- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02537119
Massage Therapy on Hamstrings in Patients With Nonspecific Low Back Pain
January 26, 2016 updated by: Fco. Javier Montanez Aguilera, Cardenal Herrera University
Effectiveness of a technique of dynamic massage therapy in the hamstrings in patients with nonspecific low back pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Valencia
-
Moncada, Valencia, Spain, 46113
- CEU Cardenal Herrera University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dynamic massage therapy
Rubbing on hamstrings combined with articular movement
|
Dynamic massage therapy on hamstring combined with knee extension
|
Active Comparator: Massage therapy
Rubbing on hamstrings
|
Rubbing on hamstrings
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamstrings extensibility measured with sit-and-reach test
Time Frame: Two weeks
|
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.
|
Two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low back pain measured with visual analog scale
Time Frame: Two weeks. Participants will be followed for four weeks after completion of the intervention
|
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
|
Two weeks. Participants will be followed for four weeks after completion of the intervention
|
Low back disability measured with the Oswestry Disability Questionnaire
Time Frame: Two weeks. Participants will be followed for four weeks after completion of the intervention
|
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% |
Two weeks. Participants will be followed for four weeks after completion of the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: FJavier Montañez-Aguilera, Doctor, Cardenal Herrera University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
June 26, 2015
First Submitted That Met QC Criteria
August 29, 2015
First Posted (Estimate)
September 1, 2015
Study Record Updates
Last Update Posted (Estimate)
January 27, 2016
Last Update Submitted That Met QC Criteria
January 26, 2016
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cardenal Herrera University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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