist Therapeutic Application of a Musically Modulated Electromagnetic Field (TAMMEF) while listening to music (N=20)* Components of intervention: TAMMEF was delivered by applying magnets to the shoulder while the participant listened to music. The electromagnetic field parameters (frequency, intensity, waveform) were modified in time, randomly varying within the respective ranges, so that all the possible codes can occur during a single application Dosage: 30 minutes Frequency of administration: Daily for 15 days (15 sessions) Provider: Physicist Simulated (placebo) electromagnetic field while listening to music (N=20) Components of intervention: A simulated (placebo) electromagnetic field was delivered by applying magnets to the shoulder while the participant listened to music Dosage: 30 minutes Frequency of administration: Daily for 15 days (15 sessions) Provider: Physicist |
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Outcomes | Outcomes measured at baseline, day 7, day 15 (end of treatment), and day 45 (30 days post‐treatment cessation). No primary outcome was specified by the trialists 1. Shoulder pain and disability index (SPADI) (0‐100 scale where a higher score indicates worse pain and/or disability) 2. Joint function, rated as 0 = absence of functional limitation; 1 = slight limitation; 2 = moderate limitation; 3 = severe limitation |
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Notes | *This intervention is not a standard type of pulsed electromagnetic field therapy that can be applied by physical therapists, so no data for this group was included in the review. Article is in Italian. MP used Google Translate to translate into English. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "We examined 60 subjects, aged between 37 and 66 years, 28 women and 32 men, suffering from painful shoulder easier to less than 3 months, who were randomly divided into three groups: A = 20 patients undergoing TAMMEF, B = 20 patients undergoing ELF and C = 20 patients undergoing simulated field, listening to music" (Google Translate translation of Italian article) Comment: No information about how the allocation sequence was generated was reported |
Allocation concealment (selection bias) | Unclear risk | Comment: No information about how the allocation sequence was concealed was reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "This study was conducted in a blinded fashion" (Google Translate translation of Italian article) Comment: The trialists did not specify who was blind to treatment in this study (participants, personnel, or outcome assessors, or more than one of these parties), but given the nature of the interventions, it is likely that participants were blinded |
Blinding of outcome assessment (detection bias) Self‐reported outcomes | Low risk | "This study was conducted in a blinded fashion" (Google Translate translation of Italian article) Comment: Participants self‐reported pain and disability, and were probably blind to treatment |
Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | "This study was conducted in a blinded fashion" (Google Translate translation of Italian article) Comment: The trialists did not specify who was blind to treatment in this study (participants, personnel, or outcome assessors, or more than one of these parties), and while participants were likely to have been blinded, it is unclear whether assessors of joint function were |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "All patients in groups A and B have completed the course of therapy, without the occurrence of noteworthy local or systemic effects that would require the suspension of such treatment" (Google Translate translation of Italian article) Quote: "After the first week of treatment, 8 patients (40%) in group C had to stop treatment because of ineffective applications. The remaining 12 patients (60%) completed the cycle in the manner already described" (Google Translate translation of Italian article) Comment: A high proportion of the placebo group withdrew due to lack of response to treatment, which is likely to bias the results of the study in favour of the two active treatment groups |
Selective reporting (reporting bias) | Unclear risk | Comment: Data for most outcomes listed in the methods section were present in the results section of the report (except for improvement at day 45, in which data was not reported for the simulated electromagnetic field therapy group). Also, without a trial protocol it is unclear whether other outcomes were assessed but not reported based on the results |
Other bias | Low risk | Comment: No other sources of bias identified |