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Proprioceptive Neuromuscular Facilitation Techniques in Proximal Humerus Fractures

Primary Purpose

Proximal Humeral Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Proprioceptive Neuromuscular Facilitation
Control Group Exercise
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Humeral Fracture

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PNF group

    Control group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Disability of the Arm, Shoulder and Hand (DASH) questionnaire
    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.

    Secondary Outcome Measures

    The Constant-Murley (CSM)
    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
    Visual Analog Scale (VAS)
    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
    Range of Motion (ROM)
    Shoulder flexion, extension, abduction, external and internal rotation will measure with a digital goniometer.
    Muscle strength
    Shoulder flexion, abduction, and scaption in the sitting position, and shoulder internal and external rotation strength will assess by hand-held dynamometer.
    The Tampa Scale for Kinesiophobia (TSK)
    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.
    Short Form-36 (SF-36)
    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.
    The Global Rating of Change Scale (GRC)
    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.

    Full Information

    First Posted
    July 17, 2023
    Last Updated
    July 17, 2023
    Sponsor
    Istanbul University - Cerrahpasa (IUC)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05960435
    Brief Title
    Proprioceptive Neuromuscular Facilitation Techniques in Proximal Humerus Fractures
    Official Title
    The Effects of Proprioceptive Neuromuscular Facilitation Techniques on Clinical Outcomes in Patients With Proximal Humerus Fractures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 28, 2023 (Anticipated)
    Primary Completion Date
    February 25, 2024 (Anticipated)
    Study Completion Date
    February 28, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University - Cerrahpasa (IUC)

    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
    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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Proximal Humeral Fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PNF group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Proprioceptive Neuromuscular Facilitation
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Control Group Exercise
    Intervention Description
    The control group will include static stretching, capsule stretching, progressive ROM exercises and strengthening exercises.
    Primary Outcome Measure Information:
    Title
    Disability of the Arm, Shoulder and Hand (DASH) questionnaire
    Description
    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.
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    The Constant-Murley (CSM)
    Description
    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
    Time Frame
    6 weeks
    Title
    Visual Analog Scale (VAS)
    Description
    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
    Time Frame
    6 weeks
    Title
    Range of Motion (ROM)
    Description
    Shoulder flexion, extension, abduction, external and internal rotation will measure with a digital goniometer.
    Time Frame
    6 weeks
    Title
    Muscle strength
    Description
    Shoulder flexion, abduction, and scaption in the sitting position, and shoulder internal and external rotation strength will assess by hand-held dynamometer.
    Time Frame
    6 weeks
    Title
    The Tampa Scale for Kinesiophobia (TSK)
    Description
    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.
    Time Frame
    6 weeks
    Title
    Short Form-36 (SF-36)
    Description
    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.
    Time Frame
    6 weeks
    Title
    The Global Rating of Change Scale (GRC)
    Description
    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.
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Feray Güngör
    Phone
    2124141500
    Ext
    +90
    Email
    feray.gungorr@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ayse Zengin Alpozgen
    Organizational Affiliation
    Istanbul University - Cerrahpasa (IUC)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Proprioceptive Neuromuscular Facilitation Techniques in Proximal Humerus Fractures

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