Low Back PainPhase 1NCT02065531

Myofascial Release and Mobilization With Impulse Technique Torsion in Low Back Pain

A Phase 1 study testing Myofascial Soft Tissue Release and Mobilization with impulse technique. in people with Low Back Pain and Chronic Disease, run by Universidad de Almeria at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the current randomized clinical trial was to compare the effectiveness of myofascial soft tissue release versus mobilization with impulse technique torsion (anterior) on pain, disability, and kinesiophobia in individuals with chronic non-specific 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, Chronic Disease
What is being tested?: Myofascial Soft Tissue Release and Mobilization with impulse technique.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteSpain
Study dates: Jan 2014to Nov 2014
Phase: Phase 1
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

Score ≥4 on the Roland Morris Disability Questionnaire
Inability to achieve lumbar muscle flexion-relaxation in trunk flexion
Low back pain for ≥3 months
Not undergoing another physical therapy treatment

Who cannot join

Disease of the central or peripheral nervous system
Having previously undergone spinal manipulative therapy
Contraindication to low back thrust manipulation
A history of spinal surgery
Treatment with corticosteroid in the past two weeks
Clinical signs of radiculopathy
Presence of lumbar stenosis
Diagnosis of spondylolisthesis

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universidad de Almeria
Almería, Almería, 04120

Other trials in Spain

About this study

Official title: Effects of Myofascial Soft Tissue Release and Mobilization With Impulse Technique Torsion in Subjects With Chronic Non-specific Low Back Pain: A Randomized Clinical Trial

Read the detailed description

Design: Randomized Clinical Trial. Objective: to determine the effects of myofascial soft tissue release versus mobilization with impulse technique torsion (anterior) on pain, disability and kinesiophobia in individuals with chronic non-specific low back pain.

Methods and Measures: sixty-four individuals will be randomly assigned to one of two groups.

Intervention: For 12-week, the group 1 will undergo treatment comprising a myofascial soft tissue release protocol (1/week) and the group 2 will receive a mobilization with impulse technique torsion (anterior) (1/week).

Main Outcome Measures: Intensity of pain, disability, fear of movement, isometric endurance of trunk flexor muscles and lumbar mobility in flexion data will be collected at baseline, and 24hr after the last manual therapy application. Mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome measure.

Conditions: Low Back Pain, Chronic Disease
Being tested: Myofascial Soft Tissue Release, Mobilization with impulse technique.
Keywords: Low Back Pain, Chronic Pain, Manipulation, Manual Therapy, Randomized Controlled Trial
Medical subject headings: Low Back Pain, Chronic Disease, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Myofascial Soft Tissue ReleaseOther
Protocol: Transverse Plane-Level Clavicular Release. Diaphragmatic Transverse Plane Release. Square the Lumbar Fascia Release. Gluteal Fascia Release. Hint Of Pubic Region Release. Fascia Psoas Release. Lumbo-sacral Decompression. Pelvic Floor Release.
Mobilization with impulse technique.Other
Subject in lateral decubitus with extension and lower limb traction contact the couch with contralateral lower limb was performed triple flexion and left trunk rotation. This technique reduces the slack (tension joints) of the ventral pelvis, head and into the contralateral side of the sacrum support (base) with the forearm.

Study groups in NCT02065531
Study group	Role	What they receive
Myofascial Soft Tissue Release	Experimental	Protocol: Transverse Plane-Level Clavicular Release. Diaphragmatic Transverse Plane Release. Square the Lumbar Fascia Release. Gluteal Fascia Release. Hint Of Pubic Region Release. Fascia Psoas Release. Lumbo-sacral Decompression. Pelvic Floor Release. Receives: Other: Myofascial Soft Tissue Release
Mobilization with impulse technique	Active comparator	Subject in lateral decubitus with extension and lower limb traction contact the couch with contralateral lower limb was performed triple flexion and left trunk rotation. This technique reduces the slack (tension joints) of the ventral pelvis, head and into the contralateral side of the sacrum support (base) with the forearm. Receives: Other: Mobilization with impulse technique.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities.
Measured: At baseline, 12 weeks and 16 weeks

Secondary outcomes (5)

Change from baseline in Oswestry Low Back Pain Disability Index (ODI)
The ODI has 10 items referring to activities of daily living that might be disrupted by low back pain. Each item is answered on a 6-point Likert scale ranging from "no problem at all" [0] to "not possible" [5]. The total score ranges from 0 to 50.
Measured: At baseline, 12 weeks and 16 weeks
Change from baseline in Numerical Pain Rating Scale
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain, and the worst and lowest level of pain experienced in the preceding 24 hours.
Measured: At baseline, 12 weeks and 16 weeks
Change from baseline in Tampa Scale of Kinesiophobia
The Tampa Scale of Kinesiophobia (TSK) is a 17-item questionnaire developed to measure the fear of movement and (re)injury. Each item is scored on a four-point Likert scale ranging from "strongly disagree" [1] to "strongly agree" [4].
Measured: At baseline, 12 weeks and 16 weeks
Change from baseline in Isometric endurance of trunk flexor muscles
The McQuade test measures the isometric resistance of abdominal muscles in seconds.
Measured: At baseline, 12 weeks and 16 weeks
Change from baseline in Lumbar mobility in flexion
Lumbar mobility in flexion is determined by measuring the finger-to-floor distance with a tape.
Measured: At baseline, 12 weeks and 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Nov 2014

First posted19 Feb 2014 (estimated)
Study startJan 2014
Primary completionOct 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02065531
Sponsor's protocol ID: UAL-021
Status last verified: Nov 2014
First submitted: 10 Jan 2014
Last updated: 25 Nov 2014
Results posted: No
Data monitoring committee: No

Publications

Cymet TC. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: an illustration of osteopathic semantic confusion. J Am Osteopath Assoc. 2014 Jan;114(1):6-7. doi: 10.7556/jaoa.2014.002. No abstract available.
PubMed 24384968
Hidalgo B, Hall T, Nielens H, Detrembleur C. Intertester agreement and validity of identifying lumbar pain provocative movement patterns using active and passive accessory movement tests. J Manipulative Physiol Ther. 2014 Feb;37(2):105-15. doi: 10.1016/j.jmpt.2013.09.006. Epub 2014 Jan 6.
PubMed 24401656
Ebert R, Campbell A, Kemp-Smith K, O'Sullivan P. Lumbar spine side bending is reduced in end range extension compared to neutral and end range flexion postures. Man Ther. 2014 Apr;19(2):114-8. doi: 10.1016/j.math.2013.08.004. Epub 2013 Sep 4.
PubMed 24315299
Rabin A, Shashua A, Pizem K, Dickstein R, Dar G. A clinical prediction rule to identify patients with low back pain who are likely to experience short-term success following lumbar stabilization exercises: a randomized controlled validation study. J Orthop Sports Phys Ther. 2014 Jan;44(1):6-B13. doi: 10.2519/jospt.2014.4888. Epub 2013 Nov 21.
PubMed 24261926
Zimney K, Louw A, Puentedura EJ. Use of Therapeutic Neuroscience Education to address psychosocial factors associated with acute low back pain: a case report. Physiother Theory Pract. 2014 Apr;30(3):202-9. doi: 10.3109/09593985.2013.856508. Epub 2013 Nov 19.
PubMed 24252071
Haskins R, Osmotherly PG, Southgate E, Rivett DA. Physiotherapists' knowledge, attitudes and practices regarding clinical prediction rules for low back pain. Man Ther. 2014 Apr;19(2):142-51. doi: 10.1016/j.math.2013.09.005. Epub 2013 Oct 3.
PubMed 24176916
Licciardone JC. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: an illustration of osteopathic semantic confusion. Author reply. J Am Osteopath Assoc. 2013 Sep;113(9):661-2. doi: 10.7556/jaoa.2013.031. No abstract available.
PubMed 24133757
Kumar S, Beaton K, Hughes T. The effectiveness of massage therapy for the treatment of nonspecific low back pain: a systematic review of systematic reviews. Int J Gen Med. 2013 Sep 4;6:733-41. doi: 10.2147/IJGM.S50243.
PubMed 24043951
Leysen P, Bombeke K, Remmen R. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: an illustration of osteopathic semantic confusion. J Am Osteopath Assoc. 2013 Sep;113(9):660-1. doi: 10.7556/jaoa.2013.030. No abstract available.
PubMed 24005084
Bachmann S, Oesch P. [Physiotherapy and rehabilitation for low back pain]. Ther Umsch. 2013 Sep;70(9):543-8. doi: 10.1024/0040-5930/a000444. German.
PubMed 23985153
Hands-on treatment helps low back pain. Harv Womens Health Watch. 2013 Jun;20(10):8. No abstract available.
PubMed 23977709
Eirikstoft H, Kongsted A. Patient characteristics in low back pain subgroups based on an existing classification system. A descriptive cohort study in chiropractic practice. Man Ther. 2014 Feb;19(1):65-71. doi: 10.1016/j.math.2013.07.007. Epub 2013 Aug 6.
PubMed 23932099
Muir JM. Chiropractic management of a patient with low back pain and Castellvi type II lumbosacral transitional vertebrae. J Chiropr Med. 2012 Dec;11(4):254-9. doi: 10.1016/j.jcm.2012.02.005.
PubMed 23843757
Donaldson M, Learman K, O'Halloran B, Showalter C, Cook C. The role of patients' expectation of appropriate initial manual therapy treatment in outcomes for patients with low back pain. J Manipulative Physiol Ther. 2013 Jun;36(5):276-83. doi: 10.1016/j.jmpt.2013.05.016.
PubMed 23829882

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Myofascial Soft Tissue Release and Mobilization With Impulse Technique Torsion in Subjects With Chronic Non-specific Low Back Pain: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT02065531
Acronym / sponsor ID: UAL-021
Conditions: Low Back Pain, Chronic Disease
Keywords: Low Back Pain, Chronic Pain, Manipulation, Manual Therapy, Randomized Controlled Trial
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Universidad de AlmeriaUniversity, hospital or other
Study start: Jan 2014
Primary completion: Oct 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 19 Feb 2014 (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.

Detailed description

Methods and Measures: sixty-four individuals will be randomly assigned to one of two groups.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Myofascial Soft Tissue Release	Experimental	Other: Myofascial Soft Tissue ReleaseProtocol: Transverse Plane-Level Clavicular Release. Diaphragmatic Transverse Plane Release. Square the Lumbar Fascia Release. Gluteal Fascia Release. Hint Of Pubic Region Release. Fascia Psoas Release. Lumbo-sacral Decompression. Pelvic Floor Release.
Mobilization with impulse technique	Active comparator	Other: Mobilization with impulse technique.Subject in lateral decubitus with extension and lower limb traction contact the couch with contralateral lower limb was performed triple flexion and left trunk rotation. This technique reduces the slack (tension joints) of the ventral pelvis, head and into the contralateral side of the sacrum support (base) with the forearm.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Score ≥4 on the Roland Morris Disability Questionnaire
Inability to achieve lumbar muscle flexion-relaxation in trunk flexion
Low back pain for ≥3 months
Not undergoing another physical therapy treatment

Key exclusion criteria (8 listed)

Disease of the central or peripheral nervous system
Having previously undergone spinal manipulative therapy
Contraindication to low back thrust manipulation
A history of spinal surgery
Treatment with corticosteroid in the past two weeks

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 Soft Tissue ReleaseProtocol: Transverse Plane-Level Clavicular Release. Diaphragmatic Transverse Plane Release. Square the Lumbar Fascia Release. Gluteal Fascia Release. Hint Of Pubic Region Release. Fascia Psoas Release. Lumbo-sacral Decompression. Pelvic Floor Release.	Other	Myofascial Soft Tissue Release
Mobilization with impulse technique.Subject in lateral decubitus with extension and lower limb traction contact the couch with contralateral lower limb was performed triple flexion and left trunk rotation. This technique reduces the slack (tension joints) of the ventral pelvis, head and into the contralateral side of the sacrum support (base) with the forearm.	Other	Mobilization with impulse technique

Primary outcome

Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
Time frame: At baseline, 12 weeks and 16 weeks
This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities.

5 secondary outcomes

Change from baseline in Oswestry Low Back Pain Disability Index (ODI)
Time frame: At baseline, 12 weeks and 16 weeks
Change from baseline in Numerical Pain Rating Scale
Time frame: At baseline, 12 weeks and 16 weeks
Change from baseline in Tampa Scale of Kinesiophobia
Time frame: At baseline, 12 weeks and 16 weeks
Change from baseline in Isometric endurance of trunk flexor muscles
Time frame: At baseline, 12 weeks and 16 weeks
Change from baseline in Lumbar mobility in flexion
Time frame: At baseline, 12 weeks and 16 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 25 Nov 2014.
Background: PubMed 24384968Cymet TC. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: an illustration of osteopathic semantic confusion. J Am Osteopath Assoc. 2014 Jan;114(1):6-7. doi: 10.7556/jaoa.2014.002. No abstract available.
Background: PubMed 24401656Hidalgo B, Hall T, Nielens H, Detrembleur C. Intertester agreement and validity of identifying lumbar pain provocative movement patterns using active and passive accessory movement tests. J Manipulative Physiol Ther. 2014 Feb;37(2):105-15. doi: 10.1016/j.jmpt.2013.09.006. Epub 2014 Jan 6.
Background: PubMed 24315299Ebert R, Campbell A, Kemp-Smith K, O'Sullivan P. Lumbar spine side bending is reduced in end range extension compared to neutral and end range flexion postures. Man Ther. 2014 Apr;19(2):114-8. doi: 10.1016/j.math.2013.08.004. Epub 2013 Sep 4.
Background: PubMed 24261926Rabin A, Shashua A, Pizem K, Dickstein R, Dar G. A clinical prediction rule to identify patients with low back pain who are likely to experience short-term success following lumbar stabilization exercises: a randomized controlled validation study. J Orthop Sports Phys Ther. 2014 Jan;44(1):6-B13. doi: 10.2519/jospt.2014.4888. Epub 2013 Nov 21.
Background: PubMed 24252071Zimney K, Louw A, Puentedura EJ. Use of Therapeutic Neuroscience Education to address psychosocial factors associated with acute low back pain: a case report. Physiother Theory Pract. 2014 Apr;30(3):202-9. doi: 10.3109/09593985.2013.856508. Epub 2013 Nov 19.
Background: PubMed 24176916Haskins R, Osmotherly PG, Southgate E, Rivett DA. Physiotherapists' knowledge, attitudes and practices regarding clinical prediction rules for low back pain. Man Ther. 2014 Apr;19(2):142-51. doi: 10.1016/j.math.2013.09.005. Epub 2013 Oct 3.
Background: PubMed 24133757Licciardone JC. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: an illustration of osteopathic semantic confusion. Author reply. J Am Osteopath Assoc. 2013 Sep;113(9):661-2. doi: 10.7556/jaoa.2013.031. No abstract available.
Background: PubMed 24043951Kumar S, Beaton K, Hughes T. The effectiveness of massage therapy for the treatment of nonspecific low back pain: a systematic review of systematic reviews. Int J Gen Med. 2013 Sep 4;6:733-41. doi: 10.2147/IJGM.S50243.
Background: PubMed 24005084Leysen P, Bombeke K, Remmen R. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: an illustration of osteopathic semantic confusion. J Am Osteopath Assoc. 2013 Sep;113(9):660-1. doi: 10.7556/jaoa.2013.030. No abstract available.
Background: PubMed 23985153Bachmann S, Oesch P. [Physiotherapy and rehabilitation for low back pain]. Ther Umsch. 2013 Sep;70(9):543-8. doi: 10.1024/0040-5930/a000444. German.
Background: PubMed 23977709Hands-on treatment helps low back pain. Harv Womens Health Watch. 2013 Jun;20(10):8. No abstract available.
Background: PubMed 23932099Eirikstoft H, Kongsted A. Patient characteristics in low back pain subgroups based on an existing classification system. A descriptive cohort study in chiropractic practice. Man Ther. 2014 Feb;19(1):65-71. doi: 10.1016/j.math.2013.07.007. Epub 2013 Aug 6.

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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.

Adelaida Castro-Sánchez, Lecturer principal investigator

Universidad de Almeria

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Myofascial Soft Tissue Release and Mobilization with impulse technique. in people with Low Back Pain and Chronic Disease, run by Universidad de Almeria 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 4 inclusion and 8 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 25 Nov 2014. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change from baseline in Roland Morris Disability Questionnaire (RMDQ) (time frame: At baseline, 12 weeks and 16 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 NCT02065531, which also lists 14 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 25 Nov 2014.