IFC Therapy in Proximal Humerus Fractures

NCT04553497 | Completed Results

• 1 other identifier: 15-10.1/43
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Proximal humerus fracture; interferential current; Constant-Murley score

Outcome Measures

Primary Outcomes (1)

• Constant-Murley Score

  The primary outcome was shoulder global function which was measured by the Constant-Murley score (CMS). The questionnaire assesses four shoulder functions: 1) pain; 2) activities of daily living (sleeping, work, leisure); 3) range of motion; and 4) muscle strength. The total score ranges from 0 to 100, with a higher score indicating better shoulder function.

  1. At the end of the treatment 2. The second evaluation: Six weeks after the first one (6th week post-treatment) 3. The last evaluation: Three months after the second one (18th week post-treatment)

Secondary Outcomes (2)

• Visual Analogue Scale

  Visual analogue scale was recorded at the end of the treatment, at 6-weeks and 18-weeks post-treatment

• Disabilities of the Arm, Shoulder and Hand (DASH) Score

  Disabilities of the Arm, Shoulder and Hand (DASH) Score was recorded at the end of the treatment, at 6-weeks and 18-weeks post-treatment

Study Arms (2)

Rehabilitation and interferential current therapy

ACTIVE COMPARATOR

Flipping a coin was used for simple randomization (tails - interferential current). In this arm, interferential current therapy was applied to the patients in addition to the rehabilitation program.

Device: Interferential current; Other: Rehabilitation program

Rehabilitation and sham therapy

SHAM COMPARATOR

Flipping a coin was used for simple randomization (heads - sham). In this arm, sham therapy was applied to the patients in addition to the rehabilitation program.

Device: Interferential current; Other: Rehabilitation program

Interventions

Interferential current DEVICE

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.

Rehabilitation and interferential current therapy; Rehabilitation and sham therapy

Rehabilitation program OTHER

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).

Rehabilitation and interferential current therapy; Rehabilitation and sham therapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University, School of Medicine, Department of Physical Medicine and Rehabilitation Outpatient Clinic

Izmir, 35040, Turkey (Türkiye)

Location

Related Publications (4)

• Hodgson SA, Mawson SJ, Stanley D. Rehabilitation after two-part fractures of the neck of the humerus. J Bone Joint Surg Br. 2003 Apr;85(3):419-22. doi: 10.1302/0301-620x.85b3.13458.

  PMID: 12729121 RESULT

• Hodgson S. Proximal humerus fracture rehabilitation. Clin Orthop Relat Res. 2006 Jan;442:131-8.

  PMID: 16394751 RESULT

• Cheing GL, So EM, Chao CY. Effectiveness of electroacupuncture and interferential eloctrotherapy in the management of frozen shoulder. J Rehabil Med. 2008 Mar;40(3):166-70. doi: 10.2340/16501977-0142.

  PMID: 18292916 RESULT

• Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

  PMID: 35727196 RESULT

MeSH Terms

Interventions

Electric Stimulation Therapy; Rehabilitation

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Emine Duran
• Organization: Ege University Faculty of Medicine, Physical Medicine and Rehabilitation

docemineduran@gmail.com

+905372103145

Study Officials

• Emine Duran

  Ege University, School of Medicine, Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Berrin Durmaz

  Ege University, School of Medicine, Physical Medicine and Rehabilitation

  STUDY DIRECTOR

• Funda A Çalış

  Ege University, School of Medicine, Physical Medicine and Rehabilitation

  STUDY CHAIR

• Mehmet R Kadı

  Ege University, School of Medicine, Physical Medicine and Rehabilitation

  STUDY CHAIR

• Levent Küçük

  Ege University, School of Medicine, Orthopaedic Surgery

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients and the outcome assessor were blind to the treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: After the patients were randomized, interferential current was applied for 3 times a week before the each exercise session by another physiotherapist. 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.

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 17, 2020
• Study Start: April 1, 2014
• Primary Completion: May 15, 2015
• Study Completion: October 15, 2015
• Last Updated: November 24, 2023
• Results First Posted: December 7, 2020

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)