Posterior Tibial Tendon DysfunctionPNENCT05370092
Effect of Percutaneous Needle Electrolysis (PNE) on Tendinopathy
A study testing Percutaneous needle electrolysis, Therapeutic exercise and Manual therapy in people with Posterior Tibial Tendon Dysfunction, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
The aim of this study is to test the efficacy of percutaneous electrolysis in posterior tibial tendinopathies. The posterior tibial tendon injury is one of the most frequent pathologies in the lower extremities, and therefore a correct study and evaluation of it is necessary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posterior Tibial Tendon Dysfunction
- What is being tested?
- Percutaneous needle electrolysis, Therapeutic exercise and Manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2022to 30 Jun 2025
- 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
- Subjects over 18 years of age
- Mild inflammation, swelling and/or tenderness posterior to the medial malleolus
- Pain posterior and/or superior to the medial malleolus, aggravated by activity
- Pain present for at least 3 months
- One or more signs of flexible flatfoot deformity, including excessive valgus deformity of the hindfoot during weight bearing and/or excessive foot abduction (many toes sign).
- Pain when performing the Hell Rise Test or performed incorrectly.
- Signs of tenosynovitis on ultrasound examination.
- As the inclusion criteria are based on side-to-side comparison all participants had to have unilateral involvement.
Who cannot join
- Previous surgery on the affected foot, leg or knee.
- Disabling osteoarthritis of the knee on the affected side.
- Fixed hindfoot deformities.
- Recurrent ankle sprains on the affected side.
- Ligament tears or bony abnormalities of the affected foot.
- A physical or medical condition that contraindicates the testing protocol.
- Pregnancy.
- FCD or FLH tendinopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Percutaneous Needle Electrolysis on Tibialis Posterior Tendinopathy
The aim of this study is to test the efficacy of percutaneous electrolysis in posterior tibial tendinopathies. The posterior tibial tendon injury is one of the most frequent pathologies in the lower extremities, and therefore a correct study and evaluation of it is necessary. This study aims to compare the therapeutic effect of percutaneous electrolysis comparing a control group with an experimental group. To evaluate functionality, pain and its ultrasound pattern before and after treatment, in order to assess the efficacy of the treatment.
Read the detailed description
A single-blind, longitudinal, randomised, controlled, single-blind, longitudinal, randomised, controlled clinical trial will be conducted. First, the participant will receive a FOOT AND ANKLE ABILITY (FAAM) survey, along with a numerical pain scale, both of which must be completed. Next, an ultrasound study of the foot will be performed, focusing on pain in the inner ankle, to check for possible pathology in the posterior tibial tendon. Finally, the physiotherapist's intervention will be carried out to check the effectiveness of the technique, which may cause some pain, and finally, the numerical pain scale will be passed again. Four sessions will be carried out in four different weeks, always using the same day of the week for the intervention and following the same steps as above. The purpose of this study is to test the efficacy of PD in posterior tibial tendinopathy and whether PD is therefore a safe technique for this type of intervention. All patients will sign an informed consent form and will be informed about the study beforehand.
- Conditions
- Posterior Tibial Tendon Dysfunction
- Being tested
- Percutaneous needle electrolysis, Therapeutic exercise, Manual therapy
- Medical subject headings
- Posterior Tibial Tendon Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous needle electrolysisOther
Electrolysis is the process by which water (H2O) and sodium chloride (NaCl) molecules, which are present in the biological tissues and body compartments of our organism, are organically broken down into their constituent chemical elements, regrouping to create entirely new substances such as sodium hydroxide (NaOH), hydrogen gas (H2) and chlorine gas (Cl2). This process occurs thanks to the passage of a flow of direct electric current, also known as galvanic current, which is a totally athermal process. The passage of this current allows a local inflammatory response to occur (increase in lymphocytes and macrophages) as well as an increase in vasodilatation, inducing phagocytosis and biological stimulation of tendon repair.
Therapeutic exerciseOther
The first exercise they will perform will be the Short-Foot Exercise holding the position 5 seconds isometrically. The second exercise will be plantar flexion of the ankle with adduction of the foot and inversion with elastic band in its concentric and eccentric phase
Manual therapyOther
The manual therapy (TM) treatment for tendinopathies is mainly focused on soft tissue mobilization and deep transverse friction massage (Cyriax).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients assigned to this group will receive a session of manual therapy and therapeutic exercise. The manual therapy (TM) treatment for tendinopathies is mainly focused on soft tissue mobilization and deep transverse friction massage (Cyriax).
The therapeutic exercise session participants will perform 2 exercises for 4 weeks 3 days per week. The first exercise they will perform will be the Short-Foot Exercise holding the position 5 seconds isometrically. The second exercise will be plantar flexion of the ankle with adduction of the foot and inversion with elastic band in its concentric and eccentric phase. Each exercise will be performed in 3 series of 15 repetitions, with 1 minute rest between series, the exercise session will follow the TM and will last approximately 15-20 minutes. Receives: Other: Therapeutic exercise; Other: Manual therapy |
| Intervention group | Experimental | Participants in this group will receive 4 sessions (once a week during their respective treatment session) of percutaneous electrolysis guided by MUSCULO-SKELETAL ECOGRAPHY, by a physiotherapist with extensive clinical experience in this therapeutic approach. The technique will be applied using a specifically developed and medically certified device (EPI Advanced Medicine®, Barcelona, Spain. EPI®). The galvanic current will be applied using acupuncture needles. In the present study, a 0.30*25 mm needle (Agupunt, Barcelona, Spain) will be used, with an intensity of 2 mA for a total of 3-5 seconds and 3-5 impacts on the liquid content (TTP tenosynovitis) and 2 mA for a total of 3 seconds and 2-3 impacts if in the tendon (intrasubstance). The technique shall be applied under ultrasound guidance.
The needle shall be introduced at an angle of 80° in a short-axis cross-section to the skin, with the tip of the needle directed towards the posterior tibial tendon. Receives: Other: Percutaneous needle electrolysis; Other: Therapeutic exercise; Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NUMERICAL PAIN RATE SCALE (NPRS. 0-10)
The scale consists of a horizontal line of 11 numbers, at the ends of which are the extreme manifestations of a symptom that allows observers to measure the intensity of pain with maximum reproducibility. On the far left is 0 or the total absence of pain and on the far right is 10 or the maximum pain that can be tolerated. The patient will be asked to select the number where they consider their pain to be.
Measured: 6 months
Secondary outcomes (1)
FOOT AND ANKLE ABILITY (FAAM)
The FAAM questionnaire consists of 29 items separated into two subscales: the ADL subscale with 21 items and the Sport subscale with 8 items. Each one has a maximum Likert scale score of 5 points ranging from "no difficulty" to "impossible to perform". All scores will be converted to percentages, with a higher percentage indicating a higher level of functionality and lower pathology. At the end of the scale, the functionality percentage will be calculated, ranging from 0% (inability to perform any activity) to 100% (normal functionality level). Finally, patients will rate the condition of their ankle and foot on a 4-point scale that includes "normal," "almost normal," "abnormal," and "severely abnormal." The intention of the study is that the patient recovers 100% of functionality or better the percentage that has been marked prior to the intervention. As in the 4-point scale, the condition of your ankle should be normal.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start20 Mar 2022
- Primary completion31 Jan 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Posterior Tibial Tendon DysfunctionStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Rejas Fenández, Universidad Rey Juan Carlos
- Investigators
- Antonio Rejas Fernández, Principal investigator, Universidad Rey Juan CarlosJose Luis Arias Buría, Study director, Universidad Rey Juan CarlosAna Isabel De La Llave Rincón, Study director, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370092
- Sponsor's protocol ID
- 1801202201622
- Acronym
- PNE
- Status last verified
- Nov 2025
- First submitted
- 31 Mar 2022
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abat F, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibanez JM. Clinical results after ultrasound-guided intratissue percutaneous electrolysis (EPI(R)) and eccentric exercise in the treatment of patellar tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2015 Apr;23(4):1046-52. doi: 10.1007/s00167-014-2855-2. Epub 2014 Jan 30.
PubMed 24477495Abat F, Diesel WJ, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibanez JM. Effectiveness of the Intratissue Percutaneous Electrolysis (EPI(R)) technique and isoinertial eccentric exercise in the treatment of patellar tendinopathy at two years follow-up. Muscles Ligaments Tendons J. 2014 Jul 14;4(2):188-93. eCollection 2014 Apr.
PubMed 25332934Margalef R, Bosque M, Minaya-Munoz F, Valera-Garrido F, Santafe MM. Safety analysis of percutaneous needle electrolysis: a study of needle composition, morphology, and electrical resistance. Acupunct Med. 2021 Oct;39(5):471-477. doi: 10.1177/0964528420988007. Epub 2021 Feb 7.
PubMed 33550820Lopez-Royo MP, Gomez-Trullen EM, Ortiz-Lucas M, Galan-Diaz RM, Bataller-Cervero AV, Al-Boloushi Z, Hamam-Alcober Y, Herrero P. Comparative study of treatment interventions for patellar tendinopathy: a protocol for a randomised controlled trial. BMJ Open. 2020 Feb 16;10(2):e034304. doi: 10.1136/bmjopen-2019-034304.
PubMed 32066608Arias-Buria JL, Truyols-Dominguez S, Valero-Alcaide R, Salom-Moreno J, Atin-Arratibel MA, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:315219. doi: 10.1155/2015/315219. Epub 2015 Nov 15.
PubMed 26649058Gomez-Chiguano GF, Navarro-Santana MJ, Cleland JA, Arias-Buria JL, Fernandez-de-Las-Penas C, Ortega-Santiago R, Plaza-Manzano G. Effectiveness of Ultrasound-Guided Percutaneous Electrolysis for Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Pain Med. 2021 May 21;22(5):1055-1071. doi: 10.1093/pm/pnaa342.
PubMed 33155055Cook JL, Purdam CR. Is tendon pathology a continuum? A pathology model to explain the clinical presentation of load-induced tendinopathy. Br J Sports Med. 2009 Jun;43(6):409-16. doi: 10.1136/bjsm.2008.051193. Epub 2008 Sep 23.
PubMed 18812414Rabbito M, Pohl MB, Humble N, Ferber R. Biomechanical and clinical factors related to stage I posterior tibial tendon dysfunction. J Orthop Sports Phys Ther. 2011 Oct;41(10):776-84. doi: 10.2519/jospt.2011.3545. Epub 2011 Jul 12.
PubMed 21765219Johnson KA, Strom DE. Tibialis posterior tendon dysfunction. Clin Orthop Relat Res. 1989 Feb;(239):196-206.
PubMed 2912622Mills FB 4th, Williams K, Chu CH, Bornemann P, Jackson JB 3rd. Prevalence of Abnormal Ultrasound Findings in Asymptomatic Posterior Tibial Tendons. Foot Ankle Int. 2020 Sep;41(9):1049-1055. doi: 10.1177/1071100720931085. Epub 2020 Jun 21.
PubMed 32567358Bellew SD, Colbenson KM, Bellamkonda VR. Posterior Tibial Tendon Tenosynovitis Diagnosed by Point-of-Care Ultrasound. Clin Pract Cases Emerg Med. 2017 Oct 18;1(4):439-440. doi: 10.5811/cpcem.2017.6.34430. eCollection 2017 Nov. No abstract available.
PubMed 29849380Ikpeze TC, Brodell JD Jr, Chen RE, Oh I. Evaluation and Treatment of Posterior Tibialis Tendon Insufficiency in the Elderly Patients. Geriatr Orthop Surg Rehabil. 2019 Jan 24;10:2151459318821461. doi: 10.1177/2151459318821461. eCollection 2019.
PubMed 30719400Ross MH, Smith MD, Mellor R, Vicenzino B. Exercise for posterior tibial tendon dysfunction: a systematic review of randomised clinical trials and clinical guidelines. BMJ Open Sport Exerc Med. 2018 Sep 19;4(1):e000430. doi: 10.1136/bmjsem-2018-000430. eCollection 2018.
PubMed 30271611Sanchez-Sanchez JL, Calderon-Diez L, Herrero-Turrion J, Mendez-Sanchez R, Arias-Buria JL, Fernandez-de-Las-Penas C. Changes in Gene Expression Associated with Collagen Regeneration and Remodeling of Extracellular Matrix after Percutaneous Electrolysis on Collagenase-Induced Achilles Tendinopathy in an Experimental Animal Model: A Pilot Study. J Clin Med. 2020 Oct 15;9(10):3316. doi: 10.3390/jcm9103316.
PubMed 33076550Millar NL, Silbernagel KG, Thorborg K, Kirwan PD, Galatz LM, Abrams GD, Murrell GAC, McInnes IB, Rodeo SA. Tendinopathy. Nat Rev Dis Primers. 2021 Jan 7;7(1):1. doi: 10.1038/s41572-020-00234-1.
PubMed 33414454
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Percutaneous Needle Electrolysis on Tibialis Posterior Tendinopathy
- ClinicalTrials.gov ID
- NCT05370092
- Acronym / sponsor ID
- PNE / 1801202201622
- Conditions
- Posterior Tibial Tendon Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 11 May 2022 (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 aim of this study is to test the efficacy of percutaneous electrolysis in posterior tibial tendinopathies. The posterior tibial tendon injury is one of the most frequent pathologies in the lower extremities, and therefore a correct study and evaluation of it is necessary. This study aims to compare the therapeutic effect of percutaneous electrolysis comparing a control group with an experimental group. To evaluate functionality, pain and its ultrasound pattern before and after treatment, in order to assess the efficacy of the treatment.
Detailed description
A single-blind, longitudinal, randomised, controlled, single-blind, longitudinal, randomised, controlled clinical trial will be conducted. First, the participant will receive a FOOT AND ANKLE ABILITY (FAAM) survey, along with a numerical pain scale, both of which must be completed. Next, an ultrasound study of the foot will be performed, focusing on pain in the inner ankle, to check for possible pathology in the posterior tibial tendon. Finally, the physiotherapist's intervention will be carried out to check the effectiveness of the technique, which may cause some pain, and finally, the numerical pain scale will be passed again. Four sessions will be carried out in four different weeks, always using the same day of the week for the intervention and following the same steps as above. The purpose of this study is to test the efficacy of PD in posterior tibial tendinopathy and whether PD is therefore a safe technique for this type of intervention. All patients will sign an informed consent form and will be informed about the study beforehand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Therapeutic exercise, Other: Manual therapyPatients assigned to this group will receive a session of manual therapy and therapeutic exercise. The manual therapy (TM) treatment for tendinopathies is mainly focused on soft tissue mobilization and deep transverse friction massage (Cyriax). The therapeutic exercise session participants will perform 2 exercises for 4 weeks 3 days per week. The first exercise they will perform will be the Short-Foot Exercise holding the position 5 seconds isometrically. The second exercise will be plantar flexion of the ankle with adduction of the foot and inversion with elastic band in its concentric and eccentric phase. Each exercise will be performed in 3 series of 15 repetitions, with 1 minute rest between series, the exercise session will follow the TM and will last approximately 15-20 minutes. |
| Intervention group | Experimental | Other: Percutaneous needle electrolysis, Other: Therapeutic exercise, Other: Manual therapyParticipants in this group will receive 4 sessions (once a week during their respective treatment session) of percutaneous electrolysis guided by MUSCULO-SKELETAL ECOGRAPHY, by a physiotherapist with extensive clinical experience in this therapeutic approach. The technique will be applied using a specifically developed and medically certified device (EPI Advanced Medicine®, Barcelona, Spain. EPI®). The galvanic current will be applied using acupuncture needles. In the present study, a 0.30*25 mm needle (Agupunt, Barcelona, Spain) will be used, with an intensity of 2 mA for a total of 3-5 seconds and 3-5 impacts on the liquid content (TTP tenosynovitis) and 2 mA for a total of 3 seconds and 2-3 impacts if in the tendon (intrasubstance). The technique shall be applied under ultrasound guidance. The needle shall be introduced at an angle of 80° in a short-axis cross-section to the skin, with the tip of the needle directed towards the posterior tibial tendon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects over 18 years of age
- Mild inflammation, swelling and/or tenderness posterior to the medial malleolus
- Pain posterior and/or superior to the medial malleolus, aggravated by activity
- Pain present for at least 3 months
- One or more signs of flexible flatfoot deformity, including excessive valgus deformity of the hindfoot during weight bearing and/or excessive foot abduction (many toes sign).
Key exclusion criteria (8 listed)
- Previous surgery on the affected foot, leg or knee.
- Disabling osteoarthritis of the knee on the affected side.
- Fixed hindfoot deformities.
- Recurrent ankle sprains on the affected side.
- Ligament tears or bony abnormalities of the affected foot.
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 |
|---|---|---|
| Percutaneous needle electrolysisElectrolysis is the process by which water (H2O) and sodium chloride (NaCl) molecules, which are present in the biological tissues and body compartments of our organism, are organically broken down into their constituent chemical elements, regrouping to create entirely new substances such as sodium hydroxide (NaOH), hydrogen gas (H2) and chlorine gas (Cl2). This process occurs thanks to the passage of a flow of direct electric current, also known as galvanic current, which is a totally athermal process. The passage of this current allows a local inflammatory response to occur (increase in lymphocytes and macrophages) as well as an increase in vasodilatation, inducing phagocytosis and biological stimulation of tendon repair. | Other | Intervention group |
| Therapeutic exerciseThe first exercise they will perform will be the Short-Foot Exercise holding the position 5 seconds isometrically. The second exercise will be plantar flexion of the ankle with adduction of the foot and inversion with elastic band in its concentric and eccentric phase | Other | Control group, Intervention group |
| Manual therapyThe manual therapy (TM) treatment for tendinopathies is mainly focused on soft tissue mobilization and deep transverse friction massage (Cyriax). | Other | Control group, Intervention group |
Primary outcome
NUMERICAL PAIN RATE SCALE (NPRS. 0-10)
Time frame: 6 months
The scale consists of a horizontal line of 11 numbers, at the ends of which are the extreme manifestations of a symptom that allows observers to measure the intensity of pain with maximum reproducibility. On the far left is 0 or the total absence of pain and on the far right is 10 or the maximum pain that can be tolerated. The patient will be asked to select the number where they consider their pain to be.
1 secondary outcome
FOOT AND ANKLE ABILITY (FAAM)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 24477495Abat F, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibanez JM. Clinical results after ultrasound-guided intratissue percutaneous electrolysis (EPI(R)) and eccentric exercise in the treatment of patellar tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2015 Apr;23(4):1046-52. doi: 10.1007/s00167-014-2855-2. Epub 2014 Jan 30.
- Background: PubMed 25332934Abat F, Diesel WJ, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibanez JM. Effectiveness of the Intratissue Percutaneous Electrolysis (EPI(R)) technique and isoinertial eccentric exercise in the treatment of patellar tendinopathy at two years follow-up. Muscles Ligaments Tendons J. 2014 Jul 14;4(2):188-93. eCollection 2014 Apr.
- Background: PubMed 33550820Margalef R, Bosque M, Minaya-Munoz F, Valera-Garrido F, Santafe MM. Safety analysis of percutaneous needle electrolysis: a study of needle composition, morphology, and electrical resistance. Acupunct Med. 2021 Oct;39(5):471-477. doi: 10.1177/0964528420988007. Epub 2021 Feb 7.
- Background: PubMed 32066608Lopez-Royo MP, Gomez-Trullen EM, Ortiz-Lucas M, Galan-Diaz RM, Bataller-Cervero AV, Al-Boloushi Z, Hamam-Alcober Y, Herrero P. Comparative study of treatment interventions for patellar tendinopathy: a protocol for a randomised controlled trial. BMJ Open. 2020 Feb 16;10(2):e034304. doi: 10.1136/bmjopen-2019-034304.
- Background: PubMed 26649058Arias-Buria JL, Truyols-Dominguez S, Valero-Alcaide R, Salom-Moreno J, Atin-Arratibel MA, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:315219. doi: 10.1155/2015/315219. Epub 2015 Nov 15.
- Background: PubMed 33155055Gomez-Chiguano GF, Navarro-Santana MJ, Cleland JA, Arias-Buria JL, Fernandez-de-Las-Penas C, Ortega-Santiago R, Plaza-Manzano G. Effectiveness of Ultrasound-Guided Percutaneous Electrolysis for Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Pain Med. 2021 May 21;22(5):1055-1071. doi: 10.1093/pm/pnaa342.
- Background: PubMed 18812414Cook JL, Purdam CR. Is tendon pathology a continuum? A pathology model to explain the clinical presentation of load-induced tendinopathy. Br J Sports Med. 2009 Jun;43(6):409-16. doi: 10.1136/bjsm.2008.051193. Epub 2008 Sep 23.
- Background: PubMed 21765219Rabbito M, Pohl MB, Humble N, Ferber R. Biomechanical and clinical factors related to stage I posterior tibial tendon dysfunction. J Orthop Sports Phys Ther. 2011 Oct;41(10):776-84. doi: 10.2519/jospt.2011.3545. Epub 2011 Jul 12.
- Background: PubMed 2912622Johnson KA, Strom DE. Tibialis posterior tendon dysfunction. Clin Orthop Relat Res. 1989 Feb;(239):196-206.
- Background: PubMed 32567358Mills FB 4th, Williams K, Chu CH, Bornemann P, Jackson JB 3rd. Prevalence of Abnormal Ultrasound Findings in Asymptomatic Posterior Tibial Tendons. Foot Ankle Int. 2020 Sep;41(9):1049-1055. doi: 10.1177/1071100720931085. Epub 2020 Jun 21.
- Background: PubMed 29849380Bellew SD, Colbenson KM, Bellamkonda VR. Posterior Tibial Tendon Tenosynovitis Diagnosed by Point-of-Care Ultrasound. Clin Pract Cases Emerg Med. 2017 Oct 18;1(4):439-440. doi: 10.5811/cpcem.2017.6.34430. eCollection 2017 Nov. No abstract available.
- Background: PubMed 30719400Ikpeze TC, Brodell JD Jr, Chen RE, Oh I. Evaluation and Treatment of Posterior Tibialis Tendon Insufficiency in the Elderly Patients. Geriatr Orthop Surg Rehabil. 2019 Jan 24;10:2151459318821461. doi: 10.1177/2151459318821461. eCollection 2019.
- 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.
Antonio Rejas Fernández principal investigator
Universidad Rey Juan Carlos
Jose Luis Arias Buría study director
Universidad Rey Juan Carlos
Ana Isabel De La Llave Rincón study director
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous needle electrolysis, Therapeutic exercise and Manual therapy in people with Posterior Tibial Tendon Dysfunction, run by Universidad Rey Juan Carlos 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 25 Nov 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NUMERICAL PAIN RATE SCALE (NPRS. 0-10) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05370092, which also lists 15 linked publications.
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 25 Nov 2025.