UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044353 |
|---|---|
| Receipt number | R000050662 |
| Scientific Title | The effect of exercise therapy according to the Directional Preference for neck symptoms |
| Date of disclosure of the study information | 2021/06/10 |
| Last modified on | 2024/05/29 09:19:08 |
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Basic information
Public title
The effect of exercise therapy according to the Directional Preference for neck symptoms
Acronym
The effect of exercise therapy according to the Directional Preference for neck symptoms
Scientific Title
The effect of exercise therapy according to the Directional Preference for neck symptoms
Scientific Title:Acronym
The effect of exercise therapy according to the Directional Preference for neck symptoms
Region
| Japan |
Condition
Condition
Those with neck symptoms for 1 week or more
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate whether the repetitive exercise of retraction and/or extension of the neck is effective for those with neck symptoms who have the directional preference (DP) for retraction and/or extension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Global Recovery of Change Scale (3 and 6 weeks after the randomisation)
Key secondary outcomes
Pain intensity: P4 (baseline, 3 and 6 weeks after the randomisation)
Quality of life: EuroQol 5 Dimension (baseline, 3 and 6 weeks after the randomisation)
Disability: Neck Disability Index, Patient Specific Functional Scale (baseline, 3 and 6 weeks after the randomisation)
Neck range of motion (baseline, 3 and 6 weeks after the randomisation)
Exercise adherence: Exercise adherence rating scale (3 and 6 weeks after the randomisation)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group will undertake home exercises of retraction or extension of the neck 10 to 15 times every 1-3 hours. The exercises will be corrected and modified once or twice a week.
Interventions/Control_2
The control group will act as usual.
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
Neck symptoms for more than a week
Students in the Saitama Prefectural University
No intervention other than massage or pain relief patch
Neck Disability Index is 16% or higher
No history of trauma or surgery on the spine or upper limbs
Those who have no complications and are healthy except for the cervical symptoms
Key exclusion criteria
No clear directional preference of retraction or extension of the neck during the baseline evaluation
Receiving medical managements in hospitals during the intervention period
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takasaki |
Organization
Saitama Prefectural University
Division name
Physical Therapy
Zip code
3438540
Address
Sannomiya 820, Koshigaya, Saitama
TEL
0489734706
takasaki-hiroshi@spu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takasaki |
Organization
Saitama Prefectural University
Division name
Physical Therapy
Zip code
3438540
Address
Sannomiya 820, Koshigaya, Saitama
TEL
0489734706
Homepage URL
takasaki-hiroshi@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Saitama Prefectural University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Prefectural University
Address
Sannomiya 820, Koshigaya, Saitama
Tel
0489710500
rinri@spu.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
| 2021 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.jospt.org/doi/10.2519/josptopen.2024.0810
Publication of results
Published
Result
URL related to results and publications
https://www.jospt.org/doi/10.2519/josptopen.2024.0810
Number of participants that the trial has enrolled
40
Results
RESULTS: Twenty participants in each group completed the study. The effect of MDT in comparison with the wait-and-see approach was large enough to be meaningful at 6 weeks after randomization.
Results date posted
| 2024 | Year | 05 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The inclusion criteria were (1) university students aged 18 to 60 years, (2) those who had no complications and were healthy except for neck symptoms, (3) neck symptoms for 1 week or more, (4) neck disability index (NDI) of 16% or more, indicating a condition that is above the level of clinical disability in Japan, (5) no history of trauma or surgery on the spine or upper limbs, and (6) no interventions other than massage and compresses. The exclusion criteria were as follows: (1) absence of DP for cervical retraction or extension during the baseline evaluation and (2) receiving medical treatment at medical institutions during the intervention period.
Participant flow
Participants were recruited via university email between June 2021 and November 2021.
Adverse events
None
Outcome measures
For the primary outcome, an 11-point global rating of change scale (GRCS) (-5 [very much worse] to 5 [completely recovered]) was assessed at the third and sixth weeks of follow-up after randomization.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2021 | Year | 05 | Month | 28 | Day |
Last modified on
| 2024 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050662
