IFC Therapy in Proximal Humerus Fractures
Condition: Interferential Current in Proximal Humerus Fractures
MeSH terms: Fractures, Bone; Humeral Fractures
Study type: Interventional

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.
    

Intervention name(s): Interferential current; Rehabilitation program
Intervention type(s): Device; Other
Intervention description(s): 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.; 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).
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Proximal humerus fracture; interferential current; Constant-Murley score