IFC Therapy in Proximal Humerus Fractures

NCT04553497 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-11-24

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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.

Conditions

  • Interferential Current in Proximal Humerus Fractures

Interventions

DEVICE

Interferential current

Interferential current or sham were applied to the patients before the each exercise session. Pre-modulated bipolar method with the currier frequency of 4 kHz by a combination therapy unit (Sonopuls 692, Enraf-Nonius) with two electrodes (8×6 cm) was used. One electrode was placed on the lateral part of the deltoid muscle; the other was placed on the trapezium muscle close to the shoulder. Subjects were told that in order to produce an effect, the intensity of the stimulator must be maintained at a "strong but comfortable level" at all times. The sham interferential current therapy consisted of the placement of the same pads for the same time but no electrical stimulation was applied to the probes.

OTHER

Rehabilitation program

The orthopedic rehabilitation programme was applied to all patients three times a week for 4 weeks under the guidance of the same physiotherapist. The first phase (0-3 weeks) involved the elbow, wrist, and hand active range of motion (ROM) and pendulum (clockwise and counterclockwise) exercises in the 0-2 weeks of the non-displaced fracture. For displaced fractures, elbow, wrist, and hand active range of motion was started immediately, but pendulum exercises were initiated two weeks later. The patients were instructed to continue exercises 3-5 times per day for 30 minutes. After two weeks, active assistive ROM and isometric exercises were performed supine position. During the second phase (3-6 weeks), active forward elevation in supine was carried out and then progressed to sitting and standing position. At the end of the sixth week, a home exercise program was given by the physiotherapist, including resistance exercises using an elastic band (Thera-Band).

Sponsors & Collaborators

  • Ege University

    lead OTHER

Principal Investigators

  • Emine Duran · Ege University, School of Medicine, Physical Medicine and Rehabilitation

  • Berrin Durmaz · Ege University, School of Medicine, Physical Medicine and Rehabilitation

  • Funda A Çalış · Ege University, School of Medicine, Physical Medicine and Rehabilitation

  • Mehmet R Kadı · Ege University, School of Medicine, Physical Medicine and Rehabilitation

  • Levent Küçük · Ege University, School of Medicine, Orthopaedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-01
Primary Completion
2015-05-15
Completion
2015-10-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04553497 on ClinicalTrials.gov