Shoulder PainNCT00884065
Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder
A study testing Diacutaneous Fibrolysis in people with Shoulder Pain, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
While Diacutaneous fibrolysis (DF) has achieved promising results empirically, its effectiveness has not been tested in clinical trials. The investigators hypothesized that the use of DF in patients suffering from painful shoulder would increase the active mobility and reduce the pain during movement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Diacutaneous Fibrolysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2007to Jan 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years of age
- being referred for treatment of painful shoulder (except for adhesive capsulitis)
- not having been previously treated with DF
Who cannot join
- Damaged skin and/or cutaneous lesions in the shoulder area
- History of shoulder surgery
- Vascular abnormalities
- Platelet antiaggregant therapy
- Acute inflammatory condition of the shoulder (<1 week)
- Patients with a pending litigation or court claim
Trial locations and contacts
1 site in 1 country.
Spain1 site
Catalan Institute of Health - Servei de Rhb Sant Ildefons
Cornellà de Llobregat, Barcelona, 08940
About this study
Official title: Effectiveness of Diacutaneous Fibrolysis on Pain and Mobility in Patients Suffering From Painful Shoulder. A Randomized Pilot Study.
While Diacutaneous fibrolysis (DF) has achieved promising results empirically, its effectiveness has not been tested in clinical trials. The investigators hypothesized that the use of DF in patients suffering from painful shoulder would increase the active mobility and reduce the pain during movement. To test the hypothesis a double blind (patient and investigator) randomized clinical trial was carried out in two public Primary Health Care Centres. Fifty patients were randomly allocated to two groups: the intervention group, who received a real DF session, and the control group, who received a placebo DF session.
Read the detailed description
Background and objectives:
Diacutaneous fibrolysis (DF) is a manual technique to treat the mechanical pain of the musculoskeletal system. While this technique has achieved promising results empirically, its effectiveness has not been tested in clinical trials. We aimed at evaluating the effectiveness of a single session of DF on pain and mobility in patients suffering from painful shoulder.
Subjects and methods:
This clinical trial took place in two public Primary Health Care Centres. Fifty patients were randomly allocated to two groups: the intervention group, who received a real DF session, and the control group, who received a placebo DF session. The degree of active mobility (flexion, abduction, extension, external and internal rotation), the pain in the hand behind back position and the participant's perception of the technique in terms of comfort and results obtained were measured.
- Conditions
- Shoulder Pain
- Being tested
- Diacutaneous Fibrolysis, Diacutaneous Fibrolysis (placebo)
- Keywords
- Physiotherapy, Manual therapy, Painful Shoulder, Diacutaneous Fibrolysis
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diacutaneous FibrolysisOther
Also called Manual therapy
The implementation of the technique consists of three consecutive stages: The first stage involves manual palpation, which is carried out by the hand that is not holding the hook, with the objective to find the area to be treated; the second, or instrumental palpation stage, is carried out by introducing the spatula of the hook together with the index finger of the palpatory hand to locate with precision the adherent connective fibers or fibrous corpuscles; the third, or fibrolysis stage, is the actual treatment. Here, a brief supplementary traction is carried out with the hook.
Diacutaneous Fibrolysis (placebo)Other
Also called Manual therapy
The placebo was designed for this study and the stages of manual and instrumental palpation occur strictly at a superficial level. In the third stage, instead of fibrolysis a pinch of skin is hold with the thumb of the palpatory hand and the tip of the spatula, so that the patient feels the hook distinctly but without any action taking place on the deep tissular planes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group was treated with a single session of DF following the procedure as described by the authors. Receives: Other: Diacutaneous Fibrolysis |
| Control Group | Placebo comparator | The control group was treated with a single placebo session of DF. Receives: Other: Diacutaneous Fibrolysis (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Active Flexion Movement After Intervention Minus Baseline
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)
Measured: Baseline and the same day (just after intervention)
Change in Active Abduction Movement After Intervention Minus Baseline
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
Measured: Baseline and the same day (just after intervention)
Change in Active extensión Movement After Intervention Minus Baseline
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)
Measured: Baseline and the same day (just after intervention)
Change in Active External Rotation After Intervention Minus Baseline
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)
Measured: Baseline and the same day (just after intervention)
Change in Active Internal Rotation After Intervention Minus Baseline
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
Measured: Baseline and the same day (just after intervention)
Secondary outcomes (1)
Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline
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.
Measured: Baseline and the same day (just after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startJun 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martín-Eusebio Barra-López, PT, Principal investigator, Catalan Institute of HealthCarlos López-de-Celis, DO, PT, Principal investigator, Catalan Institute of HealthGabriela Fernández-Jentsch, PT, Principal investigator, Servicio Gallego de SaludErnesto Murillo-Barrios, PT, Principal investigator, Servicio Gallego de SaludEdurne Villar-Mateo, PT, Principal investigator, Catalan Institute of HealthLaura Raya-de-Cardenas, PT, Principal investigator, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884065
- Sponsor's protocol ID
- Idiap08/187
- Status last verified
- Mar 2015
- First submitted
- 9 Feb 2009
- Last updated
- 23 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Barra ME, Lopez C, Fernandez 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. doi: 10.1177/0269215510385480. Epub 2010 Nov 15.
PubMed 21078700
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Diacutaneous Fibrolysis on Pain and Mobility in Patients Suffering From Painful Shoulder. A Randomized Pilot Study.
- ClinicalTrials.gov ID
- NCT00884065
- Acronym / sponsor ID
- Idiap08/187
- Conditions
- Shoulder Pain
- Keywords
- Physiotherapy, Manual therapy, Painful Shoulder, Diacutaneous Fibrolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 20 Apr 2009 (estimated)
- Results
- Posted 20 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While Diacutaneous fibrolysis (DF) has achieved promising results empirically, its effectiveness has not been tested in clinical trials. The investigators hypothesized that the use of DF in patients suffering from painful shoulder would increase the active mobility and reduce the pain during movement. To test the hypothesis a double blind (patient and investigator) randomized clinical trial was carried out in two public Primary Health Care Centres. Fifty patients were randomly allocated to two groups: the intervention group, who received a real DF session, and the control group, who received a placebo DF session.
Detailed description
Background and objectives:
Diacutaneous fibrolysis (DF) is a manual technique to treat the mechanical pain of the musculoskeletal system. While this technique has achieved promising results empirically, its effectiveness has not been tested in clinical trials. We aimed at evaluating the effectiveness of a single session of DF on pain and mobility in patients suffering from painful shoulder.
Subjects and methods:
This clinical trial took place in two public Primary Health Care Centres. Fifty patients were randomly allocated to two groups: the intervention group, who received a real DF session, and the control group, who received a placebo DF session. The degree of active mobility (flexion, abduction, extension, external and internal rotation), the pain in the hand behind back position and the participant's perception of the technique in terms of comfort and results obtained were measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Diacutaneous FibrolysisThe intervention group was treated with a single session of DF following the procedure as described by the authors. |
| Control Group | Placebo comparator | Other: Diacutaneous Fibrolysis (placebo)The control group was treated with a single placebo session of DF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over 18 years of age
- being referred for treatment of painful shoulder (except for adhesive capsulitis)
- not having been previously treated with DF
Key exclusion criteria (6 listed)
- Damaged skin and/or cutaneous lesions in the shoulder area
- History of shoulder surgery
- Vascular abnormalities
- Platelet antiaggregant therapy
- Acute inflammatory condition of the shoulder (<1 week)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diacutaneous FibrolysisAlso: Manual therapyThe implementation of the technique consists of three consecutive stages: The first stage involves manual palpation, which is carried out by the hand that is not holding the hook, with the objective to find the area to be treated; the second, or instrumental palpation stage, is carried out by introducing the spatula of the hook together with the index finger of the palpatory hand to locate with precision the adherent connective fibers or fibrous corpuscles; the third, or fibrolysis stage, is the actual treatment. Here, a brief supplementary traction is carried out with the hook. | Other | Intervention Group |
| Diacutaneous Fibrolysis (placebo)Also: Manual therapyThe placebo was designed for this study and the stages of manual and instrumental palpation occur strictly at a superficial level. In the third stage, instead of fibrolysis a pinch of skin is hold with the thumb of the palpatory hand and the tip of the spatula, so that the patient feels the hook distinctly but without any action taking place on the deep tissular planes. | Other | Control Group |
Primary outcome
Change in Active Flexion Movement After Intervention Minus Baseline
Time frame: 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)
Change in Active Abduction Movement After Intervention Minus Baseline
Time frame: 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
Change in Active extensión Movement After Intervention Minus Baseline
Time frame: 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)
Change in Active External Rotation After Intervention Minus Baseline
Time frame: 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)
Change in Active Internal Rotation After Intervention Minus Baseline
Time frame: 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
1 secondary outcome
Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline
Time frame: Baseline and the same day (just after intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21078700Barra ME, Lopez C, Fernandez 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. doi: 10.1177/0269215510385480. Epub 2010 Nov 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martín-Eusebio Barra-López, PT principal investigator
Catalan Institute of Health
Carlos López-de-Celis, DO, PT principal investigator
Catalan Institute of Health
Gabriela Fernández-Jentsch, PT principal investigator
Servicio Gallego de Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diacutaneous Fibrolysis in people with Shoulder Pain, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Active Flexion Movement After Intervention Minus Baseline (time frame: Baseline and the same day (just after intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00884065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2015.