Influence of Placebo on Intratissue Percutaneous Electrolysis in Patellar Tendinopathy

University of Valencia

Status: Enrolling

Conditions: Patellar Tendinopathy

Treatments: Other: IPE not applied, participants believe they are receiving IPE; Other: IPE applied, participants believe they are receiving IPE; Other: IPE not applied, participants believe they are receiving placebo; Other: IPE applied, participants believe they are receiving placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04640337

1264955

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Other: IPE applied, participants believe they are receiving IPE

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

Placebo Comparator group

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.

Treatment:

Other: IPE applied, participants believe they are receiving placebo

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

Placebo Comparator group

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.

Treatment:

Other: IPE not applied, participants believe they are receiving IPE

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

Placebo Comparator group

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.

Treatment:

Other: IPE not applied, participants believe they are receiving placebo