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Trial registered on ANZCTR


Registration number
ACTRN12615000580572
Ethics application status
Approved
Date submitted
15/05/2015
Date registered
3/06/2015
Date last updated
16/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of functional motor control exercise training in patients with chronic low back pain
Scientific title
The effectiveness of functional motor control exercise training versus general exercise on movement control ability, pain intensity, disability in patients with chronic low back pain
Secondary ID [1] 286711 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 295070 0
Condition category
Condition code
Musculoskeletal 295318 295318 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 295319 295319 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Functional motor control exercise including core muscle strengthening, spine segmental control, trunk and extremity dissociated movement control retraining will be administered by a physiotherapist. Participants in this group will receive 16 one-to-one sessions (45 minutes/session), twice a week for 8 weeks.
The exercise programs will be tailored to individual patient. Outcome will be assessed upon completion of the 8-week program and at 6-week follow-up after the treatment.
Intervention code [1] 291864 0
Rehabilitation
Intervention code [2] 291865 0
Treatment: Other
Comparator / control treatment
General exercise will include trunk and extremity strengthening, stretching exercises. Each patient will receive at least 10 sessions (30 minutes/session) of treatment in 8 weeks. The program will be one-to-one sessions with a physiotherapist. The maximum number of sessions that may be administered is 16.
Control group
Active

Outcomes
Primary outcome [1] 295059 0
Movement control ability assessed by a battery of movement control tests including 7 flexion control tests and 7 extension control tests
Timepoint [1] 295059 0
baseline, upon completion of 8-week training, 6-week follow-up
Primary outcome [2] 295060 0
Psychological impairment: Fear avoidance beliefs questionnaire (FABQ)
Timepoint [2] 295060 0
baseline, upon completion of 8-week training, 6-week follow-up
Secondary outcome [1] 314682 0
Pain intensity: Numeric rating scale
Timepoint [1] 314682 0
baseline, upon completion of 8-week training, 6-week follow-up
Secondary outcome [2] 314953 0
Disability: Oswestry low back pain disability questionnaire
Timepoint [2] 314953 0
baseline, upon completion of 8-week training, 6-week follow-up
Secondary outcome [3] 314954 0
Movement confidence: Low back activity confidence scale (LoBACS)
Timepoint [3] 314954 0
baseline, upon completion of 8-week training, 6-week follow-up
Secondary outcome [4] 314955 0
Perceived improvement: Global rating of change scale (GRoCS)
Timepoint [4] 314955 0
upon completion of 8-week training, 6-week follow-up
Secondary outcome [5] 314956 0
Function: Patient specific functional scale (PSFS)
Timepoint [5] 314956 0
baseline, upon completion of 8-week training, 6-week follow-up
Secondary outcome [6] 314957 0
Physical performance: Repeated sit-to-stand test
Timepoint [6] 314957 0
baseline, upon completion of 8-week training, 6-week follow-up

Eligibility
Key inclusion criteria
1. Aged 20-65 patients with chronic low back pain (more than 3 months)
2. Pain intensity (numeric rating scale) > 4/10
3. No lower extremity symptoms
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Tumor
2. Spinal/lower extremity surgery
3. Osteoporosis
4. Hip/knee osteoarthritis
5. Pregnancy
6. Experiencing any of the spinal inflammatory diseases (such as ankylosing spondylitis, rheumatoid arthritis)

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


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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2014
Actual
25/07/2014
Date of last participant enrolment
Anticipated
Actual
8/09/2015
Date of last data collection
Anticipated
Actual
15/01/2016
Sample size
Target
60
Accrual to date
Final
52
Recruitment outside Australia
Country [1] 6879 0
Taiwan, Province Of China
State/province [1] 6879 0

Funding & Sponsors
Funding source category [1] 291274 0
Self funded/Unfunded
Name [1] 291274 0
Wendy Tzyy-Jiuan Wang
Country [1] 291274 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang-Ming University
Address
155, Sec. 2, Li-Nong St.
Beitou District, Taipei 11221
Country
Taiwan, Province Of China
Secondary sponsor category [1] 289947 0
Hospital
Name [1] 289947 0
Cheng Hsin General Hospital
Address [1] 289947 0
No.45, Cheng Hsin St., Baitou District, Taipei, 11220
Country [1] 289947 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292834 0
Institutional Review Board of Cheng Hsin General Hospital
Ethics committee address [1] 292834 0
Ethics committee country [1] 292834 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 292834 0
Approval date [1] 292834 0
01/07/2014
Ethics approval number [1] 292834 0

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

Contacts
Principal investigator
Name 57274 0
A/Prof Wendy Tzyy-Jiuan Wang
Address 57274 0
155, Sec. 2, Li-Nong St. Beitou District, Taipei, 11221
National Yang-Ming University
Country 57274 0
Taiwan, Province Of China
Phone 57274 0
+886228267091
Fax 57274 0
+886228201841
Email 57274 0
tjwang@ym.edu.tw
Contact person for public queries
Name 57275 0
Wendy Tzyy-Jiuan Wang
Address 57275 0
155, Sec. 2, Li-Nong St. Beitou District, Taipei 11221
National Yang-Ming University
Country 57275 0
Taiwan, Province Of China
Phone 57275 0
+886228267091
Fax 57275 0
+886228201841
Email 57275 0
tjwang@ym.edu.tw
Contact person for scientific queries
Name 57276 0
Wendy Tzyy-Jiuan Wang
Address 57276 0
155, Sec. 2, Li-Nong St. Beitou District, Taipei, 11221
National Yang-Ming University
Country 57276 0
Taiwan, Province Of China
Phone 57276 0
+886228267091
Fax 57276 0
+886228201841
Email 57276 0
tjwang@ym.edu.tw

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.