Low Back PainNCT02128607
A Randomized Placebo Controlled Trial on the Efficacy of Sustained Natural Apophyseal Glide (SNAG) in Low Back Pain Patients
A study testing SNAG in people with Low Back Pain and Manual Therapy, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Objectives: Determine the efficacy of the SNAG technique (Mulligan) applied to a subgroup of people with non-specific low back pain (LBP) on two new kinematic-algorythms, on pain, functional disability and kinesiophobia. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Low Back Pain, Manual Therapy, Sustained Natural Apophyseal Glide (SNAG)
- What is being tested?
- SNAG
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2014to Jul 2014
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- non-specific LBP, mechanical LBP with a pain in flexion direction, the pain in flexion is reduce with the application of SNAG therapy
Who cannot join
- specific LBP, non-mechanical LBP, the pain is not release in a flexion direction when SNAG is appllied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate and Short-term Effects of Mulligan "Sustained Natural Apophyseal Glides" for a Subgroup of Low Back Pain Patients: A Randomized Placebo Controlled Trial
Objectives:
Determine the efficacy of the SNAG technique (Mulligan) applied to a subgroup of people with non-specific low back pain (LBP) on two new kinematic-algorythms, on pain, functional disability and kinesiophobia.
Read more
Design:
A randomized double blinded placebo controlled trial with double arms in accordance with the CONSORT statement.
Subjects:
Patients with non-specific low back pain will be recruting from Saint-Luc hospital, only a subgroup of them will be included according to specific inclusion criteria tailored for indication of application of SNAG's therapy (Mulligan technique applied on the lumbar spine).
Method:
Subjects will be randomized in 2 groups; real-SNAG and sham-SNAG groups. All patients will be treated during a single session, and real/sham SNAG will be applied from a sitting position with the belt, and in a flexion direction. Two kinematic-algorythms (ROM and Speed) from a validated kinematic spine model will be used and recorded with an opto-electronic device (BTS-Elite). Pain at rest and during flexion, as well as functional disability and kinesiophobia will be recorded by self-reported measures. These outcomes will be blindly evaluated before and after treatment to compare both groups with " Two-Way-ANOVA " statistic with for factors; time and groups.
- Being tested
- SNAG, Sham
- Keywords
- low back pain, manual therapy, Mulligan, sustained natural apophyseal glide (SNAG), Kinematic spine model
- 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.
SNAGDevice
sustained natural apophyseal glide: SNAG / Mulligan technique
ShamDevice
| Study group | Role | What they receive |
|---|---|---|
| Real SNAG | Active comparator | A real sustained natural apophyseal glide (SNAG / Mulligan technique) applied on the lumbar spine from a sitting position, and in a trunk flexion direction with the use of the belt. Receives: Device: SNAG |
| Sham SNAG | Placebo comparator | A sham (placebo) sustained natural apophyseal glide (SNAG / Mulligan technique) applied on the lumbar spine from a sitting position, and in a trunk flexion direction with the use of the belt. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic spine model (Hidalgo et al 2012 Journal of rehabilitation medicine)
Use of quantitative variables for ROM and SPEED kinematic (Logit scores index)
Measured: Change from baseline until discharge of treatment (same day, single session)
Secondary outcomes (3)
Oswestry Disability questionnaire
Measured: change from baseline until 2 weeks after treatment
present pain with visual analog scale (VAS)
Measured: change from baseline and after treatment the same day (single session)
Tampa scale for kinesiophobia
Measured: change from baseline until two weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Hidalgo, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128607
- Sponsor's protocol ID
- IoNS-UCL-Hidalgo-02
- Status last verified
- Aug 2014
- First submitted
- 29 Apr 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 24401656Hidalgo B, Gobert F, Bragard D, Detrembleur C. Effects of proprioceptive disruption on lumbar spine repositioning error in a trunk forward bending task. J Back Musculoskelet Rehabil. 2013;26(4):381-7. doi: 10.3233/BMR-130396.
PubMed 23948825Hidalgo B, Gilliaux M, Poncin W, Detrembleur C. Reliability and validity of a kinematic spine model during active trunk movement in healthy subjects and patients with chronic non-specific low back pain. J Rehabil Med. 2012 Sep;44(9):756-63. doi: 10.2340/16501977-1015.
PubMed 22847223Moutzouri M, Billis E, Strimpakos N, Kottika P, Oldham JA. The effects of the Mulligan Sustained Natural Apophyseal Glide (SNAG) mobilisation in the lumbar flexion range of asymptomatic subjects as measured by the Zebris CMS20 3-D motion analysis system. BMC Musculoskelet Disord. 2008 Oct 1;9:131. doi: 10.1186/1471-2474-9-131.
PubMed 18828921
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Short-term Effects of Mulligan "Sustained Natural Apophyseal Glides" for a Subgroup of Low Back Pain Patients: A Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02128607
- Acronym / sponsor ID
- IoNS-UCL-Hidalgo-02
- Keywords
- low back pain, manual therapy, Mulligan, sustained natural apophyseal glide (SNAG), Kinematic spine model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 1 May 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.
Objectives:
Determine the efficacy of the SNAG technique (Mulligan) applied to a subgroup of people with non-specific low back pain (LBP) on two new kinematic-algorythms, on pain, functional disability and kinesiophobia.
Design:
A randomized double blinded placebo controlled trial with double arms in accordance with the CONSORT statement.
Subjects:
Patients with non-specific low back pain will be recruting from Saint-Luc hospital, only a subgroup of them will be included according to specific inclusion criteria tailored for indication of application of SNAG's therapy (Mulligan technique applied on the lumbar spine).
Method:
Subjects will be randomized in 2 groups; real-SNAG and sham-SNAG groups. All patients will be treated during a single session, and real/sham SNAG will be applied from a sitting position with the belt, and in a flexion direction. Two kinematic-algorythms (ROM and Speed) from a validated kinematic spine model will be used and recorded with an opto-electronic device (BTS-Elite). Pain at rest and during flexion, as well as functional disability and kinesiophobia will be recorded by self-reported measures. These outcomes will be blindly evaluated before and after treatment to compare both groups with " Two-Way-ANOVA " statistic with for factors; time and groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real SNAG | Active comparator | Device: SNAGA real sustained natural apophyseal glide (SNAG / Mulligan technique) applied on the lumbar spine from a sitting position, and in a trunk flexion direction with the use of the belt. |
| Sham SNAG | Placebo comparator | Device: ShamA sham (placebo) sustained natural apophyseal glide (SNAG / Mulligan technique) applied on the lumbar spine from a sitting position, and in a trunk flexion direction with the use of the belt. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- non-specific LBP, mechanical LBP with a pain in flexion direction, the pain in flexion is reduce with the application of SNAG therapy
Key exclusion criteria (1 listed)
- specific LBP, non-mechanical LBP, the pain is not release in a flexion direction when SNAG is appllied
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 |
|---|---|---|
| SNAGsustained natural apophyseal glide: SNAG / Mulligan technique | Device | Real SNAG |
| Sham | Device | Sham SNAG |
Primary outcome
Kinematic spine model (Hidalgo et al 2012 Journal of rehabilitation medicine)
Time frame: Change from baseline until discharge of treatment (same day, single session)
Use of quantitative variables for ROM and SPEED kinematic (Logit scores index)
3 secondary outcomes
Oswestry Disability questionnaire
Time frame: change from baseline until 2 weeks after treatment
present pain with visual analog scale (VAS)
Time frame: change from baseline and after treatment the same day (single session)
Tampa scale for kinesiophobia
Time frame: change from baseline until two weeks after treatment
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 15 Aug 2014.
- 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 23948825Hidalgo B, Gobert F, Bragard D, Detrembleur C. Effects of proprioceptive disruption on lumbar spine repositioning error in a trunk forward bending task. J Back Musculoskelet Rehabil. 2013;26(4):381-7. doi: 10.3233/BMR-130396.
- Background: PubMed 22847223Hidalgo B, Gilliaux M, Poncin W, Detrembleur C. Reliability and validity of a kinematic spine model during active trunk movement in healthy subjects and patients with chronic non-specific low back pain. J Rehabil Med. 2012 Sep;44(9):756-63. doi: 10.2340/16501977-1015.
- Background: PubMed 18828921Moutzouri M, Billis E, Strimpakos N, Kottika P, Oldham JA. The effects of the Mulligan Sustained Natural Apophyseal Glide (SNAG) mobilisation in the lumbar flexion range of asymptomatic subjects as measured by the Zebris CMS20 3-D motion analysis system. BMC Musculoskelet Disord. 2008 Oct 1;9:131. doi: 10.1186/1471-2474-9-131.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SNAG in people with Low Back Pain and Manual Therapy, run by Université Catholique de Louvain at 1 site in Belgium.
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 1 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 15 Aug 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 Belgium. 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?
Kinematic spine model (Hidalgo et al 2012 Journal of rehabilitation medicine) (time frame: Change from baseline until discharge of treatment (same day, single session)). 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 NCT02128607, which also lists 4 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 15 Aug 2014.