Trial Outcomes & Findings for Efficacy of Capacitive-Resistive Therapy on the Treatment of Myofascial Pain (NCT NCT04287517)
NCT ID: NCT04287517
Last Updated: 2020-06-02
Results Overview
The VAS is a tool used to help a person rate the intensity of certain sensations and feelings. This Outcome Measure will assess pain. This VAS is a straight horizontal line of fixed length from 0 to 10 cm with 0 cm indicating no pain and 10 cm indicating the worst pain imaginable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
baseline, pre-intervention and 24 hours after the last intervention
Results posted on
2020-06-02
Participant Flow
Forty volunteer patients who had active pain in the neck region for the last 1 month, who applied to our clinic (Istanbul University Faculty of Medicine Sports Medicine Department), between 12 December 2019 - 01 March 2020, and who had an active myofascial trigger point were evaluated and included in the study.
Although 2 patients met the diagnostic criteria, they were not included in the study due to cervical hernia and cervical stenosis.
Participant milestones
| Measure |
Capacitive-Resistive Therapy Group
This group was treated with capacitive resistive diathermy and exercise
Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
|
Sham Group
This group was treated with sham capacitive-resistive diathermy and exercise
Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Capacitive-Resistive Therapy Group
This group was treated with capacitive resistive diathermy and exercise
Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
|
Sham Group
This group was treated with sham capacitive-resistive diathermy and exercise
Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Efficacy of Capacitive-Resistive Therapy on the Treatment of Myofascial Pain
Baseline characteristics by cohort
| Measure |
Capacitive-Resistive Therapy Group
n=18 Participants
This group was treated with capacitive resistive diathermy and exercise
Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
|
Sham Group
n=18 Participants
This group was treated with sham capacitive-resistive diathermy and exercise
Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
43.7 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
42.9 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Height
|
163.7 centimeters
STANDARD_DEVIATION 6.3 • n=5 Participants
|
165.3 centimeters
STANDARD_DEVIATION 10.0 • n=7 Participants
|
164.5 centimeters
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
weight
|
62.0 kg
STANDARD_DEVIATION 8.4 • n=5 Participants
|
70.4 kg
STANDARD_DEVIATION 12.8 • n=7 Participants
|
66.2 kg
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
BMI
|
23.3 kg/m2
STANDARD_DEVIATION 4.0 • n=5 Participants
|
25.8 kg/m2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
24.5 kg/m2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, pre-intervention and 24 hours after the last interventionThe VAS is a tool used to help a person rate the intensity of certain sensations and feelings. This Outcome Measure will assess pain. This VAS is a straight horizontal line of fixed length from 0 to 10 cm with 0 cm indicating no pain and 10 cm indicating the worst pain imaginable.
Outcome measures
| Measure |
Capacitive-Resistive Therapy Group
n=18 Participants
This group was treated with capacitive resistive diathermy and exercise
Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
|
Sham Group
n=18 Participants
This group was treated with sham capacitive-resistive diathermy and exercise
Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
|
|---|---|---|
|
Visual Analog Scale (VAS) Score Change
pre-intervention
|
5.9 score on a scale
Standard Deviation 1.3
|
5.1 score on a scale
Standard Deviation 1.2
|
|
Visual Analog Scale (VAS) Score Change
24 hours after the last intervention
|
4.1 score on a scale
Standard Deviation 2.1
|
2.3 score on a scale
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: baseline, pre-intervention and 24 hours after the last interventionPPT is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom. Higher scores mean better outcome.
Outcome measures
| Measure |
Capacitive-Resistive Therapy Group
n=18 Participants
This group was treated with capacitive resistive diathermy and exercise
Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
|
Sham Group
n=18 Participants
This group was treated with sham capacitive-resistive diathermy and exercise
Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
|
|---|---|---|
|
Pain Pressure Threshold (PPT) Score Change
Left Side 24 hours after the last intervention
|
2.8 N/m^2
Standard Deviation 1.1
|
2.8 N/m^2
Standard Deviation 0.8
|
|
Pain Pressure Threshold (PPT) Score Change
Right Side pre-intervention
|
2.0 N/m^2
Standard Deviation 0.8
|
2.2 N/m^2
Standard Deviation 0.5
|
|
Pain Pressure Threshold (PPT) Score Change
Right Side 24 hours after the last intervention
|
2.8 N/m^2
Standard Deviation 0.9
|
3.1 N/m^2
Standard Deviation 0.9
|
|
Pain Pressure Threshold (PPT) Score Change
Left Side pre-intervention
|
2.5 N/m^2
Standard Deviation 1.3
|
2.4 N/m^2
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: baseline, pre-intervention and 24 hours after the last interventionThe Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. Each question has six statement, the first statement is marked the section score = 0, if the last statement is marked it = 5. Maximum score is 50 and minimum is 0. Lower scores mean better outcome.
Outcome measures
| Measure |
Capacitive-Resistive Therapy Group
n=18 Participants
This group was treated with capacitive resistive diathermy and exercise
Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
|
Sham Group
n=18 Participants
This group was treated with sham capacitive-resistive diathermy and exercise
Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
|
|---|---|---|
|
Neck Disability Index (NDI) Score Change
pre-intervention
|
28.0 score on a scale
Standard Deviation 10.2
|
24.0 score on a scale
Standard Deviation 8.4
|
|
Neck Disability Index (NDI) Score Change
24 hours after the last intervention
|
19.7 score on a scale
Standard Deviation 11.2
|
12.9 score on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: baseline, pre-intervention and 24 hours after the last interventionThe cervical spine's range of motion is approximately 80° to 90° of flexion, 70° of extension, 20° to 45° of lateral flexion, and up to 90° of rotation to both sides.
Outcome measures
| Measure |
Capacitive-Resistive Therapy Group
n=18 Participants
This group was treated with capacitive resistive diathermy and exercise
Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
|
Sham Group
n=18 Participants
This group was treated with sham capacitive-resistive diathermy and exercise
Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
|
|---|---|---|
|
Cervical Range of Motion (cROM) Change
Flexion ROM pre-intervention
|
60 Degree
Standard Deviation 12
|
63 Degree
Standard Deviation 9
|
|
Cervical Range of Motion (cROM) Change
Flexion ROM 24 hours after the last intervention
|
65 Degree
Standard Deviation 9
|
66 Degree
Standard Deviation 11
|
|
Cervical Range of Motion (cROM) Change
Extension ROM pre-intervention
|
59 Degree
Standard Deviation 11
|
70 Degree
Standard Deviation 14
|
|
Cervical Range of Motion (cROM) Change
Extension ROM 24 hours after the last intervention
|
66 Degree
Standard Deviation 12
|
68 Degree
Standard Deviation 14
|
|
Cervical Range of Motion (cROM) Change
Left Lateral Flexion ROM pre-intervention
|
51 Degree
Standard Deviation 12
|
49 Degree
Standard Deviation 11
|
|
Cervical Range of Motion (cROM) Change
Left Lateral Flexion ROM 24 hours after the last i
|
53 Degree
Standard Deviation 9
|
56 Degree
Standard Deviation 12
|
|
Cervical Range of Motion (cROM) Change
Right Lateral Flexion ROM pre-intervention
|
47 Degree
Standard Deviation 13
|
43 Degree
Standard Deviation 9
|
|
Cervical Range of Motion (cROM) Change
Right Lateral Flexion ROM 24 hours after the last
|
49 Degree
Standard Deviation 11
|
54 Degree
Standard Deviation 12
|
|
Cervical Range of Motion (cROM) Change
Left Lateral Rotation ROM pre-intervention
|
77 Degree
Standard Deviation 14
|
78 Degree
Standard Deviation 10
|
|
Cervical Range of Motion (cROM) Change
Left Lateral Rotation ROM 24 hours after the last
|
84 Degree
Standard Deviation 7
|
82 Degree
Standard Deviation 13
|
|
Cervical Range of Motion (cROM) Change
Right Lateral Rotation ROM pre-intervention
|
75 Degree
Standard Deviation 12
|
78 Degree
Standard Deviation 12
|
|
Cervical Range of Motion (cROM) Change
Right Lateral Rotation ROM 24 hours after the last
|
82 Degree
Standard Deviation 10
|
80 Degree
Standard Deviation 12
|
SECONDARY outcome
Timeframe: baseline, pre-intervention and 24 hours after the last interventionThe Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and an abbreviated variant of it. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Capacitive-Resistive Therapy Group
n=18 Participants
This group was treated with capacitive resistive diathermy and exercise
Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
|
Sham Group
n=18 Participants
This group was treated with sham capacitive-resistive diathermy and exercise
Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
|
|---|---|---|
|
Short Form - 36 (SF-36) Score Change
Social Role Functioning 24 hours after the last in
|
83 score on a scale
Standard Deviation 19
|
81 score on a scale
Standard Deviation 14
|
|
Short Form - 36 (SF-36) Score Change
Social Role Functioning pre-intervention
|
70 score on a scale
Standard Deviation 20
|
72 score on a scale
Standard Deviation 19
|
|
Short Form - 36 (SF-36) Score Change
Physical Functioning pre-intervention
|
77 score on a scale
Standard Deviation 11
|
71 score on a scale
Standard Deviation 16
|
|
Short Form - 36 (SF-36) Score Change
Physical Functioning 24 hours after the last inter
|
80 score on a scale
Standard Deviation 14
|
79 score on a scale
Standard Deviation 13
|
|
Short Form - 36 (SF-36) Score Change
Physical Role Functioning pre-intervention
|
60 score on a scale
Standard Deviation 39
|
61 score on a scale
Standard Deviation 40
|
|
Short Form - 36 (SF-36) Score Change
Physical Role Functioning 24 hours after the last
|
71 score on a scale
Standard Deviation 37
|
77 score on a scale
Standard Deviation 32
|
|
Short Form - 36 (SF-36) Score Change
Bodily Pain pre-intervention
|
49 score on a scale
Standard Deviation 12
|
54 score on a scale
Standard Deviation 17
|
|
Short Form - 36 (SF-36) Score Change
Bodily Pain 24 hours after the last intervention
|
60 score on a scale
Standard Deviation 15
|
70 score on a scale
Standard Deviation 16
|
|
Short Form - 36 (SF-36) Score Change
General Health Perceptions pre-intervention
|
59 score on a scale
Standard Deviation 20
|
59 score on a scale
Standard Deviation 17
|
|
Short Form - 36 (SF-36) Score Change
General Health Perceptions 24 hours after the last
|
59 score on a scale
Standard Deviation 20
|
68 score on a scale
Standard Deviation 15
|
|
Short Form - 36 (SF-36) Score Change
Vitality pre-intervention
|
50 score on a scale
Standard Deviation 16
|
55 score on a scale
Standard Deviation 21
|
|
Short Form - 36 (SF-36) Score Change
Vitality 24 hours after the last intervention
|
49 score on a scale
Standard Deviation 18
|
62 score on a scale
Standard Deviation 15
|
|
Short Form - 36 (SF-36) Score Change
Emotional Role Functioning pre-intervention
|
63 score on a scale
Standard Deviation 20
|
63 score on a scale
Standard Deviation 34
|
|
Short Form - 36 (SF-36) Score Change
Emotional Role Functioning 24 hours after the last
|
82 score on a scale
Standard Deviation 24
|
74 score on a scale
Standard Deviation 18
|
|
Short Form - 36 (SF-36) Score Change
Mental Health pre-intervention
|
68 score on a scale
Standard Deviation 12
|
68 score on a scale
Standard Deviation 20
|
|
Short Form - 36 (SF-36) Score Change
Mental Health 24 hours after the last intervention
|
72 score on a scale
Standard Deviation 11
|
74 score on a scale
Standard Deviation 13
|
Adverse Events
Capacitive-Resistive Therapy Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Group
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. Sergen Devran, Residency in Istanbul University Sports Medicine Department
Istanbul University Faculty of Medicine Sports Medicine Department
Phone: 00905377782594
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place