Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
Study NCT ID:
NCT04273568
Status:
COMPLETED
Last Update Posted:
2020-02-18
First Post:
2020-02-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Scapular Proprioceptive Neuromuscular Facilitation Techniques on Pain and Functionality in Subacromial Impingement Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-17', 'studyFirstSubmitDate': '2020-02-11', 'studyFirstSubmitQcDate': '2020-02-17', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Satisfaction: Global Rating of Change (GRC) scale', 'timeFrame': 'At the end of the 6-weeks treatment', 'description': 'Patient Satisfaction was assessed Global Rating of Change (GRC) scale. The scale used included 5 points (-2: I am much worse. -1: I am worse, 0: I am the same, +1: I am better, +2: I am much better).'}], 'primaryOutcomes': [{'measure': 'Change from Baseline Pain intensity of the patients at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': '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.'}, {'measure': 'Change from Baseline Functional Status of the patients at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Shoulder Range of Motion (ROM)', 'timeFrame': 'Baseline and 6 weeks', 'description': 'EHA evaluations of flexion, abduction, internal rotation and external rotation of the shoulder joint were performed in the supine position using the digital goniometer.'}, {'measure': 'Pain Pressure Threshold (PPT)', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Pressure pain threshold was evaluated using the Algometer (dolorimeter).'}, {'measure': 'Scapular dyskinesis', 'timeFrame': 'Baseline and 6 weeks', 'description': '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.'}, {'measure': 'Active trigger points', 'timeFrame': 'Baseline and 6 weeks', 'description': '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.'}, {'measure': 'Emotional state', 'timeFrame': 'Baseline and 6 weeks', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Proprioceptive Neuromuscular Facilitation', 'Shoulder pain'], 'conditions': ['Shoulder Impingement Syndrome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '32 patients between the ages of 20-60 diagnosed with SIS were included in the study.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 20 and 60\n* Diagnosed with SIS by MRI and clinical examination and a specialist physician\n* Positive impingement tests (Hawkings, Neer and Jobe test) or painful motion arc (60 ° -120 °)\n* Unilateral shoulder pain that has been going on for at least 3 months\n* Signed voluntary consent form\n\nExclusion Criteria:\n\n* Diagnosed with adhesive capsulitis or massive rotator cuff tear\n* Having undergone upper limb surgery\n* Presence of rheumatological systemic diseases\n* Presence of Glenohumeral instability\n* Having a neurological disease affecting the upper extremity\n* Diagnosed with cervical radiculopathy\n* Degenerative joint disorders\n* Having communication problems\n* Steroid injection therapy or physiotherapy in the past 6 months have been rehabilitated'}, 'identificationModule': {'nctId': 'NCT04273568', 'briefTitle': 'The Effect of Scapular Proprioceptive Neuromuscular Facilitation Techniques on Pain and Functionality in Subacromial Impingement Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Arel University'}, 'officialTitle': 'The Effect of Scapular Proprioceptive Neuromuscular Facilitation Techniques on Pain and Functionality in Subacromial Impingement Syndrome', 'orgStudyIdInfo': {'id': 'tugbaakguller'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group1 (PNF group)', 'description': 'Scapular PNF and exercise program was applied to the PNF group.', 'interventionNames': ['Other: Scapular PNF', 'Other: Exercise program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 (Exercise group)', 'description': 'Exercise program was applied to the exercise group', 'interventionNames': ['Other: Exercise program']}], 'interventions': [{'name': 'Scapular PNF', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Group1 (PNF group)']}, {'name': 'Exercise program', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Group 2 (Exercise group)', 'Group1 (PNF group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Aydin University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tuğba Akgüller', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Tuğba Akgüller', 'investigatorAffiliation': 'Istanbul Arel University'}}}}