Low Back PainNCT07692347
Global Myofascial Treatment With Shockwave for Non-Specific Low Back Pain
A study testing Shockwave therapy and Conventional physiotherapy in people with Low Back Pain, run by University Hospital Muenster at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Shockwave therapy and Conventional physiotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2022to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Muskuloskelettale Medizin (IMM) Abteilung für Regenerative Muskuloskelettale Medizin
Münster, North Rhine-Westphalia, 48149
About this study
Official title: Global Myofascial Treatment With Focused Shockwave for Non-Specific Low Back Pain: a Randomized Control Trial.
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.
Read more
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.
- Conditions
- Low Back Pain
- Being tested
- Shockwave therapy, Conventional physiotherapy
- Keywords
- low back pain, chronic low back pain, shockwave
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave therapyDevice
Shockwave therapy can stimulate these trigger points, potentially leading to muscle and fascia relaxation and, as a result, a decrease in pain.
Conventional physiotherapyProcedure or surgery
Conventional physiotherapy to treat low back pain
| Study group | Role | What they receive |
|---|---|---|
| shockwave therapy | Experimental | Not described Receives: Device: Shockwave therapy |
| conventional manual physiotherapy | Placebo comparator | Not described Receives: Procedure: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Secondary outcomes (3)
Quebec Back Pain Disability Scale
Functional disability measured using the Quebec Back Pain Disability Scale (QBPDS). Scores range from 0 to 100, where higher scores indicate greater disability and a worse outcome.
Measured: 3 Months
SF-12 Health Survey
Health-related quality of life measured using the 12-Item Short Form Health Survey (SF-12). Scores range from 0 to 100 for the Physical Component Summary (PCS) and Mental Component Summary (MCS), where higher scores indicate better health-related quality of life and a better outcome.
Measured: 3 months
Roland-Morris Disability Questionnaire (RMDQ)
Physical disability measured using the Roland-Morris Disability Questionnaire (RMDQ). Scores range from 0 to 24, with higher scores indicating greater disability and a worse outcome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Aug 2022
- Primary completion31 Dec 2022
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Stange, Prof., Study director, Institut für Muskuloskelettale Medizin (IMM) Abteilung für Muskuloskelettale Regenerative Medizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692347
- Sponsor's protocol ID
- 2022-303-f-S
- Status last verified
- Apr 2026
- First submitted
- 2 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD planed
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Myofascial Treatment With Focused Shockwave for Non-Specific Low Back Pain: a Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT07692347
- Acronym / sponsor ID
- 2022-303-f-S
- Conditions
- Low Back Pain
- Keywords
- low back pain, chronic low back pain, shockwave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 9 Jul 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| shockwave therapy | Experimental | Device: Shockwave therapy |
| conventional manual physiotherapy | Placebo comparator | Procedure: Conventional physiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
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 |
|---|---|---|
| Shockwave therapyShockwave therapy can stimulate these trigger points, potentially leading to muscle and fascia relaxation and, as a result, a decrease in pain. | Device | shockwave therapy |
| Conventional physiotherapyConventional physiotherapy to treat low back pain | Procedure or surgery | conventional manual physiotherapy |
Primary outcome
Visual Analog Scale for Pain
Time frame: 3 months
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.
Oswestry Disability Index
Time frame: 3 months
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 secondary outcomes
Quebec Back Pain Disability Scale
Time frame: 3 Months
SF-12 Health Survey
Time frame: 3 months
Roland-Morris Disability Questionnaire (RMDQ)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No. No IPD planed
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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.
Richard Stange, Prof. study director
Institut für Muskuloskelettale Medizin (IMM) Abteilung für Muskuloskelettale Regenerative Medizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave therapy and Conventional physiotherapy in people with Low Back Pain, run by University Hospital Muenster at 1 site in Germany.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 16 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analog Scale for Pain (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2026.