Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder

This study has been completed.

Sponsor:

Information provided by:

Jordi Gol i Gurina Foundation

ClinicalTrials.gov Identifier:

NCT00884065

First received: February 9, 2009

Last updated: August 24, 2011

Last verified: August 2011

History of Changes

Results First Received: February 9, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Shoulder Pain
Interventions:	Other: Diacutaneous Fibrolysis Other: Diacutaneous Fibrolysis (placebo)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Intervention Group (Diacutaneous Fibrolysis)	Control Group (Placebo)
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Intervention Group (Diacutaneous Fibrolysis)	Control Group (Placebo)	Total
Number of Participants [units: participants]	25	25	50
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	17	15	32
>=65 years	8	10	18
Age [units: years] Mean ± Standard Deviation	56.76 ± 10.33	60.8 ± 10.12	58.78 ± 10.33
Gender [units: participants]
Female	16	13	29
Male	9	12	21
Region of Enrollment [units: participants]
Spain	25	25	50
Months of pain [units: Months] Mean ± Standard Deviation	14.48 ± 16.21	17.88 ± 27.56	16.18 ± 22.44

Outcome Measures

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1. Primary:

Change in Active Flexion Movement After Intervention Minus Baseline [ Time Frame: Baseline and the same day (just after intervention) ]

Measure Type	Primary
Measure Title	Change in Active Flexion Movement After Intervention Minus Baseline
Measure Description	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)
Time Frame	Baseline and the same day (just after intervention)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
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.

Measured Values

	Intervention Group (Diacutaneous Fibrolysis)	Control Group (Placebo)
Number of Participants Analyzed [units: participants]	25	25
Change in Active Flexion Movement After Intervention Minus Baseline [units: Sexagesimal Degrees] Mean ± Standard Deviation	9.48 ± 10.86	-1.92 ± 9.03

Statistical Analysis 1 for Change in Active Flexion Movement After Intervention Minus Baseline

Groups ^[1]	All groups
Method ^[2]	t-test, 2 sided
P Value ^[3]	<0.01
Mean Difference (Final Values) ^[4]	11.40
Standard Error of the mean	± 2.83
95% Confidence Interval	( 5.72 to 17.08 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4]	Other relevant estimation information:
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2. Primary:

Change in Active Abduction Movement After Intervention Minus Baseline [ Time Frame: Baseline and the same day (just after intervention) ]

Measure Type	Primary
Measure Title	Change in Active Abduction Movement After Intervention Minus Baseline
Measure Description	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
Time Frame	Baseline and the same day (just after intervention)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
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.

Measured Values

	Intervention Group (Diacutaneous Fibrolysis)	Control Group (Placebo)
Number of Participants Analyzed [units: participants]	25	25
Change in Active Abduction Movement After Intervention Minus Baseline [units: Sexagesimal degrees] Mean ± Standard Deviation	7.88 ± 9.61	0.64 ± 8.69

Statistical Analysis 1 for Change in Active Abduction Movement After Intervention Minus Baseline

Groups ^[1]	All groups
Method ^[2]	t-test, 2 sided
P Value ^[3]	<0,01
Mean Difference (Final Values) ^[4]	7.24
Standard Error of the mean	± 2.59
95% Confidence Interval	( 2.03 to 12.45 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
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3. Primary:

Change in Active extensión Movement After Intervention Minus Baseline [ Time Frame: Baseline and the same day (just after intervention) ]

Measure Type	Primary
Measure Title	Change in Active extensión Movement After Intervention Minus Baseline
Measure Description	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)
Time Frame	Baseline and the same day (just after intervention)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
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.

Measured Values

	Intervention Group (Diacutaneous Fibrolysis)	Control Group (Placebo)
Number of Participants Analyzed [units: participants]	25	25
Change in Active extensión Movement After Intervention Minus Baseline [units: Sexagesimal degrees] Mean ± Standard Deviation	2.08 ± 5.66	0.16 ± 6.44

Statistical Analysis 1 for Change in Active extensión Movement After Intervention Minus Baseline

Groups ^[1]	All groups
Method ^[2]	t-test, 2 sided
P Value ^[3]	>0,05
Mean Difference (Final Values) ^[4]	1.92
Standard Error of the mean	± 1.72
95% Confidence Interval	( -1.53 to 5.37 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

4. Primary:

Change in Active External Rotation After Intervention Minus Baseline [ Time Frame: Baseline and the same day (just after intervention) ]

Measure Type	Primary
Measure Title	Change in Active External Rotation After Intervention Minus Baseline
Measure Description	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)
Time Frame	Baseline and the same day (just after intervention)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
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.

Measured Values

	Intervention Group (Diacutaneous Fibrolysis)	Control Group (Placebo)
Number of Participants Analyzed [units: participants]	25	25
Change in Active External Rotation After Intervention Minus Baseline [units: Sexagesimal degrees] Mean ± Standard Deviation	0.76 ± 9.55	0.16 ± 5.24

Statistical Analysis 1 for Change in Active External Rotation After Intervention Minus Baseline

Groups ^[1]	All groups
Method ^[2]	t-test, 2 sided
P Value ^[3]	>0,05
Mean Difference (Final Values) ^[4]	0.60
Standard Error of the mean	± 2.18
95% Confidence Interval	( -3.81 to 5.01 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

5. Primary:

Change in Active Internal Rotation After Intervention Minus Baseline [ Time Frame: Baseline and the same day (just after intervention) ]

Measure Type	Primary
Measure Title	Change in Active Internal Rotation After Intervention Minus Baseline
Measure Description	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
Time Frame	Baseline and the same day (just after intervention)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
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.

Measured Values

	Intervention Group (Diacutaneous Fibrolysis)	Control Group (Placebo)
Number of Participants Analyzed [units: participants]	25	25
Change in Active Internal Rotation After Intervention Minus Baseline [units: Centimeters] Mean ± Standard Deviation	4.50 ± 6.79	1.42 ± 3.12

Statistical Analysis 1 for Change in Active Internal Rotation After Intervention Minus Baseline

Groups ^[1]	All groups
Method ^[2]	t-test, 2 sided
P Value ^[3]	<0,01
Mean Difference (Final Values) ^[4]	3.08
Standard Error of the mean	± 1.49
95% Confidence Interval	( 0.08 to 6.09 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

6. Secondary:

Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline [ Time Frame: Baseline and the same day (just after intervention) ]

Measure Type	Secondary
Measure Title	Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline
Measure Description	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.
Time Frame	Baseline and the same day (just after intervention)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
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.

Measured Values

	Intervention Group (Diacutaneous Fibrolysis)	Control Group (Placebo)
Number of Participants Analyzed [units: participants]	25	25
Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline [units: Millimeters] Mean ± Standard Deviation	-9.20 ± 15.16	-7.48 ± 13.68

Statistical Analysis 1 for Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline

Groups ^[1]	All groups
Method ^[2]	t-test, 2 sided
P Value ^[3]	>0,05
Mean Difference (Final Values) ^[4]	-1.72
Standard Error of the mean	± 4.08
95% Confidence Interval	( -9.93 to 6.49 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Martín Eusebio Barra López
Organization: Catalan Institut of Health - Servei de Rhb Sant Ildefons
e-mail: martinbarra@gmail.com

Publications:

Barra ME, López C, Fernández G, Murillo E, Villar E, Raya L. The immediate effects of diacutaneous fibrolysis on pain and mobility in patients suffering from painful shoulder: a randomized placebo-controlled pilot study. Clin Rehabil. 2011 Apr;25(4):339-48. Epub 2010 Nov 15.

ClinicalTrials.gov Identifier:	NCT00884065 History of Changes
Other Study ID Numbers:	Idiap08/187
Study First Received:	February 9, 2009
Results First Received:	February 9, 2009
Last Updated:	August 24, 2011
Health Authority:	Spain: Comité Ético de Investigación Clínica

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