Condition category
Injury, Occupational Diseases, Poisoning
Date applied
27/10/2019
Date assigned
16/12/2019
Last edited
16/12/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Although programmes based on exercises may be recommended after surgery for proximal humeral fractures, there is a lack of evidence about their clinical impact as well as their long-term effects in working adults as most studies are conducted in older ages. Evidence is also required when defining characteristics (general physiotherapy, mainly including strengthening, stretching, and mobilization exercises, or task-oriented exercises, primarily aimed at early functional recovery and independence in ADL), intensity, frequency and duration of exercise-based programmes. The aim of this study is to find out whether a 12-week rehabilitation programme of functional exercises improves disability, pain, and quality of life, and whether these positive effects are maintained up to at least one year later.

Who can participate?
Patients aged 20-65 undergoing surgical treatment of proximal humeral fractures

What does the study involve?
Participants are randomly allocated to one of two treatment programmes: either an enriched programme incorporating task-oriented exercises, or general physiotherapy alone. The treatment programmes last 12 weeks, the rehab sessions are performed three times a week and the duration is 1 hour. The follow-up is for 1 year.

What are the possible benefits and risks of participating?
Possible benefits are clinically significant improvements in disability, pain, and quality of life. No side effects are expected.

Where is the study run from?
Operative Unit of the Scientific Institute of Lissone, Monza Brianza (Italy)

When is the study starting and how long is it expected to run for?
May 2012 to June 2017

Who is funding the study?
University of Cagliari, UNICA (Italy)

Who is the main contact?
Marco Monticone
marco.monticone@unica.it

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marco Monticone

ORCID ID

http://orcid.org/0000-0002-6526-888X

Contact details

Dept. Medical Sciences and Public Health - Faculty of Medicine
Cittadella Universitaria S.S. 554 Bivio Monserrato - Sestu
Cagliari
09042
Italy
+39 (0)706753109
marco.monticone@unica.it

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

4/2012

Study information

Scientific title

Task-oriented exercises improve disability of working adults with surgically treated proximal humeral fractures: a randomized controlled trial with one-year follow-up

Acronym

Study hypothesis

A 12-week rehabilitation programme of functional exercises would produce clinically significant improvements in disability, pain, and quality of life (QoL) in these subjects vs. general physiotherapy, and that these positive effects would have maintained up to at least one year later.

Ethics approval

Approved 04/05/2012, Ethical Committee Salvatore Maugeri Foundation (Via Monsignor Ennio
Bernasconi, 16, 20851 Lissone MB, Italy; Tel: +39 (0)39 4657277), ref: 4

Study design

Randomised parallel-group superiority-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Proximal humeral fracture, following surgery

Intervention

Experimental group. Task-oriented exercises and occupational therapy.
Control group. Passive humeral and upper limb mobilisation, strengthening, muscle segmentary stretching, and
postural control.

Randomization: the biostatistician randomized the subjects to one of the two treatment programmes using a permuted-block randomization procedure. The list of treatment codes was previously generated and stored in Matlab and an automatic assignment system, also developed in Matlab, was used to conceal the allocation.

The treatment programme took place at the outpatient rehabilitative gym at the hospital and was led by two physiatrists, an occupational therapist, and two equally-experienced physiotherapists. The interventions lasted 12 weeks, the rehab sessions were performed three times a week and the duration was of 1 hour. The follow-up was of 1 year. During the treatment period, the questionnaires were administered by secretarial staff who checked them and returned any uncompleted part to the subjects for completion. At follow-up, the patients were contacted personally by the same secretarial staff in order to ensure that the questionnaires were properly completed.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Disability assessed using the validated Italian version of the self-reported Disability Arm Shoulder Hand questionnaire before treatment, at the end (12 weeks) and at follow-up (one year after the end of treatment).

Secondary outcome measures

1. Pain intensity assessed using an 11-point numerical rating scale at baseline, 12 weeks and 12 months
2. Quality of life assessed using the Italian version of the self-report Short-Form Health Survey (SF-36) at baseline, 12 weeks and 12 months
3. Patient-rated efficacy of treatment assessed using the Global Perceived Effect scale (GPE) at end of treatment

Overall trial start date

01/05/2012

Overall trial end date

30/06/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Subjects undergoing surgical treatment of PHFs classified as Arbeitsgemeinschaft Osteosynthese (AO) Foundation for the Study of Internal Fixation type 11 (2)
2. A good understanding of Italian
3. Working age (20-65 years old)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant exclusion criteria

1. Cognitive impairment (Mini-Mental State Examination Score of<24), unstable cardiovascular and pulmonary diseases, and systemic or neuromuscular diseases, ruled out by means of case histories and imaging
2. Subjects with isolated tuberculum majus fracture (AO 11, A1), or fractures with involvement of the glenoid cavity, double fractures or injury of the plexus or the axillary nerve
3. Subjects who had workers’ compensation

Recruitment start date

01/06/2012

Recruitment end date

30/06/2016

Locations

Countries of recruitment

Italy

Trial participating centre

Scientific Institute of Lissone
Via Monsignor Bernasconi, 16
Lissone (Monza Brianza)
20851
Laos

Sponsor information

Organisation

Università degli Studi di Cagliari

Sponsor details

Dept. Medical Science and Public Health - Faculty of Medicine
Cittadella Universitaria S.S. 554 Bivio Monserrato - Sestu
Cagliari
09042
Italy
+39 (0)706753120
mloi@amm.unica.it

Sponsor type

University/education

Website

https://www.unica.it/unica/it/dip_scienzemedsanpub.page

Funders

Funder type

University/education

Funder name

Università degli Studi di Cagliari

Alternative name(s)

University of Cagliari, UNICA

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

Italy

Results and Publications

Publication and dissemination plan

Peer-reviewed journals with special interest to spinal disorders. No additional documents are available.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from Marco Monticone (marco.monticone@unica.it) on reasonable request on publication and from that day on; no access criteria; all of the analyses; consent was obtained; no comments on data anonymisation; no ethical or legal restrictions; no other comments.

Intention to publish date

31/03/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/11/2019: Trial's existence confirmed by ethics committee.