Study of botulinum toxin injections to treat pain in patients with piriformis muscle syndrome

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What is this study about?

This study focuses on Piriformis Muscle Syndrome, a condition where the piriformis muscle in the buttock region causes pain and discomfort along the sciatic nerve. The research evaluates the effectiveness of XEOMIN, which contains botulinum toxin, compared to placebo in treating this condition. The medication is specifically designed for patients who have not found relief through conventional treatments like physiotherapy, muscle relaxants, or pain medications.

The purpose of the study is to determine if a single injection of botulinum toxin can reduce sciatic pain in people with Piriformis Muscle Syndrome. During the study, participants will receive one injection of either XEOMIN or placebo into the affected muscle. The injection will be guided by ultrasound or computed tomography to ensure accurate placement. The treatment’s effects will be monitored over six months, with particular attention to pain levels after six weeks.

The medication being tested, XEOMIN, is administered as a solution for injection into the muscle. Each dose contains up to 200 units of botulinum toxin. Some patients may receive a second injection after 12 weeks if needed. Throughout the study, participants will be asked to report their pain levels and overall quality of life through various assessment tools.

1 Initial assessment

Your sciatic pain intensity will be measured using a visual scale from 0 to 100 (where 0 means no pain and 100 means worst possible pain)

You will be asked about the average intensity of your pain over the last 24 hours

Your buttock pain will also be measured using the same scale

You will complete quality of life questionnaires

2 Treatment injection

You will receive a single injection into the muscle, guided by ultrasound or CT scan

The injection will contain either botulinum toxin or an inactive substance

Neither you nor your doctor will know which substance you receive

3 Follow-up visits

You will attend follow-up visits at 6, 12, 18, and 24 weeks after the injection

At each visit, your pain levels will be reassessed

You will complete questionnaires about your quality of life, physical functioning, anxiety, depression, and disability

Your ability to sit comfortably will be evaluated

Any use of pain medications will be recorded

Any side effects will be monitored

4 Potential second injection

At 12 weeks after the first injection, your doctor will evaluate if you need a second injection

The total study duration will be 6 months from your first injection

Who Can Join the Study?

  • You must be between 18 and 80 years old
  • You must have been diagnosed with piriformis muscle syndrome affecting one side of your body for at least 3 months
  • Your diagnosis must be confirmed with a score of 8 or higher on the Clinical Scoring System for Piriformis Muscle Syndrome
  • Your sciatic pain level must be at least 4 points on a pain scale when the study begins
  • Previous treatments (such as physiotherapy, muscle relaxants, and pain medications) must have been unsuccessful in treating your condition
  • You must not have a herniated disc (bulging disc) in your lower back that could explain your pain, as confirmed by MRI or CT scan
  • You must be willing to provide written informed consent to participate in the study
  • You must have health insurance coverage through the social security system

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Known allergy or sensitivity to botulinum toxin
  • Previous treatment with botulinum toxin in the past 6 months
  • Pregnancy or breastfeeding
  • Neuromuscular junction disorders (conditions affecting nerve and muscle connections)
  • Active infection at the injection site
  • Use of medications that could interact with botulinum toxin
  • Presence of bleeding disorders or use of blood thinners
  • History of back surgery in the past year
  • Uncontrolled medical conditions that could affect study participation
  • Radiculopathy (nerve root compression) confirmed by imaging
  • Participation in another clinical trial within the past 30 days
  • Inability to follow study procedures or attend follow-up visits
  • History of substance abuse that could interfere with the study
  • Mental conditions that could affect ability to provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Beaujon Clichy France
Bexqejav Utdzrersgr Hxhwvqvw Cdzzbx Besançon France
Hpjaiahp Uvewzydxlstwka Slgwspeyaz &locxzk Hphqpxj dt Hgwozsamqry STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.07.2025

Trial locations

Botulinum toxin is a medication that helps relax muscles by blocking nerve signals. In this trial, it is injected directly into the piriformis muscle (a muscle in the buttocks region) under ultrasound or CT guidance. The medication is used to treat piriformis muscle syndrome, a condition that causes pain in the buttocks and along the sciatic nerve. This treatment aims to reduce pain and improve quality of life for patients suffering from this condition.

Investigated diseases:

Piriformis Muscle Syndrome – A neuromuscular condition where the piriformis muscle, located deep in the buttock, compresses or irritates the sciatic nerve. The condition typically causes pain, tingling, and numbness that begins in the buttocks and can extend down the back of the leg along the sciatic nerve pathway. Symptoms often worsen with prolonged sitting, climbing stairs, or performing squatting movements. The condition can develop gradually over time and may be related to muscle spasm, tightening, or swelling of the piriformis muscle. In some cases, anatomical variations in how the sciatic nerve passes through or around the piriformis muscle can contribute to the development of symptoms.

Trial ID:
2024-517948-66-00
Protocol code:
PHRCN/2019/AD-01
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

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    Investigated diseases:
    Investigated drugs:
    The Netherlands