Lower Back PainNCT04012970
Investigating the Effects of a Spinal Mobilisation Intervention in People With Lower Back Pain
A study testing Manual spinal mobilisations in people with Lower Back Pain, run by Edinburgh Napier University at 1 site in United Kingdom.
Trial summary
The objective of the study is to measure and analyse the effect of a spinal mobilisation intervention on muscle tissue quality in people with lower back pain. The mobilisation intervention will be compared to a control with participants taking part in both conditions for a factorial, within-subject repeated measures… Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- Manual spinal mobilisations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2016to 30 Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Suffering from lower back pain (region between 12th rib and gluteal folds), acute or chronic.
Who cannot join
- Respond positively to any absolute contraindications for spinal therapy, including:
- segment instability
- infectious disease
- osteomyelitis
- bone tumours
- neurological deficit
Show all 26Show fewer
- upper motor neuron lesion
- spinal cord damage
- cervical arterial dysfunction
- Respond positively to relative contra-indications, excluded based on severity, including:
- osteoporosis
- spinal instability
- rheumatoid arthritis
- inflammatory disease
- active history of cancer
- hypermobile syndrome
- segment hypermobility
- cardiovascular disease
- cervical anomalies
- nerve root disorder
- spinal surgery
- respiratory problems
- thrombosis
- open wounds
- local infection
- fractures or dislocations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Investigation of Muscle Stiffness, Tone and Elasticity After a Spinal Mobilisation Intervention in People With Lower Back Pain
The objective of the study is to measure and analyse the effect of a spinal mobilisation intervention on muscle tissue quality in people with lower back pain. The mobilisation intervention will be compared to a control with participants taking part in both conditions for a factorial, within-subject repeated measures study. The study will analyse lumbar muscle response to the manual intervention and analyse the potential influence of anthropometric measures of participants. The study hypothesises a decrease in lumbar stiffness post the intervention, compared to the control session.
Read the detailed description
Various types of spinal manual therapies have been common practice for many years, particularly for treatment of lower back pain. Spinal mobilisation is a specific technique within spinal physiotherapy, often used as a treatment for lower back pain. This is despite limited objective evidence of the effect on muscle tissue quality.
The objective of this study is to measure and analyse the acute effect of a spinal mobilisation intervention on muscle tissue quality in people with lower back pain. The intervention consists of the mobilisation of the lumbar spine for 30 minutes, at a specific rate and pressure. This will be performed by a chartered physiotherapist. This will be tested with 40 participants with lower back pain. This was the recommended sample size given by G Power for a medium effect size, a power of 0.95 and alpha level of 0.05.
Participants will take part in an intervention and a control condition. Lumbar muscle response will be measured for stiffness, tone and elasticity immediately before and after the intervention and the control. The control session consists of lying still for the 30 minutes. Results for both sessions will then be compared. A myometer (MyotonPRO) will be used to assess the change in lumbar muscle objectively. This is a non-invasive, handheld device with many reliability studies on its functionality. Analysis will consider the degree of muscle response with individual covariates involved. This includes gender, height, weight, waist circumference, BMI and level of back pain (discerned by score on Oswestry Disability Index).
The results will compared in 2-way repeated measures, within participant ANOVA for significant differences between conditions and time. Anthropometric measures will be analysed in separate ANOCOVAs to determine any significant factors contributing to level of change.
- Conditions
- Lower Back Pain
- Being tested
- Manual spinal mobilisations
- Keywords
- lower back pain, myometer, muscle stiffness, spinal mobilisations
- 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.
Manual spinal mobilisationsOther
| Study group | Role | What they receive |
|---|---|---|
| A - Intervention then control | Experimental | Intervention (30 minutes spinal mobilisations) received in first session, then control (30 minutes lying still) received in second session. Receives: Other: Manual spinal mobilisations |
| B - Control then intervention | Experimental | Control (30 minutes lying still) received in first session, then intervention (30 minutes spinal mobilisations) received in second session. Receives: Other: Manual spinal mobilisations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Erector Spinae Stiffness Change
Stiffness values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.
Measured: Change in muscle stiffness immediately after the 30 minute spinal mobilisation intervention.
Control Erector Spinae Stiffness Change.
Stiffness values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.
Measured: Change in muscle stiffness immediately after the 30 minute control session (lying still).
Secondary outcomes (4)
Intervention Erector Spinae Tone Change
Tone values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.
Measured: Change in muscle tone immediately after the 30 minute spinal mobilisation intervention.
Control Erector Spinae Tone Change
Tone values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.
Measured: Change in muscle tone immediately after the 30 minute control session (lying still).
Intervention Erector Spinae Elasticity Change
Elasticity values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. The device records the logarithmic decrement of the tissue by recording the dissipation of the mechanical energy of the tissue when it recovers shape after deformation. Elasticity is then inversely proportional to the decrement, so a higher decrement value equates to a higher dissipation of mechanical energy and a lower elasticity value. Recorded 3 times and mean value used for analysis.
Measured: Change in muscle elasticity immediately after the 30 minute spinal mobilisation intervention.
Control Erector Spinae Elasticity Change
Elasticity values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. The device records the logarithmic decrement of the tissue by recording the dissipation of the mechanical energy of the tissue when it recovers shape after deformation. Elasticity is then inversely proportional to the decrement, so a higher decrement value equates to a higher dissipation of mechanical energy and a lower elasticity value. Recorded 3 times and mean value used for analysis.
Measured: Change in muscle elasticity immediately after the 30 minute control session (lying still).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Jul 2016
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lower 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
- Model description
- Cross-over study design, within-subject repeated measures (intervention versus no intervention).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edinburgh Napier University
- Sponsor type
- University, hospital or other
- Collaborators
- Scottish Hospital Endowments Research Trust, Pacla Medical Limited
- Responsible party
- Principal investigator, Rebecca Hamilton, Edinburgh Napier University
- Investigators
- Susan Brown, Study director, Director of PhD Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012970
- Sponsor's protocol ID
- PILOT_LBP_1
- Status last verified
- Nov 2019
- First submitted
- 3 Jul 2019
- Last updated
- 29 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data sets that underlie the results for publication will be shared on a raw data set. This includes the muscle quality data, back pain result, and anthropometric data.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Muscle Stiffness, Tone and Elasticity After a Spinal Mobilisation Intervention in People With Lower Back Pain
- ClinicalTrials.gov ID
- NCT04012970
- Acronym / sponsor ID
- PILOT_LBP_1
- Conditions
- Lower Back Pain
- Keywords
- lower back pain, myometer, muscle stiffness, spinal mobilisations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Edinburgh Napier UniversityUniversity, hospital or other
- Collaborators
- Scottish Hospital Endowments Research Trust, Pacla Medical Limited
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Posted 29 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to measure and analyse the effect of a spinal mobilisation intervention on muscle tissue quality in people with lower back pain. The mobilisation intervention will be compared to a control with participants taking part in both conditions for a factorial, within-subject repeated measures study. The study will analyse lumbar muscle response to the manual intervention and analyse the potential influence of anthropometric measures of participants. The study hypothesises a decrease in lumbar stiffness post the intervention, compared to the control session.
Detailed description
Various types of spinal manual therapies have been common practice for many years, particularly for treatment of lower back pain. Spinal mobilisation is a specific technique within spinal physiotherapy, often used as a treatment for lower back pain. This is despite limited objective evidence of the effect on muscle tissue quality.
The objective of this study is to measure and analyse the acute effect of a spinal mobilisation intervention on muscle tissue quality in people with lower back pain. The intervention consists of the mobilisation of the lumbar spine for 30 minutes, at a specific rate and pressure. This will be performed by a chartered physiotherapist. This will be tested with 40 participants with lower back pain. This was the recommended sample size given by G Power for a medium effect size, a power of 0.95 and alpha level of 0.05.
Participants will take part in an intervention and a control condition. Lumbar muscle response will be measured for stiffness, tone and elasticity immediately before and after the intervention and the control. The control session consists of lying still for the 30 minutes. Results for both sessions will then be compared. A myometer (MyotonPRO) will be used to assess the change in lumbar muscle objectively. This is a non-invasive, handheld device with many reliability studies on its functionality. Analysis will consider the degree of muscle response with individual covariates involved. This includes gender, height, weight, waist circumference, BMI and level of back pain (discerned by score on Oswestry Disability Index).
The results will compared in 2-way repeated measures, within participant ANOVA for significant differences between conditions and time. Anthropometric measures will be analysed in separate ANOCOVAs to determine any significant factors contributing to level of change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-over study design, within-subject repeated measures (intervention versus no intervention).
| Arm | Type | Receives |
|---|---|---|
| A - Intervention then control | Experimental | Other: Manual spinal mobilisationsIntervention (30 minutes spinal mobilisations) received in first session, then control (30 minutes lying still) received in second session. |
| B - Control then intervention | Experimental | Other: Manual spinal mobilisationsControl (30 minutes lying still) received in first session, then intervention (30 minutes spinal mobilisations) received in second session. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Suffering from lower back pain (region between 12th rib and gluteal folds), acute or chronic.
Key exclusion criteria (26 listed)
- segment instability
- infectious disease
- osteomyelitis
- bone tumours
- neurological deficit
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 |
|---|---|---|
| Manual spinal mobilisations | Other | A - Intervention then control, B - Control then intervention |
Primary outcome
Intervention Erector Spinae Stiffness Change
Time frame: Change in muscle stiffness immediately after the 30 minute spinal mobilisation intervention.
Stiffness values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.
Control Erector Spinae Stiffness Change.
Time frame: Change in muscle stiffness immediately after the 30 minute control session (lying still).
Stiffness values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.
4 secondary outcomes
Intervention Erector Spinae Tone Change
Time frame: Change in muscle tone immediately after the 30 minute spinal mobilisation intervention.
Control Erector Spinae Tone Change
Time frame: Change in muscle tone immediately after the 30 minute control session (lying still).
Intervention Erector Spinae Elasticity Change
Time frame: Change in muscle elasticity immediately after the 30 minute spinal mobilisation intervention.
Control Erector Spinae Elasticity Change
Time frame: Change in muscle elasticity immediately after the 30 minute control session (lying still).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Participant data sets that underlie the results for publication will be shared on a raw data set. This includes the muscle quality data, back pain result, and anthropometric data.
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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.
Susan Brown study director
Director of PhD Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual spinal mobilisations in people with Lower Back Pain, run by Edinburgh Napier University at 1 site in United Kingdom.
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 26 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 29 Nov 2019. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 29 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intervention Erector Spinae Stiffness Change (time frame: Change in muscle stiffness immediately after the 30 minute spinal mobilisation intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2019.