Clinical trial NCT05960435: 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
Overall status: COMPLETED
Phase: NA
Conditions: Proximal Humeral Fracture
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Disability of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: 6 weeks
Secondary outcomes:
measure: The Constant-Murley (CSM)
timeFrame: 6 weeks
measure: Visual Analog Scale (VAS)
timeFrame: 6 weeks
measure: Range of Motion (ROM)
timeFrame: 6 weeks
measure: Muscle strength
timeFrame: 6 weeks
measure: The Tampa Scale for Kinesiophobia (TSK)
timeFrame: 6 weeks
measure: Short Form-36 (SF-36)
timeFrame: 6 weeks
measure: The Global Rating of Change Scale (GRC)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ayse Zengin Alpozgen
role: PRINCIPAL_INVESTIGATOR
References: