Low Back PainNCT01241071
Effects of Myofascial Release on Pain, Disability and Electromyography of Erector Spinae in Chronic Low Back Pain
A study testing myofascial treatment in people with Low Back Pain and Disability, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether myofascial release techniques are effective in the improvement of pain, disability and electromyography response of lumbar muscles in patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain, Disability, Motor Activity
- What is being tested?
- myofascial treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Mar 2013
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- low back pain for more than 3 months
Who cannot join
- vertebra fractures
- systemic disease (spondylitis, neoplasia, infectious, vascular, endocrine or metabolic disorders)
- spinal surgery
- advanced lumbar instability
- osteoporosis (in advanced stage)
- degenerative articular disease
Show all 30Show fewer
- acute soft tissue inflammation
- rheumatoid arthritis
- osteomyelitis
- neuromuscular disease
- lower limb musculoskeletal injuries
- radiculopathy
- cauda equine syndrome
- myelopathy
- stenosis
- structural spine deformity (kyphoscoliosis...)
- pregnancy
- abundant menstruation
- IUD carrier
- mental disease
- dermatologic disease
- skin sensitivity
- aneurysma
- corticosteroids treatment
- anticoagulant therapy
- hypertension
- diabetes
- hemophilia
- leucemia
- rejection to manual contact
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Myofascial Release Protocol on Pain, Disability and Activation Pattern of Erector Spinae in Patients With Chronic Low Back Pain
The purpose of this study is to determine whether myofascial release techniques are effective in the improvement of pain, disability and electromyography response of lumbar muscles in patients with chronic low back pain.
- Conditions
- Low Back Pain, Disability, Motor Activity, Range of Motion
- Being tested
- myofascial treatment, Placebo
- Keywords
- Lumbar region, Pain, Fascia, Electromyography, Goniometry
- Medical subject headings
- Low Back Pain, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myofascial treatmentOther
myofascial release techniques of different muscles implicated in low back pain
PlaceboOther
A manual sham intervention will be applied to different muscles implicated in low back pain
| Study group | Role | What they receive |
|---|---|---|
| Myofascial treatment | Experimental | Myofascial release techniques of different muscles implicated in low back pain Receives: Other: myofascial treatment |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar Pain
Short Form McGill Pain Questionnaire. Visual Analogical Scale
Measured: 3 weeks
Secondary outcomes (4)
Disability
Roland Morris Disability Questionnaire
Measured: 3 weeks
Fear Avoidance Beliefs
Fear Avoidance Beliefs Questionnaire
Measured: 3 weeks
EMG Erector Spinae
Electromyography record (MEGAWIN 6000)
Measured: 3 weeks
Lumbar ROM
Electrogonyometry Fastrak (Polhemus)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Arnau de Vilanova
- Responsible party
- Principal investigator, Eva Segura Ortí, Cardenal Herrera University
- Investigators
- Javier Romero, Dean, Study director, Health Science Faculty CEU-UCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241071
- Sponsor's protocol ID
- CEU-UCH-88
- Status last verified
- Aug 2017
- First submitted
- 15 Nov 2010
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
FLOYD WF, SILVER PH. Function of erectores spinae in flexion of the trunk. Lancet. 1951 Jan 20;1(6647):133-4. doi: 10.1016/s0140-6736(51)91212-3. No abstract available.
PubMed 14795792Alschuler KN, Neblett R, Wiggert E, Haig AJ, Geisser ME. Flexion-relaxation and clinical features associated with chronic low back pain: A comparison of different methods of quantifying flexion-relaxation. Clin J Pain. 2009 Nov-Dec;25(9):760-6. doi: 10.1097/AJP.0b013e3181b56db6.
PubMed 19851155Grinnell F. Fibroblast mechanics in three-dimensional collagen matrices. J Bodyw Mov Ther. 2008 Jul;12(3):191-3. doi: 10.1016/j.jbmt.2008.03.005. Epub 2008 May 23.
PubMed 19083673Fernandez-Perez AM, Peralta-Ramirez MI, Pilat A, Villaverde C. Effects of myofascial induction techniques on physiologic and psychologic parameters: a randomized controlled trial. J Altern Complement Med. 2008 Sep;14(7):807-11. doi: 10.1089/acm.2008.0117.
PubMed 18724827Schleip R, Klingler W, Lehmann-Horn F. Active fascial contractility: Fascia may be able to contract in a smooth muscle-like manner and thereby influence musculoskeletal dynamics. Med Hypotheses. 2005;65(2):273-7. doi: 10.1016/j.mehy.2005.03.005.
PubMed 15922099Saiz-Llamosas JR, Fernandez-Perez AM, Fajardo-Rodriguez MF, Pilat A, Valenza-Demet G, Fernandez-de-Las-Penas C. Changes in neck mobility and pressure pain threshold levels following a cervical myofascial induction technique in pain-free healthy subjects. J Manipulative Physiol Ther. 2009 Jun;32(5):352-7. doi: 10.1016/j.jmpt.2009.04.009.
PubMed 19539117Ritvanen T, Zaproudina N, Nissen M, Leinonen V, Hanninen O. Dynamic surface electromyographic responses in chronic low back pain treated by traditional bone setting and conventional physical therapy. J Manipulative Physiol Ther. 2007 Jan;30(1):31-7. doi: 10.1016/j.jmpt.2006.11.010.
PubMed 17224353
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Myofascial Release Protocol on Pain, Disability and Activation Pattern of Erector Spinae in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01241071
- Acronym / sponsor ID
- CEU-UCH-88
- Conditions
- Low Back Pain, Disability, Motor Activity, Range of Motion
- Keywords
- Lumbar region, Pain, Fascia, Electromyography, Goniometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Collaborators
- Hospital Arnau de Vilanova
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Nov 2010 (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.
The purpose of this study is to determine whether myofascial release techniques are effective in the improvement of pain, disability and electromyography response of lumbar muscles in patients with chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofascial treatment | Experimental | Other: myofascial treatmentMyofascial release techniques of different muscles implicated in low back pain |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- low back pain for more than 3 months
Key exclusion criteria (30 listed)
- vertebra fractures
- systemic disease (spondylitis, neoplasia, infectious, vascular, endocrine or metabolic disorders)
- spinal surgery
- advanced lumbar instability
- osteoporosis (in advanced stage)
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 |
|---|---|---|
| myofascial treatmentmyofascial release techniques of different muscles implicated in low back pain | Other | Myofascial treatment |
| PlaceboA manual sham intervention will be applied to different muscles implicated in low back pain | Other | Placebo |
Primary outcome
Lumbar Pain
Time frame: 3 weeks
Short Form McGill Pain Questionnaire. Visual Analogical Scale
4 secondary outcomes
Disability
Time frame: 3 weeks
Fear Avoidance Beliefs
Time frame: 3 weeks
EMG Erector Spinae
Time frame: 3 weeks
Lumbar ROM
Time frame: 3 weeks
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 8 Aug 2017.
- Background: PubMed 14795792FLOYD WF, SILVER PH. Function of erectores spinae in flexion of the trunk. Lancet. 1951 Jan 20;1(6647):133-4. doi: 10.1016/s0140-6736(51)91212-3. No abstract available.
- Background: PubMed 19851155Alschuler KN, Neblett R, Wiggert E, Haig AJ, Geisser ME. Flexion-relaxation and clinical features associated with chronic low back pain: A comparison of different methods of quantifying flexion-relaxation. Clin J Pain. 2009 Nov-Dec;25(9):760-6. doi: 10.1097/AJP.0b013e3181b56db6.
- Background: PubMed 19083673Grinnell F. Fibroblast mechanics in three-dimensional collagen matrices. J Bodyw Mov Ther. 2008 Jul;12(3):191-3. doi: 10.1016/j.jbmt.2008.03.005. Epub 2008 May 23.
- Background: PubMed 18724827Fernandez-Perez AM, Peralta-Ramirez MI, Pilat A, Villaverde C. Effects of myofascial induction techniques on physiologic and psychologic parameters: a randomized controlled trial. J Altern Complement Med. 2008 Sep;14(7):807-11. doi: 10.1089/acm.2008.0117.
- Background: PubMed 15922099Schleip R, Klingler W, Lehmann-Horn F. Active fascial contractility: Fascia may be able to contract in a smooth muscle-like manner and thereby influence musculoskeletal dynamics. Med Hypotheses. 2005;65(2):273-7. doi: 10.1016/j.mehy.2005.03.005.
- Background: PubMed 19539117Saiz-Llamosas JR, Fernandez-Perez AM, Fajardo-Rodriguez MF, Pilat A, Valenza-Demet G, Fernandez-de-Las-Penas C. Changes in neck mobility and pressure pain threshold levels following a cervical myofascial induction technique in pain-free healthy subjects. J Manipulative Physiol Ther. 2009 Jun;32(5):352-7. doi: 10.1016/j.jmpt.2009.04.009.
- Background: PubMed 17224353Ritvanen T, Zaproudina N, Nissen M, Leinonen V, Hanninen O. Dynamic surface electromyographic responses in chronic low back pain treated by traditional bone setting and conventional physical therapy. J Manipulative Physiol Ther. 2007 Jan;30(1):31-7. doi: 10.1016/j.jmpt.2006.11.010.
- CEU Cardenal Herrera University is the first private university in the Valencian Community. It belongs to the San Pablo CEU Foundation which is a leading educational organization in Spain with three universities all over Spain.Link provided by the sponsor.
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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.
Javier Romero, Dean study director
Health Science Faculty CEU-UCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myofascial treatment in people with Low Back Pain and Disability, 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 1 inclusion and 30 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 8 Aug 2017. 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. Some participants in this study may receive a placebo. 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?
Lumbar Pain (time frame: 3 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 NCT01241071, which also lists 7 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 8 Aug 2017.