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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05960435
Other study ID # IUC35
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 28, 2023
Est. completion date February 28, 2024

Study information

Verified date July 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact Feray Güngör
Phone 2124141500
Email feray.gungorr@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date February 28, 2024
Est. primary completion date February 25, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

Other:
Proprioceptive Neuromuscular Facilitation
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.
Control Group Exercise
The control group will include static stretching, capsule stretching, progressive ROM exercises and strengthening exercises.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 weeks
Secondary 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 6 weeks
Secondary 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 6 weeks
Secondary Range of Motion (ROM) Shoulder flexion, extension, abduction, external and internal rotation will measure with a digital goniometer. 6 weeks
Secondary Muscle strength Shoulder flexion, abduction, and scaption in the sitting position, and shoulder internal and external rotation strength will assess by hand-held dynamometer. 6 weeks
Secondary 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. 6 weeks
Secondary 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. 6 weeks
Secondary 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. 6 weeks
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