Influence of Placebo on Intratissue Percutaneous Electrolysis in Patellar Tendinopathy

May 8, 2023 updated by: Mercè Balasch i Bernat, University of Valencia

Influence of Placebo on Intratissue Percutaneous Electrolysis (IPE) Treatment in Patients With Patellar Tendinopathy

The main aim of this study is to verify the influence of placebo on the effectiveness of Intratissue Percutaneous Electrolysis (IPE) in patients suffering from with chronic patellar tendinopathy (PT).

The secondary aim is to investigate the possible influence of the IPE on pain perception and conditioned pain modulation (CPM) in patients with chronic PT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to investigate the influence of placebo on the effectiveness of Intratissue Percutaneous Electrolysis (IPE) in patients with chronic PT. For this purpose a randomized clinical trial will be carried out, with a sample of patients diagnosed of chronic PT based on signs, symptoms and clinical examination. Subjects will be randomly allocated to four different groups: group E1, IPE will be applied, participants will believe they are receiving IPE; group E2, IPE will be applied, participants will believe they are receiving placebo; group P1, IPE will not be applied, participants will believe they are receiving IPE; and group P2, IPE will not be applied, participants will believe they are receiving placebo.

IPE treatment will consist of a total of 3 sessions, with a time interval of one week between the 1st and 2nd sessions and 2 weeks between the 2nd and 3rd sessions.

To evaluate the effect of intervention, the subjects will be assessed at baseline (V0), one week after the end of the intervention (V1) and 3 weeks after the intervention (V2).

In V0, sociodemographic (sex, age, profession, height, body mass index (BMI), sport activity, hours of sport per week) and clinical data (associated pathologies, affected lower limb, dominant lower limb, duration of symptoms) will be registered. In each assessment time information regarding BMI, sports activity, hours of sport per week and location of pain will be obtained. Moreover, in all assessments participants were evaluated for four physical performance tests, pain and functional scales, ultrasound examination, pressure pain thresholds, conditioned pain modulation, and expectations questionnaires.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Recruiting
        • Mercè Balasch i Bernat
        • Contact:
        • Principal Investigator:
          • Mercè Balasch i Bernat, PhD
        • Sub-Investigator:
          • Enrique Lluch Girbés, PhD
        • Sub-Investigator:
          • Ana Santonja Calderón, PhD student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years old or older
  • presenting the following signs and symptoms of patellar tendinopathy: pain when jumping, landing, running o changing direction, pain at the inferior pole of the patella, Victorian Institute of Sport Assessment-Patella (VISA-P) score <80, symptoms duration of at least 3 months.

Exclusion Criteria:

  • prior knee surgery
  • patients having received local corticosteroids injection in the tendon within the preceding 6 months
  • patients presenting any inflammatory disease, metabolic bone disease, type II diabetes, fibromyalgia, hypercholesterolemia, pregnancy or chemotherapy within the 3 months prior to the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group E1: IPE applied, participants believe they are receiving IPE.
IPE will be applied following the standard protocol for PT. Participants will believe they are receiving IPE.
Other: IPE applied, participants believe they are receiving IPE
Participants will receive a total of 3 sessions of IPE, with a time interval of one week between the 1st and 2nd session and 2 weeks between the 2nd and 3rd session. IPE will be applied following the standard protocol for PT. Participants will believe they are receiving IPE.
Placebo Comparator: Group E2: IPE applied, participants believe they are receiving placebo.
IPE will be applied following the standard protocol for PT. Subjects will be led to believe that the intensity of the current is below the threshold necessary to cause changes in the tissue.
Other: IPE applied, participants believe they are receiving placebo
Participants will receive a total of 3 sessions of IPE, with a time interval of one week between the 1st and 2nd session and 2 weeks between the 2nd and 3rd session. IPE will be applied following the standard protocol for PT. Subjects will be led to belie
Placebo Comparator: Group P1: IPE not applied, participants believe they are receiving IPE.
The needle will be inserted under the skin but the current will not be passing through. The subjects will see a shame video on the ultrasound screen so they will believe that the IPE is being performed.
Other: IPE not applied, participants believe they are receiving IPE
Participants will receive a total of 3 sessions of IPE-placebo, with a time interval of one week between the 1st and 2nd session and 2 weeks between the 2nd and 3rd session. The needle will be inserted under the skin but the current will not be passing th
Placebo Comparator: Group P2: IPE not applied, participants believe they are receiving placebo.
The needle will be inserted under the skin, subjects will be led to believe that the intensity of the current is below the threshold necessary to cause changes in the tissue.
Other: IPE not applied, participants believe they are receiving placebo
Participants will receive a total of 3 sessions of IPE-placebo, with a time interval of one week between the 1st and 2nd session and 2 weeks between the 2nd and 3rd session. The needle will be inserted under the skin, subjects will be led to believe that the intensity of the current is below the threshold necessary to cause changes in the tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Baseline
Knee pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain).
Baseline
Pain intensity
Time Frame: One week post-intervention
Knee pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain).
One week post-intervention
Pain intensity
Time Frame: Three weeks post-intervention
Knee pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain).
Three weeks post-intervention
Patellar tendon function
Time Frame: Baseline
Victorian Institute of Sport Assessment-Patellar Tendon (VISA-P, 0-100, 0=minimum score, 100=maximum score) will aso be used to evaluate function of the patellar tendon. A score between 80-100 points is considered as the optimal outcome.
Baseline
Patellar tendon function
Time Frame: One week post-intervention
Victorian Institute of Sport Assessment-Patellar Tendon (VISA-P, 0-100, 0=minimum score, 100=maximum score) will aso be used to evaluate function of the patellar tendon. A score between 80-100 points is considered as the optimal outcome.
One week post-intervention
Patellar tendon function
Time Frame: Three weeks post-intervention
Victorian Institute of Sport Assessment-Patellar Tendon (VISA-P, 0-100, 0=minimum score, 100=maximum score) will aso be used to evaluate function of the patellar tendon. A score between 80-100 points is considered as the optimal outcome.
Three weeks post-intervention
Physical performance of the knee
Time Frame: Baseline
Physical performance of the knee will be assessed by the Single Leg Decline squat (SLDS), which consists of performing a squat with one leg on a decline board with an angle of 25º.
Baseline
Physical performance of the knee
Time Frame: One week post-intervention
Physical performance of the knee will be assessed by the Single Leg Decline squat (SLDS), which consists of performing a squat with one leg on a decline board with an angle of 25º.
One week post-intervention
Physical performance of the knee
Time Frame: Three weeks post-intervention
Physical performance of the knee will be assessed by the Single Leg Decline squat (SLDS), which consists of performing a squat with one leg on a decline board with an angle of 25º.
Three weeks post-intervention
Cross-sectional area (CSA) of the patellar tendon
Time Frame: Baseline
CSA at rest, with a knee flexion of 20º, will be measured by ultrasonography.
Baseline
Cross-sectional area (CSA) of the patellar tendon
Time Frame: One week post-intervention
CSA at rest, with a knee flexion of 20º, will be measured by ultrasonography.
One week post-intervention
Cross-sectional area (CSA) of the patellar tendon
Time Frame: Three weeks post-intervention
CSA at rest, with a knee flexion of 20º, will be measured by ultrasonography.
Three weeks post-intervention
Presence of neovascularity of the patellar tendon
Time Frame: Baseline
The presence (yes/no) of neovascularity of the patellar tendon will be measured by ultrasonography.
Baseline
Presence of neovascularity of the patellar tendon
Time Frame: One week post-intervention
The presence (yes/no) of neovascularity of the patellar tendon will be measured by ultrasonography.
One week post-intervention
Presence of neovascularity of the patellar tendon
Time Frame: Three weeks post-intervention
The presence (yes/no) and amount (0=no vascularity, 1=low fow, 2=mild flow, 3=high flow) of neovascularity of the patellar tendon will be measured by ultrasonography.
Three weeks post-intervention
Amount of neovascularity of the patellar tendon
Time Frame: Baseline
The amount (0=no vascularity, 1=low fow, 2=mild flow, 3=high flow) of neovascularity of the patellar tendon will be measured by ultrasonography.
Baseline
Amount of neovascularity of the patellar tendon
Time Frame: One week post-intervention
The amount (0=no vascularity, 1=low fow, 2=mild flow, 3=high flow) of neovascularity of the patellar tendon will be measured by ultrasonography.
One week post-intervention
Amount of neovascularity of the patellar tendon
Time Frame: Three weeks post-intervention
The amount (0=no vascularity, 1=low fow, 2=mild flow, 3=high flow) of neovascularity of the patellar tendon will be measured by ultrasonography.
Three weeks post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure Pain Thresholds (PPT)
Time Frame: Baseline
PPTs will be recorded using an electronic algometer at the ipsilateral (affected) patellar tendon, the contralateral patellar tendon and the ipsilateral upper trapezius. Higher values represent a better outcome.
Baseline
Pressure Pain Thresholds (PPT)
Time Frame: One week post-intervention
PPTs will be recorded using an electronic algometer at the ipsilateral (affected) patellar tendon, the contralateral patellar tendon and the ipsilateral upper trapezius. Higher values represent a better outcome.
One week post-intervention
Pressure Pain Thresholds (PPT)
Time Frame: Three weeks post-intervention
PPTs will be recorded using an electronic algometer at the ipsilateral (affected) patellar tendon, the contralateral patellar tendon and the ipsilateral upper trapezius. Higher values represent a better outcome.
Three weeks post-intervention
Conditioned pain modulation (CPM)
Time Frame: Baseline
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Baseline
Conditioned pain modulation (CPM)
Time Frame: One week post-intervention
CPM will be tested using the upper extremity submaximal effort tourniquet test.
One week post-intervention
Conditioned pain modulation (CPM)
Time Frame: Three weeks post-intervention
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Three weeks post-intervention
Patients' expectations
Time Frame: Baseline
Patients' expectations with the treatment will be registered using an add-hoc questionnaire consisting of 2 questions: "What do you think will be the intensity of your pain when this intervention takes effect?" (NPRS, 0-10, 10 severe pain, 0=no pain) and "Do you expect to have more pain, less pain or the same intensity of pain after treatment?" (more pain, less pain, same pain).
Baseline
Self-perceived change with the treatment
Time Frame: One week post-intervention
Participants' will rate the results/outcomes obtained with the treatment by the Global rating of change scale (GROC) ((-7)-(+7), -7= very great deal worse, +7= very great deal better).
One week post-intervention
Self-perceived change with the treatment
Time Frame: Three weeks post-intervention
Participants' will rate the results/outcomes obtained with the treatment by the Global rating of change scale (GROC) ((-7)-(+7), -7= very great deal worse, +7= very great deal better).
Three weeks post-intervention
Self-perceived pain after treatment
Time Frame: One week post-intervention
Self-perceived pain after treatment will be assessed by the question "What do you think your pain is like now (after treatment): more pain, less pain or the same pain intensity compared to before treatment?" (more pain, less pain, same pain).
One week post-intervention
Self-perceived pain after treatment
Time Frame: Three weeks post-intervention
Self-perceived pain after treatment will be assessed by the question "What do you think your pain is like now (after treatment): more pain, less pain or the same pain intensity compared to before treatment?" (more pain, less pain, same pain).
Three weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2020

Primary Completion (Anticipated)

December 20, 2023

Study Completion (Anticipated)

March 20, 2024

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 17, 2020

First Posted (Actual)

November 23, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1264955

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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