NCT07692347

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Aug 2022

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
Last Updated

July 16, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

July 2, 2026

Last Update Submit

July 14, 2026

Conditions

Low Back Pain

Keywords

low back painchronic low back painshockwave

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale for Pain

    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.

    3 months

  • Oswestry Disability Index

    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.

    3 months

Secondary Outcomes (3)

  • Quebec Back Pain Disability Scale

    3 Months

  • SF-12 Health Survey

    3 months

  • Roland-Morris Disability Questionnaire (RMDQ)

    3 months

Study Arms (2)

shockwave therapy

EXPERIMENTAL
Device: Shockwave therapy

conventional manual physiotherapy

PLACEBO COMPARATOR
Procedure: Conventional physiotherapy

Interventions

Shockwave therapyDEVICE

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

shockwave therapy
Conventional physiotherapyPROCEDURE

Conventional physiotherapy to treat low back pain

conventional manual physiotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Richard Stange, Prof.

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 9, 2026

Study Start

August 1, 2022

Primary Completion

December 31, 2022

Study Completion

April 15, 2026

Last Updated

July 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

No IPD planed

Locations

DE(1)