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NCT Number: NCT05308641

Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients With Chronic Low Back Pain

Analysis of the effectiveness of radial shock wave therapy as part of a multimodal pain therapy in the inpatient setting. Different therapy protocols are compared in previously non-operated and in previously operated patients.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Low-back Pain (cLBP)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik Blankenstein

Hattingen, 45527, Germany

About this study

Radial shock wave therapy is an approved pain therapy procedure that has been used in various degenerative orthopedic diseases for years. There are a few studies on the subject of chronic back pain. Some studies suggest that this method can be used sensibly. A direct comparison of different therapy protocols has not been carried out so far.

As part of inpatient multimodal pain therapy (including infiltration and physiotherapy) in patients with chronic lumbar back pain with or without degenerative surgery in the area of the lumbar spine radial shock wave therapy after a specific protocol is used. Only inpatients will be admitted to the study. All patients are informed verbally and give their written consent. Comprehensive patient information will be provided before the start of the study, handed out and explained as part of the information discussion. There will be 2 groups ((a) patients with previous degenerative surgery in the area of the lumbar spine, (b) patients without such a pre-operation) examined each with 4 sub-groups depending of the different therapy protocols.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • chronic lumbar back pain of min 3 months duration

Exclusion criteria

  • radicular pain of higher intensity than chronic low back pain (cLBP)
  • new neurologic deficits
  • anticoagulant therapy
  • new trauma to the lumbar spine
  • spine bacterial infection
  • spine tumor
  • pregnancy
  • coagulation disorder
  • previous infiltration to the lumbar spine within 6 weeks prior to study inclusion
  • fibromyalgia

Treatment and study plan

radial extracorporeal shockwave therapy_4000_20

Procedure

application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz

radial extracorporeal shockwave therapy_500_2

Procedure

application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz

standard multimodal pain therapy

Procedure

standard multimodal pain therapy

Primary outcomes

  1. change in Numeric Rating Scale (NRS)

    Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months

    Pain intensity measured by Numeric Rating Scale (NRS)

    • 11-point scale / min. 0 (better outcome) / max. 10 (worse outcome)

Secondary outcomes

  1. change in Oswestry Disability Index (ODI)

    Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months

    Oswestry Disability Index (ODI)

  2. change in European Quality of Life 5 Dimensions (EQ5D)

    Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months

    European Quality of Life 5 Dimensions (EQ5D)

  3. change in Pain Self-Efficacy Questionnaire (PSEQ)

    Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months

    Pain Self-Efficacy Questionnaire (PSEQ)

  4. change in Patient Health Questionnaire-9 (PHQ-9)

    Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months

    Patient Health Questionnaire-9 (PHQ-9)

  5. change in Perseverative Thinking Questionnaire (PTQ)

    Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months

    Perseverative Thinking Questionnaire (PTQ)

  6. change in Patient Specific Functional Scale (PSFS)

    Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months

    Patient Specific Functional Scale (PSFS)

    • five daily important activities are rated on a 11-point scale
    • min. 0 (worse outcome) / max. 10 (better outcome)

  7. change in The World Health Organisation- Five Well-Being Index (WHO-5)

    Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months

    The World Health Organisation- Five Well-Being Index (WHO-5)

  8. change in Big Five Inventory-SocioOeconomicPanel (BFI-S)

    Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months

    Big Five Inventory-SocioOeconomicPanel (BFI-S)

  9. change in Questionnaire Subgroups for Targeted Treatment (STarT-G)

    Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months

    Subgroups for Targeted Treatment (STarT-G)

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients With Chronic Low Back Pain - Randomized Controlled Trial

Acronym: ShockEffect

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Apr 4, 2022
Registry last updated
Apr 6, 2025

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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