Proximal Humeral FractureNCT05960435
Proprioceptive Neuromuscular Facilitation Techniques in Proximal Humerus Fractures
A study testing Proprioceptive Neuromuscular Facilitation in people with Proximal Humeral Fracture, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Proximal Humeral Fracture
- What is being tested?
- Proprioceptive Neuromuscular Facilitation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jul 2023to 2 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Bad union of tuberculum majus
- Advanced osteoporosis
- Humeral head avascular necrosis
- Presence of severe cardiac disease
- Uncontrollable hypertension
- Presence of neurological and rheumatological disease
Show all 9Show fewer
- Presence of recurrent infection and open wound incision in the region
- Patients with communication problems
- Patients for whom exercise is not indicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Proximal Humeral Fracture
- Being tested
- Proprioceptive Neuromuscular Facilitation, Control Group Exercise
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular FacilitationOther
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 ExerciseOther
The control group will include static stretching, capsule stretching, progressive ROM exercises and strengthening exercises.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control Group Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (7)
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
Measured: 6 weeks
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
Measured: 6 weeks
Range of Motion (ROM)
Shoulder flexion, extension, abduction, external and internal rotation will measure with a digital goniometer.
Measured: 6 weeks
Muscle strength
Shoulder flexion, abduction, and scaption in the sitting position, and shoulder internal and external rotation strength will assess by hand-held dynamometer.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start28 Jul 2023
- Primary completion25 Oct 2024
- Study completion2 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proximal Humeral FractureStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Zengin Alpozgen, Istanbul University - Cerrahpasa
- Investigators
- Ayse Zengin Alpozgen, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960435
- Sponsor's protocol ID
- IUC35
- Status last verified
- Nov 2024
- First submitted
- 17 Jul 2023
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40170293
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Proprioceptive Neuromuscular Facilitation Techniques on Clinical Outcomes in Patients with Proximal Humerus Fractures
- ClinicalTrials.gov ID
- NCT05960435
- Acronym / sponsor ID
- IUC35
- Conditions
- Proximal Humeral Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 2 Nov 2024 (actual)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNF group | Experimental | Other: Proprioceptive Neuromuscular FacilitationPatients 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. |
| Control group | Active comparator | Other: Control Group ExercisePatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Bad union of tuberculum majus
- Advanced osteoporosis
- Humeral head avascular necrosis
- Presence of severe cardiac disease
- Uncontrollable hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive Neuromuscular FacilitationPNF, 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. | Other | PNF group |
| Control Group ExerciseThe control group will include static stretching, capsule stretching, progressive ROM exercises and strengthening exercises. | Other | Control group |
Primary outcome
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.
7 secondary outcomes
The Constant-Murley (CSM)
Time frame: 6 weeks
Visual Analog Scale (VAS)
Time frame: 6 weeks
Range of Motion (ROM)
Time frame: 6 weeks
Muscle strength
Time frame: 6 weeks
The Tampa Scale for Kinesiophobia (TSK)
Time frame: 6 weeks
Short Form-36 (SF-36)
Time frame: 6 weeks
The Global Rating of Change Scale (GRC)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Derived from this study: PubMed 40170293Kus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse Zengin Alpozgen principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Neuromuscular Facilitation in people with Proximal Humeral Fracture, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability of the Arm, Shoulder and Hand (DASH) questionnaire (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05960435, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.