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. 2016 Jun 10;2016(6):CD012225. doi: 10.1002/14651858.CD012225

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:
  • positive impingement test (Neer, Hawkins‐Kennedy, painful arc)

  • positive subacromial injection test


Any restriction on duration of symptoms
  • None


Inclusion Criteria (not listed above)
  • None


Exclusion Criteria (not listed above)
  • Other concomitant shoulder pathologies such as adhesive capsulitis, calcific tendinitis, partial and full‐thickness tears of the rotator cuff, osteoarthritis of the acromioclavicular joint, dislocations, acute traumatic conditions, etc.

  • Cervical pain or other painful conditions such as fibromyalgia

  • Inflammatory or systemic diseases

  • History of gastritis or peptic ulcer that may cause complications with NSAID use

  • Prior applications of any treatment modality such as physiotherapy, corticosteroid injections, and NSAID during the preceding 3 months

  • Malignancy

  • Female patients who might be pregnant

  • Pulmonary disorders and cardiac pace makers


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
  • Exercise: Codman's pendulum exercises

  • Cold pack: cold pack gel


Dose
  • Exercise: 5 min each time

  • Cold pack: 20 min per session


Method of administration
  • Cold pack: applied to painful shoulder


Frequency
  • Exercise: 5 times per day for 3 weeks

  • Cold pack: 5 times per day for 3 weeks


Any additional treatment during trial
  • Restriction of above‐head activities

  • 15 mg daily Meloxicam tablet

Outcomes Outcomes assessed at 3 weeks
  • Function: Constant total score (0‐100 with higher scores denoting better function)

  • Rest pain: VAS 0‐10 where 0 = no pain and 10 = intolerable pain

  • Pain on motion: VAS 0‐10 where 0 = no pain and 10 = intolerable pain

  • Night pain: VAS 0‐10 where 0 = no pain and 10 = intolerable pain

  • Active range of motion (Constant sub‐score 0‐40, higher = better ROM)

  • Strength (Constant sub‐score 0‐25, higher = better strength)

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
HHS Vulnerability Disclosure