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Trial registered on ANZCTR


Registration number
ACTRN12617000649314
Ethics application status
Approved
Date submitted
27/04/2017
Date registered
4/05/2017
Date last updated
18/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effectiveness of Common Physical Therapy Interventions on Soft Tissue Hardness in Subjects with Low Back Pain
Scientific title
The Effectiveness of Common Physical Therapy Interventions on Soft Tissue Hardness in Subjects with Low Back Pain
Secondary ID [1] 291744 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 302955 0
Condition category
Condition code
Physical Medicine / Rehabilitation 302422 302422 0 0
Physiotherapy
Musculoskeletal 302423 302423 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Soft tissue mobilization group: Patients in this group received soft tissue mobilization provided by an experienced physical therapist. The physical therapist used hands to apply forces in order to release on erector spinae, quadratus lumborum and thoracolumbar fascia area. The duration of treatment was 20 minutes.
Intervention code [1] 297849 0
Rehabilitation
Comparator / control treatment
Stretching exercise group: Patients in this group were instructed a stretching exercise program by an experienced physical therapist. Eight stretching exercises in this program contained prayer stretching in 3 directions, trunk lateral flexion stretching in sitting position for both sides, trunk rotation stretching in supine position for both sides, and knee to chest stretching. Patients had to sustain each stretching for 15 seconds. and perform 5 times with the assistance of physical therapist first and 5 times by themselves. Completing all stretching exercises would take 20 minutes. Patients only received one session stretching exercise program.

Superficial heat group: Patients in this group were positioned in prone position with a heating pad on their low back region for 20 minutes once. The temperature of heating pad was around 65 Celsius degrees.
Control group
Active

Outcomes
Primary outcome [1] 301839 0
Soft tissue hardness was assessed by the myotonometer (Neurogenic Technologies Inc., Missoula, MT, USA)
Timepoint [1] 301839 0
Baseline, and immediately after treatment
Primary outcome [2] 301840 0
Pain intensity was assessed by numeric rating scale (NRS)
Timepoint [2] 301840 0
Baseline, and immediately after treatment
Primary outcome [3] 301841 0
Pressure pain threshold was assessed by an algometer (OE-220, ITO, Japan)
Timepoint [3] 301841 0
Baseline, and immediately after treatment
Secondary outcome [1] 333989 0
Lumbar mobility with the Spinal Mouse (Aditus systems Inc., Switzerland,)
Timepoint [1] 333989 0
Baseline, and immediately after treatment
Secondary outcome [2] 333990 0
Perceived global improvement was assessed by the Global Rating of Change (GROC)
Timepoint [2] 333990 0
Baseline, immediately after treatment

Eligibility
Key inclusion criteria
1) 20-65 years old
2) non-specific low back pain with or without leg pain for at least one month
Minimum age
20 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Low back pain with neurological symptoms
2) Specific spinal pathology
3) History of previous spinal fracture or spinal surgery
4) Cognitive deficits

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8835 0
Taiwan, Province Of China
State/province [1] 8835 0

Funding & Sponsors
Funding source category [1] 296249 0
Self funded/Unfunded
Name [1] 296249 0
Tzyy-Jiuan Wang
Address [1] 296249 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country [1] 296249 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang-ming University
Address
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country
Taiwan, Province Of China
Secondary sponsor category [1] 295164 0
None
Name [1] 295164 0
Address [1] 295164 0
Country [1] 295164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297487 0
Institutional Review Board, Taipei Veterans General Hospital
Ethics committee address [1] 297487 0
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217, R.O.C.
Ethics committee country [1] 297487 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 297487 0
18/06/2012
Approval date [1] 297487 0
20/07/2012
Ethics approval number [1] 297487 0
2012-07-27B

Summary
Brief summary
The relationship between the improvement of pain intensity and decrease of the soft tissue hardness has not been investigated in previous studies. The purposes of this randomized controlled trial were to compare the immediate effects among soft tissue mobilization, stretching exercises, and superficial heat on decreasing soft tissue hardness, pain, increasing pressure pain threshold, lumbar mobility, and perceived improvement in subjects with low back pain and to examine the relationships among decrease of the soft tissue hardness and improvement of the pain intensity and pressure pain threshold. The hypothesis is that soft tissue mobilization group shows the most positive improvement on all outcome measures.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 45194 0
A/Prof Tzyy-Jiuan Wang
Address 45194 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country 45194 0
Taiwan, Province Of China
Phone 45194 0
+886 2 28267000 #7091
Fax 45194 0
Email 45194 0
tjwang@ym.edu.tw
Contact person for public queries
Name 45195 0
Mr Fu-Lien Wu
Address 45195 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country 45195 0
Taiwan, Province Of China
Phone 45195 0
+886 2 28267000 #5865
Fax 45195 0
Email 45195 0
qazwsx783@msn.com
Contact person for scientific queries
Name 45196 0
Mr Fu-Lien Wu
Address 45196 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country 45196 0
Taiwan, Province Of China
Phone 45196 0
+886 2 28267000 #5865
Fax 45196 0
Email 45196 0
qazwsx783@msn.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary