Pubalgia and Adductor Tendinopathies Refractory to Medical Treatment (PETRA)
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|ClinicalTrials.gov Identifier: NCT03496649|
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : May 20, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Groin Injury Tendinopathy||Drug: Dysport 500 Unit Powder for Injection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasability Study on the Use of Botulinum Toxin A in Primary Adductor Tendinopathies Refractory to Medical Treatment|
|Actual Study Start Date :||May 2, 2019|
|Estimated Primary Completion Date :||August 2, 2020|
|Estimated Study Completion Date :||August 2, 2020|
Dysport administration by intramuscular injection Each patient will receive one dose of Dysport at Visit 1.
At least 2 of the 4 muscles below will be injected, depending on which muscles are affected:
250 IU for the gracilis muscle 200 IU for the pectineus muscle 300 IU for the adductor longus muscle 200 IU for the adductor brevis muscle
These injections will be uni or bilateral, it will depend on clinical diagnosis.
If necessary, the 4 muscles will be injected with a maximum of 1500U Dysport. The total dose cannot exceed 1500 units.
Drug: Dysport 500 Unit Powder for Injection
Dysport administered by intramuscular injection
- Proportion of patients with a pain reduction (VAS) [ Time Frame: Between Day 80 and Day 90 ]
Proportion 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.
- Exercise-induced pain intensity (VAS) [ Time Frame: Daily between Day 0 and Day 90 ]Average intensity of exercise-induced pain evaluated daily by the patient on a VAS type numerical scale
- Pain relief [ Time Frame: On Day 30 and Day 90 ]Percentage of patients with over 50% pain relief compared to baseline
- Goal Attainment Scaling (GAS) [ Time Frame: On Day 30 and Day 90 ]Percentage of patients with over 50% GAS objective reached
- Blazina clinical classification system [ Time Frame: On Day 30 and Day 90 ]Improvement of at least 1 point on the Blazina clinical classification system in 50% of patients
- Adductor strength [ Time Frame: On Day 30 and Day 90 ]Preservation 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-evaluation [ Time Frame: On Day 30 and Day 90 ]Percentage 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 evaluation [ Time Frame: On Day 30 and Day 90 ]Percentage of patients with over 50% cure rate based on the physicians' evaluation of the patients' improvement
- Treatment [ Time Frame: On Day 30 and Day 90 ]Percentage of patients not asking for further treatment
- Pain diary [ Time Frame: On Day 30 and Day 90 ]Determination 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 questionnaire [ Time Frame: On Day 30 and Day 90 ]Improvement on the 6 dimensions of the HAGOS self-reported questionnaire
- Tolerance [ Time Frame: Day 1, Day 7, Day 14, Day 30, Day 90 ]Tolerance evaluation: description and frequency of adverse effects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496649
|Contact: Mathieu De Seze, PHfirstname.lastname@example.org|