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N/A N=35 Randomized Triple-blind Treatment

IFC Therapy in Proximal Humerus Fractures

Interferential Current in Proximal Humerus Fractures

Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Constant-Murley Score — 57.0; 48.2; 69.0; 60.7 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Interferential current (Device); Rehabilitation program (Other)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Ege University
Primary completion
May 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Constant-Murley Score
57.0; 48.2; 69.0; 60.7; 79.6; 69.3
SECONDARY
Visual Analogue Scale
3.9; 4.7; 2.0; 3.0; 0.7; 1.7
SECONDARY
Disabilities of the Arm, Shoulder and Hand (DASH) Score
28; 38.4; 15.3; 23.3; 7.7; 12.5

Summary

Proximal humerus fractures (PHFs) frequently occur in the elderly and osteoporotic population, but these fractures are also common in individuals under age 60 years. Conservative treatment of PHF usually involves a short period of immobilization followed by orthopedic rehabilitation. However, the severe pain of some patients with fractures limits their participation in the exercise programme, and shoulder muscle atrophy and frozen shoulder may occur in these patients due to immobilization. There are conflicting results regarding the use of physical therapy modalities in the shoulder pain management. Interferential current (IFC) therapy is believed to be effective for the pain-relieving through several mechanisms. Although IFC has been investigated in many painful shoulder disorders, there is no reported study on the effectiveness of IFC therapy in patients with PHF. This study aimed to investigate the effectiveness of IFC added to exercise on shoulder function, pain, and disability compared with placebo in patients with conservative treated PHF. Patients were evaluated within the first week of PHF and divided into two groups to receive either IFC or sham using a simple randomization method. The orthopedic rehabilitation programme was applied to all patients three times a week for four weeks under the guidance of the same physiotherapist. IFC or sham therapy was applied three times a week for 20 minutes before each exercise session by another physiotherapist. Shoulder functions, pain (visual analogue scale), disability and range of motion was evaluated at the end of the rehabilitation program, at 6-weeks and 18-weeks post-treatment by the physiatrist (ED) who did not know which group the patients belonged to. In addition, the amount of acetaminophen usage was noted at each visit.

Eligibility Criteria

Inclusion criteria were as follows: age ≥ 40 years, PHFs did not require surgery by the orthopedic surgeon, and admission to our outpatient clinic within the first two weeks after the fracture

Exclusion Criteria

  • Any surgery history for shoulder pathologies
  • Previous electrotherapy experience before the fracture (to ensure blinding of therapy)
  • Any contraindication such as pacemaker, malignancy, pregnancy, etc. for IFC
  • Rheumatic disease such as rheumatoid arthritis and ankylosing spondylitis
  • Shoulder subluxation; having other fractures in addition to the PHF
  • Known or suspected joint infection or a specific condition such as peripheral or central nervous system lesions
  • Neoplasm; diabetes mellitus or osteonecrosis
  • Any mental disorder that may make it difficult to adapt to exercise
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04553497). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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