Low Back PainNCT01928784
Radial Extracorporeal Shock Wave Therapy on Chronic Low Back Pain: a Prospective Controlled Study
A study testing Radial Extracorporeal Shock Wave Therapy 2000 impulses and Radial Extracorporeal Shock Wave Therapy 4000 impulses in people with Low Back Pain, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
The aim of this prospective study is to explore the pain-alleviating effect of low-energy extracorporeal shock wave therapy(ESWT) in patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Radial Extracorporeal Shock Wave Therapy 2000 impulses and Radial Extracorporeal Shock Wave Therapy 4000 impulses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Sep 2013
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptom of low back pain during last 4 weeks
- Low back pain history for more than 3 months
Who cannot join
- Have lower limbs radiating pain beyond knee joints
- Spinal tumorous or infectious disease, fracture, ankylosing spondylitis, cauda equina syndrome or other severe spinal diseases
- Spinal surgical history
- Severe heart, lung, liver, kidney disease or high blood pressure
- With cardiac pacemaker
- Coagulopathy or thrombosis
Show all 9Show fewer
- Have ESW therapy or pharmaceutical treatment for low back pain during last 1 months
- Mental illnesses or none cooperation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035
Yan An, MD, +86-13693163634, weilanersheng@sina.com
Yan An, MD
About this study
The aim of this prospective study is to explore the pain-alleviating effect of low-energy extracorporeal shock wave therapy(ESWT) in patients with chronic low back pain.
Read the detailed description
26 patients who suffered from persistent symptoms for more than 3 months are going to be treated with DOLORCLAST radial extracorporeal shock wave(EMS, Swiss). Patients are assigned to two groups according to the exist of specific pain spot. Group I(have specific pain spot) received a total of 2000 impulses of 2.5 Bar; group II(controls, no specific pain spot) 4000 impulses of 2.5 Bar. Patients is going to be treated once. The efficacy of therapy is going to be evaluated by VAS scale before and after the treatment.
- Conditions
- Low Back Pain
- Being tested
- Radial Extracorporeal Shock Wave Therapy 2000 impulses, Radial Extracorporeal Shock Wave Therapy 4000 impulses
- Keywords
- Low back pain, extracorporeal shock wave therapy, Trigger Points
- 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.
Radial Extracorporeal Shock Wave Therapy 2000 impulsesDevice
Also called SWISS DOLORCLAST® CLASSIC, EMS, Swiss
Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 2000 impulses
Radial Extracorporeal Shock Wave Therapy 4000 impulsesDevice
Also called SWISS DOLORCLAST® CLASSIC, EMS, Swiss
Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 4000 impulses
| Study group | Role | What they receive |
|---|---|---|
| Specific pain spot | Experimental | Radial Extracorporeal Shock Wave Therapy 2000 impulses, Patients with specific pain spot for low back pain Receives: Device: Radial Extracorporeal Shock Wave Therapy 2000 impulses |
| No specific pain spot | Experimental | Radial Extracorporeal Shock Wave Therapy 4000 impulses, Patients without specific pain spot for low back pain Receives: Device: Radial Extracorporeal Shock Wave Therapy 4000 impulses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual analogue scale scores(VAS) of patients before and after therapy
Change of Visual analogue scale score(VAS) of patients before and after shock wave therapy
Measured: baseline, 1 hour after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2013 (estimated)
- Study completionSep 2013 (estimated)
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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Zeng, Beijing Jishuitan Hospital
- Investigators
- Yajun Liu, MD, Study director, Beijing Jishuitan HospitalYan An, MD, Principal investigator, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928784
- Sponsor's protocol ID
- SW-LBP-01
- Status last verified
- Aug 2013
- First submitted
- 21 Aug 2013
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
PubMed 21982256Dagenais S, Tricco AC, Haldeman S. Synthesis of recommendations for the assessment and management of low back pain from recent clinical practice guidelines. Spine J. 2010 Jun;10(6):514-29. doi: 10.1016/j.spinee.2010.03.032.
PubMed 20494814
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Extracorporeal Shock Wave Therapy on Chronic Low Back Pain: a Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT01928784
- Acronym / sponsor ID
- SW-LBP-01
- Conditions
- Low Back Pain
- Keywords
- Low back pain, extracorporeal shock wave therapy, Trigger Points
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 27 Aug 2013 (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 aim of this prospective study is to explore the pain-alleviating effect of low-energy extracorporeal shock wave therapy(ESWT) in patients with chronic low back pain.
Detailed description
26 patients who suffered from persistent symptoms for more than 3 months are going to be treated with DOLORCLAST radial extracorporeal shock wave(EMS, Swiss). Patients are assigned to two groups according to the exist of specific pain spot. Group I(have specific pain spot) received a total of 2000 impulses of 2.5 Bar; group II(controls, no specific pain spot) 4000 impulses of 2.5 Bar. Patients is going to be treated once. The efficacy of therapy is going to be evaluated by VAS scale before and after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific pain spot | Experimental | Device: Radial Extracorporeal Shock Wave Therapy 2000 impulsesRadial Extracorporeal Shock Wave Therapy 2000 impulses, Patients with specific pain spot for low back pain |
| No specific pain spot | Experimental | Device: Radial Extracorporeal Shock Wave Therapy 4000 impulsesRadial Extracorporeal Shock Wave Therapy 4000 impulses, Patients without specific pain spot for low back pain |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Symptom of low back pain during last 4 weeks
- Low back pain history for more than 3 months
Key exclusion criteria (9 listed)
- Have lower limbs radiating pain beyond knee joints
- Spinal tumorous or infectious disease, fracture, ankylosing spondylitis, cauda equina syndrome or other severe spinal diseases
- Spinal surgical history
- Severe heart, lung, liver, kidney disease or high blood pressure
- With cardiac pacemaker
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 Shock Wave Therapy 2000 impulsesAlso: SWISS DOLORCLAST® CLASSIC, EMS, SwissRadial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 2000 impulses | Device | Specific pain spot |
| Radial Extracorporeal Shock Wave Therapy 4000 impulsesAlso: SWISS DOLORCLAST® CLASSIC, EMS, SwissRadial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 4000 impulses | Device | No specific pain spot |
Primary outcome
Change in Visual analogue scale scores(VAS) of patients before and after therapy
Time frame: baseline, 1 hour after therapy
Change of Visual analogue scale score(VAS) of patients before and after shock wave therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2013.
- Background: PubMed 21982256Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
- Background: PubMed 20494814Dagenais S, Tricco AC, Haldeman S. Synthesis of recommendations for the assessment and management of low back pain from recent clinical practice guidelines. Spine J. 2010 Jun;10(6):514-29. doi: 10.1016/j.spinee.2010.03.032.
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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.
Yajun Liu, MD study director
Beijing Jishuitan Hospital
Yan An, MD principal investigator
Beijing Jishuitan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Extracorporeal Shock Wave Therapy 2000 impulses and Radial Extracorporeal Shock Wave Therapy 4000 impulses in people with Low Back Pain, run by Beijing Jishuitan Hospital at 1 site in China.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 27 Aug 2013. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Tian, MD (+86-010-58516688, drliuyajun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual analogue scale scores(VAS) of patients before and after therapy (time frame: baseline, 1 hour after therapy). 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 NCT01928784, 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 27 Aug 2013.