Acute Low Back Pain (Low Back Pain for Less Than 3 Months)NCT02253771
Shockwave Therapy for Acute Low Back Pain
A study testing shockwave therapy in people with Acute Low Back Pain (Low Back Pain for Less Than 3 Months), run by University Hospital Muenster at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether shockwave therapy is more effective in the treatment of unspecific acute low back pain than sham therapy. 60 patients with acute low back pain will be recruited to a single-blinded, randomized, placebo-controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Low Back Pain (Low Back Pain for Less Than 3 Months)
- What is being tested?
- shockwave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteGermany
- Study dates
- 8 Nov 2017to 15 Jan 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- low back pain for less than 3 months
Who cannot join
- Patients with relevant leg pain
- Patients with spine operations in the past
- neurologic symptoms
- scoliosis with Cobb angle > 10°
- Patients experienced in shock wave therapy
- Patientes with ongoing therapy with blood diluting drugs such as phenprocumon
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- Patients with osteoporosis
- Patients with back pain after trauma
- Patients with infective diseases or tumor diseases
- Patients with relevant psychological diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie
Münster, North Rhine-Westphalia, 48149
About this study
Official title: Shockwave Therapy for Acute Low Back Pain: a Randomized Placebo-controlled Clinical Trial
The purpose of this study is to determine whether shockwave therapy is more effective in the treatment of unspecific acute low back pain than sham therapy.
60 patients with acute low back pain will be recruited to a single-blinded, randomized, placebo-controlled trial. They are randomized to receive either shockwave therapy or sham treatment by a identically looking device for 4 weeks, twice a week. Additionally patients receive physiotherapy twice a week and are allowed to take an anti-inflammatory drug, if necessary for even 4 weeks. The primary outcome variable will be measured at day 0, every week during treatment (day 7; 14; 21 and 28) and up to 4 weeks after the last treatment. The clinical outcome will be primarily measured by pain intensity using a visual analogue scale. Secondary outcome measures are Oswestry Disability Index, Beck's Pain Depression Scale, Roland Morris Disability Questionnaire and the EQ-5D. Data will be analysed for the difference in change of scores between groups using one-way t-test.
- Being tested
- shockwave therapy, placebo shockwave therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shockwave therapyDevice
Also called EMS Swiss Dolorclast® Classic (EMS Electro Medical Systems S.a.), CE Certificate: 0124
Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week
placebo shockwave therapyDevice
sham shockwave therapy by an identically looking device without any function
| Study group | Role | What they receive |
|---|---|---|
| shockwave therapy | Experimental | shockwave therapy Receives: Device: shockwave therapy |
| Placebo treatment | Placebo comparator | sham shockwave therapy by an identically looking device without any function Receives: Device: placebo shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain, using visual analogue scale (VAS)
Change in pain, using visual analogue scale (VAS 1-10)
Measured: Day 0; 7; 14; 21; 28, after 6 and 8 weeks.
Secondary outcomes (4)
Change in other clinical questionnaires (Oswestry disability Index)
Oswestry disability Index
Measured: day 0; 7; 14; 21, after 6 and 8 weeks.
Change in other clinical questionnaires (Beck's depression scale)
Beck's depression scale
Measured: day 0; 7; 14; 21, after 6 and 8 weeks.
Change in other clinical questionnaires (EQ-5D)
EQ-5D
Measured: day 0; 7; 14; 21, after 6 and 8 weeks.
Change in other clinical questionnaires (Roland-Morris-Score)
Roland-Morris-Score
Measured: day 0; 7; 14; 21, after 6 and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study start8 Nov 2017
- Primary completion13 Sep 2018
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Low Back Pain (Low Back Pain for Less Than 3 Months)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
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niklas Deventer, University Hospital Muenster
- Investigators
- Niklas Deventer, Dr. med., Principal investigator, Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und TumororthopädieTobias Schulte, Prof. Dr. med., Study director, Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University BochumTobias Lange, Dr. med., MBA, Principal investigator, Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253771
- Sponsor's protocol ID
- Orth-001
- Status last verified
- Jan 2021
- First submitted
- 31 Aug 2014
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barker KL, Elliott CJ, Sackley CM, Fairbank JC. Treatment of chronic back pain by sensory discrimination training. A Phase I RCT of a novel device (FairMed) vs. TENS. BMC Musculoskelet Disord. 2008 Jun 28;9:97. doi: 10.1186/1471-2474-9-97.
PubMed 18588702Seco J, Kovacs FM, Urrutia G. The efficacy, safety, effectiveness, and cost-effectiveness of ultrasound and shock wave therapies for low back pain: a systematic review. Spine J. 2011 Oct;11(10):966-77. doi: 10.1016/j.spinee.2011.02.002. Epub 2011 Apr 9.
PubMed 21482199
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shockwave Therapy for Acute Low Back Pain: a Randomized Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02253771
- Acronym / sponsor ID
- Orth-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 1 Oct 2014 (estimated)
- 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.
The purpose of this study is to determine whether shockwave therapy is more effective in the treatment of unspecific acute low back pain than sham therapy.
60 patients with acute low back pain will be recruited to a single-blinded, randomized, placebo-controlled trial. They are randomized to receive either shockwave therapy or sham treatment by a identically looking device for 4 weeks, twice a week. Additionally patients receive physiotherapy twice a week and are allowed to take an anti-inflammatory drug, if necessary for even 4 weeks. The primary outcome variable will be measured at day 0, every week during treatment (day 7; 14; 21 and 28) and up to 4 weeks after the last treatment. The clinical outcome will be primarily measured by pain intensity using a visual analogue scale. Secondary outcome measures are Oswestry Disability Index, Beck's Pain Depression Scale, Roland Morris Disability Questionnaire and the EQ-5D. Data will be analysed for the difference in change of scores between groups using one-way t-test.
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 therapyshockwave therapy |
| Placebo treatment | Placebo comparator | Device: placebo shockwave therapysham shockwave therapy by an identically looking device without any function |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- low back pain for less than 3 months
Key exclusion criteria (10 listed)
- Patients with relevant leg pain
- Patients with spine operations in the past
- neurologic symptoms
- scoliosis with Cobb angle > 10°
- Patients experienced in shock wave therapy
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 therapyAlso: EMS Swiss Dolorclast® Classic (EMS Electro Medical Systems S.a.), CE Certificate: 0124Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week | Device | shockwave therapy |
| placebo shockwave therapysham shockwave therapy by an identically looking device without any function | Device | Placebo treatment |
Primary outcome
Change in pain, using visual analogue scale (VAS)
Time frame: Day 0; 7; 14; 21; 28, after 6 and 8 weeks.
Change in pain, using visual analogue scale (VAS 1-10)
4 secondary outcomes
Change in other clinical questionnaires (Oswestry disability Index)
Time frame: day 0; 7; 14; 21, after 6 and 8 weeks.
Change in other clinical questionnaires (Beck's depression scale)
Time frame: day 0; 7; 14; 21, after 6 and 8 weeks.
Change in other clinical questionnaires (EQ-5D)
Time frame: day 0; 7; 14; 21, after 6 and 8 weeks.
Change in other clinical questionnaires (Roland-Morris-Score)
Time frame: day 0; 7; 14; 21, after 6 and 8 weeks.
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 2 Feb 2021.
- Background: PubMed 18588702Barker KL, Elliott CJ, Sackley CM, Fairbank JC. Treatment of chronic back pain by sensory discrimination training. A Phase I RCT of a novel device (FairMed) vs. TENS. BMC Musculoskelet Disord. 2008 Jun 28;9:97. doi: 10.1186/1471-2474-9-97.
- Background: PubMed 21482199Seco J, Kovacs FM, Urrutia G. The efficacy, safety, effectiveness, and cost-effectiveness of ultrasound and shock wave therapies for low back pain: a systematic review. Spine J. 2011 Oct;11(10):966-77. doi: 10.1016/j.spinee.2011.02.002. Epub 2011 Apr 9.
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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.
Niklas Deventer, Dr. med. principal investigator
Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie
Tobias Schulte, Prof. Dr. med. study director
Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum
Tobias Lange, Dr. med., MBA principal investigator
Department of Orthopaedics and Trauma Surgery, University 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?
A study testing shockwave therapy in people with Acute Low Back Pain (Low Back Pain for Less Than 3 Months), 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 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: finished, as of the sponsor's last update on 2 Feb 2021. 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?
Change in pain, using visual analogue scale (VAS) (time frame: Day 0; 7; 14; 21; 28, after 6 and 8 weeks.). 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 NCT02253771, which also lists 2 linked publications.
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 2 Feb 2021.