Clinical trial NCT04640337: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Patellar Tendinopathy
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain intensity
timeFrame: Baseline
measure: Pain intensity
timeFrame: One week post-intervention
measure: Pain intensity
timeFrame: Three weeks post-intervention
measure: Patellar tendon function
timeFrame: Baseline
measure: Patellar tendon function
timeFrame: One week post-intervention
measure: Patellar tendon function
timeFrame: Three weeks post-intervention
measure: Physical performance of the knee
timeFrame: Baseline
measure: Physical performance of the knee
timeFrame: One week post-intervention
measure: Physical performance of the knee
timeFrame: Three weeks post-intervention
measure: Cross-sectional area (CSA) of the patellar tendon
timeFrame: Baseline
measure: Cross-sectional area (CSA) of the patellar tendon
timeFrame: One week post-intervention
measure: Cross-sectional area (CSA) of the patellar tendon
timeFrame: Three weeks post-intervention
measure: Presence of neovascularity of the patellar tendon
timeFrame: Baseline
measure: Presence of neovascularity of the patellar tendon
timeFrame: One week post-intervention
measure: Presence of neovascularity of the patellar tendon
timeFrame: Three weeks post-intervention
measure: Amount of neovascularity of the patellar tendon
timeFrame: Baseline
measure: Amount of neovascularity of the patellar tendon
timeFrame: One week post-intervention
measure: Amount of neovascularity of the patellar tendon
timeFrame: Three weeks post-intervention
Secondary outcomes:
measure: Pressure Pain Thresholds (PPT)
timeFrame: Baseline
measure: Pressure Pain Thresholds (PPT)
timeFrame: One week post-intervention
measure: Pressure Pain Thresholds (PPT)
timeFrame: Three weeks post-intervention
measure: Conditioned pain modulation (CPM)
timeFrame: Baseline
measure: Conditioned pain modulation (CPM)
timeFrame: One week post-intervention
measure: Conditioned pain modulation (CPM)
timeFrame: Three weeks post-intervention
measure: Patients' expectations
timeFrame: Baseline
measure: Self-perceived change with the treatment
timeFrame: One week post-intervention
measure: Self-perceived change with the treatment
timeFrame: Three weeks post-intervention
measure: Self-perceived pain after treatment
timeFrame: One week post-intervention
measure: Self-perceived pain after treatment
timeFrame: Three weeks post-intervention
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Mercè Balasch i Bernat
Study officials:
References: