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Influence of Placebo on Intratissue Percutaneous Electrolysis in Patellar Tendinopathy

Primary Purpose

Patellar Tendinopathy

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
IPE applied, participants believe they are receiving IPE
IPE applied, participants believe they are receiving placebo
IPE not applied, participants believe they are receiving IPE
IPE not applied, participants believe they are receiving placebo
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellar Tendinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mercè Balasch i BernatRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Group E1: IPE applied, participants believe they are receiving IPE.

Group E2: IPE applied, participants believe they are receiving placebo.

Group P1: IPE not applied, participants believe they are receiving IPE.

Group P2: IPE not applied, participants believe they are receiving placebo.

Arm Description

IPE will be applied following the standard protocol for PT. Participants will believe they are receiving IPE.

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.

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.

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.

Outcomes

Primary Outcome Measures

Pain intensity
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).
Pain intensity
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).
Pain intensity
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).
Patellar tendon function
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.
Patellar tendon function
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.
Patellar tendon function
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.
Physical performance of the knee
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.
Physical performance of the knee
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.
Physical performance of the knee
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.
Cross-sectional area (CSA) of the patellar tendon
CSA at rest, with a knee flexion of 20º, will be measured by ultrasonography.
Cross-sectional area (CSA) of the patellar tendon
CSA at rest, with a knee flexion of 20º, will be measured by ultrasonography.
Cross-sectional area (CSA) of the patellar tendon
CSA at rest, with a knee flexion of 20º, will be measured by ultrasonography.
Presence of neovascularity of the patellar tendon
The presence (yes/no) of neovascularity of the patellar tendon will be measured by ultrasonography.
Presence of neovascularity of the patellar tendon
The presence (yes/no) of neovascularity of the patellar tendon will be measured by ultrasonography.
Presence of neovascularity of the patellar tendon
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.
Amount of neovascularity of the patellar tendon
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.
Amount of neovascularity of the patellar tendon
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.
Amount of neovascularity of the patellar tendon
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.

Secondary Outcome Measures

Pressure Pain Thresholds (PPT)
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.
Pressure Pain Thresholds (PPT)
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.
Pressure Pain Thresholds (PPT)
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.
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Patients' expectations
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).
Self-perceived change with the treatment
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).
Self-perceived change with the treatment
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).
Self-perceived pain after treatment
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).
Self-perceived pain after treatment
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).

Full Information

First Posted
November 10, 2020
Last Updated
May 8, 2023
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT04640337
Brief Title
Influence of Placebo on Intratissue Percutaneous Electrolysis in Patellar Tendinopathy
Official Title
Influence of Placebo on Intratissue Percutaneous Electrolysis (IPE) Treatment in Patients With Patellar Tendinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2020 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
March 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants don't know to which intervention group they belong to. The outcomes assessor doesn't know to which intervention group the patient belongs to.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group E1: IPE applied, participants believe they are receiving IPE.
Arm Type
Experimental
Arm Description
IPE will be applied following the standard protocol for PT. Participants will believe they are receiving IPE.
Arm Title
Group E2: IPE applied, participants believe they are receiving placebo.
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Group P1: IPE not applied, participants believe they are receiving IPE.
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Group P2: IPE not applied, participants believe they are receiving placebo.
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
IPE applied, participants believe they are receiving IPE
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
IPE applied, participants believe they are receiving placebo
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
IPE not applied, participants believe they are receiving IPE
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
IPE not applied, participants believe they are receiving placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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).
Time Frame
Baseline
Title
Pain intensity
Description
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).
Time Frame
One week post-intervention
Title
Pain intensity
Description
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).
Time Frame
Three weeks post-intervention
Title
Patellar tendon function
Description
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.
Time Frame
Baseline
Title
Patellar tendon function
Description
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.
Time Frame
One week post-intervention
Title
Patellar tendon function
Description
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.
Time Frame
Three weeks post-intervention
Title
Physical performance of the knee
Description
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.
Time Frame
Baseline
Title
Physical performance of the knee
Description
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.
Time Frame
One week post-intervention
Title
Physical performance of the knee
Description
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.
Time Frame
Three weeks post-intervention
Title
Cross-sectional area (CSA) of the patellar tendon
Description
CSA at rest, with a knee flexion of 20º, will be measured by ultrasonography.
Time Frame
Baseline
Title
Cross-sectional area (CSA) of the patellar tendon
Description
CSA at rest, with a knee flexion of 20º, will be measured by ultrasonography.
Time Frame
One week post-intervention
Title
Cross-sectional area (CSA) of the patellar tendon
Description
CSA at rest, with a knee flexion of 20º, will be measured by ultrasonography.
Time Frame
Three weeks post-intervention
Title
Presence of neovascularity of the patellar tendon
Description
The presence (yes/no) of neovascularity of the patellar tendon will be measured by ultrasonography.
Time Frame
Baseline
Title
Presence of neovascularity of the patellar tendon
Description
The presence (yes/no) of neovascularity of the patellar tendon will be measured by ultrasonography.
Time Frame
One week post-intervention
Title
Presence of neovascularity of the patellar tendon
Description
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.
Time Frame
Three weeks post-intervention
Title
Amount of neovascularity of the patellar tendon
Description
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.
Time Frame
Baseline
Title
Amount of neovascularity of the patellar tendon
Description
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.
Time Frame
One week post-intervention
Title
Amount of neovascularity of the patellar tendon
Description
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.
Time Frame
Three weeks post-intervention
Secondary Outcome Measure Information:
Title
Pressure Pain Thresholds (PPT)
Description
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.
Time Frame
Baseline
Title
Pressure Pain Thresholds (PPT)
Description
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.
Time Frame
One week post-intervention
Title
Pressure Pain Thresholds (PPT)
Description
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.
Time Frame
Three weeks post-intervention
Title
Conditioned pain modulation (CPM)
Description
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Time Frame
Baseline
Title
Conditioned pain modulation (CPM)
Description
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Time Frame
One week post-intervention
Title
Conditioned pain modulation (CPM)
Description
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Time Frame
Three weeks post-intervention
Title
Patients' expectations
Description
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).
Time Frame
Baseline
Title
Self-perceived change with the treatment
Description
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).
Time Frame
One week post-intervention
Title
Self-perceived change with the treatment
Description
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).
Time Frame
Three weeks post-intervention
Title
Self-perceived pain after treatment
Description
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).
Time Frame
One week post-intervention
Title
Self-perceived pain after treatment
Description
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).
Time Frame
Three weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Mercè Balasch i Bernat
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mercè B Balasch i Bernat, PhD, PT
Phone
963983855
Ext
51225
Email
merce.balasch@uv.es
First Name & Middle Initial & Last Name & Degree
Mercè Balasch i Bernat, PhD
First Name & Middle Initial & Last Name & Degree
Enrique Lluch Girbés, PhD
First Name & Middle Initial & Last Name & Degree
Ana Santonja Calderón, PhD student

12. IPD Sharing Statement

Plan to Share IPD
No

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Influence of Placebo on Intratissue Percutaneous Electrolysis in Patellar Tendinopathy

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