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. 2014 Oct 1;2014(10):CD011324. doi: 10.1002/14651858.CD011324

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)
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
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
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
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.
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