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Completed

NCT Number: NCT07692347

Global Myofascial Treatment With Shockwave for Non-Specific Low Back Pain

This study aims to examine the effects of shockwave therapy on myofascial tissue (muscles, fascia, and connective tissue), focusing on pain reduction and improvement of mobility. The results will be compared with those of conventional manual physiotherapy.

Myofascial tissue can be a source of back pain, as it may contain painful spots known as myofascial trigger points (MTrPs). Shockwave therapy can stimulate these trigger points, potentially leading to muscle and fascia relaxation and, as a result, a decrease in pain.

The study investigates how focused shockwave trigger point therapy influences back function and pain perception compared to traditional physiotherapeutic treatment.

Participation is voluntary. The examinations will only be carried out if you provide written informed consent. You may refuse participation or withdraw your consent at any time without any disadvantages.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut für Muskuloskelettale Medizin (IMM) Abteilung für Regenerative Muskuloskelettale Medizin

Münster, North Rhine-Westphalia, 48149, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic low back pain (LBP) of the lumbar spine lasting more than 12 weeks
  • age between 18 and 70 years
  • pain stage 1 or 2 according to Gerbershagen
  • female, male or diverse
  • capable of giving informed consent

Exclusion criteria

  • Severe neurological
  • vascular
  • neoplastic or bony disorders, as well as cognitive impairments
  • according to the judgment and assessment of the examiner
  • flexisting radicular symptoms (e.g., foot drop).

Treatment and study plan

Shockwave therapy

Device

Shockwave therapy can stimulate these trigger points, potentially leading to muscle and fascia relaxation and, as a result, a decrease in pain.

Conventional physiotherapy

Procedure

Conventional physiotherapy to treat low back pain

Primary outcomes

  1. Visual Analog Scale for Pain

    Time frame: 3 months

    Pain intensity measured using the Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.

  2. Oswestry Disability Index

    Time frame: 3 months

    Disability related to low back pain measured using the Oswestry Disability Index (ODI). Scores range from 0 to 100, where higher scores indicate greater disability and worse functional outcome.

Secondary outcomes

  1. Quebec Back Pain Disability Scale

    Time frame: 3 Months

    Functional disability measured using the Quebec Back Pain Disability Scale (QBPDS). Scores range from 0 to 100, where higher scores indicate greater disability and a worse outcome.

  2. SF-12 Health Survey

    Time frame: 3 months

    Health-related quality of life measured using the 12-Item Short Form Health Survey (SF-12). Scores range from 0 to 100 for the Physical Component Summary (PCS) and Mental Component Summary (MCS), where higher scores indicate better health-related quality of life and a better outcome.

  3. Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: 3 months

    Physical disability measured using the Roland-Morris Disability Questionnaire (RMDQ). Scores range from 0 to 24, with higher scores indicating greater disability and a worse outcome.

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

Global Myofascial Treatment With Focused Shockwave for Non-Specific Low Back Pain: a Randomized Control Trial.

Important dates

Study start
2022
Primary completion
2022
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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