Low Back Pain, MechanicalNCT03062293
Newcastle Low Back Pain Intervention Study
A study testing Functional Re-adaptive Exercise Device in people with Low Back Pain, Mechanical, run by Northumbria University.
Trial summary
The aim of this study is to investigate if six-weeks of exercise intervention, 3 times per week on the Functional Re-adaptive Exercise Device (FRED) reduces non-specific mechanical low back pain in adults ages 18-60. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Functional Re-adaptive Exercise Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Mar 2017
- 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
- Mechanical LBP for 8 weeks or longer
- Score of < 15 on FABQ
- Age 18-60
- Commitment to taking part in the study for its full duration
Who cannot join
- Presence of "red flags" - indicative of non-mechanical LBP
- Score of > 15 on FABQ or other indicators of a likely poor response to a solely physical approach to treatment incl. seeking compensation for LBP
- Exercise contraindicated as per Physical Activity Readiness Questionnaire
- Inability to exercise safely on the FRED
- Pregnancy
- Surgery within the previous nine months
Show all 10Show fewer
- Difficulty to exercise safely in standing for 30 mins 3x/week
- Cardio/respiratory disease
- Neurological disorders
- BMI > 28 where adipose tissue infringes on ultrasound imaging and intramuscular electrode placement
About this study
The aim of this study is to investigate if six-weeks of exercise intervention, 3 times per week on the Functional Re-adaptive Exercise Device (FRED) reduces non-specific mechanical low back pain in adults ages 18-60.
Read the detailed description
The aim of this study is to investigate whether an six-week FRED exercise intervention reduces low back pain (LBP) and improves a range of related outcomes.
The objectives of this study are to examine
- whether FRED exercise reduces mechanical LBP ( low back pain);
- whether FRED exercise improves functional and static balance in people with LBP;
- whether FRED exercise has an effect on cross-sectional area (CSA) of relevant lumbo-pelvic muscles;
- whether FRED exercise has an effect on TrA (Transversus Abdominis), LM ( Lumbar Multifidus), lumbar Erector Spinae, External and Internal Oblique muscle activity and function in individuals with LBP;
- whether FRED exercise has an effect on TrA and internal oblique muscle thickness;
- the rate of muscle physiology change in response to FRED exercise in people with LBP;
- whether FRED exercise affects the analgesic intake, need for intervention and physical activity level of individuals with LBP;
- whether FRED exercise affects wellbeing and every-day function in people with LBP;
- the rate of change of level of pain, wellbeing and of function (incl. balance) in response to FRED exercise in people with LBP.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Functional Re-adaptive Exercise Device
- Keywords
- Lumbo-pelvic muscles, Rehabilitation, Exercise, Low back pain, Functional Re-adaptive Exercise Device
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Re-adaptive Exercise DeviceDevice
Also called FRED
Exercise intervention 3 times per week for up to 30min. Difficulty and time will be progressed as indicated by clinical presentation, assessed by the Physiotherapist team.
| Study group | Role | What they receive |
|---|---|---|
| Functional Re-adaptive Exercise Device | Experimental | Single arm for within subject repeated measures design. Receives: Device: Functional Re-adaptive Exercise Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intramuscular EMG of Lumbo-pelvic muscles
iEMG of Lumbar Multifudus (LM), Transversus Abdominus (TrA), External Obliques and Internal obliques during exercise and balance tasks
Measured: within 1 week prior to intervention, and within 1 week post intervention (2 data collection
Secondary outcomes (6)
Change in muscular arcitecture via Ultrasound imaging
USI of cross sectional area and thickness of Lumbar Multifudus (LM),and thickness of Transversus Abdominus (TrA)
Measured: At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, 1 x week during intervention, and at intervention +12 weeks (10 data collections)
VICON/ force plate kinematic data
Measuring postural sway changes in center of pressure during the balance and rapid arm movement tasks, repeated measure throughout study
Measured: within 1 week prior to intervention and and within 1 week post intervention (2 data collections)
Participant Activity Log
Measured: Daily from baseline data collection to intervention +16 weeks follow-up (total 203 days)
SF-36 II .
Version 2, UK, acute recall
Measured: At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, at intervention +6 week, +12 weeks and +16 weeks follow up (5 data collections)
Patient Specific Functional Scale
repeated measure throughout study
Measured: At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, at intervention +6 week, +12 weeks and +16 weeks follow up (5 data collections)
Numeric Rating Scale for Pain
Measured: At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, at intervention +6 week, +12 weeks and +16 weeks follow up (5 data collections)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startSep 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
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 Pain, MechanicalStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Repeat measures within subject design
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- European Space Agency, The University of Queensland, International Space University, Aalborg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062293
- Sponsor's protocol ID
- FRED2016
- Status last verified
- Feb 2017
- First submitted
- 11 Oct 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: NO IPD will be available to researchers outside of the research team.
Publications
Caplan, N, Gibbon, KC, Hibbs, A & Debuse, D 2014, 'Phasic-to-tonic shift in tunk muscle activity during low-impact weight bearing exercise', Acta Astronautica, vol 104, pp. 388-395.
Debuse D, Birch O, St Clair Gibson A, Caplan N. Low impact weight-bearing exercise in an upright posture increases the activation of two key local muscles of the lumbo-pelvic region. Physiother Theory Pract. 2013 Jan;29(1):51-60. doi: 10.3109/09593985.2012.698718. Epub 2012 Jul 12.
PubMed 22789062Gibbon KC, Debuse D, Caplan N. Low impact weight-bearing exercise in an upright posture achieves greater lumbopelvic stability than overground walking. J Bodyw Mov Ther. 2013 Oct;17(4):462-8. doi: 10.1016/j.jbmt.2013.02.004. Epub 2013 Apr 22.
PubMed 24139004Evetts SN, Caplan N, Debuse D, Lambrecht G, Damann V, Petersen N, Hides J. Post space mission lumbo-pelvic neuromuscular reconditioning: a European perspective. Aviat Space Environ Med. 2014 Jul;85(7):764-5. doi: 10.3357/asem.3943.2014.
PubMed 25022167
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Newcastle Low Back Pain Intervention Study
- ClinicalTrials.gov ID
- NCT03062293
- Acronym / sponsor ID
- FRED2016
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Lumbo-pelvic muscles, Rehabilitation, Exercise, Low back pain, Functional Re-adaptive Exercise Device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- European Space Agency, The University of Queensland, International Space University, Aalborg University
- Study start
- Sep 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 23 Feb 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.
The aim of this study is to investigate if six-weeks of exercise intervention, 3 times per week on the Functional Re-adaptive Exercise Device (FRED) reduces non-specific mechanical low back pain in adults ages 18-60.
Detailed description
The aim of this study is to investigate whether an six-week FRED exercise intervention reduces low back pain (LBP) and improves a range of related outcomes.
The objectives of this study are to examine
- whether FRED exercise reduces mechanical LBP ( low back pain);
- whether FRED exercise improves functional and static balance in people with LBP;
- whether FRED exercise has an effect on cross-sectional area (CSA) of relevant lumbo-pelvic muscles;
- whether FRED exercise has an effect on TrA (Transversus Abdominis), LM ( Lumbar Multifidus), lumbar Erector Spinae, External and Internal Oblique muscle activity and function in individuals with LBP;
- whether FRED exercise has an effect on TrA and internal oblique muscle thickness;
- the rate of muscle physiology change in response to FRED exercise in people with LBP;
- whether FRED exercise affects the analgesic intake, need for intervention and physical activity level of individuals with LBP;
- whether FRED exercise affects wellbeing and every-day function in people with LBP;
- the rate of change of level of pain, wellbeing and of function (incl. balance) in response to FRED exercise in people with LBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeat measures within subject design
| Arm | Type | Receives |
|---|---|---|
| Functional Re-adaptive Exercise Device | Experimental | Device: Functional Re-adaptive Exercise DeviceSingle arm for within subject repeated measures design. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Mechanical LBP for 8 weeks or longer
- Score of < 15 on FABQ
- Age 18-60
- Commitment to taking part in the study for its full duration
Key exclusion criteria (10 listed)
- Presence of "red flags" - indicative of non-mechanical LBP
- Score of > 15 on FABQ or other indicators of a likely poor response to a solely physical approach to treatment incl. seeking compensation for LBP
- Exercise contraindicated as per Physical Activity Readiness Questionnaire
- Inability to exercise safely on the FRED
- Pregnancy
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 |
|---|---|---|
| Functional Re-adaptive Exercise DeviceAlso: FREDExercise intervention 3 times per week for up to 30min. Difficulty and time will be progressed as indicated by clinical presentation, assessed by the Physiotherapist team. | Device | Functional Re-adaptive Exercise Device |
Primary outcome
Change in Intramuscular EMG of Lumbo-pelvic muscles
Time frame: within 1 week prior to intervention, and within 1 week post intervention (2 data collection
iEMG of Lumbar Multifudus (LM), Transversus Abdominus (TrA), External Obliques and Internal obliques during exercise and balance tasks
6 secondary outcomes
Change in muscular arcitecture via Ultrasound imaging
Time frame: At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, 1 x week during intervention, and at intervention +12 weeks (10 data collections)
VICON/ force plate kinematic data
Time frame: within 1 week prior to intervention and and within 1 week post intervention (2 data collections)
Participant Activity Log
Time frame: Daily from baseline data collection to intervention +16 weeks follow-up (total 203 days)
SF-36 II .
Time frame: At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, at intervention +6 week, +12 weeks and +16 weeks follow up (5 data collections)
Patient Specific Functional Scale
Time frame: At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, at intervention +6 week, +12 weeks and +16 weeks follow up (5 data collections)
Numeric Rating Scale for Pain
Time frame: At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, at intervention +6 week, +12 weeks and +16 weeks follow up (5 data collections)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- BackgroundCaplan, N, Gibbon, KC, Hibbs, A & Debuse, D 2014, 'Phasic-to-tonic shift in tunk muscle activity during low-impact weight bearing exercise', Acta Astronautica, vol 104, pp. 388-395.
- Background: PubMed 22789062Debuse D, Birch O, St Clair Gibson A, Caplan N. Low impact weight-bearing exercise in an upright posture increases the activation of two key local muscles of the lumbo-pelvic region. Physiother Theory Pract. 2013 Jan;29(1):51-60. doi: 10.3109/09593985.2012.698718. Epub 2012 Jul 12.
- Background: PubMed 24139004Gibbon KC, Debuse D, Caplan N. Low impact weight-bearing exercise in an upright posture achieves greater lumbopelvic stability than overground walking. J Bodyw Mov Ther. 2013 Oct;17(4):462-8. doi: 10.1016/j.jbmt.2013.02.004. Epub 2013 Apr 22.
- Background: PubMed 25022167Evetts SN, Caplan N, Debuse D, Lambrecht G, Damann V, Petersen N, Hides J. Post space mission lumbo-pelvic neuromuscular reconditioning: a European perspective. Aviat Space Environ Med. 2014 Jul;85(7):764-5. doi: 10.3357/asem.3943.2014.
- Individual participant dataSharing planned: No. NO IPD will be available to researchers outside of the research team.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Re-adaptive Exercise Device in people with Low Back Pain, Mechanical, run by Northumbria University.
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 10 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: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 in Intramuscular EMG of Lumbo-pelvic muscles (time frame: within 1 week prior to intervention, and within 1 week post intervention (2 data collection). 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 NCT03062293, 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 23 Feb 2017.