Tennis ElbowPhase 3NCT02343809
Diacutaneous Fibrolysis on Lateral Epicondylitis
A Phase 3 study testing Actual Diacutaneous Fibrolysis and Protocolized Physiotherapy in people with Tennis Elbow, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Diacutaneous Fibrolysis (DF) is a manual method of treatment, usually adjuvant, addressed to the mechanical pain of the locomotor system. In our clinical practice a favorable effect is observed in patients with chronic lateral epicondylitis, but there are no published studies evaluating the results of this technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- Actual Diacutaneous Fibrolysis and Protocolized Physiotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2014to Jan 2016
- Phase
- Phase 3
- 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
- 18 years old and over
- Diagnosis of chronic lateral epicondylalgia
- Sign the informed consent form
Who cannot join
- Concomitant conditions affecting the same upper extremity
- Contraindications for Diacutaneous Fibrolysis
- Corticosteroid injections or similar agents in the three months prior to study inclusion
- Pending litigation or legal claim
- Poor language and communication skills making difficult to understand the informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Catalan Institut of Health - Sant Ildefons Rehabilitation Center
Cornellà de Llobregat, Barcelona, 08940
Carlos López, M.Sc, 934711912, carlesldc@gmail.com
About this study
Official title: Effectiveness of Diacutaneous Fibrolysis on Chronic Lateral Epicondylitis. A Randomized Controlled Trial.
Diacutaneous Fibrolysis (DF) is a manual method of treatment, usually adjuvant, addressed to the mechanical pain of the locomotor system. In our clinical practice a favorable effect is observed in patients with chronic lateral epicondylitis, but there are no published studies evaluating the results of this technique.
The objective of this trial is to evaluate if DF provides a further improvement in pain intensity, pain-pressure threshold, function and pain-free grip strength, in patients with chronic lateral epicondylitis being treated with physiotherapy. For this purpose, we conduct a randomized controlled trial, double-blind (patient and evaluator) in a Public Primary Care Center.
Read more
Sixty subjects will be randomized (computer application) into three groups: Intervention Group, Placebo Group and Control Group. All the three groups receive the same protocolized treatment of physiotherapy and additionally. Additionally, the Intervention Group receives six sessions (two sessions in a week during three weeks) of real DF and the Placebo Group receives six sessions (two sessions in a week during three weeks) of sham DF. The Control Group receives the protocolized treatment of physiotherapy only.
Pain intensity (VAS), pain-pressure threshold (pressure algometry), function (DASH questionnaire) and pain-free grip strength (digital dynamometer) will be measured at baseline, after treatment period, and three months after discharge from treatment. After discharge for treatment the patient subjective opinion about their evolution will be collected through the Global Rating of Change (GROC) scale.
- Conditions
- Tennis Elbow
- Being tested
- Actual Diacutaneous Fibrolysis, Sham Diacutaneous Fibrolysis, Protocolized Physiotherapy
- Keywords
- Physiotherapy, Lateral epicondylitis, Manual therapy
- Medical subject headings
- Tennis Elbow
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. The hook is deeply applied following the intermuscular septum between the muscles with an anatomical of functional relationship with the painful structure in order to release adherences between musculoskeletal structures.
Sham Diacutaneous FibrolysisOther
Sham Diacutaneous Fibrolysis is applied at a superficial level. 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 PhysiotherapyOther
Protocolized physiotherapeutic treatment: Three weeks fo daily stretching exercises, ultrasound and analgesic electrotherapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Actual Diacutaneous Fibrolysis and Protocolized Physiotherapy Receives: Other: Actual Diacutaneous Fibrolysis; Other: Protocolized Physiotherapy |
| Placebo Group | Sham comparator | Sham Diacutaneous Fibrolysis and Protocolized Physiotherapy Receives: Other: Sham Diacutaneous Fibrolysis; Other: Protocolized Physiotherapy |
| Control Group | Other | Protocolized Physiotherapy Receives: Other: Protocolized Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity (VAS)
Measured: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Secondary outcomes (4)
Pressure Pain Threshold
pressure algometry
Measured: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Pain free grip strength
digital dynamometer
Measured: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Functional status
DASH questionnaire
Measured: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Global Rating of Change scale
Measured: post-intervention, after three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionNov 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343809
- Sponsor's protocol ID
- P14/032
- Status last verified
- Jan 2015
- First submitted
- 16 Jan 2015
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Diacutaneous Fibrolysis on Chronic Lateral Epicondylitis. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02343809
- Acronym / sponsor ID
- P14/032
- Conditions
- Tennis Elbow
- Keywords
- Physiotherapy, Lateral epicondylitis, Manual therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 22 Jan 2015 (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.
Diacutaneous Fibrolysis (DF) is a manual method of treatment, usually adjuvant, addressed to the mechanical pain of the locomotor system. In our clinical practice a favorable effect is observed in patients with chronic lateral epicondylitis, but there are no published studies evaluating the results of this technique.
The objective of this trial is to evaluate if DF provides a further improvement in pain intensity, pain-pressure threshold, function and pain-free grip strength, in patients with chronic lateral epicondylitis being treated with physiotherapy. For this purpose, we conduct a randomized controlled trial, double-blind (patient and evaluator) in a Public Primary Care Center.
Sixty subjects will be randomized (computer application) into three groups: Intervention Group, Placebo Group and Control Group. All the three groups receive the same protocolized treatment of physiotherapy and additionally. Additionally, the Intervention Group receives six sessions (two sessions in a week during three weeks) of real DF and the Placebo Group receives six sessions (two sessions in a week during three weeks) of sham DF. The Control Group receives the protocolized treatment of physiotherapy only.
Pain intensity (VAS), pain-pressure threshold (pressure algometry), function (DASH questionnaire) and pain-free grip strength (digital dynamometer) will be measured at baseline, after treatment period, and three months after discharge from treatment. After discharge for treatment the patient subjective opinion about their evolution will be collected through the Global Rating of Change (GROC) scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Actual Diacutaneous Fibrolysis, Other: Protocolized PhysiotherapyActual Diacutaneous Fibrolysis and Protocolized Physiotherapy |
| Placebo Group | Sham comparator | Other: Sham Diacutaneous Fibrolysis, Other: Protocolized PhysiotherapySham Diacutaneous Fibrolysis and Protocolized Physiotherapy |
| Control Group | Other | Other: Protocolized PhysiotherapyProtocolized Physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old and over
- Diagnosis of chronic lateral epicondylalgia
- Sign the informed consent form
Key exclusion criteria (5 listed)
- Concomitant conditions affecting the same upper extremity
- Contraindications for Diacutaneous Fibrolysis
- Corticosteroid injections or similar agents in the three months prior to study inclusion
- Pending litigation or legal claim
- Poor language and communication skills making difficult to understand the informed consent
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. The hook is deeply applied following the intermuscular septum between the muscles with an anatomical of functional relationship with the painful structure in order to release adherences between musculoskeletal structures. | Other | Intervention Group |
| Sham Diacutaneous FibrolysisSham Diacutaneous Fibrolysis is applied at a superficial level. 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 Group |
| Protocolized PhysiotherapyProtocolized physiotherapeutic treatment: Three weeks fo daily stretching exercises, ultrasound and analgesic electrotherapy | Other | Control Group, Intervention Group, Placebo Group |
Primary outcome
Pain intensity
Time frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Pain intensity (VAS)
4 secondary outcomes
Pressure Pain Threshold
Time frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Pain free grip strength
Time frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Functional status
Time frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Global Rating of Change scale
Time frame: post-intervention, after three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
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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.
Catalan Institut of Health - Sant Ildefons Rehabilitation Center
Cornellà de Llobregat, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Actual Diacutaneous Fibrolysis and Protocolized Physiotherapy in people with Tennis Elbow, 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: status not confirmed, as of the sponsor's last update on 22 Jan 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three 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 22 Jan 2015.