NCT01835795

Brief Summary

The purpose of this study is to evaluate the efficacy of treatment of radial shockwave in myofascial pain syndrome in the lumbar region compared to placebo through questionnaires and imaging exams.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2019

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

5.2 years

First QC Date

April 14, 2013

Last Update Submit

April 27, 2019

Conditions

Myofascial Pain SyndromesLow Back PainLumbago

Keywords

Myofascial Pain SyndromesMyofascial Trigger PointLow Back PainLumbagoShock Waves, High-EnergyHigh-Energy Shock WavesInterdisciplinary Health TeamMultidisciplinary Pain Centers

Outcome Measures

Primary Outcomes (1)

  • Evidence of pain relief by visual analogue scale (VAS) of radial extracorporeal shock waves in myofascial pain syndrome in the lumbar and gluteal region compared to placebo

    The outcome will be assessed by Visual Analogue Scale (VAS)

    12 weeks after the last session of shockwave

Study Arms (2)

Radial Extracorporeal Shock Wave

ACTIVE COMPARATOR

Swiss DolorClast® CLASSIC applicator

Device: Swiss DolorClast® CLASSIC applicator

Placebo

PLACEBO COMPARATOR

Swiss DolorClast® CLASSIC placebo applicator

Device: Swiss DolorClast® CLASSIC placebo applicator

Interventions

Swiss DolorClast® CLASSIC applicatorDEVICE

Radial Extracorporeal Shock Wave applicator use in 6 sessions with 1 week of interval, 1000 impulses per myofascial trigger point, 5 to 7 hertz frequency, 2 to 4 bar pressure

Radial Extracorporeal Shock Wave
Swiss DolorClast® CLASSIC placebo applicatorDEVICE

Placebo applicator, use in 6 sessions with 1 week of interval, 1000 impulses per myofascial trigger point, 5 to 7 hertz frequency, 2 to 4 bar pressure

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presenting clinical complaints of lumbar and / or gluteal pains for 3 months or more
  • Display pain of moderate to severe intensity: visual analogue scale (VAS)\> 4
  • Diagnosis of myofascial pain syndrome in the lumbar and / or gluteal
  • Authorize in writing the term of free and informed consent to participate in the study
  • Availability of frequent attendance at hospital

You may not qualify if:

  • Organic or psychological disorders that contraindication participation of patients in study
  • Metabolic, infectious, oncological or rheumatologic disorders
  • Fibromyalgia
  • Labor dispute
  • Indication for surgery in column
  • Contraindications to therapy of shock waves:
  • Coagulopathy and / or anticoagulant
  • Pregnancy
  • Acute infection in soft tissue or bone
  • Systemic Infections
  • Presence of ulcers at treatment sites
  • Presence of larger vessels or nerves at treatment sites
  • Polyneuropathies
  • Malignancies
  • Cardiac arrhythmias or use of pacemaker
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Myofascial Pain SyndromesLow Back Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ricardo Kobayashi

    IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher and Collaborator of Pain Group

Study Record Dates

First Submitted

April 14, 2013

First Posted

April 19, 2013

Study Start

January 7, 2013

Primary Completion

March 19, 2018

Study Completion

January 18, 2019

Last Updated

April 30, 2019

Record last verified: 2019-04

Locations

BR(1)