MedDataX Logo

Radial Extracorporeal Shock Wave Therapy on Chronic Low Back Pain: a Prospective Controlled Study

NCT ID: NCT01928784

Last Updated: 2013-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Low back pain extracorporeal shock wave therapy Trigger Points

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Specific pain spot

Radial Extracorporeal Shock Wave Therapy 2000 impulses, Patients with specific pain spot for low back pain

Group Type EXPERIMENTAL

Radial Extracorporeal Shock Wave Therapy 2000 impulses

Intervention Type DEVICE

Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 2000 impulses

No specific pain spot

Radial Extracorporeal Shock Wave Therapy 4000 impulses, Patients without specific pain spot for low back pain

Group Type EXPERIMENTAL

Radial Extracorporeal Shock Wave Therapy 4000 impulses

Intervention Type DEVICE

Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 4000 impulses

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radial Extracorporeal Shock Wave Therapy 2000 impulses

Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 2000 impulses

Intervention Type DEVICE

Radial Extracorporeal Shock Wave Therapy 4000 impulses

Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 4000 impulses

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SWISS DOLORCLAST® CLASSIC, EMS, Swiss SWISS DOLORCLAST® CLASSIC, EMS, Swiss

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Symptom of low back pain during last 4 weeks
* Low back pain history for more than 3 months

Exclusion Criteria

* 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
* Have ESW therapy or pharmaceutical treatment for low back pain during last 1 months
* Mental illnesses or none cooperation
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Jishuitan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cheng Zeng

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yajun Liu, MD

Role: STUDY_DIRECTOR

Beijing Jishuitan Hospital

Yan An, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Jishuitan Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wei Tian, MD

Role: CONTACT

Phone: +86-010-58516688

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yan An, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21982256 (View on PubMed)

Dagenais 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.

Reference Type BACKGROUND
PMID: 20494814 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SW-LBP-01

Identifier Type: -

Identifier Source: org_study_id