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Study on the Effect of Botulinum Toxin Type A and Physiological NaCl 0.9% in Patients with Piriformis Syndrome

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of piriformis syndrome, a condition where the piriformis muscle in the buttock region becomes tight and causes pain. The treatment being tested in this study is Botulinum Toxin Type A, commonly known as Botox, which is a protein used to relax muscles. The study will also use a solution called physiological NaCl 0.9%, which is a saltwater solution often used in medical treatments.

The purpose of the study is to see if using Botox can help people with piriformis syndrome return to sports activities. Participants in the study will receive an injection of Botox, and their progress will be monitored over a period of time. The study will involve regular check-ups to see how well the treatment is working and to ensure the safety of the participants.

Participants who are part of the study will be observed for any changes in their condition, and their ability to resume sports activities will be assessed. The study aims to provide valuable information on whether Botox can be an effective treatment for reducing muscle tightness and pain associated with piriformis syndrome, ultimately helping individuals return to their active lifestyles.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including a positive effect of a test block with lidocaine and methylprednisolone, age between 18-60 years, and active participation in a sport where walking is involved.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the condition known as piriformis hypertonia. This assessment helps in understanding the baseline status before any treatment is administered.

  3. Step 3

    Administration of treatment

    The treatment involves an injectable solution of botulinum toxin type A. This is administered to address the symptoms associated with piriformis syndrome.

  4. Step 4

    Monitoring and follow-up

    After the injection, regular monitoring is conducted to observe the effects of the treatment. The primary objective is to assess the resumption of sports activities post-injection.

  5. Step 5

    Outpatient clinic visit

    If treatment is withdrawn, a follow-up visit is scheduled at the outpatient clinic 12 weeks after the initial test block to evaluate the patient's condition and any changes.

  6. Step 6

    Completion of trial

    The trial is estimated to conclude by December 23, 2024. At this point, a final assessment is conducted to determine the overall effectiveness of the treatment.

Who can join the trial?

3 criteria

  • The patient must have a positive effect from a test block using lidocaine and methylprednisolone. This means that when these medicines are used, the patient should feel an improvement in their condition.
  • The patient must be between 18 and 60 years old.
  • The patient must be actively participating in a sport. This can include activities where walking is considered part of the sport.

Who cannot join the trial?

4 criteria

  • Individuals who are not between the ages of 18 and 65.
  • Individuals who are not experiencing piriformis hypertonia. This is a condition where a muscle in the buttock area is too tight.
  • Individuals who are not able to resume sports activities after receiving a BoNT-A injection. This is a type of treatment that involves injecting a substance to help relax muscles.
  • Individuals who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Botox: This medication is used in the trial to treat Piriformis syndrome. It is injected into the affected muscle to help relieve pain and improve muscle function. The goal is to see if it helps patients return to sports activities.

What is already known about the treatment

Botox – This medication is administered through injection directly into the affected muscle. It is currently being studied for its effectiveness in treating piriformis hypertonia, a condition that causes muscle tightness and pain. Botox is primarily used to help relax muscles, allowing for improved movement and reduced discomfort. It works by blocking the release of a chemical called acetylcholine, which is responsible for muscle contraction. Classified as a neuromuscular blocker, Botox is widely recognized in medical literature for its use in various muscle-related conditions.

Investigated diseases

Piriformis Syndrome – This condition involves the piriformis muscle, which is located in the buttock region. It occurs when the muscle becomes tight or spasms, leading to compression of the sciatic nerve. This can cause pain, tingling, or numbness in the buttocks and along the path of the sciatic nerve descending down the leg. The discomfort often worsens with prolonged sitting, climbing stairs, or running. Over time, the symptoms may fluctuate in intensity, sometimes improving with rest and exacerbating with activity. The condition is often associated with repetitive movements or prolonged sitting.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504427-61-01Estimated enrolment36 patientsSponsorStichting Alrijne Zorggroep

sourced from the EU Clinical Trials Register and site verification

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