ClinicalTrials.gov
ClinicalTrials.gov Menu

Pubalgia and Adductor Tendinopathies Refractory to Medical Treatment (PETRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03496649
Recruitment Status : Not yet recruiting
First Posted : April 12, 2018
Last Update Posted : July 23, 2018
Sponsor:
Collaborator:
Ipsen
Information provided by (Responsible Party):
University Hospital, Bordeaux

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, 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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasability Study on the Use of Botulinum Toxin A in Primary Adductor Tendinopathies Refractory to Medical Treatment
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Tendinitis

Arm Intervention/treatment
Experimental: Dysport

Dysport administration by intramuscular injection Each patient will receive one dose of Dysport at Visit 1.

At least 2 of the 3 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 These injections will be uni or bilateral, it will depend on clinical diagnosis.

If necessary, the 3 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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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

  2. Pain relief [ Time Frame: On Day 30 and Day 90 ]
    Percentage of patients with over 50% pain relief compared to baseline

  3. Goal Attainment Scaling (GAS) [ Time Frame: On Day 30 and Day 90 ]
    Percentage of patients with over 50% GAS objective reached

  4. 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

  5. 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

  6. 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

  7. 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

  8. Treatment [ Time Frame: On Day 30 and Day 90 ]
    Percentage of patients not asking for further treatment

  9. 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.

  10. HAGOS self-reported questionnaire [ Time Frame: On Day 30 and Day 90 ]
    Improvement on the 6 dimensions of the HAGOS self-reported questionnaire

  11. Tolerance [ Time Frame: Day 1, Day 7, Day 14, Day 30, Day 90 ]
    Tolerance evaluation: description and frequency of adverse effects.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patient 18 to 65 years old
  • Patient with first episode of isolated 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
  • Patient with a condition involving the pubic inguinal area or abdominal wall
  • Relapse tendinopathy
  • Chronic Joint Pain
  • Neuralgia
  • Post-operative pain
  • Acute muscle injury
  • Progressive disease at the time of inclusion
  • Anticoagulant treatment: heparin administered with an electrical syringe or AVK therapy with effective doses

Exclusion criteria related to Dysport injection (botulinum toxin type A) :

  • Known hypersensitivity to botulinum toxin type A or to any of the components in the formulation (20% human albumin solution, lactose monohydrate)
  • Subject with a significant deficit of clinical or subclinical neuromuscular transmission (myasthenia or Lambert-Eaton syndrome)
  • Treatment that directly or indirectly interferes with neuromuscular transmission (aminoglycosides, curare, anticholinesterase, aminoquinoline, cyclosporine, etc.)
  • Previous surgery with curarisation less than a month ago
  • History of neuromuscular disorders
  • Pregnant or breastfeeding woman
  • Women of child-bearing potential not using contraceptive methods during the study duration

Information from the National Library of Medicine

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


Contacts
Contact: Mathieu De Seze, PH 0556795516 mathieu.de-seze@chu-bordeaux.fr

Locations
France
CHU de Bordeaux Not yet recruiting
Bordeaux, France, 33076
Contact: Mathieu De Seze, PH    0556795516    mathieu.de-seze@chu-bordeaux.fr   
Contact: Cécile Klochendler       cecile.klochendler@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
Ipsen

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03496649     History of Changes
Other Study ID Numbers: CHUBX2014/21
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Any exploitation of the data by Ipsen or for another research will be submitted to the preliminary agreement of CHU de Bordeaux and, in case of agreement, of a negotiated contract between the parties.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
Primary Adductor tendinopathies
Pubalgia
Botulinum toxin type A

Additional relevant MeSH terms:
Muscular Diseases
Tendon Injuries
Tendinopathy
Musculoskeletal Diseases
Wounds and Injuries
Botulinum Toxins
abobotulinumtoxinA
Botulinum Toxins, Type A
onabotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents