UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052926 |
|---|---|
| Receipt number | R000058343 |
| Scientific Title | Effects of thoracic spine manipulation on patients with non-specific neck pain: a randomized controlled trial |
| Date of disclosure of the study information | 2023/11/27 |
| Last modified on | 2024/02/14 15:50:21 |
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Basic information
Public title
Effects of thoracic spine intervention on individuals with neck pain.
Acronym
Effects of thoracic spine intervention on individuals with neck pain.
Scientific Title
Effects of thoracic spine manipulation on patients with non-specific neck pain: a randomized controlled trial
Scientific Title:Acronym
Effects of thoracic spine manipulation on patients with non-specific neck pain: a randomized controlled trial
Region
| Japan |
Condition
Condition
Neck pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of thoracic spine manipulation in patients with nonspecific neck pain using a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Pain intensity; The Numeric Pain Rating Scale
Key secondary outcomes
1) Degree of functional disability; Neck Disability Index (NDI)
2) Basic patient information (gender, age, height, weight, BMI)
3) Range of motion of cervical rotation
4) Thoracic range of motion
5) Global Rating of Change Score (GRoC)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
In addition to general physical therapy of the neck, thoracic manipulation is performed. Thoracic manipulation is performed on the thoracic spine from the seventh cervical vertebra to the ninth thoracic vertebra. The subject is placed in a relaxed supine position on the bed. The arms are crossed in front of the chest. The manipulator turns the subject's body once on its side. The manipulator holds one hand in a pistol grip position and secures it at one lower segment of the segment to be manipulated. The manipulator then supports the subject while gradually returning the trunk to its original supine position. The subject takes a deep breath in that position. The manipulator performs low-amplitude, high-speed manipulation in time with the subject's exhalation.
Interventions/Control_2
In addition to general physical therapy to the neck, Sham manipulation to the 7th cervical to 9th thoracic vertebrae will be performed. The subject is supine on the bed, as in the TSM group, with arms crossed in front of the chest. The manipulator turns the subject's body to the side once. The manipulator holds the subject with fingers extended and hands open at one segment below the segment where the Sham manipulation is performed. The subject takes deep breaths as in the TSM group but does not perform manipulation.
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
| 18 | years-old | < |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
18-60 years of age with a diagnosis of neck pain and classified as "Mobility" in the Classification System for Patients With Neck Pain.
Key exclusion criteria
Have had previous spine surgery or may be pregnant.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Yoshida |
Organization
Tokyo Metropolitan University
Division name
Graduation school
Zip code
116-8551
Address
7-2-10 Higashioji, Arakawa Ward, Tokyo
TEL
03-3819-1211
yoshida-ryota1@ed.tmu.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Yoshida |
Organization
Tokyo Metropolitan University
Division name
Graduation school
Zip code
116-8551
Address
7-2-10 Higashioji, Arakawa Ward, Tokyo
TEL
03-3819-1211
Homepage URL
yoshida-ryota1@ed.tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Ryota Yoshida
Funding Source
Organization
Nothing
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
Research Ethics Committee, Tokyo Metropolitan University Arakawa Campus
Address
7-2-10 Higashioji, Arakawa Ward, Tokyo
Tel
03-3819-1211
yoshida-ryota1@ed.tmu.ac.jp
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
| 2023 | Year | 11 | Month | 27 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 27 | Day |
Last modified on
| 2024 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058343
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