NCT05960435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

July 28, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2024

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

July 17, 2023

Last Update Submit

November 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • The Constant-Murley (CSM)

    6 weeks

  • Visual Analog Scale (VAS)

    6 weeks

  • Range of Motion (ROM)

    6 weeks

  • Muscle strength

    6 weeks

  • The Tampa Scale for Kinesiophobia (TSK)

    6 weeks

  • +2 more secondary outcomes

Study Arms (2)

PNF group

EXPERIMENTAL

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.

Other: Proprioceptive Neuromuscular Facilitation

Control group

ACTIVE COMPARATOR

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.

Other: Control Group Exercise

Interventions

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.

PNF group

The control group will include static stretching, capsule stretching, progressive ROM exercises and strengthening exercises.

Control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Kus G, Zengin Alpozgen A, Razak Ozdincler A, Gungor F, Altun S. The effectiveness of proprioceptive neuromuscular facilitation techniques versus conventional therapy in patients with proximal humerus fracture: randomized controlled trial. Physiother Theory Pract. 2025 Sep;41(9):1851-1865. doi: 10.1080/09593985.2025.2486418. Epub 2025 Apr 1.

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ayse Zengin Alpozgen

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 17, 2023

First Posted

July 25, 2023

Study Start

July 28, 2023

Primary Completion

October 25, 2024

Study Completion

November 2, 2024

Last Updated

November 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations