UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046178 |
|---|---|
| Receipt number | R000052708 |
| Scientific Title | Effectiveness of proprioceptive neuromuscular fascilitation and myofascial release techniques in patients with subacromial impingement syndrome. |
| Date of disclosure of the study information | 2021/11/26 |
| Last modified on | 2021/11/25 16:12:06 |
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Basic information
Public title
Effectiveness of proprioceptive neuromuscular fascilitation and myofascial release techniques in patients with subacromial impingement syndrome
Acronym
Effeciveness of PNF and myofascial release techniques in subacromialimpingement syndrome
Scientific Title
Effectiveness of proprioceptive neuromuscular fascilitation and myofascial release techniques in patients with subacromial impingement syndrome.
Scientific Title:Acronym
Effeciveness of PNF and myofascial release techniques in subacromialimpingement syndrome
Region
| Asia(except Japan) |
Condition
Condition
RANDOMIZED CONTROLLED STUDY
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
examine and compare the both acute and long term effects of PNF and PNF combined with MRT in addition to conventional physiotherapy on pain, range of motion, muscle strength, quality of life and functionality, disability in patients with subacromial impingement syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
pain
Key secondary outcomes
range of motion, muscle strength, quality of life and functionality, disability
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Patients in the PNF group were performed PNF with hold-relax technique, home exercise program and patient education in addition to conventional physiotherapy. Both treatment methods were performed all application for 3 session in a week, during 4 weeks.
Interventions/Control_2
In the PNF combined with MRT group, the MRT to the upper trapezius muscle were applied in addition to the applications in the PNF group. Both treatment methods were performed all application for 3 session in a week, during 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were age between 18-65 year and diagnosed with Stage I and Stage II subacromial impingement syndrome according to Neer classification system by physician were enrolled in this study
Key exclusion criteria
Patient were excluded if they were had shoulder fracture, presence of cervical disc herniation, any systemic disease that cannot be controlled by the drug, any accompanying neurological problem, malignancy and pregnancy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | manolya |
| Middle name | |
| Last name | acar |
Organization
Baskent University
Division name
Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences
Zip code
06790
Address
Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Baskent University, Ankara, Turkey.
TEL
+9005392699266
acarmanolya@hotmail.com
Public contact
Name of contact person
| 1st name | manolya |
| Middle name | |
| Last name | acar |
Organization
Baskent university
Division name
Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences,
Zip code
06790
Address
Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Baskent University, A
TEL
+9005392699266
Homepage URL
acarmanolya@hotmail.com
Sponsor or person
Institute
Baskent University
Institute
Department
Personal name
Funding Source
Organization
Baskent University
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
bASKENT university
Address
Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences,
Tel
+9005392699266
acarmanolya@hotmail.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
| 2021 | Year | 11 | Month | 26 | 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
30
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
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 01 | 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 | 11 | Month | 25 | Day |
Last modified on
| 2021 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052708
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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