Trials / Unknown
UnknownNCT04640337
Influence of Placebo on Intratissue Percutaneous Electrolysis in Patellar Tendinopathy
Influence of Placebo on Intratissue Percutaneous Electrolysis (IPE) Treatment in Patients With Patellar Tendinopathy
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- University of Valencia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| 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. |
Timeline
- Start date
- 2020-10-16
- Primary completion
- 2023-12-20
- Completion
- 2024-03-20
- First posted
- 2020-11-23
- Last updated
- 2023-05-09
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT04640337. Inclusion in this directory is not an endorsement.