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Pubalgia and Adductor Tendinopathies Refractory to Medical Treatment

Feasability Study on the Use of Botulinum Toxin A in Primary Adductor Tendinopathies Refractory to Medical Treatment

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03496649
Acronym
PETRA
Enrollment
4
Registered
2018-04-12
Start date
2019-05-02
Completion date
2021-01-01
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Groin Injury, Tendinopathy

Keywords

Primary Adductor tendinopathies, Pubalgia, Botulinum toxin type A

Brief summary

Pubalgia is a pain syndrome located in the groin area. This syndrome is mainly described in young male athletes and typically affect the superficial muscles defining the boundaries of the femoral triangle, i.e. gracilis, pectineus, adductor brevis and especially adductor longus, and less commonly the deep muscles. Clinically, the pain is located in the inner aspect of the thigh, where the tendons attach onto the pubic symphysis. It is usually unilateral, and sometimes associated with neuropathic pain suggestive of obturator nerve irritation. There is no official recommendation or expert consensus on the management of pubalgia. However, a few protocols recommend a period of rest with Non-Inflammatory Anti-Steroidien Drugs (NSAIDs), icing and massages, as well as rehabilitation with passive stretching and muscle reinforcement. The use of botulinum toxin type A could be an option in cases of treatment failure. However, a feasibility study must be performed beforehand, and if results are positive, a controlled study on a larger cohort could be conducted. The major potential impact is a great effective pain relief for patients with neurological diseases.

Detailed description

The incidence of pubalgia in the literature varies, with large series reporting an incidence close to 5-10%, representing 15 to 18% of all injuries. Recurrences are also common, affecting 30 to 35% of cases. Once other differential diagnoses (such as spondylarthropathy, colorectal cancer, kidney disease…) have been ruled out, athletic pubalgia is typically divided into three main categories based on the site of the injury: * Abdominal wall, the most common form, representing 38 to 50% of all cases; * Pubic symphysis due to osteoarthropathy of the pubic bone caused by repetitive stress injury, accounting for 10 to 15% of all cases of pubalgia; * Adductor tendons, on which this study focuses, representing 22 to 38% of all cases of pubalgia, caused by repetitive tractions on the tendon insertions. There is no official recommendation or expert consensus on the management of pubalgia. However, a few protocols recommend a period of rest with Non-Inflammatory Anti-Steroidien Drugs (NSAIDs), icing and massages, as well as rehabilitation with passive stretching and muscle reinforcement. Neuromuscular reprogramming is then performed to stabilise the pelvis, followed by a progressive resumption of sporting activities, guided by the pain level. Generally, 70 to 85% of patients are able to resume their sporting activities with this management protocol. In 15 to 20% of cases of essential adductor tendinopathy, symptoms do not improve and the only currently validated solution is then a tenotomy, sometimes combined with partial tendon release in recurring cases. Recent studies showed that the use of botulinum toxin type A (BTA) produces fairly positive results in chronic tendinopathies, such as epicondylitis. However, the efficacy of BTA injections in adductor tendinopathies has not been demonstrated consistently and a feasibility study must be conducted to address this question. The hypothetical benefit of BTA in adductor tendinopathies is based on the toxin's known effects: 1. a purely analgesic effect, which reduces pain in the injected area within a few days. This type of chronic tendinopathy does not involve inflammation. The pain in such cases is most likely due to the action of neurotransmitters such as substance P and calcitonin gene-related peptide (CGRP). As BTA is known to inhibit the secretion of these neurotransmitters, this mechanism could explain the toxin's specific analgesic effect. 2. a muscle relaxant effect due to its action on the motor endplate, which reaches its maximum 6 weeks after the injection, and lasts 3 to 6 months. The resulting muscle relaxation helps improve healing of the damaged tendon, and provides sustained analgesia. A series including 39 cases showed that botulinum toxin is effective on hip adductor muscles following total hip arthroplasty, providing reduced muscle contracture and improved hip mobility without side effects. The use of botulinum toxin type A could be an option in cases of treatment failure. However, a feasibility study must be performed beforehand, and if results are positive, a study on a larger cohort could be conducted.

Interventions

DRUGDysport 500 Unit Powder for Injection

Dysport administered by intramuscular injection

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER
Ipsen
CollaboratorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Male or female patient 18 to 65 years old * Patient with episode of adductor tendinopathy, refractory to appropriate medical treatment lasting 3 months * Tendinopathy confirmed by clinical investigation, echography and MRI. * Patient naïve to intramuscular botulinum toxin injections * Patient able to self-evaluate pain on a VAS * Intensity of exercise-induced pain \> 5 on a VAS of 10 * Patient able to provide a signed informed consent freely for the study protocol and data collection

Exclusion criteria

* Subject participating or having participated in the last 3 months in another study which could interfere with the objective of the study * Neuralgia * Acute muscle injury * Progressive disease at the time of inclusion * Anticoagulant treatment: heparin administered with an electrical syringe or AVK therapy with effective doses

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with a pain reduction (VAS)Between Day 80 and Day 90Proportion of patients with a pain reduction of over 50% compared to baseline, as shown by the average pain intensity measured between D80 and D90 on a Visual Analogic Scale (VAS) from 0 to 10 (0 = no pain; 10 = worst pain imaginable). Pain intensity will be daily collected by the patient in his patient's diary.

Secondary

MeasureTime frameDescription
Exercise-induced pain intensity (VAS)Daily between Day 0 and Day 90Average intensity of exercise-induced pain evaluated daily by the patient on a VAS type numerical scale
Pain reliefOn Day 30 and Day 90Percentage of patients with over 50% pain relief compared to baseline
Goal Attainment Scaling (GAS)On Day 30 and Day 90Percentage of patients with over 50% GAS objective reached
Blazina clinical classification systemOn Day 30 and Day 90Improvement of at least 1 point on the Blazina clinical classification system in 50% of patients
Adductor strengthOn Day 30 and Day 90Preservation or improvement of adductor strength measured with a dynamometer and resumption of sport activity (Tegner activity level scale) in 50% of patients
Cure rate based on patients' self-evaluationOn Day 30 and Day 90Percentage of patients with over 50% cure rate based on the patients' self-evaluation of the improvement of their condition
Cure rate based on physician's evaluationOn Day 30 and Day 90Percentage of patients with over 50% cure rate based on the physicians' evaluation of the patients' improvement
TreatmentOn Day 30 and Day 90Percentage of patients not asking for further treatment
Pain diaryOn Day 30 and Day 90Determination of a break point on the pain intensity graph plotted by the physician, based on the pain diary completed by the patient.
HAGOS self-reported questionnaireOn Day 30 and Day 90Improvement on the 6 dimensions of the HAGOS self-reported questionnaire
ToleranceDay 1, Day 7, Day 14, Day 30, Day 90Tolerance evaluation: description and frequency of adverse effects.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026