NCT02498795

Brief 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 realized of isolated form.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
3.5 years until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2020

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

12 months

First QC Date

June 6, 2015

Last Update Submit

December 3, 2020

Conditions

Tendinopathy

Keywords

Intratissue Percutaneous ElectrolysisDry needlingEccentric exercisePatella

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Secondary Outcomes (8)

  • Pain, as measured by Visual Analog Scale

    0, 8 and 20 weeks

  • Quality of life by SF-36

    0, 8 and 20 weeks

  • Thickness of the tendon, as measured by ultrasound scan

    0, 8 and 20 weeks

  • Height of the jump

    0, 8 and 20 weeks

  • Concentric force of the low members

    0, 8 and 20 weeks

  • +3 more secondary outcomes

Study Arms (3)

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.

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.

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.

Other: Control Group

Interventions

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 Dry Needling
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.

Group of electrolysis
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.

Control Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad San Jorge

Villanueva de Gállego, Zaragoza, 50830, Spain

Location

Related Publications (2)

  • 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.

    PMID: 33556350DERIVED

  • 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.

    PMID: 32066608DERIVED

MeSH Terms

Conditions

TendinopathyPatella Fracture

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesKnee FracturesFractures, Bone

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Eva Gómez-Trullén, PhD

    Universidad de Zaragoza

    STUDY DIRECTOR

  • Pablo Herrero, PhD

    Universidad San Jorge

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate

Study Record Dates

First Submitted

June 6, 2015

First Posted

July 15, 2015

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

May 2, 2020

Last Updated

December 4, 2020

Record last verified: 2020-12

Locations

ES(1)