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

July 2, 2026 updated by: University Hospital Muenster

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Institut für Muskuloskelettale Medizin (IMM) Abteilung für Regenerative Muskuloskelettale Medizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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, and 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; for example, existing radicular symptoms (e.g., foot drop).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: shockwave therapy
Device: Shockwave therapy
Shockwave therapy can stimulate these trigger points, potentially leading to muscle and fascia relaxation and, as a result, a decrease in pain.
Placebo Comparator: conventional manual physiotherapy
Procedure: Conventional physiotherapy
Conventional physiotherapy to treat low back pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: 3 months
Pain measurement
3 months
Oswestry Disability Index
Time Frame: 3 months
Mobility
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quebec Back Pain Disability Scale
Time Frame: 3 Months
Pain and Mobility
3 Months
SF-12 Health Survey
Time Frame: 3 months
Quality of life
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Investigators

  • Study Director: Richard Stange, Prof., Institut für Muskuloskelettale Medizin (IMM) Abteilung für Muskuloskelettale Regenerative Medizin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

April 15, 2026

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-303-f-S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD planed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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