Back to resultsEffectiveness of Pressure Release Technique in Patients With Chronic Low Back Pain
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pressure Release Technique (PRT)
Control
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- chronic low back pain at least 6 months
Exclusion Criteria:
- hernia, neurologic pain
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRT group
Exercises group
Arm Description
pressure Release Technique and exercises
Only exercises
Outcomes
Primary Outcome Measures
VAS
self reported pain
VAS
self reported pain
Secondary Outcome Measures
Full Information
NCT ID
NCT04326621
First Posted
March 19, 2020
Last Updated
March 26, 2020
Sponsor
Universidad Complutense de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT04326621
Brief Title
Effectiveness of Pressure Release Technique in Patients With Chronic Low Back Pain
Official Title
Effectiveness of Pressure Release Technique in Patients With Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Pressure Release Technique will be test in patient with low back pain compared to a sham
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRT group
Arm Type
Experimental
Arm Description
pressure Release Technique and exercises
Arm Title
Exercises group
Arm Type
Active Comparator
Arm Description
Only exercises
Intervention Type
Other
Intervention Name(s)
Pressure Release Technique (PRT)
Intervention Description
A pressure applied on muscles trigger points with the finger of a physiotherapist and exercises
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
exercises
Primary Outcome Measure Information:
Title
VAS
Description
self reported pain
Time Frame
immediately after treatment
Title
VAS
Description
self reported pain
Time Frame
at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic low back pain at least 6 months
Exclusion Criteria:
hernia, neurologic pain
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gema Serrano-Hernanz, PhD
Phone
669332986
Email
gema.serrano.hernanz@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Pressure Release Technique in Patients With Chronic Low Back Pain
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