TendinopathyNCT02498795

Comparative Research Among 3 Action Protocol in Other to Approach Chronic Patellar Tendinopathy

A study testing Group of Dry Needling and Group of Electrolysis in people with Tendinopathy, run by Universidad de Zaragoza at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The accomplishment of a treatment with Intratissue Percutaneous Electrolysis of additional form to the accomplishment of eccentric exercise's program in patients with chronic patellar tendinopathy is more effective than the accomplishment of an additional treatment with dry needling or eccentric exercise's program… Read more about this study

Who is it for?: Ages 18 to 40 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: 50 participants
Where: 1 siteSpain
Study dates: 1 Jan 2019to 2 May 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 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age understood between 18 and 40 years.
To practise any sport of habitual form.
Patients diagnosed of chronic patellar tendinopathy with a minimum of 3 months of evolution and with stable symptomatology.
Pain to the palpation of the tendon in the low pole of the knee and during the training or competition.
Punctuation of the questionnaire VISA-P under 80.

Who cannot join

Patient had an operation on the knee affected in the last 6 months.
Infiltrations in the knee affected in the last 3 months.
Patient who has received pharmacological treatment or physical therapy in the last 48 hours.
Pathology with less than 3 months of evolution.
To present bilateral chronic tendinopathy.
Punctuation of the questionnaire major or equal Visa - p of 80.
Inability to apply someone of the techniques of treatment or valuation for absolute or relative contraindication.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universidad San Jorge
Villanueva de Gállego, Zaragoza, 50830

Other trials in Spain

About this study

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 patellar tendinopathy.

There take part in this study young women of both sexes, of Zaragoza and of different sports clubs of entity 18 and 40 years, that they realize of habitual form (minimum 3 times a week) a sport. All of them present chronic patellar tendinopathy.

Conditions: Tendinopathy
Being tested: Group of Dry Needling, Group of Electrolysis, Control Group
Keywords: Intratissue Percutaneous Electrolysis, Dry needling, Eccentric exercise, Patella
Medical subject headings: Tendinopathy, Patella Fracture

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 4 treatment distributed throughout 8 weeks of treatment. The program of eccentric exercises that will have to realize it in his domicile every day.
Group of ElectrolysisOther
Every group will receive a total of 4 treatment distributed throughout 8 weeks of treatment. The program of eccentric exercises that will have to realize it in his domicile every day.
Control GroupOther
Every group will receive a total of 4 treatment distributed throughout 8 weeks of treatment. The program of eccentric exercises that will have to realize it in his domicile every day.

Study groups in NCT02498795
Study group	Role	What they receive
Group of Dry Needling	Active comparator	They will receive a treatment of dry needling with ultrasound scan together with a treatment in which they will realize eccentric exercise's program that the patient will have to realize in his domicile. The needle will get in the relevant zone of treatment. The punction will be realized using the technique of entry - Hong's rapid exit. Three punction will realize in the disabled zone of 3 seconds of duration. Receives: Other: Group of Dry Needling
Group of electrolysis	Active comparator	They will receive a treatment of Intratissue Percutaneous Electrolysis with ultrasound scan together with a treatment in which they will realize eccentric exercise's program that the patient will have to realize in his domicile. The needle will get in the relevant zone of treatment. An intensity of 3 milliampere will be in use, during 3 seconds and one will repeat 3 times. Receives: Other: Group of Electrolysis
Control Group	Placebo comparator	They will receive a treatment of punction placebo with ultrasound scan together with a treatment in the one that will realize eccentric exercise's program that the patient will have to realize in his domicile. 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 functionality at 8 weeks as measured by Visa-p
This scale consists of eight questions, the first six questions of which employ an analogical visual scale in order to assign a score of 0 to 10, where 10 represents the optimum state, for the purpose of quantifying pain and function in different activities, whereas the last two questions assess the level of functionality and ability to perform physical activity.
Measured: 8 weeks

Secondary outcomes (8)

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: 0, 8 and 20 weeks
Quality of life by SF-36
Health Survey
Measured: 0, 8 and 20 weeks
Thickness of the tendon, as measured by ultrasound scan
Tendon structure
Measured: 0, 8 and 20 weeks
Height of the jump
Jump test with a force platform
Measured: 0, 8 and 20 weeks
Concentric force of the low members
Jump test with a force platform
Measured: 0, 8 and 20 weeks
Speed of the jump
Jump test with a force platform
Measured: 0, 8 and 20 weeks
Hypervascularity, as measured by ultrasound scan
Tendon structure
Measured: 0, 8 and 20 weeks
Functionality, as measured by Visa-p
This scale consists of eight questions, the first six questions of which employ an analogical visual scale in order to assign a score of 0 to 10, where 10 represents the optimum state, for the purpose of quantifying pain and function in different activities, whereas the last two questions assess the level of functionality and ability to perform physical activity.
Measured: 0 and 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20192 May 2020

First posted15 Jul 2015 (estimated)
Study start1 Jan 2019
Primary completion31 Dec 2019
Study completion2 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02498795
Sponsor's protocol ID: P115/0017
Status last verified: Dec 2020
First submitted: 6 Jun 2015
Last updated: 4 Dec 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Lopez-Royo MP, Rios-Diaz J, Galan-Diaz RM, Herrero P, Gomez-Trullen EM. A Comparative Study of Treatment Interventions for Patellar Tendinopathy: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):967-975. doi: 10.1016/j.apmr.2021.01.073. Epub 2021 Feb 6.
PubMed 33556350
Lopez-Royo MP, Gomez-Trullen EM, Ortiz-Lucas M, Galan-Diaz RM, Bataller-Cervero AV, Al-Boloushi Z, Hamam-Alcober Y, Herrero P. Comparative study of treatment interventions for patellar tendinopathy: a protocol for a randomised controlled trial. BMJ Open. 2020 Feb 16;10(2):e034304. doi: 10.1136/bmjopen-2019-034304.
PubMed 32066608

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tendinopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2020. 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 Patellar Tendinopathy
ClinicalTrials.gov ID: NCT02498795
Acronym / sponsor ID: P115/0017
Conditions: Tendinopathy
Keywords: Intratissue Percutaneous Electrolysis, Dry needling, Eccentric exercise, Patella
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Universidad de ZaragozaUniversity, hospital or other
Collaborators: Universidad San Jorge
Study start: 1 Jan 2019 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 2 May 2020 (actual)
First posted: 15 Jul 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, 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 with ultrasound scan together with a treatment in which they will realize eccentric exercise's program that the patient will have to realize in his domicile. The needle will get in the relevant zone of treatment. The punction will be realized using the technique of entry - Hong's rapid exit. Three punction will realize in the disabled zone of 3 seconds of duration.
Group of electrolysis	Active comparator	Other: Group of ElectrolysisThey will receive a treatment of Intratissue Percutaneous Electrolysis with ultrasound scan together with a treatment in which they will realize eccentric exercise's program that the patient will have to realize in his domicile. The needle will get in the relevant zone of treatment. An intensity of 3 milliampere will be in use, during 3 seconds and one will repeat 3 times.
Control Group	Placebo comparator	Other: Control GroupThey will receive a treatment of punction placebo with ultrasound scan together with a treatment in the one that will realize eccentric exercise's program that the patient will have to realize in his domicile.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Age understood between 18 and 40 years.
To practise any sport of habitual form.
Patients diagnosed of chronic patellar tendinopathy with a minimum of 3 months of evolution and with stable symptomatology.
Pain to the palpation of the tendon in the low pole of the knee and during the training or competition.
Punctuation of the questionnaire VISA-P under 80.

Key exclusion criteria (7 listed)

Patient had an operation on the knee affected in the last 6 months.
Infiltrations in the knee affected in the last 3 months.
Patient who has received pharmacological treatment or physical therapy in the last 48 hours.
Pathology with less than 3 months of evolution.
To present bilateral chronic tendinopathy.

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 4 treatment distributed throughout 8 weeks of treatment. The program of eccentric exercises that will have to realize it in his domicile every day.	Other	Group of Dry Needling
Group of ElectrolysisEvery group will receive a total of 4 treatment distributed throughout 8 weeks of treatment. The program of eccentric exercises that will have to realize it in his domicile every day.	Other	Group of electrolysis
Control GroupEvery group will receive a total of 4 treatment distributed throughout 8 weeks of treatment. The program of eccentric exercises that will have to realize it in his domicile every day.	Other	Control Group

Primary outcome

Change from baseline in functionality at 8 weeks as measured by Visa-p
Time frame: 8 weeks
This scale consists of eight questions, the first six questions of which employ an analogical visual scale in order to assign a score of 0 to 10, where 10 represents the optimum state, for the purpose of quantifying pain and function in different activities, whereas the last two questions assess the level of functionality and ability to perform physical activity.

8 secondary outcomes

Pain, as measured by Visual Analog Scale
Time frame: 0, 8 and 20 weeks
Quality of life by SF-36
Time frame: 0, 8 and 20 weeks
Thickness of the tendon, as measured by ultrasound scan
Time frame: 0, 8 and 20 weeks
Height of the jump
Time frame: 0, 8 and 20 weeks
Concentric force of the low members
Time frame: 0, 8 and 20 weeks
Speed of the jump
Time frame: 0, 8 and 20 weeks
Hypervascularity, as measured by ultrasound scan
Time frame: 0, 8 and 20 weeks
Functionality, as measured by Visa-p
Time frame: 0 and 20 weeks

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 4 Dec 2020.
Derived from this study: PubMed 33556350Lopez-Royo MP, Rios-Diaz J, Galan-Diaz RM, Herrero P, Gomez-Trullen EM. A Comparative Study of Treatment Interventions for Patellar Tendinopathy: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):967-975. doi: 10.1016/j.apmr.2021.01.073. Epub 2021 Feb 6.
Derived from this study: PubMed 32066608Lopez-Royo MP, Gomez-Trullen EM, Ortiz-Lucas M, Galan-Diaz RM, Bataller-Cervero AV, Al-Boloushi Z, Hamam-Alcober Y, Herrero P. Comparative study of treatment interventions for patellar tendinopathy: a protocol for a randomised controlled trial. BMJ Open. 2020 Feb 16;10(2):e034304. doi: 10.1136/bmjopen-2019-034304.
Individual participant dataSharing planned: Undecided

Related trials for Tendinopathy

Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis

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.

Eva Gómez-Trullén, PhD study director

Universidad de Zaragoza

Pablo Herrero, PhD study director

Universidad San Jorge

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 de Zaragoza 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: finished, as of the sponsor's last update on 4 Dec 2020. 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?

Change from baseline in functionality at 8 weeks as measured by Visa-p (time frame: 8 weeks). 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 NCT02498795, which also lists 2 linked publications.

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 4 Dec 2020.