Clinical trial NCT04553497: IFC Therapy in Proximal Humerus Fractures
Official title: Does Interferential Current Provide Additional Benefit to the Rehabilitation Program for the Patients With Proximal Humeral Fractures? A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interferential Current in Proximal Humerus Fractures
Keywords: Proximal humerus fracture
interferential current
Constant-Murley score
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Patients with conservatively treated proximal humerus fracture who admitted to Ege University Physical Medicine 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 PHF. The orthopedic rehabilitation programme was applied to all patients three times a week for four weeks under the guidance of the same physiotherapist. The patients also received a complete set of premade exercise cards, which showed all exercises to ensure that the training program was learned correctly. 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 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. The IFC therapy was applied using a combined electrotherapy device SONOPULS 692® (brand: Enraf-Nonius). The medium frequency of the IFC was 4000 Hz and 4100 Hz to produce the amplitude-modulated frequency at 100 Hz. Two rubber electrodes (8×6 cm) were fitted on the fractured shoulder. One of the electrodes was placed on the lateral part of the deltoid muscle; the other one was placed on the trapezius muscle near the shoulder. The current intensity was set to achieve a "strong but comfortable tingling" without visible muscle contraction. The sham therapy consisted of placing 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. Activity pain was measured with the visual analog scale (VAS). 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 evaluated at the end of the treatment, at 6-weeks and 18-weeks post-treatment. Only VAS resting pain was evaluated at the enrollment because the fractured side was immobile when the patients were included in the study. 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 high size effect (d=0.88), a p value of 0.05, and a 15% dropout rate.

Statistical analysis was performed using SPSS version 20.0 (IBM, Armonk, NY, USA). An intention-to-treat analysis was employed for all analysis. The variables were investigated using visual (histogram, probability plots) and analytic methods (Kolmogorov-Smirnov, skewness and curtosis) to determine whether they were normally distributed or not. . Continuous data were described as median (inter-quartile range, IQR) or mean (standar deviation, SD) and categorical variables as percentages. Chi-square or Fisher's exact test was used to compare categorical variables and Mann-Whitney U test/Student's T-test was used to compare continuous variables. All outcome values were presented in mean and standard deviation. The repeated measures ANOVA test was used in comparison of the means of the repeated measures. The results of the repeated measures ANOVA were analyzed by Mauchly's sphericity test. If the parametric tests (factorial design for repeated measures analysis) did not provide the preconditions, the Greenhouse-Geisser correction was used for corrections to the degrees of freedom or Friedman's Test. The Bonferroni correction was used for multiple comparisons. A p value of less than 0.05 was considered to show a statistically significant result.

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

Primary outcomes:
measure: Constant-Murley Score
timeFrame: 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:
measure: Visual Analogue Scale
timeFrame: Visual analogue scale was recorded at the end of the treatment, at 6-weeks and 18-weeks post-treatment
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: 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
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University, School of Medicine, Department of Physical Medicine and Rehabilitation Outpatient Clinic
Study officials:
affiliation: Ege University, School of Medicine, Physical Medicine and Rehabilitation
name: Emine Duran
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University, School of Medicine, Physical Medicine and Rehabilitation
name: Berrin Durmaz
role: STUDY_DIRECTOR
affiliation: Ege University, School of Medicine, Physical Medicine and Rehabilitation
name: Funda A Çalış
role: STUDY_CHAIR
affiliation: Ege University, School of Medicine, Physical Medicine and Rehabilitation
name: Mehmet R Kadı
role: STUDY_CHAIR
affiliation: Ege University, School of Medicine, Orthopaedic Surgery
name: Levent Küçük
role: STUDY_CHAIR
References:
citation: 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.
citation: Hodgson S. Proximal humerus fracture rehabilitation. Clin Orthop Relat Res. 2006 Jan;442:131-8.
citation: 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.
citation: 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.