Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000818639
Ethics application status
Approved
Date submitted
19/11/2013
Date registered
31/07/2014
Date last updated
31/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a randomized trial of resistance dynamic stabilization training on Fitness and Quality of Life in the management of chronic nonspecific low-back pain
Scientific title
A randomised controlled trial on the effects of resistance dynamic stabilization training on Fitness and Quality of Life in the management of chronic nonspecific low-back pain
Secondary ID [1] 283618 0
None
Universal Trial Number (UTN)
U1111-1138-9727
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of life 290543 0
Chronic nonspecific low back pain 290549 0
Condition category
Condition code
Musculoskeletal 290941 290941 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 290948 290948 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects were cited in the laboratory 2 weeks before starting the experimental protocol and performed 2 sessions of 2 hours, to collect personal and familiarization with the exercises information.

The exercise group (EG) exercised in Physiotherapy Clinic, two times per week for a 12-week period. EG was monitored by the same specialist (qualified personnel), who led each training session. At least one trained monitor was always present to verify the correct application of the methodology. Each therapy session ranged from 45 to 60 min depending on the phase. A warm-up of 6-7 min of mild cardiovascular exercise followed by 3-4 min of stretching was always performed prior to the training sessions. A cool-down of 1 min of mild cardiovascular exercise followed by 4 min of stretching was always performed after the training sessions.

The subjects were instructed in the different exercise techniques and in controlling exercise intensity through the combined use of a targeted number of repetitions and perception of effort during two sessions before beginning the training program. The criteria of body position, ranges of motion and movement speed described.

The load (resistance) for each exercise was determined according to the rating of perceived exertion in active muscles by using the OMNI resistance exercise scale for active muscles.

The control of neutral lordosis for seat pull and row exercises was determined with the pressure changes on biofeedback meter.
Intervention code [1] 288311 0
Rehabilitation
Comparator / control treatment
continued their habitual leisure-time activities. Gardening; walking; housework.
Control group
Active

Outcomes
Primary outcome [1] 290923 0
Improvements in the Health Related Quality of Life (HRQOL) of participants assessed by the Medical Outcomes Study Short Form (SF-36).
Timepoint [1] 290923 0
at 12 weeks after intervention
Primary outcome [2] 290927 0
Improvements in the pain of participants assessed by the Medical Outcomes Study visual analogue scale (VAS).
Timepoint [2] 290927 0
at 12 weeks after intervention
Primary outcome [3] 290928 0
Improvements in the functional disability of participants assessed by the Medical Outcomes Study Oswestry Disability Index (ODI)
Timepoint [3] 290928 0
at 12 weeks after intervention
Secondary outcome [1] 305602 0
Improvements in the Physical Fitness of participants assessed by the Medical Outcomes Study blind flamingo test; static back endurance test; side bridge test; abdominal curl-up test; 60-s squat test.
Timepoint [1] 305602 0
at 12 weeks after intervention

Eligibility
Key inclusion criteria
*women between 20 and 55 years of age; *subjects had low back pain as a primary complaint, without associated leg pain; *all subjects suffered from chronic (>3 months, >3 d·wk-1) nonspecific (soft tissue in origin) low-back (lumbar 5 to lumbar 1) pain; and *no history of formal exercise training
Minimum age
20 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
*were receiving concurrent treatments from another practitioner for their low back pain; *were diagnosed as having a tumor, infection, or inflammatory disease affecting the spine; *had spinal or lower-limb surgery; *had spinal fractures or structural deformities such as spondylolisthesis and spondylolysis; *had any contraindications to exercise therapy (e.g., uncontrolled hypertension, previous myocardial infarction, cerebrovascular disease, peripheral vascular disease, respiratory disorders); *were involved in workers’ compensation claims; *had signs of nerve root compromise, defined as decreased tendon reflexes, sensory loss, and motor deficits; and *were receiving medications other than analgesics and nonsteroidal anti-inflammatory drugs.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects were recruited from the patients regularly referred to Outpatient Physiotherapy Services. A physician reviewed their medical records and clinical status and confirmed the diagnosis according inclusion-exclusion criteria. The method of allocation concealment used in this trial was central randomization by phone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random order for the allocation of subjects into different groups was a simple randomization using a randomization table rested by computes software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Because the intervention requires a lot of control and supervision, the number of participating subjects (experimental group) was conditioned by number of supervisors. Was determined not to exceed more than 5 subjects for supervisor. This limited to 15 subjects for the experimental group and 15 for control.

Data were analyzed via a general linear model with repeated-measures analysis of variance (ANOVA). When the data were not normally distributed, the Friedman ANOVA followed by the Wilcoxon signed-rank test was used. Effect size was estimated with Cohen's d.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/02/2013
Actual
25/02/2013
Date of last participant enrolment
Anticipated
25/02/2013
Actual
3/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 5643 0
Spain
State/province [1] 5643 0
Alicante

Funding & Sponsors
Funding source category [1] 288298 0
University
Name [1] 288298 0
University of Alicante
Country [1] 288298 0
Spain
Primary sponsor type
University
Name
University of Alicante
Address
Campus de San Vicent del Raspeig, s/n
03690 San Vicent del Raspeig. Alicante.
Country
Spain
Secondary sponsor category [1] 287018 0
None
Name [1] 287018 0
None
Address [1] 287018 0
Country [1] 287018 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290195 0
Comite de Etica de la Unviersidad de Alicante
Ethics committee address [1] 290195 0
Ethics committee country [1] 290195 0
Spain
Date submitted for ethics approval [1] 290195 0
20/03/2012
Approval date [1] 290195 0
20/02/2013
Ethics approval number [1] 290195 0
no

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

Contacts
Principal investigator
Name 44426 0
Prof Juan M. Cortell-Tormo
Address 44426 0
University of Alicante
Campus de San Vicent del Raspeig, s/n
03690 San Vicent del Raspig. Alicante.
Country 44426 0
Spain
Phone 44426 0
+34965902142
Fax 44426 0
Email 44426 0
[email protected]
Contact person for public queries
Name 44427 0
Juan M. Cortell-Tormo
Address 44427 0
University of Alicante
Campus de San Vicent del Raspeig, s/n
03690 San Vicent del Raspig. Alicante.
Country 44427 0
Spain
Phone 44427 0
+34965902142
Fax 44427 0
Email 44427 0
[email protected]
Contact person for scientific queries
Name 44428 0
Juan M. Cortell-Tormo
Address 44428 0
University of Alicante
Campus de San Vicent del Raspeig, s/n
03690 San Vicent del Raspig. Alicante.
Country 44428 0
Spain
Phone 44428 0
+34965902142
Fax 44428 0
Email 44428 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.