Subacromial Impingement SyndromeNCT01424579
Diacutaneous Fibrolysis and Subacromial Syndrome
A study testing Actual Diacutaneous Fibrolysis and Protocolized physiotherapeutic Treatment in people with Subacromial Impingement Syndrome, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Subacromial Impingement Syndrome (SIS) is the most common cause of shoulder pain with high lifetime prevalence (one in three) in general population. In occupational population is the most common upper extremity disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Actual Diacutaneous Fibrolysis and Protocolized physiotherapeutic Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosed of Subacromial Impingement Syndrome
- Signed a written consent form.
Who cannot join
- Damaged skin and/or cutaneous lesions in the shoulder area,
- A concomitant treatment with platelet antiaggregant agents
- Acute inflammatory conditions in the shoulder
- Previous shoulder surgery
- A pending litigation or court claim
Trial locations and contacts
1 site in 1 country.
Spain1 site
ICS Servei de Rehabilitació Sant Ildefons
Cornellà de Llobregat, Barcelona, 08940
About this study
Official title: Effectiveness of Diacutaneous Fibrolysis for the Treatment of Subacromial Impingement Syndrome: a Randomised Controlled Trial
Subacromial Impingement Syndrome (SIS) is the most common cause of shoulder pain with high lifetime prevalence (one in three) in general population. In occupational population is the most common upper extremity disorder. Symptoms include pain, a variable degree of mobility limitation and a more or less pronounced functional impairment. Conservative treatment is usually the first therapeutic option and some physiotherapeutic techniques have proved its efficacy but nevertheless treatment remains challenging.
According to the investigators clinical experience, Diacutaneous Fibrolysis has a beneficial effect on patients suffering from SIS, but no one published clinical trial has evaluated this manual technique previously. The investigators hypothesis is that adding Diacutaneous Fibrolysis to a protocolized physiotherapeutic treatment can provide better outcomes. The investigators objective was to assess the effect of Diacutaneous Fibrolysis on pain, mobility and functional status in patients suffering from SIS.
Read more
A double-blind (patient and evaluator) randomized clinical trial was carried out in two public centres of Primary Health Care of the Spanish National Health System. The study protocol was approved by the Clinical Research Ethics Committee from the Jordi Gol Institute of Research in Primary Health Care and all the patients provided written consent.
A hundred and twenty patients with clinical diagnosis of SIS were included and randomly allocated to one of three groups. All groups received the same daily protocolized treatment based on therapeutic exercises, analgesic electrotherapy and cryotherapy during three weeks. Additionally, intervention group received six sessions (two a week) of actual Diacutaneous Fibrolysis; placebo group received six sessions (two a week) of placebo Diacutaneous Fibrolysis, while control group received only the protocolized treatment.
Pain intensity (VAS), active range of motion (flexion, abduction, extension, external and internal rotation) and functional status (Constant-Murley score) were measured in baseline, after the three weeks of treatment and three months after the end of treatment.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Actual Diacutaneous Fibrolysis, Placebo Diactuaneous Fibrolysis, Protocolized physiotherapeutic Treatment
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actual Diacutaneous FibrolysisOther
Diacutaneous Fibrolysis is a non-invasive physiotherapeutic technique applied by means of a set of metallic hooks ending in a spatula with bevelled edges that allow a deeper and more precise application, which could not be achieved manually. Appropriate hook is applied following the intermuscular septum between the muscles with an anatomical or functional relationship with the painful structure, in a centripetal direction towards the pain location, in order to release adherences between musculoskeletal structures.
Placebo Diactuaneous FibrolysisOther
Placebo Diacutaneous Fibrolysis was applied at a superficial level and, instead of fibrolysis, a pinch of skin was held with the thumb of the palpatory hand and the tip of the spatula, without any action taking place on the deep tissular levels.
Protocolized physiotherapeutic TreatmentOther
Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Actual Diacutaneous Fibrolysis | Experimental | The group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of actual Diacutaneous Fibrolysis. Receives: Other: Actual Diacutaneous Fibrolysis; Other: Protocolized physiotherapeutic Treatment |
| Placebo Diacutaneous Fybrolisis | Placebo comparator | This group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of placebo Diacutaneous Fibrolysis. Receives: Other: Placebo Diactuaneous Fibrolysis; Other: Protocolized physiotherapeutic Treatment |
| No Diacutaneous Fibrolysis | Other | This group received only tree weeks of a daily protocolized treatment. Receives: Other: Protocolized physiotherapeutic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline in Pain intensity at 3 weeks and 3 months
Measure instrument: Visual Analogue Scale
Measured: Baseline -3 weeks - 3 months.
Secondary outcomes (2)
Changes from Baseline in Active Range of Motion at 3 weeks and 3 months
Flexion, extension, abduction and external rotation movement were measured with a universal double-armed goniometer, and results are expressed in degrees.
For Internal rotation the distance between the position achieved by the tip of the thumb in the hand-behind-back test and the inferior tip of the spinous process of C7 was measured with a flexible metric tape and results are expressed in centimeters.
Measured: Baseline - 3 weeks - 3 months
Changes from Baseline in Functional status at 3 weeks and 3 months
Measure instrument: Constant-Murley score
Measured: Baseline - 3 weeks - 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startFeb 2008
- Primary completionAug 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies 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
- 120 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 Barra-López, PT, Principal investigator, Institut Català de la SalutCarlos López-de-Celis, DO, PT, Study chair, Institut Català de la SalutGabriela Fernández-Jentsch, PT, Study chair, Servicio Gallego de Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424579
- Sponsor's protocol ID
- CEIC-P07/22
- Status last verified
- Apr 2013
- First submitted
- 24 Aug 2011
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Diacutaneous Fibrolysis for the Treatment of Subacromial Impingement Syndrome: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01424579
- Acronym / sponsor ID
- CEIC-P07/22
- Conditions
- Subacromial Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subacromial Impingement Syndrome (SIS) is the most common cause of shoulder pain with high lifetime prevalence (one in three) in general population. In occupational population is the most common upper extremity disorder. Symptoms include pain, a variable degree of mobility limitation and a more or less pronounced functional impairment. Conservative treatment is usually the first therapeutic option and some physiotherapeutic techniques have proved its efficacy but nevertheless treatment remains challenging.
According to the investigators clinical experience, Diacutaneous Fibrolysis has a beneficial effect on patients suffering from SIS, but no one published clinical trial has evaluated this manual technique previously. The investigators hypothesis is that adding Diacutaneous Fibrolysis to a protocolized physiotherapeutic treatment can provide better outcomes. The investigators objective was to assess the effect of Diacutaneous Fibrolysis on pain, mobility and functional status in patients suffering from SIS.
A double-blind (patient and evaluator) randomized clinical trial was carried out in two public centres of Primary Health Care of the Spanish National Health System. The study protocol was approved by the Clinical Research Ethics Committee from the Jordi Gol Institute of Research in Primary Health Care and all the patients provided written consent.
A hundred and twenty patients with clinical diagnosis of SIS were included and randomly allocated to one of three groups. All groups received the same daily protocolized treatment based on therapeutic exercises, analgesic electrotherapy and cryotherapy during three weeks. Additionally, intervention group received six sessions (two a week) of actual Diacutaneous Fibrolysis; placebo group received six sessions (two a week) of placebo Diacutaneous Fibrolysis, while control group received only the protocolized treatment.
Pain intensity (VAS), active range of motion (flexion, abduction, extension, external and internal rotation) and functional status (Constant-Murley score) were measured in baseline, after the three weeks of treatment and three months after the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Actual Diacutaneous Fibrolysis | Experimental | Other: Actual Diacutaneous Fibrolysis, Other: Protocolized physiotherapeutic TreatmentThe group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of actual Diacutaneous Fibrolysis. |
| Placebo Diacutaneous Fybrolisis | Placebo comparator | Other: Placebo Diactuaneous Fibrolysis, Other: Protocolized physiotherapeutic TreatmentThis group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of placebo Diacutaneous Fibrolysis. |
| No Diacutaneous Fibrolysis | Other | Other: Protocolized physiotherapeutic TreatmentThis group received only tree weeks of a daily protocolized treatment. |
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
- Diagnosed of Subacromial Impingement Syndrome
- Signed a written consent form.
Key exclusion criteria (5 listed)
- Damaged skin and/or cutaneous lesions in the shoulder area,
- A concomitant treatment with platelet antiaggregant agents
- Acute inflammatory conditions in the shoulder
- Previous shoulder surgery
- A pending litigation or court claim
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 |
|---|---|---|
| Actual Diacutaneous FibrolysisDiacutaneous Fibrolysis is a non-invasive physiotherapeutic technique applied by means of a set of metallic hooks ending in a spatula with bevelled edges that allow a deeper and more precise application, which could not be achieved manually. Appropriate hook is applied following the intermuscular septum between the muscles with an anatomical or functional relationship with the painful structure, in a centripetal direction towards the pain location, in order to release adherences between musculoskeletal structures. | Other | Actual Diacutaneous Fibrolysis |
| Placebo Diactuaneous FibrolysisPlacebo Diacutaneous Fibrolysis was applied at a superficial level and, instead of fibrolysis, a pinch of skin was held with the thumb of the palpatory hand and the tip of the spatula, without any action taking place on the deep tissular levels. | Other | Placebo Diacutaneous Fybrolisis |
| Protocolized physiotherapeutic TreatmentTree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy. | Other | Actual Diacutaneous Fibrolysis, No Diacutaneous Fibrolysis, Placebo Diacutaneous Fybrolisis |
Primary outcome
Changes from Baseline in Pain intensity at 3 weeks and 3 months
Time frame: Baseline -3 weeks - 3 months.
Measure instrument: Visual Analogue Scale
2 secondary outcomes
Changes from Baseline in Active Range of Motion at 3 weeks and 3 months
Time frame: Baseline - 3 weeks - 3 months
Changes from Baseline in Functional status at 3 weeks and 3 months
Time frame: Baseline - 3 weeks - 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
- Related InfoLink provided by the sponsor.
Related trials for Subacromial Impingement Syndrome
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome
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 Barra-López, PT principal investigator
Institut Català de la Salut
Carlos López-de-Celis, DO, PT study chair
Institut Català de la Salut
Gabriela Fernández-Jentsch, PT study chair
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 Actual Diacutaneous Fibrolysis and Protocolized physiotherapeutic Treatment in people with Subacromial Impingement Syndrome, 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 5 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 5 Apr 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes from Baseline in Pain intensity at 3 weeks and 3 months (time frame: Baseline -3 weeks - 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2013.