Massage Therapy on Hamstrings in Patients With Nonspecific Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dynamic massage therapy
Massage therapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- 18-65 years old.
- Low back pain with over three months of evolution.
- Practice sports regularly (at least three times a week).
Exclusion Criteria:
- Fractures, Tumors, congenital anomalies, rheumatic diseases, infectious or inflammatory processes.
- Pathology Nerve root
- Presence of neurological deficit or neuromuscular diseases.
- Surgery
- Physiotherapy treatment for low back pain in the last 30 days.
- Drugs in previous 24h
Sites / Locations
- CEU Cardenal Herrera University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dynamic massage therapy
Massage therapy
Arm Description
Rubbing on hamstrings combined with articular movement
Rubbing on hamstrings
Outcomes
Primary Outcome Measures
Hamstrings extensibility measured with sit-and-reach test
Fixing a meter stick on top of a solid box so that 26 cm of the ruler extend over the front edge of the box toward the test subject. Used to check the increase in hip flexion.
Secondary Outcome Measures
Low back pain measured with visual analog scale
The subject indicates the intensity of pain by marking a 100-mm horizontal line with two extremes: no pain and worst imaginable pain. Used to check the decrease low back pain
Low back disability measured with the Oswestry Disability Questionnaire
Oswestry Disability Questionnaire is an important tool to measure functional low back disability. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows:
Example: 16 (total scored) 50 (total possible score) x 100 = 32%
Full Information
NCT ID
NCT02537119
First Posted
June 26, 2015
Last Updated
January 26, 2016
Sponsor
Cardenal Herrera University
1. Study Identification
Unique Protocol Identification Number
NCT02537119
Brief Title
Massage Therapy on Hamstrings in Patients With Nonspecific Low Back Pain
Official Title
Massage Therapy on Hamstrings in Patients With Nonspecific Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Effectiveness of a technique of dynamic massage therapy in the hamstrings in patients with nonspecific low back pain.
Detailed Description
The main objective of this study is to test the effectiveness of a technique of dynamic massage therapy in the hamstrings in patients with nonspecific low back pain. Secondary objectives are assess whether the technique of dynamic massage therapy increases the extensibility of the hamstrings, assess whether the treatment of hamstrings decreases low back pain and determine whether the application of this technique decreases the disability associated with nonspecific low back pain.
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
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dynamic massage therapy
Arm Type
Experimental
Arm Description
Rubbing on hamstrings combined with articular movement
Arm Title
Massage therapy
Arm Type
Active Comparator
Arm Description
Rubbing on hamstrings
Intervention Type
Procedure
Intervention Name(s)
Dynamic massage therapy
Intervention Description
Dynamic massage therapy on hamstring combined with knee extension
Intervention Type
Procedure
Intervention Name(s)
Massage therapy
Intervention Description
Rubbing on hamstrings
Primary Outcome Measure Information:
Title
Hamstrings extensibility measured with sit-and-reach test
Description
Fixing a meter stick on top of a solid box so that 26 cm of the ruler extend over the front edge of the box toward the test subject. Used to check the increase in hip flexion.
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Low back pain measured with visual analog scale
Description
The subject indicates the intensity of pain by marking a 100-mm horizontal line with two extremes: no pain and worst imaginable pain. Used to check the decrease low back pain
Time Frame
Two weeks. Participants will be followed for four weeks after completion of the intervention
Title
Low back disability measured with the Oswestry Disability Questionnaire
Description
Oswestry Disability Questionnaire is an important tool to measure functional low back disability. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows:
Example: 16 (total scored) 50 (total possible score) x 100 = 32%
Time Frame
Two weeks. Participants will be followed for four weeks after completion of the intervention
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:
18-65 years old.
Low back pain with over three months of evolution.
Practice sports regularly (at least three times a week).
Exclusion Criteria:
Fractures, Tumors, congenital anomalies, rheumatic diseases, infectious or inflammatory processes.
Pathology Nerve root
Presence of neurological deficit or neuromuscular diseases.
Surgery
Physiotherapy treatment for low back pain in the last 30 days.
Drugs in previous 24h
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FJavier Montañez-Aguilera, Doctor
Organizational Affiliation
Cardenal Herrera University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CEU Cardenal Herrera University
City
Moncada
State/Province
Valencia
ZIP/Postal Code
46113
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25582412
Citation
Pecos-Martin D, Montanez-Aguilera FJ, Gallego-Izquierdo T, Urraca-Gesto A, Gomez-Conesa A, Romero-Franco N, Plaza-Manzano G. Effectiveness of dry needling on the lower trapezius in patients with mechanical neck pain: a randomized controlled trial. Arch Phys Med Rehabil. 2015 May;96(5):775-81. doi: 10.1016/j.apmr.2014.12.016. Epub 2015 Jan 9.
Results Reference
background
PubMed Identifier
20555123
Citation
Montanez-Aguilera FJ, Valtuena-Gimeno N, Pecos-Martin D, Arnau-Masanet R, Barrios-Pitarque C, Bosch-Morell F. Changes in a patient with neck pain after application of ischemic compression as a trigger point therapy. J Back Musculoskelet Rehabil. 2010;23(2):101-4. doi: 10.3233/BMR-2010-0255.
Results Reference
background
PubMed Identifier
19748402
Citation
Aguilera FJ, Martin DP, Masanet RA, Botella AC, Soler LB, Morell FB. Immediate effect of ultrasound and ischemic compression techniques for the treatment of trapezius latent myofascial trigger points in healthy subjects: a randomized controlled study. J Manipulative Physiol Ther. 2009 Sep;32(7):515-20. doi: 10.1016/j.jmpt.2009.08.001.
Results Reference
background
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Massage Therapy on Hamstrings in Patients With Nonspecific Low Back Pain
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