Comparison of the Effectiveness of Proprioceptive Neuromuscular Facilitation Exercises and Shoulder Mobilization Patients With Subacromial Impingement Syndrome: A Randomised Clinical Trial
Phase: NA
Conditions: Subacromial Impingement, Subacromial Impingement Syndrome
Sponsor: Sevgi Medical Center

 
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Comparison of the Effectiveness of Proprioceptive 
Neuromuscular Facilitation Exercises and Shoulder 
Mobilization Patients with Subacromial Impingement 
Syndrome: A Randomised Clinical Trial 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Protocol with Statistical Analysis Plan (SAP) and 
Informed Consent Form (ICF) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
March 3, 2017 
 
 
 
 
 
 
 

 
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Comparison of the Effectiveness of Proprioceptive 
Neuromuscular Facilitation Exercises and Shoulder 
Mobilization Patients with Subacromial Impingement 
Syndrome: A Randomised Clinical Trial 
 
 
 
 
 
 
 
 
 
 
 
Study Protocol 
 
 
(Pages 3 – 5) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
March 3, 2017 
 
 
 
 
 
 
 
 
 
 

 
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Study Protocol 
 
 
Study titled ‘Comparison of the Effectiveness of Proprioceptive Neuromuscular 
Facilitation Exercises and Shoulder Mobilization Patients with Subacromial Impingement 
Syndrome: A Randomised Clinical Trial’ was approved by Marmara University Faculty 
of Medicine Clinical Researches Ethics Committee meeting on 03.03.2017 with approval 
number: 09.2017.200. 
 
The participants in the study were informed about the aim, duration and the 
programs to be applied throughout the study. Volunteer Information Form has been signed 
and approved in accordance with the standards deemed appropriate by the Clinical 
Researches Ethics Committee of Marmara University Faculty of Medicine (This form can 
be seen on Informed Consent Form (ICF) section). The study was conducted in accordance 
with the Declaration of Helsinki. 
 
Randomization of the Study Groups 
 
 
Individuals with Subacromial Impingement Syndrome (SIS) who applied to Sevgi 
Medical Center for physiotherapy and rehabilitation were invited to participate to the study. 
Individuals who volunteered to participate and whom met the criteria for participation were 
randomized with ‘Research Randomizer’ program and divided into three groups. In all three 
groups participants received conventional physiotherapy program. The shoulder mobilization 
techniques was added to the program of the Group II (The Shoulder Mobilization Group). 
Proprioceptive Neuromuscular Facilitation (PNF) techniques was added to the program of the 
Group III (The PNF Group). 
 
Inclusion Criteria 
 
• Volunteered to participte, 
• Aged between 25-65 years old, 
• Having the diagnosis of Subacromial Impingement Syndrome (SIS), 
• Having shoulder pain at least for four weeks 
 
 
 
 

 
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Exclusion Criteria 
 
• Patients with a neuromuscular disease, pregnancy, history of cancer, unstable angina, 
a history of surgery at neck, shoulder, elbow or/and hand, communication problem, 
pulmonary and/or vascular problems, systemic anti-inflammatory joint disease, any 
condition which was contraindicated for electrical stimulation and/or exercise, 
cervical disc herniation or radiculopathy, previous physiotherapy on the same 
shoulder due to SIS, a history of corticosteroid injection in last three months, any 
orthopedic, rheumatologic, or congenital condition that effect the targeted shoulder 
 
Applied Evaluations 
 
 
1. Shoulder Pain 
Pain was defined with Visual Analog Scale (VAS). A 10-cm long horizontal visual analog 
scale (VAS) with marks 0 point (no pain) and 10 point (unbearable pain) was used for 
evaluating the pain severity. The patients were asked to mark the representing point of their 
pain levels. The values were recorded in cm. The pain severity was asked in three occasions 
as: at resting (VASr), during activity (VASa) and during night (VASn). 
2. Function of the Shoulder 
The Disabilities of the Arm, Shoulder and Hand (DASH) Score was used to evaluate the 
upper extremity physical function. DASH includes two modules as disability / symptom section 
and work section. The scores are ranged between 0-100. Higher scores indicate lower 
functionality. 
In addition to DASH, the Constant-Murley score was used to evaluate the functionality of 
the shoulder. Constant-Murley score is a 100-point scoring system and consisted of four sub-
scores as pain (15 points), daily living activities (20 points), active range of motion (40 points), 
and muscle strength (25 points). 
3. Range of Motion 
The active range of motion was assessed by using a universal goniometer. 
 

 
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4. Muscle Strength 
The muscle strength of shoulder flexion, shoulder abduction, shoulder adduction, shoulder 
external rotation, and shoulder internal rotation were determined by using Baseline Push-Pull 
(New York, USA) dynamometer. The dynamometer was placed in a 90 degrees angle on the 
location and the patient was asked to contract in maximum for two seconds and then maintain 
this position for five seconds. Two assessments were performed, and average values were 
recorded. Pain was avoided during the measurements. 
Treatment Program 
 
 
The participants in our study were all treated in Sevgi Medical Center five days a 
week for 4 weeks, a total of 20 sessions (Duration of one session is 60 minutes) and follow-
up for 12 weeks, total follow- up time was 16 weeks.  
 
The conventional physiotherapy consisted of electrotherapy and exercise approaches. 
The electrotherapy program consisted of infrared application (for 15 minutes, from 70 cm 
distance with Hanau 201, Germany device), conventional TENS was applied in an encircled 
region (for 20 minutes with Intelect 2778 Combo, Chattanooga Group device; with 4 
electrodes, 100 Hz, 100 msec), and therapeutic Ultrasound was applied (for 3 minutes with 
Intelect 2778 Combo, Chattanooga Group device; 1 MHz, power: 1,5 W/cm²).  
 
A physiotherapist supervised entire exercise program performed following the 
electrotherapy program. Elastic resistive exercises were added at the week three. While, the 
first set of wand exercises and elastic resistive exercises was performed under supervision, 
two sets were given as the home exercise program. 
 
The PNF group received PNF exercises with contract-relax technique, in the patterns 
of “flexion-abduction-external rotation”, “extension-adduction-internal rotation”, “flexion-
adduction-external rotation” and “extension-abduction-internal rotation” along with the 
verbal and manual facilitation of the physiotherapist. 
 
In the mobilization group, while the shoulder joint was placed in the traction, anterior, 
posterior, and inferior glidings and circumduction were applied to the humerus for 2-3 
minutes. All mobilization applications were performed in painless ROM limits. The degree of 
traction and glidings were increased as the relaxing obtained in the tissues. 

 
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Comparison of the Effectiveness of Proprioceptive 
Neuromuscular Facilitation Exercises and Shoulder 
Mobilization Patients with Subacromial Impingement 
Syndrome: A Randomised Clinical Trial 
 
 
 
 
 
 
 
 
 
 
 
Statistical Analysis Plan (SAP) 
 
 
(Pages 6 – 7) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
March 3, 2017 
 
 
 
 
 
 

 
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Statistical Analysis Plan (SAP) 
 
 
The statistical program Statistical Package for Social Sciences (SPSS) Version 16.0 
(SPSS Inc., Chicago, IL, USA) was used in the data analysis of the study. The p value of 
p<0.05 was considered to be statistically significant in the data analysis. Shaphiro-Wilks test 
was used to investigate the appropriateness of the variables to normal distribution. Kruskal-
Wallis and Mann-Whitney U tests were used to compare the groups.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Comparison of the Effectiveness of Proprioceptive 
Neuromuscular Facilitation Exercises and Shoulder 
Mobilization Patients with Subacromial Impingement 
Syndrome: A Randomised Clinical Trial 
 
 
 
 
 
 
 
 
 
 
 
 
 
Informed Consent Form (ICF) 
 
 
(Pages 8 – 12) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
March 3, 2017 
 
 
 
 
 
 
 
 
 
 

 
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Informed Consent Form (ICF) 
 
 
Description of the Physiotherapist 
 
 
This study, if you accept your child to be participated, is a scientific research and it is 
titled as ‘Comparison of the Effectiveness of Proprioceptive Neuromuscular Facilitation 
Exercises and Shoulder Mobilization Patients with Subacromial Impingement Syndrome: A 
Randomised Clinical Trial’. In this study, individuals with Subacromial Impingement 
Syndrome (SIS) will be evaluated in terms of arm functions, arm joints range of motion with 
universal goniometer, muscle strength with push-pull dynamometer, pain with visual analog 
scale (VAS), functional with The Disabilities of the Arm, Shoulder and Hand (DASH) score 
and Constant-Murley Score. The study, which is planned to last in 16 weeks, requires 
participants to attend the study regularly for 5 days a week for 4 weeks and each day for one 
session which is 60 minutes, and come back in the 16th week for final evaluations. There will 
be no disruption of the body during the process. 
 
This research will be carried out by Physiotherapist Sultan IGREK (Tel: +90 537 210 06 
54) and will be under the supervision of Assoc. Prof. Tuğba KURU ÇOLAK at Marmara University, 
Institute of Health Sciences, Department of Physiotherapy and Rehabilitation. 
 
You are being invited to a research project. It is very important you to understand why 
and how this research will be done before making a decision. Please take some time and read 
the following informations carefully, discuss it with others if you wish. If you have an unclear 
section or need more detailed information, you can get information from us. You are invited to 
our research because we think your child matches the criterias to be included. We would like 
to note that participation is voluntary and that refusal to participate does not lead to any penalty 
or loss of any benefit. In the same way, you can withdraw from the research at any time. 
 
After getting the demographic information of the participants, you will be measured 
by the above physiotherapist and with the mentioned tests. The evaluation tests will be 
repeated 4 times throughout the treatment. The data obtained from the assessments will be 
recorded in the computer and the changes during pre- and post-treatment will be analyzed. 
 
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The assessments applied to the participants in our research do not have any known 
harm. In the event of any unexpected damage in the evaluation process or during the 
rehabilitation process, the information will be given immediately to you. In case of any 
damage to the participants, the necessary applications shall be covered by the researchers 
without any recourse. For this, you will not be charged any fees, neither you nor your social 
security insurance. 
 
While participation in the research does not help you immediately, it is hoped that 
our research results will have benefits for the organization, society or science in the future. 
You will not be charged any fees for the purposes of the research or for the social security 
institution to which you are affiliated. 
 
Consent of the Participant 
 
 
I have read the entire information form clearly and understood or because I do not 
know how to read/not able to or do not understand the language it was read or translated to 
me. I was given the opportunity to ask, evaluate and decide on my health status both during 
and after my application and when filling this form in. All kinds of treatment and diagnostic 
alternatives, including the possibility of not getting the treatment, their risks and dangers are 
explained. 
 
Name and the Surname of the Participant and/or Legal Representative: 
 
 
Date: 
Signature: 
 
 
Name and Surname of the Withness: 
 
Date: 
Signature: 

 
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Declaration of the Physiotherapist 
 
 
I gave the patient the necessary information about the study and the procedures to be 
performed. I believe that the patient understood this information, asked me the questions that 
she/he wanted to ask, and accepted the process with her/his free will. 
 
Researcher: Physiotherapist Sultan Igrek 
 
Address: Sevgi Medical Center – Nene Hatun Street Nr. 9/A Arnavutkoy / Istanbul / 
Turkey 
 
Mobile Phone: +90 537 210 06 54 
E-mail: sultanigrek@gmail.com 
 
Date: 
Signature: 
 
 
Declaration of the Participant / Legal Representative 
 
 
Ms. Sultan Igrek stated that a medical research will be carried out and the above 
information about this research was explained to me. I know I am invited to this research as a 
participant. If I participate in this research, I believe that the confidentiality of my information 
during research will be treated with great care and respect. I was given enough information 
that my personal information would be protected with care during the use of the research and 
the results will only used for educational and scientific purposes. During the research I can 
withdraw from the study at any time without any cause (But in that case I am aware of the 
difficult situation it would cause to the reaseachers if I do not give any notice). I don't take 
any financial responsibility for the research expenses. There will be no payment for me. 
Whether directly, indirectly arised any health problem that may occur during the research, I 
will not undergo any monetary burden. When we encounter any health problem during the 
research; at any hour, I know I can call physiotherapist Sultan Igrek from +90 537 210 06 54 
(mobile). 
 
I do not have to be participated in this research or may not participate. We have not 
experienced any compelling behavior to participate in the research. If we refuse to 
participate, I know that this will not bring any harm to our medical care and our relationship 
with my physiotherapist. 
 
 
 
 
 
 

 
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I have understood all the explanations made to me in detail. At the end of a certain 
period of thinking on my own, I decided that my child could take part in this research 
project as a participant. I accept this invitation voluntarily. 
 
Voluntary Approval Form 
 
 
I have read the text above which shows the information that should be given to the 
volunteer before investigating. These were written and was explained verbally. With these 
conditions, I agree to participate in this research without any pressure or compulsion on 
me and my child. A signed 2 copies of this form, which consists of 4 pages, a copy of the 
documents will be given to me. 
 
Name and the Surname of the Participant and/or Legal Representative: 
 
 
Date: 
Signature: 
 
 
Name and Surname of the Withness (who have witnessed the process of receipt until 
the end): 
 
Date: 
Signature: 
 
 
The researcher who made the explanations, 
Researcher: Physiotherapist Sultan Igrek 
 
Address: Sevgi Medical Center – Nene Hatun Street Nr. 9/A Arnavutkoy / Istanbul / 
Turkey 
Mobile Phone: +90 537 210 06 54 
E-mail: sultanigrek@gmail.com 
 
Date: 
Signature: