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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03386084
Other study ID # CEIM/HU/2017/19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2018
Est. completion date May 31, 2018

Study information

Verified date June 2018
Source University of Alcala
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date May 31, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain FisioWork San Sebastián De Los Reyes Madrid

Sponsors (1)

Lead Sponsor Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 4 weeks
Secondary 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.
4 weeks
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