Low Back PainNCT02537119
Massage Therapy on Hamstrings in Patients With Nonspecific Low Back Pain
A study testing Dynamic massage therapy and Massage therapy in people with Low Back Pain, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
Effectiveness of a technique of dynamic massage therapy in the hamstrings in patients with nonspecific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Dynamic massage therapy and Massage therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- May 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old.
- Low back pain with over three months of evolution.
- Practice sports regularly (at least three times a week).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Effectiveness of a technique of dynamic massage therapy in the hamstrings in patients with nonspecific low back pain.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Dynamic massage therapy, Massage therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic massage therapyProcedure or surgery
Dynamic massage therapy on hamstring combined with knee extension
Massage therapyProcedure or surgery
Rubbing on hamstrings
| Study group | Role | What they receive |
|---|---|---|
| Dynamic massage therapy | Experimental | Rubbing on hamstrings combined with articular movement Receives: Procedure: Dynamic massage therapy |
| Massage therapy | Active comparator | Rubbing on hamstrings Receives: Procedure: Massage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks
Secondary outcomes (2)
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
Measured: Two weeks. Participants will be followed for four weeks after completion of the intervention
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%
Measured: Two weeks. Participants will be followed for four weeks after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fco. Javier Montanez Aguilera, Cardenal Herrera University
- Investigators
- FJavier Montañez-Aguilera, Doctor, Principal investigator, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537119
- Sponsor's protocol ID
- Cardenal Herrera University
- Status last verified
- Sep 2015
- First submitted
- 26 Jun 2015
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 25582412Montanez-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.
PubMed 20555123Aguilera 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.
PubMed 19748402
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massage Therapy on Hamstrings in Patients With Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT02537119
- Acronym / sponsor ID
- Cardenal Herrera University
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic massage therapy | Experimental | Procedure: Dynamic massage therapyRubbing on hamstrings combined with articular movement |
| Massage therapy | Active comparator | Procedure: Massage therapyRubbing on hamstrings |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years old.
- Low back pain with over three months of evolution.
- Practice sports regularly (at least three times a week).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic massage therapyDynamic massage therapy on hamstring combined with knee extension | Procedure or surgery | Dynamic massage therapy |
| Massage therapyRubbing on hamstrings | Procedure or surgery | Massage therapy |
Primary outcome
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.
2 secondary outcomes
Low back pain measured with visual analog scale
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Background: PubMed 25582412Pecos-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.
- Background: PubMed 20555123Montanez-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.
- Background: PubMed 19748402Aguilera 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FJavier Montañez-Aguilera, Doctor principal investigator
Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic massage therapy and Massage therapy in people with Low Back Pain, run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamstrings extensibility measured with sit-and-reach test (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02537119, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.