UMIN-CTR Clinical Trial

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
Email	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
Email	acarmanolya@hotmail.com

Sponsor
Institute	Baskent University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052708