- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05960435
Proprioceptive Neuromuscular Facilitation Techniques in Proximal Humerus Fractures
July 17, 2023 updated by: Ayse Zengin Alpozgen, Istanbul University - Cerrahpasa (IUC)
The Effects of Proprioceptive Neuromuscular Facilitation Techniques on Clinical Outcomes in Patients With Proximal Humerus Fractures
The aim of this study is to compare the effect of Proprioceptive Neuromuscular Facilitation (PNF) techniques on functional status, pain, range of motion (ROM), muscle strength, quality of life, and patient satisfaction in people with Proximal Humerus Fracture.
There will be two groups, PNF and conservative treatment, and the program will consist of 6 weeks.
Patients will randomly be assigned to the conservative treatment group and the PNF group.
Patients in the conservative group will deliver shoulder muscle static stretching, active-assistive ROM exercises, scapular mobilization, posterior capsule stretching, and isometric strengthening for 3 weeks.
Between 3-6 weeks these exercises will progress and shoulder muscles strengthening via Neuromuscular Electrical Stimulation (NMES) and active ROM exercises will add to the program.
Patients in the PNF group will deliver PNF stretching, active-assistive ROM exercises, PNF scapular patterns mobilization, posterior capsule stretching, and isometric strengthening for 3 weeks.
Between 3-6 weeks PNF stretching and scapular mobilization exercises will progress and PNF strengthening and active ROM exercises will add to the program.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to compare the effect of Proprioceptive Neuromuscular Facilitation (PNF) techniques on functional status, pain, range of motion (ROM), muscle strength, quality of life, and patient satisfaction in people with Proximal Humerus Fracture.
There will be two groups, PNF and conservative treatment, and the program will consist of 6 weeks.
Patients will randomly be assigned to the conservative treatment group and the PNF group.
Patients in the conservative group will deliver shoulder muscle static stretching, active-assistive ROM exercises, scapular mobilization, posterior capsule stretching, and isometric strengthening for 3 weeks.
Between 3-6 weeks these exercises will progress and shoulder muscles strengthening via NMES and active ROM exercises will add to the program.
Patients in the PNF group will deliver PNF stretching, active-assistive ROM exercises, PNF scapular patterns mobilization, posterior capsule stretching, and isometric strengthening for 3 weeks.
Between 3-6 weeks PNF stretching and scapular mobilization exercises will progress and PNF strengthening and active ROM exercises will add to the program.
Measurements will always taken by the blinded therapist who did not deliver the interventions.
Our primary outcome measure was the function of the upper limb as assessed by the Turkish version of the Disability of the Arm, Shoulder and Hand (DASH) questionnaire.
SF-36 for quality of life andThe Global Rating of Change Scale.
(GRC).
The outcome assessments will be evaluated at three points in time: at the baseline, after a three-week intervention, and at the end of the treatment (6 weeks).
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Feray Güngör
- Phone Number: +90 2124141500
- Email: feray.gungorr@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients diagnosed with humerus proximal fracture and stable information obtained by an orthopedist
- Patients aged ≥ 18 years
- Patients who volunteered to participate in the study
Exclusion Criteria:
- Bad union of tuberculum majus
- Advanced osteoporosis
- Humeral head avascular necrosis
- Presence of severe cardiac disease
- Uncontrollable hypertension
- Presence of neurological and rheumatological disease
- Presence of recurrent infection and open wound incision in the region
- Patients with communication problems
- Patients for whom exercise is not indicated
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PNF group
Patients in the PNF group will deliver PNF stretching, active-assistive ROM exercises, PNF scapular patterns mobilization, posterior capsule stretching, and isometric strengthening for 3 weeks.
Between 3-6 weeks PNF stretching and scapular mobilization exercises will progress and PNF strengthening and active ROM exercises will add to the program.
|
PNF, a method used to increase the range of motion of the joint and strengthen the muscles in the newly gained range, is a holistic approach and is based on motor learning principles.
PNF stretching involves isometric contraction of the target muscle in addition to static stretching.
|
Active Comparator: Control group
Patients in the conservative group will deliver shoulder muscle static stretching, active-assistive ROM exercises, scapular mobilization, posterior capsule stretching, and isometric strengthening for 3 weeks.
Between 3-6 weeks these exercises will progress and shoulder muscles strengthening via NMES and active ROM exercises will add to the program.
|
The control group will include static stretching, capsule stretching, progressive ROM exercises and strengthening exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disability of the Arm, Shoulder and Hand (DASH) questionnaire
Time Frame: 6 weeks
|
The DASH is a validated score to assess the physical function and symptoms of people with upper limb disabilities.
It contains 30 questions: 6 items about symptoms and 21 items about function.
Patients answer the questions using a 5-point, scaling from 0 to 100, with higher scores indicating more disability.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Constant-Murley (CSM)
Time Frame: 6 weeks
|
CSM score evaluates the functional status of the shoulder in patients with shoulder pain.
The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).
The maximum total score is 100 points and a high score corresponds to a well-functioning shoulder
|
6 weeks
|
Visual Analog Scale (VAS)
Time Frame: 6 weeks
|
VAS is used for pain during rest, at night, and during daily activity.
In the VAS assessment, the patients are asked to place a vertical mark on a scale where 0 points indicated 'no pain' and 10 points indicated 'worst pain
|
6 weeks
|
Range of Motion (ROM)
Time Frame: 6 weeks
|
Shoulder flexion, extension, abduction, external and internal rotation will measure with a digital goniometer.
|
6 weeks
|
Muscle strength
Time Frame: 6 weeks
|
Shoulder flexion, abduction, and scaption in the sitting position, and shoulder internal and external rotation strength will assess by hand-held dynamometer.
|
6 weeks
|
The Tampa Scale for Kinesiophobia (TSK)
Time Frame: 6 weeks
|
TSK is a 11-item questionnaire used to assess the subjective rating of fear of movement.
Each question is scored on a 4-point Likert scale and Total scores range from 11 to 44.
High scores indicate an increasing degree of fear of movement.
|
6 weeks
|
Short Form-36 (SF-36)
Time Frame: 6 weeks
|
The SF-36 questionnaire consists of eight multiple-item subscales that evaluate physical functioning, social functioning and role limitations due to physical problems and role limitations due to emotional problems, mental health, vitality, pain, and general health perception.
The total score range from 0 - 100 and higher scores show a better health status.
|
6 weeks
|
The Global Rating of Change Scale (GRC)
Time Frame: 6 weeks
|
GRC is used for the perception of improvement/deterioration over time.
Patients is asked to evaluate their post-treatment status with the 5- point Likert Scale on which -2: much worse, -1: worse, 0: same, +1: better, +2: much better.
High scores were positively correlated with satisfaction.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ayse Zengin Alpozgen, Istanbul University - Cerrahpasa (IUC)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 28, 2023
Primary Completion (Estimated)
February 25, 2024
Study Completion (Estimated)
February 28, 2024
Study Registration Dates
First Submitted
July 17, 2023
First Submitted That Met QC Criteria
July 17, 2023
First Posted (Actual)
July 25, 2023
Study Record Updates
Last Update Posted (Actual)
July 25, 2023
Last Update Submitted That Met QC Criteria
July 17, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUC35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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