Hamstring InjuryNCT03273400
Effect of Mobilisations on Lumbar and Hamstring
A study testing Lumbar Mobilisations in people with Hamstring Injury, run by Teesside University at 1 site in United Kingdom.
Trial summary
To compare the immediate and short-term effects of L4 and L5 Unilateral Posterior Anterior (UPA) Mobilisations on the lumbar and hamstring range of motion and EMG activity of the Erector Spinae and Hamstring muscles. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hamstring Injury
- What is being tested?
- Lumbar Mobilisations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Sep 2017to 1 Mar 2018
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18-65. Participants willing to provide inform consent. Participants who successfully complete the medical questionnaire. No current lower back or lower limb pathology.
Who cannot join
- Current symptomatic low back pain or lower limb pathology. Participants with altered neurodynamic symptoms. Previous lumbar surgery. Under supervision of another health practionare Pregnant participants Contraindications or precautions to spinal mobilisation
- malignancy, inflammatory or infectious processes involving the spine or peripheral joints,
- osteoporosis,
- spinal disorders including spondylolisthesis, ankylosing spondylitis, spinal fusion
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Social Sciences, Business and Law
Middlesbrough, Teesside, TS1 3BA
About this study
Official title: Investigating the Effect of L4 and L5 Lumbar Posterior -Anterior Mobilisations on Measures of Lumbar and Hamstring Range of Motion, and Electromyography Activity of the Erector Spinae and Hamstring
To compare the immediate and short-term effects of L4 and L5 Unilateral Posterior Anterior (UPA) Mobilisations on the lumbar and hamstring range of motion and EMG activity of the Erector Spinae and Hamstring muscles.
Using a pre-test post-test crossover design subjects lumbar flexion and active knee extension with be recorded prior to and following unilateral zygapophyseal joint mobilisations. Measures will be taken immediately after and then 5, 10, 15, 20, 30 and 60 minutes intervals post intervention. Mobilisation force will be measured via force plates to ensure consistent mobilisation pressure.
Following data collection statistical analysis will be undertaken to analyse any potential benefit of lumbar mobilisations to influence the EMG activity of the Erector Spinae and Hamstrings. Functional assessment of lumbar range of motion and hamstring range of motion to be conducted and analyse any effect on movement
Read the detailed description
25-30 participants will be tested in the Olympia Building Biomechanics Laboratory at Teesside University.
Due to the nature of the cross-over design participants will attend the laboratory twice, one week apart.
Baseline measurements of Lumbar flexion and hamstring range of motions will be taken.
During lumbar flexion participants will be asked to stand with their arms at their side (anatomical position) and feet 8cm part. The tester will demonstrate the flexion motion then request the subject bends forwards are far as is possible, maintaining knee extension. A previous reliability study (Page 2012) has indicated four lumbar flexion movements repetitions were required to prevent the effects of passive stiffness improving the range. On the fourth trial the measurement via the modified schober test. This requires skin markers to be placed 10cm above and 5cm below the lumbar-sacral junction and the change distance calculated at end range. This will be conducted by the lead author, Paul Chesterton, a physiotherapist with appropriate insurance and qualifications.
Hamstring extensibility will be measured via the active knee extension test. Test leg will be determined by dominant/kicking leg. Subjects will be secured into anterior pelvic tilt via a belt and asked to extend the knee to maximal length. A purpose made wooden wedge will provide a right angle surface to ensure the hip is held at 90 degrees. The digital inclinometer will record the change in degrees of active knee extension post-test. The knee will be extended to end range, determined by the subject, with the hip, knee and ankle maintained in neutral. The non-dominant leg will be secured to the bed via a belt.
To record the surface electromyography (SEMG) activity in the muscles of the participants in this study the Zerowire Cometa system will be used. This system will record the muscle activity wirelessly. Every electrode unit is equipped with a small unit for signal processing and transmission to the data receiver. The electrodes are single use disposable, self-adhesive silver chloride dual snap on electrodes pre-set at a distance of 20mm.
All participants will have the skin prepared prior to the noraxon electrode being placed on their skin. Skin preparation will consist of shaving the area to remove any hair then wiping the area with alcohol wipe then the placing noraxon dual electrode in appropriate position in relation to recommendations by Seniam (2003). The electrodes are placed in line to the pennant of the muscle.
Electrodes will be attached according to European recommendation (seniam) at the Paraspinal muscles, and the Biceps Femoris of the dominant leg. A baseline sEMG will then be taken whilst the participant is at rest for 60seconds. The electrode placement and sEMG recording will be taken by a qualified laboratory technician employed by Teesside University.
The intervention will consist of unilateral lumbar mobilisations at the L4 and L5 level in a Posterior Anterior direction. The plinth will rest on force plates to allow the authors to analyse the force placed through the vertebrae. Grade three mobilisations will be applied for a one minute period three times at both L4 and L5 level. Each level will be determined by a passive physiological intervertebral movement. Participants will receive the mobilisations at L5 first for one minute followed by L4. This is an appropriate dose for mobilisation application (Maitland, 2013). This process will be carried out three times.
Following either the control or intervention all measure lumbar flexion, hamstring extensibility and sEMG activity will be recorded immediately, 5, 10, 15, 20, 30, 60 minutes post application as a single test.
Data analysis will occur using the zerowire cometa system version 1.6. The raw rate will be smoothed and rectified using a Butterworth algorithm with a high pass filter with a cut of frequency of 20Hz at order 5 with the data will be rectified using route mean square (RMS) set at a window of 20ms.
- Conditions
- Hamstring Injury
- Being tested
- Lumbar Mobilisations
- Keywords
- Lumbar, Hamstring, Mobilisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar MobilisationsOther
Please see arm (intervention) description
| Study group | Role | What they receive |
|---|---|---|
| Mobilisations | Experimental | The intervention will consist of unilateral lumbar mobilisations at the L4 and L5 level in a Posterior Anterior direction. The plinth will rest on force plates to allow the authors to analyse the force placed through the vertebrae. Grade three mobilisations will be applied for a one minute period three times at both L4 and L5 level. Each level will be determined by a passive physiological intervertebral movement. Participants will receive the mobilisations at L5 first for one minute followed by L4. This is an appropriate dose for mobilisation application (Maitland, 2013). This process will be carried out three times.
Following the intervention all measure lumbar flexion, hamstring extensibility and sEMG activity will be recorded immediately, 5, 10, 15, 20, 30, 60 minutes post application as a single test. Receives: Other: Lumbar Mobilisations |
| Control | No intervention | All outcome measures (lumbar/hamstring range of motion; EMG activity of the Biceps Femoris and Erector Spinae) will be measured. The control group will then receive no intervention and be asked to lie supine on a plinth for the treatment duration before having the outcome measures reassessed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar Range of Motion
During lumbar flexion participants will be asked to stand with their arms at their side (anatomical position) and feet 8cm part. The tester will demonstrate the flexion motion then request the subject bends forwards are far as is possible, maintaining knee extension. A previous reliability study (Page 2012) has indicated four lumbar flexion movements repetitions were required to prevent the effects of passive stiffness improving the range. On the fourth trial the measurement via the modified schober test. This requires skin markers to be placed 10cm above and 5cm below the lumbar-sacral junction and the change distance calculated at end range.
Measured: 5, 10, 15, 20, 30, 60 minutes post application as a single test.
Hamstring Range of Motion
Hamstring extensibility will be measured via the active knee extension test. Test leg will be determined by dominant/kicking leg. Subjects will be secured into anterior pelvic tilt via a belt and asked to extend the knee to maximal length. A purpose made wooden wedge will provide a right angle surface to ensure the hip is held at 90 degrees. The digital inclinometer will record the change in degrees of active knee extension post-test. The knee will be extended to end range, determined by the subject, with the hip, knee and ankle maintained in neutral. The non-dominant leg will be secured to the bed via a belt.
Measured: 5, 10, 15, 20, 30, 60 minutes post application as a single test.
Electromyography of Erector Spinae
Record electromyography (SEMG) activity in the muscles of the participants in this study the Zerowire Cometa system will be used. Every electrode unit is equipped with a small unit for signal processing and transmission to the data receiver. The electrodes are single use disposable, self-adhesive silver chloride dual snap on electrodes pre-set at a distance of 20mm.
All participants will have the skin prepared prior to the noraxon electrode being placed on their skin. Electrodes will be attached according to European recommendation (seniam) at the Paraspinal muscles (L1 region). A baseline sEMG will then be taken whilst the participant is at rest for 60seconds. The electrode placement and sEMG recording will be taken by a qualified laboratory technician employed by Teesside University.
Measured: 5, 10, 15, 20, 30, 60 minutes post application as a single test.
Electromyography of Biceps Femoris
Record electromyography (SEMG) activity in the muscles of the participants in this study the Zerowire Cometa system will be used. Every electrode unit is equipped with a small unit for signal processing and transmission to the data receiver. The electrodes are single use disposable, self-adhesive silver chloride dual snap on electrodes pre-set at a distance of 20mm.
All participants will have the skin prepared prior to the noraxon electrode being placed on their skin. Electrodes will be attached according to European recommendation (seniam) to the Biceps Femoris of the dominate leg. A baseline sEMG will then be taken whilst the participant is at rest for 60seconds. The electrode placement and sEMG recording will be taken by a qualified laboratory technician employed by Teesside University.
Measured: 5, 10, 15, 20, 30, 60 minutes post application as a single test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start22 Sep 2017
- Primary completion20 Feb 2018
- Study completion1 Mar 2018
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 Hamstring InjuryStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- The study will be a cross-over design. A pre-test post-test design will be used to evaluate the sEMG activity of the Erector Spinae muscle group and the Hamstring muscle (Biceps Femoris). Lumbar flexion range of motion and hamstring length will be tested prior too mobilisations and post intervention immediate and at intervals of 5, 10, 15, 20, 30, 60 minutes. Participants will be receive non-intervention one week and mobilisations the following week.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Chesterton, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273400
- Sponsor's protocol ID
- TeessideU
- Status last verified
- Apr 2018
- First submitted
- 1 Sep 2017
- Last updated
- 24 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chesterton P & Payton S (2017) Effects of spinal mobilisations on lumbar and hamstring ROM and sEMG: A randomised control trial. Physiotherapy Practice and Research, 38, 17-25
Szlezak AM, Georgilopoulos P, Bullock-Saxton JE, Steele MC. The immediate effect of unilateral lumbar Z-joint mobilisation on posterior chain neurodynamics: a randomised controlled study. Man Ther. 2011 Dec;16(6):609-13. doi: 10.1016/j.math.2011.06.004. Epub 2011 Jul 13.
PubMed 21742541Chesterton P, Evans W, Livadas N, McLaren SJ. Time-course changes associated with PA lumbar mobilizations on lumbar and hamstring range of motion: a randomized controlled crossover trial. J Man Manip Ther. 2019 May;27(2):73-82. doi: 10.1080/10669817.2018.1542558. Epub 2018 Nov 13.
PubMed 30935338
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of L4 and L5 Lumbar Posterior -Anterior Mobilisations on Measures of Lumbar and Hamstring Range of Motion, and Electromyography Activity of the Erector Spinae and Hamstring
- ClinicalTrials.gov ID
- NCT03273400
- Acronym / sponsor ID
- TeessideU
- Conditions
- Hamstring Injury
- Keywords
- Lumbar, Hamstring, Mobilisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 6 Sep 2017 (actual)
- 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.
To compare the immediate and short-term effects of L4 and L5 Unilateral Posterior Anterior (UPA) Mobilisations on the lumbar and hamstring range of motion and EMG activity of the Erector Spinae and Hamstring muscles.
Using a pre-test post-test crossover design subjects lumbar flexion and active knee extension with be recorded prior to and following unilateral zygapophyseal joint mobilisations. Measures will be taken immediately after and then 5, 10, 15, 20, 30 and 60 minutes intervals post intervention. Mobilisation force will be measured via force plates to ensure consistent mobilisation pressure.
Following data collection statistical analysis will be undertaken to analyse any potential benefit of lumbar mobilisations to influence the EMG activity of the Erector Spinae and Hamstrings. Functional assessment of lumbar range of motion and hamstring range of motion to be conducted and analyse any effect on movement
Detailed description
25-30 participants will be tested in the Olympia Building Biomechanics Laboratory at Teesside University.
Due to the nature of the cross-over design participants will attend the laboratory twice, one week apart.
Baseline measurements of Lumbar flexion and hamstring range of motions will be taken.
During lumbar flexion participants will be asked to stand with their arms at their side (anatomical position) and feet 8cm part. The tester will demonstrate the flexion motion then request the subject bends forwards are far as is possible, maintaining knee extension. A previous reliability study (Page 2012) has indicated four lumbar flexion movements repetitions were required to prevent the effects of passive stiffness improving the range. On the fourth trial the measurement via the modified schober test. This requires skin markers to be placed 10cm above and 5cm below the lumbar-sacral junction and the change distance calculated at end range. This will be conducted by the lead author, Paul Chesterton, a physiotherapist with appropriate insurance and qualifications.
Hamstring extensibility will be measured via the active knee extension test. Test leg will be determined by dominant/kicking leg. Subjects will be secured into anterior pelvic tilt via a belt and asked to extend the knee to maximal length. A purpose made wooden wedge will provide a right angle surface to ensure the hip is held at 90 degrees. The digital inclinometer will record the change in degrees of active knee extension post-test. The knee will be extended to end range, determined by the subject, with the hip, knee and ankle maintained in neutral. The non-dominant leg will be secured to the bed via a belt.
To record the surface electromyography (SEMG) activity in the muscles of the participants in this study the Zerowire Cometa system will be used. This system will record the muscle activity wirelessly. Every electrode unit is equipped with a small unit for signal processing and transmission to the data receiver. The electrodes are single use disposable, self-adhesive silver chloride dual snap on electrodes pre-set at a distance of 20mm.
All participants will have the skin prepared prior to the noraxon electrode being placed on their skin. Skin preparation will consist of shaving the area to remove any hair then wiping the area with alcohol wipe then the placing noraxon dual electrode in appropriate position in relation to recommendations by Seniam (2003). The electrodes are placed in line to the pennant of the muscle.
Electrodes will be attached according to European recommendation (seniam) at the Paraspinal muscles, and the Biceps Femoris of the dominant leg. A baseline sEMG will then be taken whilst the participant is at rest for 60seconds. The electrode placement and sEMG recording will be taken by a qualified laboratory technician employed by Teesside University.
The intervention will consist of unilateral lumbar mobilisations at the L4 and L5 level in a Posterior Anterior direction. The plinth will rest on force plates to allow the authors to analyse the force placed through the vertebrae. Grade three mobilisations will be applied for a one minute period three times at both L4 and L5 level. Each level will be determined by a passive physiological intervertebral movement. Participants will receive the mobilisations at L5 first for one minute followed by L4. This is an appropriate dose for mobilisation application (Maitland, 2013). This process will be carried out three times.
Following either the control or intervention all measure lumbar flexion, hamstring extensibility and sEMG activity will be recorded immediately, 5, 10, 15, 20, 30, 60 minutes post application as a single test.
Data analysis will occur using the zerowire cometa system version 1.6. The raw rate will be smoothed and rectified using a Butterworth algorithm with a high pass filter with a cut of frequency of 20Hz at order 5 with the data will be rectified using route mean square (RMS) set at a window of 20ms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study will be a cross-over design. A pre-test post-test design will be used to evaluate the sEMG activity of the Erector Spinae muscle group and the Hamstring muscle (Biceps Femoris). Lumbar flexion range of motion and hamstring length will be tested prior too mobilisations and post intervention immediate and at intervals of 5, 10, 15, 20, 30, 60 minutes. Participants will be receive non-intervention one week and mobilisations the following week.
| Arm | Type | Receives |
|---|---|---|
| Mobilisations | Experimental | Other: Lumbar MobilisationsThe intervention will consist of unilateral lumbar mobilisations at the L4 and L5 level in a Posterior Anterior direction. The plinth will rest on force plates to allow the authors to analyse the force placed through the vertebrae. Grade three mobilisations will be applied for a one minute period three times at both L4 and L5 level. Each level will be determined by a passive physiological intervertebral movement. Participants will receive the mobilisations at L5 first for one minute followed by L4. This is an appropriate dose for mobilisation application (Maitland, 2013). This process will be carried out three times. Following the intervention all measure lumbar flexion, hamstring extensibility and sEMG activity will be recorded immediately, 5, 10, 15, 20, 30, 60 minutes post application as a single test. |
| Control | No intervention | –All outcome measures (lumbar/hamstring range of motion; EMG activity of the Biceps Femoris and Erector Spinae) will be measured. The control group will then receive no intervention and be asked to lie supine on a plinth for the treatment duration before having the outcome measures reassessed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age between 18-65. Participants willing to provide inform consent. Participants who successfully complete the medical questionnaire. No current lower back or lower limb pathology.
Key exclusion criteria (4 listed)
- Current symptomatic low back pain or lower limb pathology. Participants with altered neurodynamic symptoms. Previous lumbar surgery. Under supervision of another health practionare Pregnant participants Contraindications or precautions to spinal mobilisation
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 |
|---|---|---|
| Lumbar MobilisationsPlease see arm (intervention) description | Other | Mobilisations |
Primary outcome
Lumbar Range of Motion
Time frame: 5, 10, 15, 20, 30, 60 minutes post application as a single test.
During lumbar flexion participants will be asked to stand with their arms at their side (anatomical position) and feet 8cm part. The tester will demonstrate the flexion motion then request the subject bends forwards are far as is possible, maintaining knee extension. A previous reliability study (Page 2012) has indicated four lumbar flexion movements repetitions were required to prevent the effects of passive stiffness improving the range. On the fourth trial the measurement via the modified schober test. This requires skin markers to be placed 10cm above and 5cm below the lumbar-sacral junction and the change distance calculated at end range.
Hamstring Range of Motion
Time frame: 5, 10, 15, 20, 30, 60 minutes post application as a single test.
Hamstring extensibility will be measured via the active knee extension test. Test leg will be determined by dominant/kicking leg. Subjects will be secured into anterior pelvic tilt via a belt and asked to extend the knee to maximal length. A purpose made wooden wedge will provide a right angle surface to ensure the hip is held at 90 degrees. The digital inclinometer will record the change in degrees of active knee extension post-test. The knee will be extended to end range, determined by the subject, with the hip, knee and ankle maintained in neutral. The non-dominant leg will be secured to the bed via a belt.
Electromyography of Erector Spinae
Time frame: 5, 10, 15, 20, 30, 60 minutes post application as a single test.
Record electromyography (SEMG) activity in the muscles of the participants in this study the Zerowire Cometa system will be used. Every electrode unit is equipped with a small unit for signal processing and transmission to the data receiver. The electrodes are single use disposable, self-adhesive silver chloride dual snap on electrodes pre-set at a distance of 20mm. All participants will have the skin prepared prior to the noraxon electrode being placed on their skin. Electrodes will be attached according to European recommendation (seniam) at the Paraspinal muscles (L1 region). A baseline sEMG will then be taken whilst the participant is at rest for 60seconds. The electrode placement and sEMG recording will be taken by a qualified laboratory technician employed by Teesside University.
Electromyography of Biceps Femoris
Time frame: 5, 10, 15, 20, 30, 60 minutes post application as a single test.
Record electromyography (SEMG) activity in the muscles of the participants in this study the Zerowire Cometa system will be used. Every electrode unit is equipped with a small unit for signal processing and transmission to the data receiver. The electrodes are single use disposable, self-adhesive silver chloride dual snap on electrodes pre-set at a distance of 20mm. All participants will have the skin prepared prior to the noraxon electrode being placed on their skin. Electrodes will be attached according to European recommendation (seniam) to the Biceps Femoris of the dominate leg. A baseline sEMG will then be taken whilst the participant is at rest for 60seconds. The electrode placement and sEMG recording will be taken by a qualified laboratory technician employed by Teesside University.
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 24 Apr 2018.
- BackgroundChesterton P & Payton S (2017) Effects of spinal mobilisations on lumbar and hamstring ROM and sEMG: A randomised control trial. Physiotherapy Practice and Research, 38, 17-25
- Background: PubMed 21742541Szlezak AM, Georgilopoulos P, Bullock-Saxton JE, Steele MC. The immediate effect of unilateral lumbar Z-joint mobilisation on posterior chain neurodynamics: a randomised controlled study. Man Ther. 2011 Dec;16(6):609-13. doi: 10.1016/j.math.2011.06.004. Epub 2011 Jul 13.
- Derived from this study: PubMed 30935338Chesterton P, Evans W, Livadas N, McLaren SJ. Time-course changes associated with PA lumbar mobilizations on lumbar and hamstring range of motion: a randomized controlled crossover trial. J Man Manip Ther. 2019 May;27(2):73-82. doi: 10.1080/10669817.2018.1542558. Epub 2018 Nov 13.
- 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.
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 Lumbar Mobilisations in people with Hamstring Injury, run by Teesside 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 4 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 24 Apr 2018. 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?
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 Range of Motion (time frame: 5, 10, 15, 20, 30, 60 minutes post application as a single test.). The study lists 4 primary outcomes in all. 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 NCT03273400, 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 24 Apr 2018.