NCT03386084

Brief Summary

Lumbar pain is considered one of the most frequent health problems faced by human populations on a global scale. This study will be carried out to evaluate the efficiency of motor control treatments combined with diathermy in patients diagnosed with acute lower back pain, focusing upon the potential for accelerated patient recuperation if both treatments are applied simultaneously and jointly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable low-back-pain

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

November 29, 2017

Last Update Submit

June 2, 2018

Conditions

Keywords

capacitive resistive diathermymotor control

Outcome Measures

Primary Outcomes (1)

  • Pain

    An unpleasant sensation induced by noxious stimuli which are detected by nerve endings of nociceptive neurons. The measurement tool that will be used is Visual Analog Scale. This scale is a unidimensional measure of pain intensity. It has a continuous scale comprised of a horizontal line with an interval of 10 points, where 1 is the minimum intensity of pain the patient can endure and 10 is the maximum intensity of pain the patient can endure.

    4 weeks

Secondary Outcomes (2)

  • Disability

    4 weeks

  • Satisfaction

    4 weeks

Study Arms (2)

direct application of microwave diathermy and motor control

EXPERIMENTAL
Device: microwave diathermy

application of microwave diathermy without therapeutic effects

PLACEBO COMPARATOR
Device: microwave diathermy

Interventions

Application of microwave diathermy with Monopolar CapacitiveResistive Radiofrequency Therapy (INDIBA)

application of microwave diathermy without therapeutic effectsdirect application of microwave diathermy and motor control

Eligibility Criteria

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

You may qualify if:

  • Acute low back pain (no more of 4 weeks)
  • Spanish speaker
  • Between 18-65 years

You may not qualify if:

  • Patients in whom diathermy is a contraindicated therapy
  • Pacemaker
  • Pregnant
  • Not intact skin
  • Thrombophlebitis
  • Hypotension
  • Anticoagulated patient or with local surgical intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FisioWork

San Sebastián de los Reyes, Madrid, 28703, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 29, 2017

Study Start

January 10, 2018

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

June 6, 2018

Record last verified: 2018-06

Locations