Patellar TendinopathyNCT04640337
Influence of Placebo on Intratissue Percutaneous Electrolysis in Patellar Tendinopathy
A study testing IPE applied, participants believe they are receiving IPE and IPE not applied, participants believe they are receiving IPE in people with Patellar Tendinopathy, run by University of Valencia at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patellar Tendinopathy
- What is being tested?
- IPE applied, participants believe they are receiving IPE and IPE not applied, participants believe they are receiving IPE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 16 Oct 2020to 20 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Mercè Balasch i Bernat
Valencia, 46010
Mercè B Balasch i Bernat, PhD, PT, 963983855 ext. 51225, merce.balasch@uv.es
Mercè Balasch i Bernat, PhD
About this study
Official title: Influence of Placebo on Intratissue Percutaneous Electrolysis (IPE) Treatment in Patients With Patellar Tendinopathy
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.
Read the 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
- Patellar Tendinopathy
- Being tested
- IPE applied, participants believe they are receiving IPE, IPE applied, participants believe they are receiving placebo, IPE not applied, participants believe they are receiving IPE, IPE not applied, participants believe they are receiving placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPE applied, participants believe they are receiving IPEOther
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.
IPE applied, participants believe they are receiving placeboOther
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
IPE not applied, participants believe they are receiving IPEOther
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
IPE not applied, participants believe they are receiving placeboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: IPE not applied, participants believe they are receiving placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Cross-sectional area (CSA) of the patellar tendon
CSA at rest, with a knee flexion of 20º, will be measured by ultrasonography.
Measured: 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.
Measured: 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.
Measured: Baseline
Presence of neovascularity of the patellar tendon
The presence (yes/no) of neovascularity of the patellar tendon will be measured by ultrasonography.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Three weeks post-intervention
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: Three weeks post-intervention
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Measured: Baseline
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Measured: One week post-intervention
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Three weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start16 Oct 2020
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar TendinopathyStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mercè Balasch i Bernat, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640337
- Sponsor's protocol ID
- 1264955
- Status last verified
- May 2023
- First submitted
- 10 Nov 2020
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Placebo on Intratissue Percutaneous Electrolysis (IPE) Treatment in Patients With Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT04640337
- Acronym / sponsor ID
- 1264955
- Conditions
- Patellar Tendinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Mar 2024 (estimated)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group E1: IPE applied, participants believe they are receiving IPE. | Experimental | Other: IPE applied, participants believe they are receiving IPEIPE will be applied following the standard protocol for PT. Participants will believe they are receiving IPE. |
| Group E2: IPE applied, participants believe they are receiving placebo. | Placebo comparator | Other: IPE applied, participants believe they are receiving placeboIPE 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. |
| Group P1: IPE not applied, participants believe they are receiving IPE. | Placebo comparator | Other: IPE not applied, participants believe they are receiving IPEThe 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. |
| Group P2: IPE not applied, participants believe they are receiving placebo. | Placebo comparator | Other: IPE not applied, participants believe they are receiving placeboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPE applied, participants believe they are receiving IPEParticipants 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 | Group E1: IPE applied, participants believe they are receiving IPE. |
| IPE applied, participants believe they are receiving placeboParticipants 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 | Group E2: IPE applied, participants believe they are receiving placebo. |
| IPE not applied, participants believe they are receiving IPEParticipants 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 | Group P1: IPE not applied, participants believe they are receiving IPE. |
| IPE not applied, participants believe they are receiving placeboParticipants 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. | Other | Group P2: IPE not applied, participants believe they are receiving placebo. |
Primary outcome
Pain intensity
Time frame: Baseline
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).
Pain intensity
Time frame: One week post-intervention
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).
Pain intensity
Time frame: Three weeks post-intervention
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).
Patellar tendon function
Time frame: Baseline
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.
Patellar tendon function
Time frame: One week post-intervention
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.
Patellar tendon function
Time frame: Three weeks post-intervention
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.
Physical performance of the knee
Time frame: Baseline
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.
Physical performance of the knee
Time frame: One week post-intervention
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.
Physical performance of the knee
Time frame: Three weeks post-intervention
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.
Cross-sectional area (CSA) of the patellar tendon
Time frame: Baseline
CSA at rest, with a knee flexion of 20º, will be measured by ultrasonography.
Cross-sectional area (CSA) of the patellar tendon
Time frame: One week post-intervention
CSA at rest, with a knee flexion of 20º, will be measured by ultrasonography.
Cross-sectional area (CSA) of the patellar tendon
Time frame: Three weeks post-intervention
CSA at rest, with a knee flexion of 20º, will be measured by ultrasonography.
Presence of neovascularity of the patellar tendon
Time frame: Baseline
The presence (yes/no) of neovascularity of the patellar tendon will be measured by ultrasonography.
Presence of neovascularity of the patellar tendon
Time frame: One week post-intervention
The presence (yes/no) of neovascularity of the patellar tendon will be measured by ultrasonography.
Presence of neovascularity of the patellar tendon
Time frame: Three weeks post-intervention
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.
Amount of neovascularity of the patellar tendon
Time frame: Baseline
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.
Amount of neovascularity of the patellar tendon
Time frame: One week post-intervention
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.
Amount of neovascularity of the patellar tendon
Time frame: Three weeks post-intervention
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.
11 secondary outcomes
Pressure Pain Thresholds (PPT)
Time frame: Baseline
Pressure Pain Thresholds (PPT)
Time frame: One week post-intervention
Pressure Pain Thresholds (PPT)
Time frame: Three weeks post-intervention
Conditioned pain modulation (CPM)
Time frame: Baseline
Conditioned pain modulation (CPM)
Time frame: One week post-intervention
Conditioned pain modulation (CPM)
Time frame: Three weeks post-intervention
Patients' expectations
Time frame: Baseline
Self-perceived change with the treatment
Time frame: One week post-intervention
Self-perceived change with the treatment
Time frame: Three weeks post-intervention
Self-perceived pain after treatment
Time frame: One week post-intervention
Self-perceived pain after treatment
Time frame: Three weeks post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPE applied, participants believe they are receiving IPE and IPE not applied, participants believe they are receiving IPE in people with Patellar Tendinopathy, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.