Shoulder Impingement SyndromeNCT04273568
The Effect of Scapular Proprioceptive Neuromuscular Facilitation Techniques on Pain and Functionality in Subacromial Impingement Syndrome
A study testing Scapular PNF and Exercise program in people with Shoulder Impingement Syndrome, run by Tuğba Akgüller at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effects of scapular proprioceptive neuromuscular facilitation (PNF) techniques applied in addition to exercise therapy in patients with Subacromial impingement syndrome (SIS) on pain, pressure pain threshold (PPT), range of motion (ROM), functionality, scapular dyskinesis… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Scapular PNF and Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 30 Aug 2019
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 20 and 60
- Diagnosed with SIS by MRI and clinical examination and a specialist physician
- Positive impingement tests (Hawkings, Neer and Jobe test) or painful motion arc (60 ° -120 °)
- Unilateral shoulder pain that has been going on for at least 3 months
- Signed voluntary consent form
Who cannot join
- Diagnosed with adhesive capsulitis or massive rotator cuff tear
- Having undergone upper limb surgery
- Presence of rheumatological systemic diseases
- Presence of Glenohumeral instability
- Having a neurological disease affecting the upper extremity
- Diagnosed with cervical radiculopathy
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- Degenerative joint disorders
- Having communication problems
- Steroid injection therapy or physiotherapy in the past 6 months have been rehabilitated
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to investigate the effects of scapular proprioceptive neuromuscular facilitation (PNF) techniques applied in addition to exercise therapy in patients with Subacromial impingement syndrome (SIS) on pain, pressure pain threshold (PPT), range of motion (ROM), functionality, scapular dyskinesis, active trigger points and emotional state.
Read the detailed description
32 patients between the ages of 20-60 diagnosed with SIS were included in the study.
The patients were randomly divided into two groups. The exercise group received an exercise program of 12 sessions. Scapular PNF techniques were applied to the PNF group with the same exercise program. Patients were evaluated twice; one before and one after 6 weeks of treatment; using Visual Analogue Scale (VAS) for pain, algometer for PPT, digital goniometer for range of motion (ROM), The Disabilities of Arm, Shoulder and Hand (DASH) for functional status, lateral scapular slide test (LSST) for scapular dyskinesis, Travell and Simons criteria for trigger point and Hospital Anxiety and Depression Scale (HADS) for emotional state. At the end of treatment patient satisfaction was evaluated with Global Change Scale.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Scapular PNF, Exercise program
- Keywords
- Proprioceptive Neuromuscular Facilitation, Shoulder pain
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapular PNFOther
Rhythmic initiation and repetitive stretching techniques in scapula anterior elevation-posterior depression and anterior depression-posterior elevation patterns were applied twice a week for 6 weeks.
Exercise programOther
An exercise program consisting of exercises used in the conservative treatment of shoulder impingement syndrome for both groups was applied twice a week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group1 (PNF group) | Experimental | Scapular PNF and exercise program was applied to the PNF group. Receives: Other: Scapular PNF; Other: Exercise program |
| Group 2 (Exercise group) | Active comparator | Exercise program was applied to the exercise group Receives: Other: Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Pain intensity of the patients at 6 weeks
Pain intensity of the patients at rest, during activity and at night was assessed using the VAS; Visual Analog Scale. In this evaluation, individuals were told that the number "0" on the 10 cm long horizontal line expresses "no pain", and the number "10" indicates "unbearable pain" and that individuals should mark their intensity of pain on this line.
Measured: Baseline and 6 weeks
Change from Baseline Functional Status of the patients at 6 weeks
The functional status of the patients were evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH). DASH is a scale consisting of 30 questions that question the functional status and symptoms used in musculoskeletal disorders of the upper extremity.The number of Likert scale (1: no difficulty, 5: I can not do at all) is used in answering the questions and the total score obtained is between 0 and 100.
Measured: Baseline and 6 weeks
Secondary outcomes (5)
Shoulder Range of Motion (ROM)
EHA evaluations of flexion, abduction, internal rotation and external rotation of the shoulder joint were performed in the supine position using the digital goniometer.
Measured: Baseline and 6 weeks
Pain Pressure Threshold (PPT)
Pressure pain threshold was evaluated using the Algometer (dolorimeter).
Measured: Baseline and 6 weeks
Scapular dyskinesis
Scapular Dyskinesis was evaluated with "The Lateral Scapular Slide Test (LSKT)". In this test, the distance of the inferior angle of the scapula to the nearest spinous process at 3 different positions (0°, 40-45°, 90°) is measured, and a difference of 1 cm or more between the two sides in any of the three positions is considered positive for scapular dyskinesis.
Measured: Baseline and 6 weeks
Active trigger points
Active trigger points were evaluated by palpation method according to Travell and Simons criteria. Scalene, upper trapezius, levator scapula, supraspinatus, infraspinatus, subskapularis, teres minor, teres major, deltoid anterior, middle and posterior group fibers, pectoralis major, pectoralis minor, biceps brachii muscles were evaluated with palpation method in terms of trigger point presence.
Measured: Baseline and 6 weeks
Emotional state
The emotional states of the cases were evaluated using the Hospital Anxiety and Depression Scale (HAD), which consists of 14 questions. (HAD). This scale has a 7-question anxiety (HAD-A) subscale that evaluates the anxiety state, and a 7-question depression (HAD-D) subscale that evaluates the state of depression, and a four-point likert scale is used to answer the questions. For the total score of each sub-score, 0-7 points are normal, 8-10 points are at the border, and 11 points are defined as abnormal
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Mar 2019
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuğba Akgüller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tuğba Akgüller, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273568
- Sponsor's protocol ID
- tugbaakguller
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Scapular Proprioceptive Neuromuscular Facilitation Techniques on Pain and Functionality in Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT04273568
- Acronym / sponsor ID
- tugbaakguller
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- Proprioceptive Neuromuscular Facilitation, Shoulder pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Tuğba AkgüllerUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 18 Feb 2020 (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 was to investigate the effects of scapular proprioceptive neuromuscular facilitation (PNF) techniques applied in addition to exercise therapy in patients with Subacromial impingement syndrome (SIS) on pain, pressure pain threshold (PPT), range of motion (ROM), functionality, scapular dyskinesis, active trigger points and emotional state.
Detailed description
32 patients between the ages of 20-60 diagnosed with SIS were included in the study.
The patients were randomly divided into two groups. The exercise group received an exercise program of 12 sessions. Scapular PNF techniques were applied to the PNF group with the same exercise program. Patients were evaluated twice; one before and one after 6 weeks of treatment; using Visual Analogue Scale (VAS) for pain, algometer for PPT, digital goniometer for range of motion (ROM), The Disabilities of Arm, Shoulder and Hand (DASH) for functional status, lateral scapular slide test (LSST) for scapular dyskinesis, Travell and Simons criteria for trigger point and Hospital Anxiety and Depression Scale (HADS) for emotional state. At the end of treatment patient satisfaction was evaluated with Global Change Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 (PNF group) | Experimental | Other: Scapular PNF, Other: Exercise programScapular PNF and exercise program was applied to the PNF group. |
| Group 2 (Exercise group) | Active comparator | Other: Exercise programExercise program was applied to the exercise group |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 20 and 60
- Diagnosed with SIS by MRI and clinical examination and a specialist physician
- Positive impingement tests (Hawkings, Neer and Jobe test) or painful motion arc (60 ° -120 °)
- Unilateral shoulder pain that has been going on for at least 3 months
- Signed voluntary consent form
Key exclusion criteria (9 listed)
- Diagnosed with adhesive capsulitis or massive rotator cuff tear
- Having undergone upper limb surgery
- Presence of rheumatological systemic diseases
- Presence of Glenohumeral instability
- Having a neurological disease affecting the upper extremity
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 |
|---|---|---|
| Scapular PNFRhythmic initiation and repetitive stretching techniques in scapula anterior elevation-posterior depression and anterior depression-posterior elevation patterns were applied twice a week for 6 weeks. | Other | Group1 (PNF group) |
| Exercise programAn exercise program consisting of exercises used in the conservative treatment of shoulder impingement syndrome for both groups was applied twice a week for 6 weeks. | Other | Group 2 (Exercise group), Group1 (PNF group) |
Primary outcome
Change from Baseline Pain intensity of the patients at 6 weeks
Time frame: Baseline and 6 weeks
Pain intensity of the patients at rest, during activity and at night was assessed using the VAS; Visual Analog Scale. In this evaluation, individuals were told that the number "0" on the 10 cm long horizontal line expresses "no pain", and the number "10" indicates "unbearable pain" and that individuals should mark their intensity of pain on this line.
Change from Baseline Functional Status of the patients at 6 weeks
Time frame: Baseline and 6 weeks
The functional status of the patients were evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH). DASH is a scale consisting of 30 questions that question the functional status and symptoms used in musculoskeletal disorders of the upper extremity.The number of Likert scale (1: no difficulty, 5: I can not do at all) is used in answering the questions and the total score obtained is between 0 and 100.
5 secondary outcomes
Shoulder Range of Motion (ROM)
Time frame: Baseline and 6 weeks
Pain Pressure Threshold (PPT)
Time frame: Baseline and 6 weeks
Scapular dyskinesis
Time frame: Baseline and 6 weeks
Active trigger points
Time frame: Baseline and 6 weeks
Emotional state
Time frame: Baseline and 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 18 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scapular PNF and Exercise program in people with Shoulder Impingement Syndrome, run by Tuğba Akgüller 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 5 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 18 Feb 2020. 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?
Change from Baseline Pain intensity of the patients at 6 weeks (time frame: Baseline and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2020.