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

NCT05308641 | Active Not Recruiting

• 1 other identifier: 1_1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low-back Pain (cLBP)

Keywords

radial shockwave therapy; chronic low back pain

Outcome Measures

Primary Outcomes (1)

• change in Numeric Rating Scale (NRS)

  Pain intensity measured by Numeric Rating Scale (NRS) \- 11-point scale / min. 0 (better outcome) / max. 10 (worse outcome)

  pre-intervention, 2 weeks, 1 month, 3 months, 6 months

Secondary Outcomes (9)

• change in Oswestry Disability Index (ODI)

  pre-intervention, 2 weeks, 1 month, 3 months, 6 months

• change in European Quality of Life 5 Dimensions (EQ5D)

  pre-intervention, 2 weeks, 1 month, 3 months, 6 months

• change in Pain Self-Efficacy Questionnaire (PSEQ)

  pre-intervention, 2 weeks, 1 month, 3 months, 6 months

• change in Patient Health Questionnaire-9 (PHQ-9)

  pre-intervention, 2 weeks, 1 month, 3 months, 6 months

• change in Perseverative Thinking Questionnaire (PTQ)

  pre-intervention, 2 weeks, 1 month, 3 months, 6 months

Study Arms (8)

PreviousSurgery(PrevSurg)_YES/rESWT_4000

ACTIVE COMPARATOR

Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 4000 pulse, 20 Hz

Procedure: radial extracorporeal shockwave therapy_4000_20; Procedure: standard multimodal pain therapy

PrevSurg_YES/rESWT_500

ACTIVE COMPARATOR

Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 500 pulse, 2 Hz

Procedure: radial extracorporeal shockwave therapy_500_2; Procedure: standard multimodal pain therapy

PrevSurg_YES/rESWT_no

ACTIVE COMPARATOR

Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: no

Procedure: standard multimodal pain therapy

PrevSurg_YES/rESWT_deny

ACTIVE COMPARATOR

Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: denied

Procedure: standard multimodal pain therapy

PrevSurg_NO/rESWT_4000

ACTIVE COMPARATOR

Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 4000 pulse, 20 Hz

Procedure: radial extracorporeal shockwave therapy_4000_20; Procedure: standard multimodal pain therapy

PrevSurg_NO/rESWT_500

ACTIVE COMPARATOR

Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: 500 pulse, 2 Hz

Procedure: radial extracorporeal shockwave therapy_500_2; Procedure: standard multimodal pain therapy

PrevSurg_NO/rESWT_no

ACTIVE COMPARATOR

Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: no

Procedure: standard multimodal pain therapy

PrevSurg_NO/rESWT_deny

ACTIVE COMPARATOR

Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: denied

Procedure: standard multimodal pain therapy

Interventions

radial extracorporeal shockwave therapy_4000_20 PROCEDURE

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

PrevSurg_NO/rESWT_4000; PreviousSurgery(PrevSurg)_YES/rESWT_4000

radial extracorporeal shockwave therapy_500_2 PROCEDURE

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

PrevSurg_NO/rESWT_500; PrevSurg_YES/rESWT_500

standard multimodal pain therapy PROCEDURE

standard multimodal pain therapy

PrevSurg_NO/rESWT_4000; PrevSurg_NO/rESWT_500; PrevSurg_NO/rESWT_deny; PrevSurg_NO/rESWT_no; PrevSurg_YES/rESWT_500; PrevSurg_YES/rESWT_deny; PrevSurg_YES/rESWT_no; PreviousSurgery(PrevSurg)_YES/rESWT_4000

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic lumbar back pain of min 3 months duration

You may not qualify if:

• 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
• fibromyalgia

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Klinik Blankenstein

Hattingen, 45527, Germany

Location

Related Publications (1)

• Lange T, Deventer N, Gosheger G, Lampe LP, Bockholt S, Schulze Boevingloh A, Schulte TL. Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain-Randomized Controlled Trial. J Clin Med. 2021 Nov 26;10(23):5569. doi: 10.3390/jcm10235569.

  PMID: 34884271 RESULT

Related Links

• Related Info

Study Officials

• Tobias L Schulte, Prof

  Department of Orthopaedics and Trauma Surgery, St. Josef-Hospital, Ruhr-University Bochum

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 4, 2022
• Study Start: September 18, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 7, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

DE (1)