Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000014358
Ethics application status
Approved
Date submitted
7/12/2016
Date registered
5/01/2017
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of a clinical intervention of sustained side-lying to correct lumbo-sacral scoliotic list and restore unilateral loss of ankle dorsiflexion strength due to lumbar radiculopathy caused by disc herniation
Scientific title
An investigation of a clinical intervention of sustained side-lying to correct lumbo-sacral scoliotic list and restore unilateral loss of ankle dorsiflexion strength due to lumbar radiculopathy caused by disc herniation
Secondary ID [1] 290705 0
U1111-1188-9018
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain

lumbo-sacral radiculopathy
 301256 0
sciatica 301258 0
lumbo-sacral radiculopathy 301259 0
Condition category
Condition code
Musculoskeletal 301017 301017 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 301018 301018 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research will be conducted in a primary care physiotherapy clinic in the Herne Bay suburb of Auckland. Patients of the clinic who volunteer to participate in the research will be asked to attend twice within a short period of time. The patient will be enrolled at the first session and will be tested within seven days at a second session. The anticipated date of last data collection will therefore be on the 23 November 2017, to collect enrolment data and on 30 November, to collect test data.

The first session is expected to take approximately 30 minutes. The informed choice and consent form and those forms related to exclusion criteria will be completed in this first session. In addition, the patient will be familiarised with the isometric mid-thigh pull test procedure, a test that provides an accurate measure of peak force in semi-upright standing. There will be a period of no more than seven days between this and the second session when testing will be conducted. During this interim period the patient will be asked to abstain from vigorous exercise and to maintain normal daily activity, dietary habits and medication.

The second session will involve a warm up prior to testing. This will include wall-support repeated knee bends for several minutes and then warm up trials of the isometric mid-thigh pull test, one at 50% maximal effort and one at 70% maximal effort. The test will be performed with one foot on the force plate, either affected or unaffected leg in randomised order. The test instruction will be to pull on the bar “Gradually build up to a maximum.” A further instruction to maintain effort for three to five seconds will be used. Maximum isometric ankle dorsiflexion strength, will be measured using a hand-held dynamometer with belt fixation, tested in three repeat measures of affected and unaffected lower limbs.

An intervention specific to each patient will occur immediately following ‘pre-test’ measurements. The intention of the intervention is to correct the lumbo-sacral list. The direction of list is described according to the position of the superior component, the trunk, relative to the pelvis. To correct the list the pelvis will be translocated in the frontal plane. Therefore, to correct left list the patient will lie in right side-lying. The opposite applies to correction of right list, the patient will lie in left side-lying. The plinth will remain flat with head pillows adjusted to the comfort of the patient and a pillow will be placed between the legs. The corrective position will be maintained for five minutes. The isometric mid-thigh test procedure and the dynamometric measurement of ankle dorsiflexion strength will be repeated, ‘pre-test’ and ‘post-test.’ Measurements of pain and scoliotic list will be taken immediately prior to the ‘pre-test’ and prior to the ‘post-test’ isometric mid-thigh pull and dynamometric tests. The second session is expected to take approximately 60 minutes.

The physiotherapist who will conduct the research has postgraduate qualifications in musculoskeletal physiotherapy and has co-authored radiculopathy-related publications in international journals during the last decade.
Intervention code [1] 296591 0
Treatment: Other
Intervention code [2] 296649 0
Rehabilitation
Comparator / control treatment
'No control group'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300430 0
Peak force isometric mid-thigh pull measurement
Timepoint [1] 300430 0
Within second session, pre- and post- intervention
Primary outcome [2] 300431 0
Peak force hand-held dynamometric measurement of ankle dorsiflexors
Timepoint [2] 300431 0
Within second session, pre- and post- intervention
Primary outcome [3] 300432 0
Leg pain intensity on a 0-10 verbal numeric scale
Timepoint [3] 300432 0
Within second session, pre and post- intervention
Secondary outcome [1] 329974 0
A frontal plane plumbline measurement of spine will be taken. A plumb bob will be dropped from the spinous process of the seventh cervical vertebra on a plumbline to the sacrum. A rigid rule will be used to measure the distance from the midline at the lumbo-sacral junction. This method has been found to provide a reliable and valid measurement. .
Timepoint [1] 329974 0
Within second session, pre- and post- intervention

Eligibility
Key inclusion criteria
Clinical diagnosis of lumbo-sacral radiculopathy
Unilateral ankle dorsiflexor weakness, manual muscle test Grade 4
Observable lumbo-sacral scoliotic list in standing
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe pain, Characteristic Pain Intensity, score >50/100
Major neurological deficit, manual muscle test grade < 4 and/ or progressive muscle weakness
Major functional disability, Modified Roland Morris Functional Status Score 22 or 23/23
Significant depressive disorder that requires referral, Zung Self-Rating Depression Scale > 49/100
History of previous injury or disease to the affected or unaffected lower limb
History of cardiovascular disease, diabetes, primary or metastatic cancer, spinal infection, inflammatory joint disease, spondylolisthesis, spinal stenosis, osteoporosis, osteomalacia, aortic aneurysm or bleeding disorder such as haemophilia
History of spinal surgery
Major surgery within the last six months

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
"Allocation is not concealed"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
"Not applicable"
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The study locality, an accredited private physiotherapy practice, has formalised approved emergency procedures, reporting procedures for adverse events affecting patients and a privacy policy related to confidentiality of patient records. There will be a monitoring plan for the study. Safety of the experimental test area, the equipment and room conditions for hazards will be closely monitored. Test equipment will be checked for damage including its wiring and plugs for any signs of disrepair including frayed components. Lighting will be sufficient and the temperature of the room adjusted for participants. The researcher who will conduct testing, holds a current First Aid certificate, as do all physiotherapists in the practice. Testing will only proceed if there are other physiotherapists present. Protection of the rights and wellbeing of participants will be monitored as will the security of study data. The conduct of the study in relation to the approved study protocol and the availability of health services to any participants who suffer injury as a consequence of study intervention will be monitored. The test position for the isometric mid-thigh pull test is to be in a semi-upright standing position that the patient finds most comfortable. The semi-upright position is safer than the more common lift from ankle level used in functional assessment of low back pain. Patients with minor muscle weakness and non-severe pain will be included. The intervention in side-lying to achieve pelvic translocation to correct scoliotic list is less aggressive than the commonly used intervention of pelvic translocation in standing. The duration of side-lying will be short, five minutes, to minimise long-term effects if deleterious and as stated above only patients with minor loss of muscle strength and minor symptoms will be recruited.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Determination of sample size is referred to as power analysis or as determining the power of the study. Power is the probability of avoiding a Type 1 error, the erroneous rejection of a null hypothesis, or the erroneous acceptance of a false null hypothesis, a Type 2 error. An 80% level i.e. 80% probability that a real effect in the population will be detected, is generally considered adequate. Power is a function of several variables, including the sample size and the statistical test to be employed. An adequate sample size N for the coefficient of variation and intraclass correlation coefficient statistic to be employed, power = .80 and p = .05 is calculated N = 23.

A paired t test will be used to analyse the pre-test versus post-test data. Regression analysis will be performed on the data to analyse the mean difference pre-test, post-test in relation to the pre-test percentage loss of ankle dorsiflexion strength (N), the size of list (mm), pain (VNS score), age (y), weight (kg) and height (m). Stepwise regression analysis may be indicated to identify the appropriate model to predict post-test strength difference.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2017
Actual
15/02/2017
Date of last participant enrolment
Anticipated
15/11/2019
Actual
Date of last data collection
Anticipated
29/11/2019
Actual
Sample size
Target
38
Accrual to date
29
Final
Recruitment outside Australia
Country [1] 8466 0
New Zealand
State/province [1] 8466 0
Auckland City

Funding & Sponsors
Funding source category [1] 295130 0
University
Name [1] 295130 0
Auckland University of Technology
Country [1] 295130 0
New Zealand
Primary sponsor type
Individual
Name
Kate Haswell
Address
Auckland University of Technology, Private Bag 92006, Auckland 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 293948 0
None
Name [1] 293948 0
Address [1] 293948 0
Country [1] 293948 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296478 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 296478 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 296478 0
New Zealand
Date submitted for ethics approval [1] 296478 0
03/11/2016
Approval date [1] 296478 0
21/11/2016
Ethics approval number [1] 296478 0
16/STH/178

Summary
Brief summary
Disability due to low back pain is a major health issue worldwide. Lumbo-sacral radiculopathy due to nerve root compression caused by disc herniation can result in unilateral loss of lower limb muscle strength. Muscle strength loss and lumbar scoliotic list, a spinal deformity, are the two physical signs of radiculopathy associated with very high compressive pressure on the affected lower lumbo-sacral nerve(s). The societal impact of radiculopathy is considerable as it affects people of working age whose mobility impairment due to muscle weakness can mean reduced participation including unemployment. A previous case study reported that correction of scoliotic list in side-lying resulted in improved muscle strength outcomes when measured by manual muscle tests. The objective is to demonstrate improved muscle strength with correction of scoliotic list in a one group prospective pre- post-intervention study design. In the proposed project, the isometric mid-thigh pull test, if found to be a feasible, reliable and valid measure of muscle strength loss due to radiculopathy, will be used to assess muscle strength outcomes of the side-lying intervention to correct scoliotic list. Patients included in the project will have a clinical diagnosis of lumbo-sacral radiculopathy, non-severe radicular pain, minor ankle dorsiflexion weakness, a lumbar scoliotic list in standing, and will be aged between 20 and 60 years. The project will commence January 2017 and will be completed December 2018. The project will be written up in a thesis in accordance with Auckland University of Technology regulations including introduction and conclusion chapters. The thesis may contribute to a better understanding of primary care intervention for the disabling condition, lumbo-sacral radiculopathy due to nerve compression caused by disc herniation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71002 0
Ms Kate Haswell
Address 71002 0
Gilmour and Associates Physiotherapy
134 Jervois Road
Herne Bay
Auckland 1011
Country 71002 0
New Zealand
Phone 71002 0
+6493764500
Fax 71002 0
Email 71002 0
[email protected]
Contact person for public queries
Name 71003 0
Mrs Gail Kingston
Address 71003 0
Gilmour and Associates Physiotherapy
134 Jervois Road
Herne Bay
Auckland 1011
Country 71003 0
New Zealand
Phone 71003 0
+6493764500
Fax 71003 0
Email 71003 0
[email protected]
Contact person for scientific queries
Name 71004 0
Ms Kate Haswell
Address 71004 0
Gilmour and Associates Physiotherapy
134 Jervois Road
Herne Bay
Auckland 1011
Country 71004 0
New Zealand
Phone 71004 0
+6493764500
Fax 71004 0
Email 71004 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
This is a matter I need to investigate further before making a decision. Also I need to discuss it with all of those involved in this research.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.