Chronic Low-back Pain (cLBP)ShockEffectNCT05308641

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

A study testing radial extracorporeal shockwave therapy_4000_20, radial extracorporeal shockwave therapy_500_2 and standard multimodal pain therapy in people with Chronic Low-back Pain (cLBP), run by Ruhr University of Bochum at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Chronic Low-back Pain (cLBP)
What is being tested?: radial extracorporeal shockwave therapy_4000_20, radial extracorporeal shockwave therapy_500_2 and standard multimodal pain therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 1 siteGermany
Study dates: 18 Sep 2022to 7 Dec 2025
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

chronic lumbar back pain of min 3 months duration

Who cannot join

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

Show all 10Show fewer

pregnancy
coagulation disorder
previous infiltration to the lumbar spine within 6 weeks prior to study inclusion
fibromyalgia

Trial locations and contacts

1 site in 1 country.

Germany1 site

Klinik Blankenstein
Hattingen, 45527

Other trials in Germany

About this study

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

Read the detailed description

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.

Conditions: Chronic Low-back Pain (cLBP)
Being tested: radial extracorporeal shockwave therapy_4000_20, radial extracorporeal shockwave therapy_500_2, standard multimodal pain therapy
Keywords: radial shockwave therapy, chronic low back pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

radial extracorporeal shockwave therapy_4000_20Procedure or surgery
application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz
radial extracorporeal shockwave therapy_500_2Procedure or surgery
application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz
standard multimodal pain therapyProcedure or surgery
standard multimodal pain therapy

Study groups in NCT05308641
Study group	Role	What they receive
PreviousSurgery(PrevSurg)_YES/rESWT_4000	Active comparator	Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: 4000 pulse, 20 Hz Receives: 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 Receives: 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 Receives: Procedure: standard multimodal pain therapy
PrevSurg_YES/rESWT_deny	Active comparator	Previous Surgery on degenerative pathology in lumbar spine: YES rESWT: denied Receives: 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 Receives: 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 Receives: 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 Receives: Procedure: standard multimodal pain therapy
PrevSurg_NO/rESWT_deny	Active comparator	Previous Surgery on degenerative pathology in lumbar spine: NO rESWT: denied Receives: Procedure: standard multimodal pain therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: pre-intervention, 2 weeks, 1 month, 3 months, 6 months

Secondary outcomes (9)

change in Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI)
Measured: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in European Quality of Life 5 Dimensions (EQ5D)
European Quality of Life 5 Dimensions (EQ5D)
Measured: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Pain Self-Efficacy Questionnaire (PSEQ)
Pain Self-Efficacy Questionnaire (PSEQ)
Measured: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Patient Health Questionnaire-9 (PHQ-9)
Patient Health Questionnaire-9 (PHQ-9)
Measured: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Perseverative Thinking Questionnaire (PTQ)
Perseverative Thinking Questionnaire (PTQ)
Measured: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Patient Specific Functional Scale (PSFS)
Patient Specific Functional Scale (PSFS)
- five daily important activities are rated on a 11-point scale
- min. 0 (worse outcome) / max. 10 (better outcome)
Measured: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in The World Health Organisation- Five Well-Being Index (WHO-5)
The World Health Organisation- Five Well-Being Index (WHO-5)
Measured: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Big Five Inventory-SocioOeconomicPanel (BFI-S)
Big Five Inventory-SocioOeconomicPanel (BFI-S)
Measured: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Questionnaire Subgroups for Targeted Treatment (STarT-G)
Subgroups for Targeted Treatment (STarT-G)
Measured: pre-intervention, 2 weeks, 1 month, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Sep 20227 Dec 2025

First posted4 Apr 2022
Study start18 Sep 2022
Primary completion31 Dec 2024
Study completion7 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05308641
Sponsor's protocol ID: 1_1
Acronym: ShockEffect
Status last verified: Apr 2025
First submitted: 15 Mar 2022
Last updated: 6 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 34884271

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
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Effects of Myofascial Techniques on Chronic Low Back Pain
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All Chronic Low-back Pain (cLBP) trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients With Chronic Low Back Pain - Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05308641
Acronym / sponsor ID: ShockEffect / 1_1
Conditions: Chronic Low-back Pain (cLBP)
Keywords: radial shockwave therapy, chronic low back pain
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 400 participants (estimated)
Lead sponsor: Ruhr University of BochumUniversity, hospital or other
Study start: 18 Sep 2022 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 7 Dec 2025 (estimated)
First posted: 4 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 8

Arm	Type	Receives
PreviousSurgery(PrevSurg)_YES/rESWT_4000	Active comparator	Procedure: radial extracorporeal shockwave therapy_4000_20, Procedure: standard multimodal pain therapyPrevious Surgery on degenerative pathology in lumbar spine: YES rESWT: 4000 pulse, 20 Hz
PrevSurg_YES/rESWT_500	Active comparator	Procedure: radial extracorporeal shockwave therapy_500_2, Procedure: standard multimodal pain therapyPrevious Surgery on degenerative pathology in lumbar spine: YES rESWT: 500 pulse, 2 Hz
PrevSurg_YES/rESWT_no	Active comparator	Procedure: standard multimodal pain therapyPrevious Surgery on degenerative pathology in lumbar spine: YES rESWT: no
PrevSurg_YES/rESWT_deny	Active comparator	Procedure: standard multimodal pain therapyPrevious Surgery on degenerative pathology in lumbar spine: YES rESWT: denied
PrevSurg_NO/rESWT_4000	Active comparator	Procedure: radial extracorporeal shockwave therapy_4000_20, Procedure: standard multimodal pain therapyPrevious Surgery on degenerative pathology in lumbar spine: NO rESWT: 4000 pulse, 20 Hz
PrevSurg_NO/rESWT_500	Active comparator	Procedure: radial extracorporeal shockwave therapy_500_2, Procedure: standard multimodal pain therapyPrevious Surgery on degenerative pathology in lumbar spine: NO rESWT: 500 pulse, 2 Hz
PrevSurg_NO/rESWT_no	Active comparator	Procedure: standard multimodal pain therapyPrevious Surgery on degenerative pathology in lumbar spine: NO rESWT: no
PrevSurg_NO/rESWT_deny	Active comparator	Procedure: standard multimodal pain therapyPrevious Surgery on degenerative pathology in lumbar spine: NO rESWT: denied

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

chronic lumbar back pain of min 3 months duration

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
radial extracorporeal shockwave therapy_4000_20application of radial extracorporeal shockwave therapy (rESWT) with 4000 pulses and 20 Hz	Procedure or surgery	PrevSurg_NO/rESWT_4000, PreviousSurgery(PrevSurg)_YES/rESWT_4000
radial extracorporeal shockwave therapy_500_2application of radial extracorporeal shockwave therapy (rESWT) with 500 pulses and 2 Hz	Procedure or surgery	PrevSurg_NO/rESWT_500, PrevSurg_YES/rESWT_500
standard multimodal pain therapystandard multimodal pain therapy	Procedure or surgery	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

Primary outcome

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)

9 secondary outcomes

change in Oswestry Disability Index (ODI)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in European Quality of Life 5 Dimensions (EQ5D)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Perseverative Thinking Questionnaire (PTQ)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Patient Specific Functional Scale (PSFS)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in The World Health Organisation- Five Well-Being Index (WHO-5)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Big Five Inventory-SocioOeconomicPanel (BFI-S)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
change in Questionnaire Subgroups for Targeted Treatment (STarT-G)
Time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
Results publication: PubMed 34884271Lange 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.
Related InfoLink provided by the sponsor.

Related trials for Chronic Low-back Pain (cLBP)

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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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Recruiting
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Effects of Myofascial Techniques on Chronic Low Back Pain
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tobias L Schulte, Prof study director

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in Numeric Rating Scale (NRS) (time frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05308641, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.