Trial Outcomes & Findings for Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder (NCT NCT00884065)
NCT ID: NCT00884065
Last Updated: 2015-03-23
Results Overview
A universal double armed goniometer was used to measure change in active flexión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)
COMPLETED
NA
50 participants
Baseline and the same day (just after intervention)
2015-03-23
Participant Flow
The study participants were recruited from two public services of primary health care of the Spanish National Health Service, one in Cornellà de Llobregat (Barcelona), the other in Ponteareas (Pontevedra), from June 2007 to January 2008.
Participant milestones
| Measure |
Intervention Group (Diacutaneous Fibrolysis)
The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
|
Control Group (Placebo)
The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder
Baseline characteristics by cohort
| Measure |
Intervention Group (Diacutaneous Fibrolysis)
n=25 Participants
The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
|
Control Group (Placebo)
n=25 Participants
The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32.0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18.0 Participants
n=5 Participants
|
|
Age, Continuous
|
56.76 years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 10.12 • n=7 Participants
|
58.78 years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21.0 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50.0 participants
n=5 Participants
|
|
Months of pain
|
14.48 Months
STANDARD_DEVIATION 16.21 • n=5 Participants
|
17.88 Months
STANDARD_DEVIATION 27.56 • n=7 Participants
|
16.18 Months
STANDARD_DEVIATION 22.44 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and the same day (just after intervention)A universal double armed goniometer was used to measure change in active flexión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)
Outcome measures
| Measure |
Intervention Group (Diacutaneous Fibrolysis)
n=25 Participants
The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
|
Control Group (Placebo)
n=25 Participants
The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
|
|---|---|---|
|
Change in Active Flexion Movement After Intervention Minus Baseline
|
9.48 Sexagesimal Degrees
Standard Deviation 10.86
|
-1.92 Sexagesimal Degrees
Standard Deviation 9.03
|
PRIMARY outcome
Timeframe: Baseline and the same day (just after intervention)A universal double armed goniometer was used to measure change in active abduction movement in the scapular plane with the elbow in extension and the forearm in supination
Outcome measures
| Measure |
Intervention Group (Diacutaneous Fibrolysis)
n=25 Participants
The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
|
Control Group (Placebo)
n=25 Participants
The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
|
|---|---|---|
|
Change in Active Abduction Movement After Intervention Minus Baseline
|
7.88 Sexagesimal degrees
Standard Deviation 9.61
|
0.64 Sexagesimal degrees
Standard Deviation 8.69
|
PRIMARY outcome
Timeframe: Baseline and the same day (just after intervention)A universal double armed goniometer was used to measure change in active extensión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)
Outcome measures
| Measure |
Intervention Group (Diacutaneous Fibrolysis)
n=25 Participants
The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
|
Control Group (Placebo)
n=25 Participants
The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
|
|---|---|---|
|
Change in Active extensión Movement After Intervention Minus Baseline
|
2.08 Sexagesimal degrees
Standard Deviation 5.66
|
0.16 Sexagesimal degrees
Standard Deviation 6.44
|
PRIMARY outcome
Timeframe: Baseline and the same day (just after intervention)A universal double armed goniometer was used to measure change in active external rotation measured in the neutral position of the shoulder (arm pinned to the trunk), elbow flexed to 90º and the forearm in indifferent pronosupination (thumb forward)
Outcome measures
| Measure |
Intervention Group (Diacutaneous Fibrolysis)
n=25 Participants
The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
|
Control Group (Placebo)
n=25 Participants
The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
|
|---|---|---|
|
Change in Active External Rotation After Intervention Minus Baseline
|
0.76 Sexagesimal degrees
Standard Deviation 9.55
|
0.16 Sexagesimal degrees
Standard Deviation 5.24
|
PRIMARY outcome
Timeframe: Baseline and the same day (just after intervention)Change in active internal rotation was measured with the hand behind back test. The position achieved by the tip of the thumb was marked and with a flexible metric tape (always the same) the distance in centimetres between this mark and the inferior tip of the spinous process of C7 was measured; the shorter the distance, the better the mobility
Outcome measures
| Measure |
Intervention Group (Diacutaneous Fibrolysis)
n=25 Participants
The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
|
Control Group (Placebo)
n=25 Participants
The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
|
|---|---|---|
|
Change in Active Internal Rotation After Intervention Minus Baseline
|
4.50 Centimeters
Standard Deviation 6.79
|
1.42 Centimeters
Standard Deviation 3.12
|
SECONDARY outcome
Timeframe: Baseline and the same day (just after intervention)An unmarked Visual Analogue Scale from 0 (no pain) to 100 (worst pain) millimeters was used. At baseline, participants registered the pain perceived in the position used to measure the internal rotation. After intervention, they registered the pain with the hand placed in the same position taking as a reference the mark in the first evaluation.
Outcome measures
| Measure |
Intervention Group (Diacutaneous Fibrolysis)
n=25 Participants
The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
|
Control Group (Placebo)
n=25 Participants
The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
|
|---|---|---|
|
Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline
|
-9.20 Millimeters
Standard Deviation 15.16
|
-7.48 Millimeters
Standard Deviation 13.68
|
Adverse Events
Intervention Group (Diacutaneous Fibrolysis)
Control Group (Placebo)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Martín Eusebio Barra López
Catalan Institut of Health - Servei de Rhb Sant Ildefons
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place