Influence of Placebo on Intratissue Percutaneous Electrolysis in Patellar Tendinopathy

NCT04640337 | Unknown

• 1 other identifier: 1264955
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellar Tendinopathy

Outcome Measures

Primary Outcomes (18)

• 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).

  Baseline

• 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).

  One week post-intervention

• 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).

  Three weeks post-intervention

• 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.

  Baseline

• 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.

  One week post-intervention

• 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.

  Three weeks post-intervention

• 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.

  Baseline

• 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.

  One week post-intervention

• 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.

  Three weeks post-intervention

• Cross-sectional area (CSA) of the patellar tendon

  CSA at rest, with a knee flexion of 20º, will be measured by ultrasonography.

  Baseline

• Cross-sectional area (CSA) of the patellar tendon

  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

  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

  The presence (yes/no) of neovascularity of the patellar tendon will be measured by ultrasonography.

  Baseline

• Presence of neovascularity of the patellar tendon

  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

  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

  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

  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

  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 Outcomes (11)

• Pressure Pain Thresholds (PPT)

  Baseline

• Pressure Pain Thresholds (PPT)

  One week post-intervention

• Pressure Pain Thresholds (PPT)

  Three weeks post-intervention

• Conditioned pain modulation (CPM)

  Baseline

• Conditioned pain modulation (CPM)

  One week post-intervention

Study Arms (4)

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

EXPERIMENTAL

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

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

PLACEBO COMPARATOR

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

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

PLACEBO COMPARATOR

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

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

PLACEBO COMPARATOR

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

Interventions

IPE applied, participants believe they are receiving IPE OTHER

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.

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

IPE applied, participants believe they are receiving placebo OTHER

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

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

IPE not applied, participants believe they are receiving IPE OTHER

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

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

IPE not applied, participants believe they are receiving placebo OTHER

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Mercè Balasch i Bernat

Valencia, 46010, Spain

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 23, 2020
• Study Start: October 16, 2020
• Primary Completion: December 20, 2023
• Study Completion: March 20, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)