An interventional study of IPE applied, participants believe they are receiving IPE and IPE applied, participants believe they are receiving placebo in Patellar Tendinopathy, sponsored by University of Valencia. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by University of Valencia · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
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
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
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
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
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.
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
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
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.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Cross-sectional area (CSA) of the patellar tendon
CSA at rest, with a knee flexion of 20º, will be measured by ultrasonography.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Presence of neovascularity of the patellar tendon
The presence (yes/no) of neovascularity of the patellar tendon will be measured by ultrasonography.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Three weeks post-intervention
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.
Time frame: Baseline
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.
Time frame: One week post-intervention
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.
Time frame: Three weeks post-intervention
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Time frame: Baseline
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Time frame: One week post-intervention
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Time frame: Three weeks post-intervention
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).
Time frame: Baseline
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).
Time frame: One week post-intervention
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).
Time frame: Three weeks post-intervention
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).
Time frame: One week post-intervention
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).
Time frame: Three weeks post-intervention
Plan to share: No
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