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Trial registered on ANZCTR
Registration number
ACTRN12618001612202p
Ethics application status
Not yet submitted
Date submitted
12/09/2018
Date registered
28/09/2018
Date last updated
28/09/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Effectiveness of the manipulative approach associated with a standard program of exercises in relapsing shoulder pain
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Scientific title
Effectiveness of the manipulative approach associated with a standard program of exercises in relapsing shoulder pain in nurse and health professionals
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Secondary ID [1]
296063
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Nil Known
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Universal Trial Number (UTN)
U1111-1220-3435
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
shoulder pain
309617
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Condition category
Condition code
Physical Medicine / Rehabilitation
308431
308431
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0
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Other physical medicine / rehabilitation
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Musculoskeletal
308452
308452
0
0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The treatment involves the education of the patient to the daily execution of specific stretching and strengthening exercises, for a duration of four weeks, the exercises need about 25 minutes daily.
Four weeks after enrollment, the patient will suspend the execution of daily exercises.
Follow-up is expected one month after suspension, eight weeks after enrollment.
The patient will be instructed to perform the exercises by a therapist with at least five years of experience, and will review it once a week to verify the correct execution or adapt it if necessary.
To facilitate the execution of the exercises the patient will be provided with dvd and paper support, and a daily diary to note any difficulties on.
In the second and fourth weeks the patient of this group will undergo four osteopathic manipulations: joint mobilization of the vertebral level C7 / T1, articular manipulation of the high dorsal levels, manipulation of the dysfunction in superiority of the humerus, manipulation of the dysfunction in anteriority of the humerus.
the manipulations will be performed by an osteopath with at least five years of experience.
the specific exercises included:
upper trapezius stretch, made in sitting position and keeping frontal look;
posterior shoulder stretch;
pectoralis minor stretch;
the exercises will be carried out maintaining the stretching tension for 30 seconds, for ten repetitions.
strenghtening of external rotator muscles;
strenghtening of lower trapezius;
strenghtening of anterior serratus.
the exercises will be performed by performing three cycles of 15 contractions with a elastic resistance (like theraband), which will be increased after two weeks.
Training and weekly verification of the exercises will be performed by a physiotherapist with at least five years of experience.
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Intervention code [1]
312398
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Treatment: Other
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Comparator / control treatment
The treatment involves the education of the patient to the daily execution of specific stretching and strengthening exercises, for a duration of four weeks, the exercises need about 25 minutes daily.
Four weeks after enrollment, the patient will suspend the execution of daily exercises.
Follow-up is expected one month after suspension, eight weeks after enrollment.
The patient will be instructed to perform the exercises by a therapist with at least five years of experience, and will review it once a week to verify the correct execution or adapt it if necessary.
To facilitate the execution of the exercises the patient will be provided with dvd and paper support, and a daily diary to note any difficulties on.
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Control group
Active
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Outcomes
Primary outcome [1]
307399
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shoulder pain evaluated with VNS
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Assessment method [1]
307399
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Timepoint [1]
307399
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baseline, after 4 week, after 8 week from baseline (primary timepoint)
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Secondary outcome [1]
351825
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Strength in flexion movement evaluated with dynamometer (evaluation of anterior deltoid and pectoralis muscles)
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Assessment method [1]
351825
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Timepoint [1]
351825
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baseline, after 4 week, after 8 week from baseline
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Secondary outcome [2]
351826
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strength in abduction evaluated with dynamometer (supraspinatus and deltoid muscles)
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Assessment method [2]
351826
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Timepoint [2]
351826
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baseline, after 4 week, after 8 week from baseline
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Secondary outcome [3]
351827
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active range of motion in flexion evaluated with bubble inclinometer (deltoid anterior, pectoralis, serratus anterior, upper trapezius..)
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Assessment method [3]
351827
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Timepoint [3]
351827
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baseline, after 4 week, after 8 week from baseline
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Secondary outcome [4]
351828
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active range of motion in abduction evaluated with bubble inclinometer (deltoid, supraspinatus, serratus anterior, upper trapezius)
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Assessment method [4]
351828
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Timepoint [4]
351828
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baseline, after 4 week, after 8 week from baseline
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Secondary outcome [5]
351903
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active range of motion in external rotation evaluated with bubble inclinometer (infraspinatus, teres minor, deltoid posterior)
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Assessment method [5]
351903
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Timepoint [5]
351903
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baseline, after 4 week, after 8 week from baseline
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Secondary outcome [6]
351904
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active range of motion in internal rotation evaluated with bubble inclinometer (subscapularis, pectoral major, anterior deltoid, teres major)
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Assessment method [6]
351904
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Timepoint [6]
351904
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baseline, after 4 week, after 8 week from baseline
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Secondary outcome [7]
351905
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functional evaluation evaluated with DASH scale
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Assessment method [7]
351905
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Timepoint [7]
351905
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baseline, after 4 week, after 8 week from baseline
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Secondary outcome [8]
351906
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functional evaluation evaluated with Contant Murley
scale
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Assessment method [8]
351906
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Timepoint [8]
351906
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baseline, after 4 week, after 8 week from baseline
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Eligibility
Key inclusion criteria
shoulder pain for at least six months
positivity to one or more of Howkins, Jobe;,Neer orthopaedic test
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Minimum age
25
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
rotatory cuff disease with instrumental diagnosis (ecografic, RNM...)
history of humerus, scapula, clavicle fractures;
systemic diseases
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central ramdomization using computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size was based on a significance level of 0,05 and a power of 0,80 to detect a a difference of 1,5 point *- 1 in VNS.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/09/2018
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Actual
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Date of last participant enrolment
Anticipated
30/11/2018
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Actual
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Date of last data collection
Anticipated
31/01/2019
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
20842
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Italy
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State/province [1]
20842
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bergamo
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Funding & Sponsors
Funding source category [1]
300649
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Self funded/Unfunded
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Name [1]
300649
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Address [1]
300649
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Country [1]
300649
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Primary sponsor type
Individual
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Name
massimo Busato
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Address
Ospedale "Briolini".
area omogenea riabilitativa
Via A. Manzoni, 130
24025 Gazzaniga Bergamo
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Country
Italy
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Secondary sponsor category [1]
300168
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None
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Name [1]
300168
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Address [1]
300168
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Country [1]
300168
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
301438
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comitato etico provinciale bergamo
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Ethics committee address [1]
301438
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Comitato etico di Bergamo presso HPG XXIII Piazza OMS, 1, 24127 Bergamo BG Email: comitatoetico@asst-pg23.it
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Ethics committee country [1]
301438
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Date submitted for ethics approval [1]
301438
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30/09/2018
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Approval date [1]
301438
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Ethics approval number [1]
301438
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Summary
Brief summary
shoulder pain is one of the common disease in nurse and if neglected it can lead to major organic injuries. the approach through a specific program of muscle strengthening and stretching has evidence of effectiveness and daily activity with specific exercise may reduce pain in the middle term. osteopathic manual therapy may normalize disfunction in shoulder movement. this research may verify if the association on manual therapy to a set of exercise improve the efficacy of the intervention.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Massimo Busato
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Address
86998
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Ospedale "Briolini".
area omogenea riabilitativa
Via A. Manzoni, 130
24025 Gazzaniga Bergamo
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Country
86998
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Italy
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Phone
86998
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+039 349 2136369
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Fax
86998
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Email
86998
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[email protected]
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Contact person for public queries
Name
86999
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Massimo Busato
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Address
86999
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Ospedale "Briolini".
area omogenea riabilitativa
Via A. Manzoni, 130
24025 Gazzaniga Bergamo
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Country
86999
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Italy
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Phone
86999
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+039 349 2136369
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Fax
86999
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Email
86999
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[email protected]
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Contact person for scientific queries
Name
87000
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Massimo Busato
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Address
87000
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Ospedale "Briolini".
area omogenea riabilitativa
Via A. Manzoni, 130
24025 Gazzaniga Bergamo
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Country
87000
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Italy
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Phone
87000
0
+039 349 2136369
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Fax
87000
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Email
87000
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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