UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049497 |
|---|---|
| Receipt number | R000056366 |
| Scientific Title | Effects of thoracic spine self-mobilization on low back pain patients with lumbar hypermobility |
| Date of disclosure of the study information | 2022/11/15 |
| Last modified on | 2023/05/16 22:24:19 |
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Basic information
Public title
Effects of thoracic spine self-mobilization on low back pain patients
Acronym
Effects of thoracic spine self-mobilization on low back pain patients
Scientific Title
Effects of thoracic spine self-mobilization on low back pain patients with lumbar hypermobility
Scientific Title:Acronym
Effects of thoracic spine self-mobilization on low back pain patients with lumbar hypermobility
Region
| Japan |
Condition
Condition
Low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aimed to clarify effects of thoracic spine self-mobilization on low back pain patients with lumbar hypermobility.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lumbar rotation range of motion measured by MRI before intervention, immediately after intervention, and 4 weeks after intervention.
Key secondary outcomes
Visual Analogue scale, Oswestry Disability Index, Thoracolumbar rotation ROM in sitting position, Stiffness of the erector spinae muscles measured before intervention, immediately after intervention, and 4 weeks after intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The two tennis balls are held together by tape. This device was placed in three positions. spine of scapula line, Inferior angle of scapula line and Inferior angle of rib line. With arms crossed over the chest, the patient slowly raises their shoulders off of the ground for a count of 3 seconds and then back down to the ground. Subjects peformed 10times,3sets,5days/week,4 weeks.
Interventions/Control_2
The sham group performed similar exercises without using this device. Subjects peformed 30times,3sets,5days/week,4 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.The subjects have Low back pain that has been present for longer than three months
2.Diagnosed in hypermobility in PA test
3.Positive in prone instability test
Key exclusion criteria
1. History of spine surgery
2. Excessive scoliosis in the spine
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Yasuda |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences, Department of Physical Therapy
Zip code
116-8551
Address
7-2-10 Higashiogu, Arakawa-ku, Tokyo
TEL
03-3819-1211
yasucchi0910@gmail.com
Public contact
Name of contact person
| 1st name | toru |
| Middle name | |
| Last name | yasuda |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences, Department of Physical Therapy
Zip code
116-8551
Address
7-2-10 Higashiogu, Arakawa-ku, Tokyo
TEL
03-3819-1211
Homepage URL
yasucchi0910@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan University, Graduate School of Human Health Sciences, Department of Physical Therapy
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan University
Address
7-2-10 Higashiogu, Arakawa-ku, Tokyo
Tel
03-3819-1211
yasucchi0910@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
Results
The results of the two-way repeated measures ANOVA indicated that the main effect of the group was significant (p<0.05) for VAS, sum of the lumbar rotation angle, and thoracolumbar rotation ROM. A significant group-by-time interaction was found for the sum of lumbar rotation angles. The results of the multiple comparison tests for VAS, sum of the lumbar rotation angle from L1 to S1, and thoracolumbar rotation ROM were significantly different 4 weeks later.
Results date posted
| 2023 | Year | 05 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Thirty participants were screened for eligibility. Twenty-four patients, with a mean age of 22.0 years (SD=2.3) (9 female and 15 men), satisfied the eligibility criteria, agreed to participate, and were randomly assigned to the thoracic spine mobilization (n=12) and sham (n=12) groups.
Adverse events
Outcome measures
Outcome measures were collected pre-intervention and after 4 weeks and included the visual analog scale (VAS) for pain, Oswestry Disability Index, lumbar rotation angle measured using MRI taken in the lateral position with 45 degrees of trunk rotation, thoracolumbar rotation range of motion (ROM) in the sitting position, and stiffness of the erector spinae muscles.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 16 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 16 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 14 | Day |
Last modified on
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056366
