N/A
N=35
IFC Therapy in Proximal Humerus Fractures
Interferential Current in Proximal Humerus Fractures
Bottom Line
View on ClinicalTrials.gov: NCT04553497 ↗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
| Outcome | Result | p-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
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.