Trial Outcomes & Findings for IFC Therapy in Proximal Humerus Fractures (NCT NCT04553497)
NCT ID: NCT04553497
Last Updated: 2023-11-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome 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)
Results posted on
2023-11-24
Participant Flow
35 who met the study inclusion criteria were randomly separated into two groups: the interferential current group (n = 18) and the sham group (n =17).
18 patients were excluded * Rheumatic diseases, 6 * Multiple trauma, 5 * Cerebrovasculer diseases, 3 * Peripheral nerve injury, 2 * Shoulder subluxation, 2
Participant milestones
| Measure |
Rehabilitation and Sham 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.
Sham interferential current was applied to the patients before 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. The sham interferential current therapy consisted of the placement but no electrical stimulation was applied to the probes. Rehabilitation program was performed to all patients.
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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.
Interferential current: Interferential current was applied to the patients before 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.
Rehabilitation program was performed to all patients
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|---|---|---|
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Overall Study
STARTED
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17
|
18
|
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Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IFC Therapy in Proximal Humerus Fractures
Baseline characteristics by cohort
| Measure |
Rehabilitation and Interferential Current Therapy
n=18 Participants
In this arm, interferential current therapy was applied to the patients in addition to the rehabilitation program. Interferential current: 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.
Rehabilitation program: Rehabilitation program carried out under the guidance of same physiotherapist 3 times a week for 6 weeks. At the end of 6 weeks', the physiotherapist described the home training program involving the resistance exercises by using therabands
|
Rehabilitation and Sham Therapy
n=17 Participants
In this arm, sham interferential current therapy was applied to the patients in addition to the rehabilitation program.
Sham interferential current 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. 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 program: Rehabilitation program carried out under the guidance of same physiotherapist 3 times a week for 6 weeks. At the end of 6 weeks', the physiotherapist described the home training program involving the resistance exercises by using therabands.
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Total
n=35 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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58.9 years
STANDARD_DEVIATION 10.7 • n=5 Participants
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62.0 years
STANDARD_DEVIATION 9.5 • n=7 Participants
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60.4 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
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Sex: Female, Male
Female
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12 Participants
n=5 Participants
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11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
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12 Participants
n=5 Participants
|
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Region of Enrollment
Turkey
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18 participants
n=5 Participants
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17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Body mass index
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28.0 kg/m^2
STANDARD_DEVIATION 3.2 • n=5 Participants
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30.8 kg/m^2
STANDARD_DEVIATION 5.6 • n=7 Participants
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29.3 kg/m^2
STANDARD_DEVIATION 4.7 • n=5 Participants
|
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Fracture side
Right fracture
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15 Participants
n=5 Participants
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15 Participants
n=7 Participants
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30 Participants
n=5 Participants
|
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Fracture side
Left fracture
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3 Participants
n=5 Participants
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2 Participants
n=7 Participants
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5 Participants
n=5 Participants
|
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Neer classification
Type-1 Neer Classification
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4 Participants
n=5 Participants
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2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Neer classification
Type-2 Neer Classification
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3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Neer classification
Type-3 Neer Classification
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11 Participants
n=5 Participants
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9 Participants
n=7 Participants
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20 Participants
n=5 Participants
|
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Anatomic segment of proximal humerus fracture
Greater tuberosity fracture
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5 Participants
n=5 Participants
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3 Participants
n=7 Participants
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8 Participants
n=5 Participants
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Anatomic segment of proximal humerus fracture
Surgical neck fracture
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2 Participants
n=5 Participants
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5 Participants
n=7 Participants
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7 Participants
n=5 Participants
|
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Anatomic segment of proximal humerus fracture
Greater tuberosity and Surgical neck fracture
|
11 Participants
n=5 Participants
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9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
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PRIMARY outcome
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)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.
Outcome measures
| Measure |
Rehabilitation and Interferential Current Therapy
n=18 Participants
In this arm, interferential current therapy was applied to the patients in addition to the rehabilitation program.
|
Rehabilitation and Sham Therapy
n=17 Participants
Sham therapy was applied to the patients in addition to the rehabilitation program.
|
|---|---|---|
|
Constant-Murley Score
6th week post-treatment (Constant-Murley scores)
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69.0 score on a scale
Standard Deviation 8.9
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60.7 score on a scale
Standard Deviation 12.1
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Constant-Murley Score
18th week post-treatment (Constant-Murley scores)
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79.6 score on a scale
Standard Deviation 9.4
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69.3 score on a scale
Standard Deviation 14.2
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Constant-Murley Score
Post treatment (Constant-Murley scores)
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57.0 score on a scale
Standard Deviation 7.7
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48.2 score on a scale
Standard Deviation 12.0
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SECONDARY outcome
Timeframe: Visual analogue scale was recorded at the end of the treatment, at 6-weeks and 18-weeks post-treatmentThe 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.
Outcome measures
| Measure |
Rehabilitation and Interferential Current Therapy
n=18 Participants
In this arm, interferential current therapy was applied to the patients in addition to the rehabilitation program.
|
Rehabilitation and Sham Therapy
n=17 Participants
Sham therapy was applied to the patients in addition to the rehabilitation program.
|
|---|---|---|
|
Visual Analogue Scale
VAS at the post-treatment
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3.9 score on a scale
Standard Deviation 1.5
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4.7 score on a scale
Standard Deviation 1.5
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Visual Analogue Scale
VAS at 6-weeks post-treatment
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2.0 score on a scale
Standard Deviation 1.7
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3.0 score on a scale
Standard Deviation 1.5
|
|
Visual Analogue Scale
VAS at 18-weeks post-treatment
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0.7 score on a scale
Standard Deviation 1.1
|
1.7 score on a scale
Standard Deviation 1.4
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SECONDARY outcome
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-treatmentOne 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).
Outcome measures
| Measure |
Rehabilitation and Interferential Current Therapy
n=18 Participants
In this arm, interferential current therapy was applied to the patients in addition to the rehabilitation program.
|
Rehabilitation and Sham Therapy
n=17 Participants
Sham therapy was applied to the patients in addition to the rehabilitation program.
|
|---|---|---|
|
Disabilities of the Arm, Shoulder and Hand (DASH) Score
DASH score at 18-weeks post-treatment
|
7.7 score on a scale
Standard Deviation 7.3
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12.5 score on a scale
Standard Deviation 11.3
|
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Disabilities of the Arm, Shoulder and Hand (DASH) Score
DASH score at post-treatment
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28 score on a scale
Standard Deviation 11
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38.4 score on a scale
Standard Deviation 17.5
|
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Disabilities of the Arm, Shoulder and Hand (DASH) Score
DASH score at 6-weeks post-treatment
|
15.3 score on a scale
Standard Deviation 9.2
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23.3 score on a scale
Standard Deviation 13
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Adverse Events
Rehabilitation and Interferential Current Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rehabilitation and Sham Interferential Current Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Emine Duran
Ege University Faculty of Medicine, Physical Medicine and Rehabilitation
Phone: +905372103145
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place