Comparison of the Proprioceptive Neuromuscular Facilitation and Mobilization In Subacromial Impingement Syndrome
Primary Purpose
Subacromial Impingement, Subacromial Impingement Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Physiotherapy
Shoulder Mobilization
Proprioceptive Neuromuscular Facilitation
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Impingement focused on measuring proprioceptive neuromuscular facilitation, functionality, mobilization, pnf
Eligibility Criteria
Inclusion Criteria:
- Aged between 25-65 years old,
- Having the diagnosis of Subacromial Impingement Syndrome (SIS),
- Having shoulder pain at least for four weeks
Exclusion Criteria:
- Having a neuromuscular disease,
- Pregnancy,
- History of cancer,
- Unstable angina,
- Having pulmonary and/or vascular problems,
- History of surgery at neck, shoulder, elbow or/and hand,
- Having communication problems
- Having systemic anti-inflammatory joint diseases
- Being contraindicated for electrical stimulation and/or exercise
- Having cervical disc herniation or radiculopathy
- History of physiotherapy on the same shoulder due to SIS,
- A history of corticosteroid injection in the last three months,
- Any orthopedic, rheumatologic, or congenital condition that effects the targeted shoulder
Sites / Locations
- Sevgi Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group I
Group II
Group III
Arm Description
The control group. Participants in this group received only conventional physiotherapy. Number of the participants were 14.
The shoulder mobilization group. Participants in this group received conventional physiotherapy and shoulder joint mobilization techniques. Number of the participants were 15.
The Proprioceptive Neuromuscular Facilitation (PNF) group. Participants in this group received conventional physiotherapy and PNF exercises. Number of the participants were 15.
Outcomes
Primary Outcome Measures
Shoulder pain: VAS
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).
Disability 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.
Function of the shoulder
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).
Range of motion
The active range of motion was assessed by using a universal goniometer.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03735485
First Posted
November 2, 2018
Last Updated
November 7, 2018
Sponsor
Sevgi Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03735485
Brief Title
Comparison of the Proprioceptive Neuromuscular Facilitation and Mobilization In Subacromial Impingement Syndrome
Official Title
Comparison of the Effectiveness of Proprioceptive Neuromuscular Facilitation Exercises and Shoulder Mobilization Patients With Subacromial Impingement Syndrome: A Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
October 2, 2017 (Actual)
Study Completion Date
January 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sevgi Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim of the study was to compare the effectiveness of Proprioceptive Neuromuscular Facilitation (PNF) exercises and Shoulder Mobilization (SM) on pain, range of motion (ROM), functionality, and muscle strength in patients with Subacromial Impingement Syndrome (SIS). Patients received 20 sessions (for 4 weeks) under the supervision of a physiotherapist. Patients were evaluated at baseline, at week two, at week four, and at week sixteen.
Detailed Description
Aim of the study was to compare the effectiveness of Proprioceptive Neuromuscular Facilitation (PNF) exercises and Shoulder Mobilization (SM) on pain, range of motion (ROM), functionality, and muscle strength in patients with Subacromial Impingement Syndrome (SIS). Forty-four patients were divided into three groups as Group I: Conventional physiotherapy receiving group (control group; n=14), Group II: Conventional physiotherapy + PNF exercises receiving group (PNF group; n=15), and Group III: conventional physiotherapy + SM receiving group (SM group; n=15). Pain, ROM, muscle strength, and functionality were evaluated by using visual analog scale (VAS), goniometer, push-pull dynamometer, Constant-Murley score and The Disabilities of the Arm, Shoulder and Hand (DASH) Score respectively. Patients received 20 sessions in total under supervision of a physiotherapist. Patients were evaluated at baseline, at week two, at week four, and at week sixteen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement, Subacromial Impingement Syndrome
Keywords
proprioceptive neuromuscular facilitation, functionality, mobilization, pnf
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
There were three study groups: 1. The control group: Participants in this group received only conventional physiotherapy treatment. 2. The shoulder mobilization group: Participants in this group received conventional physiotherapy and shoulder joint mobilization techniques as treatment. The Proprioceptive Neuromuscular Facilitation (PNF) group. Participants in this group received conventional physiotherapy and PNF exercises as treatment.
Masking
Participant
Masking Description
Participants did not know which treatment group they were in.
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
The control group. Participants in this group received only conventional physiotherapy. Number of the participants were 14.
Arm Title
Group II
Arm Type
Experimental
Arm Description
The shoulder mobilization group. Participants in this group received conventional physiotherapy and shoulder joint mobilization techniques. Number of the participants were 15.
Arm Title
Group III
Arm Type
Experimental
Arm Description
The Proprioceptive Neuromuscular Facilitation (PNF) group. Participants in this group received conventional physiotherapy and PNF exercises. Number of the participants were 15.
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy
Intervention Description
The conventional physiotherapy program consisted of electrotherapy and exercise approaches. The electrotherapy program consisted of infrared (for 15 minutes, from 70 cm distance), conventional Transcutaneous Electrical Nerve Stimulation (TENS) in an encircled region (for 20 minutes; with 4 electrodes, 100 Hz, 100 msec), and therapeutic Ultrasound (for 3 minutes; 1 megahertz (MHz), power: 1,5 W/cm²).
A physiotherapist supervised exercise program was 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 of the showed exercises were given as the home exercise program.
Intervention Type
Other
Intervention Name(s)
Shoulder Mobilization
Intervention Description
In shoulder mobilization technique while the shoulder joint was placed in the traction, anterior, posterior, and inferior gliding and circumduction were applied to the humerus for 2-3 minutes. All mobilization applications were performed in painless range of motion (ROM) limits. The degree of traction and gliding were increased as the relaxing obtained in the tissues.
Intervention Type
Other
Intervention Name(s)
Proprioceptive Neuromuscular Facilitation
Intervention Description
In the Proprioceptive Neuromuscular Facilitation (PNF) program participants 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.
Primary Outcome Measure Information:
Title
Shoulder pain: VAS
Description
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).
Time Frame
Change from baseline pain scale of shoulder at week 2, 4 and 16.
Title
Disability of the shoulder
Description
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.
Time Frame
Change from baseline Disabilities of the Arm, Shoulder and Hand (DASH) Score at week 2, 4 and 16.
Title
Function of the shoulder
Description
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).
Time Frame
Change from baseline Constant-Murley score at week 2, 4 and 16.
Title
Range of motion
Description
The active range of motion was assessed by using a universal goniometer.
Time Frame
Change from baseline active range of motion at week 2, 4 and 16.
Title
Muscle Strength
Description
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.
Time Frame
Change from baseline muscle strength of shoulder flexion, shoulder abduction, shoulder adduction, shoulder external rotation, and shoulder internal rotation at week 2, 4 and 16.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged between 25-65 years old,
Having the diagnosis of Subacromial Impingement Syndrome (SIS),
Having shoulder pain at least for four weeks
Exclusion Criteria:
Having a neuromuscular disease,
Pregnancy,
History of cancer,
Unstable angina,
Having pulmonary and/or vascular problems,
History of surgery at neck, shoulder, elbow or/and hand,
Having communication problems
Having systemic anti-inflammatory joint diseases
Being contraindicated for electrical stimulation and/or exercise
Having cervical disc herniation or radiculopathy
History of physiotherapy on the same shoulder due to SIS,
A history of corticosteroid injection in the last three months,
Any orthopedic, rheumatologic, or congenital condition that effects the targeted shoulder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tugba Kuru Colak, Asst. Prof.
Organizational Affiliation
Marmara University Institute of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Sevgi Medical Center
City
Istanbul
State/Province
Arnavutkoy
ZIP/Postal Code
34275
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study.
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Comparison of the Proprioceptive Neuromuscular Facilitation and Mobilization In Subacromial Impingement Syndrome
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