IFC Therapy in Proximal Humerus Fractures

Interferential Current Provides Additional Benefit to Rehabilitation Program for the Patients With Proximal Humeral Fractures: A Randomized Controlled Study

The humerus forms the bone structure of the arm area between the shoulder and the elbow. Proximal humerus is the upper end of this bone that joins with the shoulder. While proximal humerus fractures occur with high-energy trauma such as traffic accident, fall from height, gunshot injury in young patients, these fractures happen with a simple trauma in elderly patients. Surgical intervention is generally not considered in the proximal humerus fractures treatment. Exercises have very important benefits in the post-fracture period. These exercises allow the shoulder and arm to regain their former mobility. In addition, electrotherapy which is one of the auxiliary methods in the treatment process, is the use of the physical effects of the electric current for therapeutic purposes. The aim of interferential current therapy, which is a frequently used electrotherapy method, is to accelerate recovery, fracture healing, and reduce pain. The aim of this study is to investigate the effect of interferential current therapy on shoulder functions, pain and disability in patients with conservatively treated proximal humerus fractures. Patients will be randomly divided into 2 groups according to the preformed form. The reason why patients are randomly divided into 2 groups (randomization) is to make the study more objective. You have a 50% chance to join one of the 2 treatment groups. An orthopedic rehabilitation program consisting of the same exercise program will be applied to regain shoulder and arm functions for all patients participating in the study. In addition to exercise therapy, active interferential current therapy will be applied to the first group for 3 days a week before the exercises, and sham electric current therapy will be applied to the second group. Being in the second group will not affect the treatment process negatively because of interferential current is not an absolute treatment method for patients with fractures. Shoulder functions, pain (visual analogue scale), disability and range of motion will be evaluated at the end of the exercise program (6th week), 10th and 22nd weeks of all patients who accepted to participate in the study. In addition, the amount of acetaminophen usage will be noted at each visit.

Study Overview

• Status: Completed
• Conditions: Interferential Current in Proximal Humerus Fractures
• Intervention / Treatment: Device: Interferential current; Other: Rehabilitation program

Detailed Description

Patients with conservatively treated proximal humerus fracture who admitted to Ege University Physical Therapy and Rehabilitation outpatient clinic have been included in the study. All patients who met inclusion criteria were enrolled into the study at the first week of fracture. Rehabilitation program carried out under the guidance of same physiotherapist 3 times a week for 6 weeks. The patients also received a complete set of premade exercise card which has shown all exercises to ensure that the training program was learned properly. The patients were recruited at the first week after proximal humerus fracture and then allocated into the groups. The patients were separated into two groups as interferential current or sham interferential current using a simple randomization method managed by an impartial observer. Flipping a coin was used for simple randomization (heads - sham, tails - treatment). The patient's group was reported to the physiotherapist who would apply interferential current in a closed envelope. Patients and the outcome assessor were blind to the treatment groups. In literature, there is no consensus regarding the duration of treatment, so 20 minutes was selected as that is the duration routinely used in our clinic. 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. 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. Pain was measured with the visual analog scale (VAS). The patients themselves used the VAS to make an assessment of their pain with 0 representing no pain, 10 cm representing severe pain. In addition, in order to evaluate shoulder function and disability, the Disability of the Arm, Shoulder and Hand questionnaire (DASH) was used. This self-administered questionnaire includes 30 questions evaluated on a 5-point Likert scale, most of which relate to the individual's capacity to realize a task. The patients were allowed to use paracetamol during the study and the paracetamol intake was recorded as gr/week.

Clinical assessments were made at the end of the treatment (6th week), at the 1st (10th week), and 4th (22nd week) months after the treatments. At baseline, only VAS-pain was evaluated. The physician who assessed the treatment outcomes, the patients and the physiotherapist who administer the exercises were unaware of the patient's group of treatment.

A clinically meaningful difference was considered to be a change of 15 points in total CMS. In order to detect this improvement, the number of patients needed was 17 per group according to a power of 0.80, a p value of 0.05, and a 15% dropout rate.

Statistical analyses were performed with the 20.0 Statistical Package for the Social Sciences (SPSS). An intention-to-treat analysis was employed for all analysis. The nominal variables were shown using cross tabulations. The Chi-square test or Fisher's exact test was used to compere these proportions in different groups. The numeric variables were investigated using visual (histograms, probability plots) and analytical method (Shapiro-Wilk's test) to determine whether or not they are normally distributed. Descriptive analyses were presented using medians and interquartile range (IQR) for the non-normally distributed. When a normal distribution could not be shown in data with Shapiro-Wilk test, Mann-Whitney U test was used in comparison of groups. The repeated measurements were carried out with Friedman and Wilcoxon tests. In the other clinical data with normal distribution, descriptive analyses were presented using means and standard deviations and repeated-measures analysis of variance was used to evaluate the time of observation. Group comparisons were performed with independent samples t test. A p value of less than 0.05 was considered to show a statistically significant result.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35040
    • Ege University, School of Medicine, Department of Physical Medicine and Rehabilitation Outpatient Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion criteria for the study were age of ⩾40 years and that the proximal humerus fractures were no need for surgery.

Exclusion Criteria:

• had any surgery due to proximal humerus fracture
• any previous experience of any electrotherapy prior to the proximal humerus fracture (to ensure blinding of therapy)
• any contraindication for interferential current
• had experienced a known or suspected joint infection or a specific condition such as peripheral or central nervous system lesions, neoplasm, diabetes mellitus or osteonecrosis
• any history of mental impairment or poor general health status that would affect results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rehabilitation and interferential current therapy; 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; 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; Rehabilitation program carried out under the guidance of same physiotherapist 3 times a week for 6 weeks. First phase of the rehabilitation (0-3 weeks) began with elbow, wrist and hand active range of motion (ROM) and pendulum (clockwise and counter clockwise) exercises in the 0-2 weeks of the nondisplaced fracture. During second phase (3-6 weeks), active forward elevation in supine were carried out, and then progressed to sitting and standing position. At the end of 6 weeks', the physiotherapist described the home training program involving the resistance exercises by using therabands of progressive strengths for internal and external rotation, flexion, extension and abduction. Flexibility and stretching exercises were also given to progressively increase ROM in all directions. At each visit, the patients were instructed to regularly perform their exercises.
Sham Comparator: Rehabilitation and sham interferential current therapy; Flipping a coin was used for simple randomization (heads - sham). In this arm, sahm interferential current therapy was applied to the patients in addition to the rehabilitation program.	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; Rehabilitation program carried out under the guidance of same physiotherapist 3 times a week for 6 weeks. First phase of the rehabilitation (0-3 weeks) began with elbow, wrist and hand active range of motion (ROM) and pendulum (clockwise and counter clockwise) exercises in the 0-2 weeks of the nondisplaced fracture. During second phase (3-6 weeks), active forward elevation in supine were carried out, and then progressed to sitting and standing position. At the end of 6 weeks', the physiotherapist described the home training program involving the resistance exercises by using therabands of progressive strengths for internal and external rotation, flexion, extension and abduction. Flexibility and stretching exercises were also given to progressively increase ROM in all directions. At each visit, the patients were instructed to regularly perform their exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. End of the treatment (6th week) (the treatment started 2 weeks after the fracture and lasted 4 weeks) 2. The second evaluation: Four weeks after the first one (tenth week) 3. The last evaluation: Three months after the second one (twenty second week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	The secondary outcome was pain which was measured by the visual analogue scale. The patients themselves used the VAS to make an assessment of their pain with 0 representing no pain, 10 cm representing severe pain.	Visual analogue scale was recorded at baseline, end of the treatment (6th week), at the 1st (10th week), and 4th (22nd week) month after the treatments.
Disabilities of the Arm, Shoulder and Hand (DASH) Score	One of the secondary outcome was disability which was measured by the Disabilities of the Arm, Shoulder and Hand (DASH) Score. The DASH consists mainly of a 30-item disability/symptom on a 5-point Likert scale, scored 0 (no disability) to 100 (maximum disability).	Disabilities of the Arm, Shoulder and Hand (DASH) Score was recorded at the end of the treatment (6th week), at the 1st (10th week), and 4th (22nd week) month after the treatments.

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Principal Investigator: Emine Duran, Ege University, School of Medicine, Physical Medicine and Rehabilitation; Study Director: Berrin Durmaz, Ege University, School of Medicine, Physical Medicine and Rehabilitation; Study Chair: 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

Publications and helpful links

General Publications

• 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:CD000434. doi: 10.1002/14651858.CD000434.pub5. Review.
• Neer CS 2nd. Displaced proximal humeral fractures. II. Treatment of three-part and four-part displacement. J Bone Joint Surg Am. 1970 Sep;52(6):1090-103. No abstract available.
• 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.
• Hodgson S. Proximal humerus fracture rehabilitation. Clin Orthop Relat Res. 2006 Jan;442:131-8.
• 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.
• Ganne JM. Stimulation of bone healing with interferential therapy. Aust J Physiother. 1988;34(1):9-20. doi: 10.1016/S0004-9514(14)60597-3.

Helpful Links

• Interferential Current as an Adjunct to Exercise and Mobilisation in the Treatment of Proximal Humerus Fracture Pain: Lack of evidence of an additional effect

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): May 15, 2015
• Study Completion (Actual): October 15, 2015

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 7, 2020
• Last Update Submitted That Met QC Criteria: November 11, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Proximal humerus fracture; interferential current; Constant-Murley score
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: 15-10.1/43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No