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Trial registered on ANZCTR


Registration number
ACTRN12622000603718p
Ethics application status
Not yet submitted
Date submitted
29/03/2022
Date registered
22/04/2022
Date last updated
22/04/2022
Date data sharing statement initially provided
22/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of 2 different methods of pain relieving injections around a nerve in the low back .
Scientific title
Comparison of the effects of peri-neural hydro-dissection versus local anaesthetic and corticoseroid injection for the superior cluneal nerve impingement in patients on pain severity with low back pain involving the superior cluneal nerve impingement: a randomised controlled trial.
Secondary ID [1] 306548 0
None
Universal Trial Number (UTN)
U1111-1275-0666
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cluneal Nerve Impingement 325440 0
Low back pain 325908 0
Condition category
Condition code
Musculoskeletal 322820 322820 0 0
Other muscular and skeletal disorders
Neurological 322821 322821 0 0
Other neurological disorders
Anaesthesiology 323220 323220 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Particpants selcted to the active arm will be provided with a fascial hydrodissection technique using 5% glucose , lignocaine 1% (2 mls) and Dexamethasone 8 mgs. Approximately 10 mls will be used for the hydrodissection. The injections are performed ultrasound guided. Injections are usually performed on a single occasion.
Intervention code [1] 322971 0
Treatment: Drugs
Comparator / control treatment
The usual treartment for cluneal nerve impingement is an injection of a mixture of lignocaine 1% and Dexamethaosne 8 mgs, around the nerve. The injection will be performed using ultrasound guidance injection is anticapted to be used on a single occasion.
Control group
Active

Outcomes
Primary outcome [1] 330603 0
Visual Analogus score to assess pain in a quatitave manner
Timepoint [1] 330603 0
At basleine pre-injection, and at 1 month post procedure
Primary outcome [2] 330604 0
Function as recorded by validated questionnaires , Roland Morris Back Pain Disability index,
Timepoint [2] 330604 0
At basleine pre-injection and at 1 month post procedure
Primary outcome [3] 330971 0
Pain maps using a VAS score
Timepoint [3] 330971 0
At basleine pre-injection and at 1, month post procedure
Secondary outcome [1] 406923 0
Range of motion of the lumbar spine flexion as assessed by finger tips to mid thighs, knees , shins
Timepoint [1] 406923 0
Pre-injection and at 1,3 and 12 months post procedure
Secondary outcome [2] 408313 0
Quebec Back Pain inventory
Timepoint [2] 408313 0
baseline, 1,3 and 12 months post procedure

Eligibility
Key inclusion criteria
Aged 18 with the ability to provide informed consent.
Back pain diagnosed as coming from the superior l nerve
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with other sources of low back pain
Known allergies to the injectates
Inability to be available for follow up questionnaires and pain mapping and scoring

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Masking of allocation will be applied. using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation. Allocation will be via sealed opaque envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
A pilot study was conducted and a power study undertaken to determine minimum numbers to provide a statistical difference between the groups. There were 25 cases in the sample. 13 cases with superior cluneal nerve pain (exposed) and 12 cases with no superior cluneal pain (unexposed). Therefore the ratio of unexposed : exposed=12/13=0.923.

Buttock pain was reported in 12 cases. Therefore the % outcome in the unexposed group is 13/25=52%.

Full study Statistical Method: Fleiss with continuity correction

Assuming the ratio of unexposed : exposed=50/50=1.

In order to achieve 95% two-sided confidence level with 80% power, we need a sample of 38 cases.

Statitsical analysis: if the distribution appears normally distributed then an Independent group T test will be applied. If the data is not normally distributed then either Mann Whitney or Welch's t-test will be applied

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2022
Actual
Date of last participant enrolment
Anticipated
30/12/2022
Actual
Date of last data collection
Anticipated
30/12/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22061 0
Spine and Sportsmed - Meadowbank
Recruitment postcode(s) [1] 37036 0
2114 - Meadowbank
Recruitment postcode(s) [2] 37037 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 310883 0
Self funded/Unfunded
Name [1] 310883 0
Jennifer Saunders
Country [1] 310883 0
Australia
Primary sponsor type
Individual
Name
Jennifer Saunders
Address
Spine and Sportsmed
Suite 101
5 Bay Drive
MEadowbnak NSW 2114
Country
Australia
Secondary sponsor category [1] 312158 0
None
Name [1] 312158 0
None
Address [1] 312158 0
NA
Country [1] 312158 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 310443 0
University of Notre Dame Human Research Ethics Committee
Ethics committee address [1] 310443 0
Ethics committee country [1] 310443 0
Australia
Date submitted for ethics approval [1] 310443 0
30/04/2022
Approval date [1] 310443 0
Ethics approval number [1] 310443 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117686 0
A/Prof Jennifer Saunders
Address 117686 0
Spine and Sportsmed
Suite 101
5 Bay Drive
Meadowbank NSW 2114
Country 117686 0
Australia
Phone 117686 0
+61 2 95875544
Fax 117686 0
+61 2 82115247
Email 117686 0
saunders.jeni@gmail.com
Contact person for public queries
Name 117687 0
Jeni Saunders
Address 117687 0
Spine and Sportsmed
Suite 101
5 Bay Drive
Meadowbank NSW 2114
Country 117687 0
Australia
Phone 117687 0
+61295875544
Fax 117687 0
+61 2 82115247
Email 117687 0
saunders.jeni@gmail.com
Contact person for scientific queries
Name 117688 0
Jeni Saunders
Address 117688 0
Spine and Sportsmed
Suite 101
5 Bay Drive
Meadowbank NSW 2114
Country 117688 0
Australia
Phone 117688 0
+61295875544
Fax 117688 0
+61 2 82115247
Email 117688 0
saunders.jeni@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pain maps, VAS scores and questionnaires
When will data be available (start and end dates)?
After publication and to 5 years after publication
Available to whom?
Researchers who provide a sound methodological approach
Available for what types of analyses?
To achieve aims provided
How or where can data be obtained?
Contacting Researchers directly via email
saunders.jeni@gmail.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15226Clinical study report  saunders.jeni@gmail.com
15227Ethical approval  saunders.jeni@gmail.com



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.