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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
Scientific title
Effectiveness of the manipulative approach associated with a standard program of exercises in relapsing shoulder pain in nurse and health professionals
Secondary ID [1] 296063 0
Nil Known
Universal Trial Number (UTN)
U1111-1220-3435
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder pain 309617 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308431 308431 0 0
Other physical medicine / rehabilitation
Musculoskeletal 308452 308452 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 312398 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 307399 0
shoulder pain evaluated with VNS
Timepoint [1] 307399 0
baseline, after 4 week, after 8 week from baseline (primary timepoint)
Secondary outcome [1] 351825 0
Strength in flexion movement evaluated with dynamometer (evaluation of anterior deltoid and pectoralis muscles)
Timepoint [1] 351825 0
baseline, after 4 week, after 8 week from baseline
Secondary outcome [2] 351826 0
strength in abduction evaluated with dynamometer (supraspinatus and deltoid muscles)
Timepoint [2] 351826 0
baseline, after 4 week, after 8 week from baseline
Secondary outcome [3] 351827 0
active range of motion in flexion evaluated with bubble inclinometer (deltoid anterior, pectoralis, serratus anterior, upper trapezius..)
Timepoint [3] 351827 0
baseline, after 4 week, after 8 week from baseline
Secondary outcome [4] 351828 0
active range of motion in abduction evaluated with bubble inclinometer (deltoid, supraspinatus, serratus anterior, upper trapezius)
Timepoint [4] 351828 0
baseline, after 4 week, after 8 week from baseline
Secondary outcome [5] 351903 0
active range of motion in external rotation evaluated with bubble inclinometer (infraspinatus, teres minor, deltoid posterior)
Timepoint [5] 351903 0
baseline, after 4 week, after 8 week from baseline
Secondary outcome [6] 351904 0
active range of motion in internal rotation evaluated with bubble inclinometer (subscapularis, pectoral major, anterior deltoid, teres major)
Timepoint [6] 351904 0
baseline, after 4 week, after 8 week from baseline
Secondary outcome [7] 351905 0
functional evaluation evaluated with DASH scale
Timepoint [7] 351905 0
baseline, after 4 week, after 8 week from baseline
Secondary outcome [8] 351906 0
functional evaluation evaluated with Contant Murley
scale
Timepoint [8] 351906 0
baseline, after 4 week, after 8 week from baseline

Eligibility
Key inclusion criteria
shoulder pain for at least six months
positivity to one or more of Howkins, Jobe;,Neer orthopaedic test
Minimum age
25 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
rotatory cuff disease with instrumental diagnosis (ecografic, RNM...)
history of humerus, scapula, clavicle fractures;
systemic diseases

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central ramdomization using computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2018
Actual
Date of last participant enrolment
Anticipated
30/11/2018
Actual
Date of last data collection
Anticipated
31/01/2019
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 20842 0
Italy
State/province [1] 20842 0
bergamo

Funding & Sponsors
Funding source category [1] 300649 0
Self funded/Unfunded
Name [1] 300649 0
Country [1] 300649 0
Primary sponsor type
Individual
Name
massimo Busato
Address
Ospedale "Briolini".
area omogenea riabilitativa
Via A. Manzoni, 130
24025 Gazzaniga Bergamo
Country
Italy
Secondary sponsor category [1] 300168 0
None
Name [1] 300168 0
Address [1] 300168 0
Country [1] 300168 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301438 0
comitato etico provinciale bergamo
Ethics committee address [1] 301438 0
Ethics committee country [1] 301438 0
Date submitted for ethics approval [1] 301438 0
30/09/2018
Approval date [1] 301438 0
Ethics approval number [1] 301438 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86998 0
Mr Massimo Busato
Address 86998 0
Ospedale "Briolini".
area omogenea riabilitativa
Via A. Manzoni, 130
24025 Gazzaniga Bergamo
Country 86998 0
Italy
Phone 86998 0
+039 349 2136369
Fax 86998 0
Email 86998 0
mahem1971@gmail.com
Contact person for public queries
Name 86999 0
Massimo Busato
Address 86999 0
Ospedale "Briolini".
area omogenea riabilitativa
Via A. Manzoni, 130
24025 Gazzaniga Bergamo
Country 86999 0
Italy
Phone 86999 0
+039 349 2136369
Fax 86999 0
Email 86999 0
mahem1971@gmail.com
Contact person for scientific queries
Name 87000 0
Massimo Busato
Address 87000 0
Ospedale "Briolini".
area omogenea riabilitativa
Via A. Manzoni, 130
24025 Gazzaniga Bergamo
Country 87000 0
Italy
Phone 87000 0
+039 349 2136369
Fax 87000 0
Email 87000 0
mahem1971@gmail.com

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.