Rehabilitation for humeral fractures in working ages
| ISRCTN | ISRCTN17996552 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17996552 |
| Secondary identifying numbers | 4/2012 |
- Submission date
- 27/10/2019
- Registration date
- 16/12/2019
- Last edited
- 22/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
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
Contact information
Scientific
Dept. Medical Sciences and Public Health - Faculty of Medicine
Cittadella Universitaria S.S. 554 Bivio Monserrato - Sestu
Cagliari
09042
Italy
 ORCID ID |
0000-0002-6526-888X |
|---|---|
| Phone | +39 (0)706753109 |
| marco.monticone@unica.it |
Study information
| Study design | Randomised parallel-group superiority-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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 |
| 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(s) | Approved 04/05/2012, Ethical Committee Salvatore Maugeri Foundation (Via Monsignor Ennio Bernasconi, 16, 20851 Lissone MB, Italy; +39 (0)39 4657277; no email provided), ref: 4 |
| 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 |
| 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 study start date | 01/05/2012 |
| Overall study end date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 70 |
| 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 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
- Lao People's Democratic Republic
Study participating centre
Lissone (Monza Brianza)
20851
Lao People's Democratic Republic
Sponsor information
University/education
Dept. Medical Science and Public Health - Faculty of Medicine
Cittadella Universitaria S.S. 554 Bivio Monserrato - Sestu
Cagliari
09042
Italy
| Phone | +39 (0)706753120 |
|---|---|
| mloi@amm.unica.it | |
| Website | https://www.unica.it/unica/it/dip_scienzemedsanpub.page |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Università degli Studi di Cagliari, Università di Cagliari, UNICA
- Location
- Italy
Results and Publications
| Intention to publish date | 31/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Peer-reviewed journals with special interest to spinal disorders. No additional documents are available. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 20/03/2021 | 22/03/2021 | Yes | No |
Editorial Notes
22/03/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
18/11/2019: Trial's existence confirmed by ethics committee.
