TendinopathyNCT03572803
Comparative Research Among 3 Action Protocol in Other to Approach Chronic Lateral Epicondyle Tendinopathy
A study testing Group of Dry Needling and Group of Electrolysis in people with Tendinopathy, run by Universidad San Jorge at 1 site in Spain.
Trial summary
The accomplishment of a treatment with Intratissue Percutaneous Electrolysis of additional form to the accomplishment of eccentric exercises and stretching program in patients with chronic lateral epicondyle tendinopathy is more effective than the accomplishment of an additional treatment with dry needling or… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Group of Dry Needling and Group of Electrolysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 9 Apr 2018to Apr 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years.
- Patients diagnosed of chronic lateral epicondyle tendinopathy with a minimum of 3 months of evolution.
- Pain when palpating the lateral epicondyle area.
- Positive test in at least 1 of the following 3 clinical tests: Cozen, Thomson or Mill's
- Have the capacity to perform all clinical tests, understand the study process, and obtain informed consent.
Who cannot join
- Previous history of direct trauma, fractures, joint instability, surgery or rheumatic alterations of the lateral epicondyle area.
- Full elbow extension limited.
- Alterations at cervical level such as: cervical radiculopathy (C4-C7), degenerative pathology in the cervical spine, exacerbated pain increase with neck movements or cervical compression.
- Symptoms compatible with entrapment of the posterior interosseous nerve.
- NSAID intake the week before the intervention;
- Have received treatment with infiltration in the last year;
- Have received physiotherapy treatment during the last month.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Opel España
Figueruelas, Zaragoza, 50639
Rita Mª Galán Díaz, MD, +34660222284, rmgalan@usj.es
About this study
The accomplishment of a treatment with Intratissue Percutaneous Electrolysis of additional form to the accomplishment of eccentric exercises and stretching program in patients with chronic lateral epicondyle tendinopathy is more effective than the accomplishment of an additional treatment with dry needling or eccentric exercises program realized of isolated form.
Read the detailed description
Experimental study randomized with double blind, whose purpose is to compare three protocols in those who apply different protocols of physical therapy to themselves in three groups of intervention with patients with chronic lateral epicondyle tendinopathy.
There take part in this study people of both sexes, with ages between 18 and 65 years, all of them present chronic lateral epicondyle tendinopathy.
- Conditions
- Tendinopathy
- Being tested
- Group of Dry Needling, Group of Electrolysis, Control Group
- Keywords
- ntratissue Percutaneous Electrolysis, Dry needling, Eccentric exercise, Lateral epicondyle
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group of Dry NeedlingOther
Every group will receive a total of 3 treatment sessions distributed throughout 4 weeks of treatment. The program of eccentric exercises will be done by participants at home 5 days a week, two times a day.
Group of ElectrolysisOther
Every group will receive a total of 3 treatment sessions distributed throughout 4 weeks of treatment. The program of eccentric exercises will be done by participants at home 5 days a week, two times a day.
Control GroupOther
Every group will receive a total of 3 treatment sessions distributed throughout 4 weeks of treatment. The program of eccentric exercises will be done by participants at home 5 days a week, two times a day.
| Study group | Role | What they receive |
|---|---|---|
| Group of Dry Needling | Active comparator | They will receive a treatment of dry needling, guided by ultrasound, together with a self-treatment program at home based on eccentric exercises and stretching.
The needle will get in the relevant zone of treatment. The punction will be realized using Hong's technique (fast in-out). Three needle insertions will be carried out in the target area during 3 seconds Receives: Other: Group of Dry Needling |
| Group of electrolysis | Active comparator | They will receive a treatment of Intratissue Percutaneous Electrolysis, guided by ultrasound, together with a self-treatment program at home based on eccentric exercises and stretching.
The needle will get in the relevant zone of treatment. The punction will be realized simulating Hong's technique (fast in-out). Three needle insertions will be carried out in the target area during 3 seconds and 3mA each one. Receives: Other: Group of Electrolysis |
| Control Group | Sham comparator | They will receive a treatment of punction sham, guided by ultrasound, together with a self-treatment program at home based on eccentric exercises and stretching. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in quality of life by DASH
The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a 30-item, self-report questionnaire designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time. The DASH Outcome Measure contains one optional, four-item modules intended to measure symptoms and function in workers whose jobs require a high degree of physical performance.
Measured: Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)
Secondary outcomes (5)
Pain, as measured by Visual Analog Scale
Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain.
Measured: Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)
Pressure pain thresholds (PPTs)
Level of pressure tolerated by the patient just before feeling pain. The pressure is done with a digital algometer Type II(Somedic). PPTS will be assessed bilaterally in extensor carpi radialis brevis tendon and tibialis anterior muscle.
Measured: Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)
Pain free grip strength
Grip strength before feeling pain. The tool used is a hydraulic hand dynamometer (Baseline). Subjects will be asked to gradually increase the grip strength while the elbow is extended and pronated and arm alongside of the body. They will be asked to stop when pain is felt. We will take three measures with each elbow.
Measured: Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)
Thickness of the tendon, as measured by ultrasound scan
Tendon structure
Measured: Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)
Hypervascularity, as measured by ultrasound scan
Tendon structure
Measured: Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start9 Apr 2018
- Primary completionDec 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies 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, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Collaborators
- University of Seville
- Responsible party
- Sponsor
- Investigators
- Rita Mª Galán Díaz, MD, Principal investigator, Universidad San JorgePablo Herrero Gallego, PhD, Study director, Universidad San JorgeCleofas Rodríguez Blanco, PhD, Study director, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572803
- Sponsor's protocol ID
- C3P_CLET
- Status last verified
- Mar 2018
- First submitted
- 14 Jun 2018
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Research Among 3 Action Protocol in Other to Approach Chronic Lateral Epicondyle Tendinopathy
- ClinicalTrials.gov ID
- NCT03572803
- Acronym / sponsor ID
- C3P_CLET
- Conditions
- Tendinopathy
- Keywords
- ntratissue Percutaneous Electrolysis, Dry needling, Eccentric exercise, Lateral epicondyle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Collaborators
- University of Seville
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 28 Jun 2018 (actual)
- 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.
The accomplishment of a treatment with Intratissue Percutaneous Electrolysis of additional form to the accomplishment of eccentric exercises and stretching program in patients with chronic lateral epicondyle tendinopathy is more effective than the accomplishment of an additional treatment with dry needling or eccentric exercises program realized of isolated form.
Detailed description
Experimental study randomized with double blind, whose purpose is to compare three protocols in those who apply different protocols of physical therapy to themselves in three groups of intervention with patients with chronic lateral epicondyle tendinopathy.
There take part in this study people of both sexes, with ages between 18 and 65 years, all of them present chronic lateral epicondyle tendinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group of Dry Needling | Active comparator | Other: Group of Dry NeedlingThey will receive a treatment of dry needling, guided by ultrasound, together with a self-treatment program at home based on eccentric exercises and stretching. The needle will get in the relevant zone of treatment. The punction will be realized using Hong's technique (fast in-out). Three needle insertions will be carried out in the target area during 3 seconds |
| Group of electrolysis | Active comparator | Other: Group of ElectrolysisThey will receive a treatment of Intratissue Percutaneous Electrolysis, guided by ultrasound, together with a self-treatment program at home based on eccentric exercises and stretching. The needle will get in the relevant zone of treatment. The punction will be realized simulating Hong's technique (fast in-out). Three needle insertions will be carried out in the target area during 3 seconds and 3mA each one. |
| Control Group | Sham comparator | Other: Control GroupThey will receive a treatment of punction sham, guided by ultrasound, together with a self-treatment program at home based on eccentric exercises and stretching. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years.
- Patients diagnosed of chronic lateral epicondyle tendinopathy with a minimum of 3 months of evolution.
- Pain when palpating the lateral epicondyle area.
- Positive test in at least 1 of the following 3 clinical tests: Cozen, Thomson or Mill's
- Have the capacity to perform all clinical tests, understand the study process, and obtain informed consent.
Key exclusion criteria (7 listed)
- Previous history of direct trauma, fractures, joint instability, surgery or rheumatic alterations of the lateral epicondyle area.
- Full elbow extension limited.
- Alterations at cervical level such as: cervical radiculopathy (C4-C7), degenerative pathology in the cervical spine, exacerbated pain increase with neck movements or cervical compression.
- Symptoms compatible with entrapment of the posterior interosseous nerve.
- NSAID intake the week before the intervention;
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 |
|---|---|---|
| Group of Dry NeedlingEvery group will receive a total of 3 treatment sessions distributed throughout 4 weeks of treatment. The program of eccentric exercises will be done by participants at home 5 days a week, two times a day. | Other | Group of Dry Needling |
| Group of ElectrolysisEvery group will receive a total of 3 treatment sessions distributed throughout 4 weeks of treatment. The program of eccentric exercises will be done by participants at home 5 days a week, two times a day. | Other | Group of electrolysis |
| Control GroupEvery group will receive a total of 3 treatment sessions distributed throughout 4 weeks of treatment. The program of eccentric exercises will be done by participants at home 5 days a week, two times a day. | Other | Control Group |
Primary outcome
Change from baseline in quality of life by DASH
Time frame: Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)
The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a 30-item, self-report questionnaire designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time. The DASH Outcome Measure contains one optional, four-item modules intended to measure symptoms and function in workers whose jobs require a high degree of physical performance.
5 secondary outcomes
Pain, as measured by Visual Analog Scale
Time frame: Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)
Pressure pain thresholds (PPTs)
Time frame: Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)
Pain free grip strength
Time frame: Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)
Thickness of the tendon, as measured by ultrasound scan
Time frame: Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)
Hypervascularity, as measured by ultrasound scan
Time frame: Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
Rita Mª Galán Díaz, MD principal investigator
Universidad San Jorge
Pablo Herrero Gallego, PhD study director
Universidad San Jorge
Cleofas Rodríguez Blanco, PhD study director
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group of Dry Needling and Group of Electrolysis in people with Tendinopathy, run by Universidad San Jorge 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 5 inclusion and 7 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 28 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rita Mª Galán Díaz, MD (+34660222284, rmgalan@usj.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in quality of life by DASH (time frame: Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)). 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 28 Jun 2018.