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Efficacy of Motor Control and Diathermy Treatment in Acute Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
microwave diathermy
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring capacitive resistive diathermy, motor control

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • FisioWork

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

direct application of microwave diathermy and motor control

application of microwave diathermy without therapeutic effects

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Disability
Determination of the degree of a physical patient´s handicap. The measurement tool that will be used is Roland Morris Disability Questionnaire. This questionnaire is used to establish physical disability degree of people with non specific acute low back pain. It has 24 questions the patient should point out to determinate his/her limitation for make normal activities.
Satisfaction
To evaluate the assessment of the satisfaction regarding the attention and quality of the services received and the degree of compliance with the patient's expectations about the treatment. The measurement tool that will be used is Client Satisfaction Questionnaire. This questionnaire is used to evaluate patient's satisfaction with the care and quality of the health services received. It has 8 items from 1 to 4 points (where 1 is the minimum satisfaction and 4 is the maximum satisfaction) to assess the satisfaction degree.

Full Information

First Posted
November 29, 2017
Last Updated
June 2, 2018
Sponsor
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT03386084
Brief Title
Efficacy of Motor Control and Diathermy Treatment in Acute Low Back Pain
Official Title
Efficacy of Motor Control Treatment Combined With Resistive Capacitive Diathermy in Acute Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
capacitive resistive diathermy, motor control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
direct application of microwave diathermy and motor control
Arm Type
Experimental
Arm Title
application of microwave diathermy without therapeutic effects
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
microwave diathermy
Intervention Description
Application of microwave diathermy with Monopolar CapacitiveResistive Radiofrequency Therapy (INDIBA)
Primary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Disability
Description
Determination of the degree of a physical patient´s handicap. The measurement tool that will be used is Roland Morris Disability Questionnaire. This questionnaire is used to establish physical disability degree of people with non specific acute low back pain. It has 24 questions the patient should point out to determinate his/her limitation for make normal activities.
Time Frame
4 weeks
Title
Satisfaction
Description
To evaluate the assessment of the satisfaction regarding the attention and quality of the services received and the degree of compliance with the patient's expectations about the treatment. The measurement tool that will be used is Client Satisfaction Questionnaire. This questionnaire is used to evaluate patient's satisfaction with the care and quality of the health services received. It has 8 items from 1 to 4 points (where 1 is the minimum satisfaction and 4 is the maximum satisfaction) to assess the satisfaction degree.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute low back pain (no more of 4 weeks) Spanish speaker Between 18-65 years Exclusion Criteria: Patients in whom diathermy is a contraindicated therapy Pacemaker Pregnant Not intact skin Thrombophlebitis Hypotension Anticoagulated patient or with local surgical intervention
Facility Information:
Facility Name
FisioWork
City
San Sebastián De Los Reyes
State/Province
Madrid
ZIP/Postal Code
28703
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Efficacy of Motor Control and Diathermy Treatment in Acute Low Back Pain

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