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Trial registered on ANZCTR


Registration number
ACTRN12615000306516
Ethics application status
Not yet submitted
Date submitted
9/12/2014
Date registered
1/04/2015
Date last updated
1/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Chronic back pain rehabilitation in small groups: pain, disability and function a quasi-randomized trial
Scientific title
In patients with chronic back pain is rehabilitation in small groups following the international guidelines as good or better than classic approach with back school (postural education, strengthening exercises, stretching exercises) for relief of pain, reduction of disability, and increase of function
Secondary ID [1] 285812 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic back pain
 293713 0
Condition category
Condition code
Musculoskeletal 294011 294011 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 294012 294012 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2-week exercise rehabilitation program. Back School based exercise involving stretching of back muscles, exercise of abdomen strenghtening, postural education, floor based exercise. Back School home-based exercises (the same exercises performed during treatment sessions) are reported in a book given at the end of the treatment. Evidence based exercise involving progressive exposure (with a progressive increase in repetitions and coordination and decrease of balance till fatigue), aerobic global exercise (involving the muscles of both legs and of the back in the way to increase the heart beat from the one at rest). Evidence based home-based exercises involves global aerobic exercises floor based exercises and auto-mobilization of peripheral nervous system, those exercises will be taught to the patients during the treatment sessions.
Prescription is 5 x 1/2 hours sessions per week for 2-weeks. All directly supervised from the physiotherapist in a group format (5 people per group session). All sessions will be performed in a outpatient service of the public health system. No intervention group will completes both the back and evidence based exercises. Adherence to the intervention will be assessed through the presences to the treatment sessions and an adherence scale at follow-up assessment.
Intervention code [1] 290784 0
Rehabilitation
Comparator / control treatment
Evidence based exercise involving progressive exposure (with a graded increment of range of motion, repetitions, and balance), aerobic global exercise (using both arms and legs muscles in the way to increase the heart beat from the one at rest), neurodynamic exercise (with auto-mobilization techniques of the peripheral nervous system). Sessions will be supervised by the physical therapist.
Prescription is 5 x 1/2 hours sessions per week for 2-weeks. All directly supervised in a group format (5 people per group session).

Waitlist control group will be treated in one of the two groups above (Back school group or Evidence based group) in not more than 12 month. they will be assigned to the group they will choose (blinded from the type of treatment) during reservation of the rehabilitation cycle. None of the control group will perform any type of rehabilitation program including home based exercises.
Control group
Active

Outcomes
Primary outcome [1] 293789 0
Pain intensity (Verbally administred Numerical Pain Rating Scale)
Timepoint [1] 293789 0
Baseline (pre), 2-weeks (post program) and 3 month (follow up)
Primary outcome [2] 293790 0
Disability (Roland Morris Disability Questionnaire)
Timepoint [2] 293790 0
Baseline (pre), 2-weeks (post program) and 3 month (follow up)
Primary outcome [3] 293791 0
Functioning (SF-36)
Timepoint [3] 293791 0
Baseline (pre), 2-weeks (post program) and 3 month (follow up)
Secondary outcome [1] 311855 0
Adeherence to the Physical therapist indications on home exercises (SIRAS)
Timepoint [1] 311855 0
3 month (follow up)
Secondary outcome [2] 311856 0
number of exercise remembered will be assessed during the administration of the scales at follow up in a written form.

"Report here how many exercises you remeber from those learnt during the treatment sessions_________"
Timepoint [2] 311856 0
3 month (follow up)
Secondary outcome [3] 311857 0
other health system access for unresolved back pain will be assessed during the administration of the scales at follow up in a written form.

"Report here how many other accesses to the health system you have done for your unresolved back pain after the treatment sessions_________"
Timepoint [3] 311857 0
3 month (follow-up)

Eligibility
Key inclusion criteria
Male and female participants with chronic back pain. This group excludes those with oncological disease or neurological progressive diseases and dementia(as assessed from described history of participants), because of possible interaction with diseases problems related , which introduces confounding factors for interpretation of the results.
Participants will have had LBP for at least 12 weeks and have provided written informed consent confirming
their participation.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded for the following reasons: presence of severe postural abnormality or neuromuscular disorder, previous diagnosis of pathology (confirmed by previous magnetic resonance imaging or radiograph).
Participants must not have engaged in any specific rehabilitation program in the last 3-months, and
must not be regularly seeing a physiotherapist or any spinal manipulation practitioner.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Effect size expected (d of Cohen) was a strong clinical effect ( d = 0.80).
Sample size was estimated with a alpha = 0.05 (5% chance of type I error) and 1- beta =0.80 (power 80%). This provided an estimated total sample size of n = 52. Allowing for a 20% dropout rate increased the sample size required to n = 64 (n = 32 in each group of tretment) plus n = 32 waitlist control group.

Variations in responses will be assessed through a Generalised Multinomial Model (GLM) to assess the impact that can have time or rehabilitation or the interaction between them in the modification of those values. Statistical analysis will be performed through correlation assessment in changes of she scale scores using Student T test and Spearman's Rho test. also the impact of adherence to the physical therapist's indication on exercise to be performed at home will be assessed through a GLM

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/05/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment outside Australia
Country [1] 6515 0
Italy
State/province [1] 6515 0
Milano

Funding & Sponsors
Funding source category [1] 290372 0
Self funded/Unfunded
Name [1] 290372 0
None
Country [1] 290372 0
Primary sponsor type
Individual
Name
Giacomo Carta
Address
Isituti Clinici di Perfezionamento

Viale Andrea Doria 52

Milano

20122
Country
Italy
Secondary sponsor category [1] 289099 0
None
Name [1] 289099 0
Address [1] 289099 0
Country [1] 289099 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292075 0
Isituti Clinici di Perfezionamento
Ethics committee address [1] 292075 0
Ethics committee country [1] 292075 0
Italy
Date submitted for ethics approval [1] 292075 0
15/01/2015
Approval date [1] 292075 0
Ethics approval number [1] 292075 0

Summary
Brief summary
the aim of the study is to assess the impact of rehabilitation in small groups (2-5 people) on chronic back pain. In particular we want to assess the changes on pain intensity, disability and functioning. A comparison will be made between classic treatment (Back School approach), waiting list and guidelines on chronic back pain follower.
We also want to assess the changes during time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53370 0
Dr Giacomo Carta
Address 53370 0
Isituti Clinici di Perfezionamento

Viale Andrea Doria 52

Milano

20122
Country 53370 0
Italy
Phone 53370 0
+39 3405950493
Fax 53370 0
Email 53370 0
[email protected]
Contact person for public queries
Name 53371 0
Giacomo Carta
Address 53371 0
Isituti Clinici di Perfezionamento

Viale Andrea Doria 52

Milano

20122
Country 53371 0
Italy
Phone 53371 0
+39 3405950493
Fax 53371 0
Email 53371 0
[email protected]
Contact person for scientific queries
Name 53372 0
Giacomo Carta
Address 53372 0
Isituti Clinici di Perfezionamento

Viale Andrea Doria 52

Milano

20122
Country 53372 0
Italy
Phone 53372 0
+39 3405950493
Fax 53372 0
Email 53372 0
[email protected]

No information has been provided regarding IPD availability


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.