Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000829011
Ethics application status
Approved
Date submitted
28/09/2010
Date registered
5/10/2010
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Relationship between therapeutic alliance, symptoms remission and function improvement in chronic nonspecific low back pain patients after a lumbar stabilization program
Scientific title
Influence of therapeutic alliance on function improvement in chronic nonspecific low back pain patients after eight weeks of lumbar stabilization program
Secondary ID [1] 252760 0
Nil
Universal Trial Number (UTN)
U1111-1117-2416
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Nonspecific Low Back Pain 258263 0
Condition category
Condition code
Musculoskeletal 258454 258454 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 258455 258455 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lumbar stabilization program during eight weeks. The treatment looking for decrease activation of the superficial lumbar muscles and improve activation of the deep muscles (multifidus and transversus abdominals). The protocol will be divided in two parts where each one is compound for 4 weeks. On first part, the patients will visit the clinic twice a week during 4 weeks for learn how relax the superficial muscles and activate the transversus abdominal and multifidus for then do exercises while maintaining contraction of the transversus abdominal. At the second part of protocol, the sessions will be once a week for others 4 weeks and patients will learn to do controlled movements of lumbar spine in a range of motion free of pain, later, the speed of the exercises is increased and functional movements are practiced. The exercises were grouped in a protocol elaborated using the motor control principle. Each session will have 50-60 minutes of duration.
Intervention code [1] 257276 0
Rehabilitation
Comparator / control treatment
no comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259287 0
Therapeutic Alliance evaluated using the Work Alliance Inventory
Timepoint [1] 259287 0
At the middle of treatment after 4 weeks and in the end after 8 weeks
Primary outcome [2] 259288 0
Muscle activation of the transversus abdominal, internal and external obliques abdominal evaluated with rehabilitative ultrasound imaging and superficial electromyography assessment of the internal oblique abdominal (inferior fibers) and multifidus. The assessment will be made in right and left sides.
Timepoint [2] 259288 0
Baseline before begin of treatment, at middle of treatment after 4 weeks and in the end after 8 weeks.
Primary outcome [3] 259304 0
Function evaluated with Rolland Morris Questionaire
Timepoint [3] 259304 0
Baseline before begin of treatment, at middle of treatment after 4 weeks and in the end after 8 weeks.
Secondary outcome [1] 265711 0
Pain assessed using the McGill Questionnaire of Pain
Timepoint [1] 265711 0
Baseline before begin of treatment, at middle of treatment after 4 weeks and in the end after 8 weeks.
Secondary outcome [2] 265735 0
kinesiophobia measured with Tampa Scale for Kinesiophobia
Timepoint [2] 265735 0
just in baseline
Secondary outcome [3] 265736 0
Health Locus of Control using Multidimensional Health Locus
of Control Scale
Timepoint [3] 265736 0
just in baseline

Eligibility
Key inclusion criteria
back pain for more 6 six month with pain complaint when upon entry of the study
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
structural alteration at low limb and/or spine; surgery in abdominal or spine region; presence of red flags, clear signs of radiculopathy with alteration of reflex, dermatome and/or myotome (at least two of these signs must be positive in a same segment of spine); rheumathic disease in lumbar spine; urinary incontinence; cognitive impairment; obesity, pregnancy or puerperal period

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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2935 0
Brazil
State/province [1] 2935 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 257717 0
Government body
Name [1] 257717 0
Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior (CAPES) - Ministerio da Educacao
Country [1] 257717 0
Brazil
Primary sponsor type
Individual
Name
Paulo Roberto Carvalho do Nascimento
Address
Roberto Simonsen Street, 305, Presidente Prudente/SP, Zip Code 19060-900
Country
Brazil
Secondary sponsor category [1] 256935 0
Individual
Name [1] 256935 0
Ruben de Faira Negrao Filho
Address [1] 256935 0
Roberto Simonsen Street, 305, Presidente Prudente/SP, Zipe Code 19060-900
Country [1] 256935 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259768 0
Ethic and Research Committee of the Faculty of Science and Tecnology, University State Paulista - Julio de Mesquita Filho
Ethics committee address [1] 259768 0
Roberto Simonsen Street, 305, Presidente Prudente/SP, Zip Code 19060-900
Ethics committee country [1] 259768 0
Brazil
Date submitted for ethics approval [1] 259768 0
05/05/2009
Approval date [1] 259768 0
03/07/2009
Ethics approval number [1] 259768 0
53/2009

Summary
Brief summary
The main objective of this study is to analyze the association of the relationship between patient and therapist, the remission of symptoms and function improvement at the end of a period of eight weeks of treatment for lumbar stabilization
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31695 0
Address 31695 0
Country 31695 0
Phone 31695 0
Fax 31695 0
Email 31695 0
Contact person for public queries
Name 14942 0
Paulo Roberto Carvalho do Nascimento
Address 14942 0
Roberto Simonsen Street, 305, Presidente Prudente/SP, Zip Code 19060-900
Country 14942 0
Brazil
Phone 14942 0
+55 18 32295388 branch line 5416
Fax 14942 0
+55 18 32295353
Email 14942 0
[email protected]
Contact person for scientific queries
Name 5870 0
Paulo Roberto Carvalho do Nascimento
Address 5870 0
Roberto Simonsen Street, 305, Presidente Prudente/SP, Zip Code 19060-900
Country 5870 0
Brazil
Phone 5870 0
+55 18 32295388 branch line 5416
Fax 5870 0
+55 18 32295353
Email 5870 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.