BTA vs Baclofen for Pelvic Myofascial Pain Syndrome

NCT05617118 | Unknown

• 1 other identifier: 22/30 301
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to test the hypothesis that oral taking of baclofen in therapeutic dosage for 60 days is equally effective as injection of botulinum toxin type "A" in the area of trigger points of the pelvic muscles.

Conditions

Chronic Pain; Chronic Pelvic Pain Syndrome; Myofascial Pain Syndrome; Myofascial Trigger Point Pain; Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (1)

• PGI-I

  Patients Global Impression of Improvement (PGI-I). The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse.

  60 days

Secondary Outcomes (4)

• VAS

  14, 30, 60 days

• The Lamont Scale

  14, 30, 60 days

• IPSS/QoL

  14, 30, 60 days

• Clavien-Dindo Complication rate

  14, 30, 60 days

Study Arms (2)

Baclofen

A cohort of patients who have not previously received baclofen will be offered a course of the drug therapy at a dosage of 10 mg according to the scheme: 1-3 days - 1 tablet per day; 4-6 days - 2 tablets per day; 7-9 days - 3 tablets per day; 10 days and then 4 tablets per day (morning and evening).

Drug: Baclofen 10mg

BTA

A cohort of patients who previously received baclofen and canceled the course due to the development of side effects and/or individual intolerance, or who have contraindications to the use of this drug, will receive several injections with a total volume of 100 units. botulinum toxin type "A" in dilution up to 20 ml, distributed at the trigger points of the pelvic floor muscles.

Drug: Botulinum toxin type A

Interventions

Baclofen 10mg DRUG

Baclofen is a medication, a central myorelaxant, a GABAb stimulator.

Also known as: Baclosan

Baclofen

Botulinum toxin type A DRUG

Botulinum toxin, often shortened to BoNT, is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species.

Also known as: Botox, Xeomin, Dysport

BTA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with long-term chronic pelvic pain syndrome who have not previously received targeted treatment for myofascial pelvic pain syndrome

You may qualify if:

• Myofascial pain syndrome (presence of trigger points), confirmed by palpation during examination.
• Ineffectiveness (with subsequent discontinuation) of at least one treatment method, including outpatient physiotherapy and /or oral analgesics, or NSAIDs.

You may not qualify if:

• The presence of any organic disease of the pelvic organs requiring active treatment, confirmed by anamnesis, consultation of a specialist (urologist, proctologist, gynecologist) and one of the objective imaging methods: CT, MRI, endoscopical or laboratory methods: general urine analysis or prostate secretion analysis. Such diseases include interstitial cystitis / SBMP, chronic prostatitis types I, II, IIIA according to the NIH classification.
• The presence in the anamnesis of the fact of previously conducted therapy with baclofen or injection of botulinum toxin type "A" into the pelvic floor muscles.
• Individual intolerance to botulinum toxin type "A" and /or baclofen.
• Pregnancy

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead
• Ural State Medical University: collaborator

Study Sites (1)

SBPSU

Saint Petersburg, Russia

RECRUITING

Related Publications (12)

• Zondervan K, Barlow DH. Epidemiology of chronic pelvic pain. Baillieres Best Pract Res Clin Obstet Gynaecol. 2000 Jun;14(3):403-14. doi: 10.1053/beog.1999.0083.

  PMID: 10962634 BACKGROUND

• Tu FF, As-Sanie S, Steege JF. Prevalence of pelvic musculoskeletal disorders in a female chronic pelvic pain clinic. J Reprod Med. 2006 Mar;51(3):185-9.

  PMID: 16674013 BACKGROUND

• Zermann D, Ishigooka M, Doggweiler R, Schmidt R. Chronic prostatitis: A myofascial pain syndrome? Infections in Urology 1999;12:84-92

  BACKGROUND

• Jha S, Toozs-Hobson P, Roper JC, Gurung S, Brair A, Bach F. Botulinum injections for myofascial pelvic pain. Int Urogynecol J. 2021 May;32(5):1151-1156. doi: 10.1007/s00192-020-04435-w. Epub 2020 Jul 21.

  PMID: 32696187 BACKGROUND

• Hite M, Curran T. Biofeedback for Pelvic Floor Disorders. Clin Colon Rectal Surg. 2021 Jan;34(1):56-61. doi: 10.1055/s-0040-1714287. Epub 2020 Sep 4.

  PMID: 33536850 BACKGROUND

• Peñas CF de las, Campo MS, Carnero JF, Page JCM. Manual therapies in myofascial trigger point treatment: A systematic review. Journal of Bodywork and Movement Therapies 2005;9:27-34. doi:10.1016/j.jbmt.2003.11.001.

  BACKGROUND

• Chang WJ. Muscle Relaxants for Acute and Chronic Pain. Phys Med Rehabil Clin N Am. 2020 May;31(2):245-254. doi: 10.1016/j.pmr.2020.01.005. Epub 2020 Mar 13.

  PMID: 32279727 BACKGROUND

• Morrissey D, El-Khawand D, Ginzburg N, Wehbe S, O'Hare P 3rd, Whitmore K. Botulinum Toxin A Injections Into Pelvic Floor Muscles Under Electromyographic Guidance for Women With Refractory High-Tone Pelvic Floor Dysfunction: A 6-Month Prospective Pilot Study. Female Pelvic Med Reconstr Surg. 2015 Sep-Oct;21(5):277-82. doi: 10.1097/SPV.0000000000000177.

  PMID: 25900057 BACKGROUND

• Luo FY, Nasr-Esfahani M, Jarrell J, Robert M. Botulinum toxin injection for chronic pelvic pain: A systematic review. Acta Obstet Gynecol Scand. 2020 Dec;99(12):1595-1602. doi: 10.1111/aogs.13946. Epub 2020 Jul 16.

  PMID: 32597494 BACKGROUND

• Levesque A, Ploteau S, Michel F, Siproudhis L, Bautrant E, Eggermont J, Rabischong B, Volteau C, Perrouin-Verbe MA, Labat JJ. Botulinum toxin infiltrations versus local anaesthetic infiltrations in pelvic floor myofascial pain: Multicentre, randomized, double-blind study. Ann Phys Rehabil Med. 2021 Jan;64(1):101354. doi: 10.1016/j.rehab.2019.12.009. Epub 2020 Jan 22.

  PMID: 31981833 BACKGROUND

• Parsons BA, Goonewardene S, Dabestani S, Pacheco-Figueiredo L, Yuan Y, Zumstein V, Cottrell AM, Borovicka J, Dinis-Oliveira P, Berghmans B, Elneil S, Hughes J, Messelink BEJ, de C Williams AC, Baranowski AP, Engeler DS. The Benefits and Harms of Botulinum Toxin-A in the Treatment of Chronic Pelvic Pain Syndromes: A Systematic Review by the European Association of Urology Chronic Pelvic Pain Panel. Eur Urol Focus. 2022 Jan;8(1):320-338. doi: 10.1016/j.euf.2021.01.005. Epub 2021 Jan 30.

  PMID: 33526405 BACKGROUND

• Cook D, Lauzier F, Rocha MG, Sayles MJ, Finfer S. Serious adverse events in academic critical care research. CMAJ. 2008 Apr 22;178(9):1181-4. doi: 10.1503/cmaj.071366. No abstract available.

  PMID: 18427095 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Myofascial Pain Syndromes; Pelvic Floor Disorders

Interventions

Baclofen; Botulinum Toxins, Type A; incobotulinumtoxinA; abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Gleb Kovalev, MD, PhD

CONTACT

‭+7(911)199-72-75‬; kovalev2207@gmail.com

Ivan Labetov, MD

CONTACT

+7(931)307-01-39; ivanlabetov@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kovalev Gleb, head of outpatient urology department, urologist

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 15, 2022
• Study Start: December 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: May 1, 2024
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available upon request after the study is completed

Locations

RU (1)