Ultrasound-guided steroid injection and rehabilitation exercises to ease shoulder pain in women who have undergone surgery for breast cancer
ISRCTN | ISRCTN10358568 |
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DOI | https://doi.org/10.1186/ISRCTN10358568 |
Secondary identifying numbers | 0005266 |
- Submission date
- 16/08/2022
- Registration date
- 04/10/2022
- Last edited
- 04/10/2022
- Recruitment status
- Recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Recent advances in cancer treatments significantly improved the overall survival of breast cancer (BC) patients. However, BC survivors might often be affected by several disabling cancer treatment adverse effects with crucial implications for physical function and quality of life.
In this scenario, shoulder pain called subacromial pain syndrome (SPS) is very common in BC survivors, causing significant pain and upper limb dysfunction. Several treatments have been proposed to improve pain in patients with SPS; however, there are still some controversies about the optimal therapeutic approach for BC survivors. Therefore, in this study we aim to assess the efficacy of ultrasound (US)-guided injections below the uppermost part of the shoulder blade, the subacromial bursa, followed by a personalized rehabilitation program for breast cancer (BC) survivors.
Who can participate?
Adult women with subacromial pain syndrome without tendon lesions and with a history of post-surgical non-metastatic BC
What does the study involve?
Our findings might provide evidence supporting the role of a multidisciplinary approach including US-guided corticosteroid injections combined with a personalized rehabilitation program in improving pain intensity and quality of life of BC survivors with sub-acromial pain syndrome. Some patients will join Group A and undergo interdisciplinary treatment including US-guided injections in the subacromial bursa including triamcinolone acetonide, a steroid, combined with lidocaine, a pain medication, followed by a supervised rehabilitation program. Other patients will join Group B and undergo only the US-guided injections in the subacromial bursa without any rehabilitative treatment.
What are the possible benefits and risks of participating?
The procedures assessed in this study are already used in common clinical practice, so no additional benefits and risks associated with participation have been identified.
Where is the study run from?
National Hospital S.S. Antonio and Biagio and Cesare Arrigo (Italy)
When is the study starting and how long is it expected to run for?
April 2021 to April 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Lorenzo Lippi
lorenzolippi.mt@gmail.com
Contact information
Principal Investigator
Via Venezia, 16
Alessandria
15121
Italy
Phone | +39 3485908877 |
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lorenzolippi.mt@gmail.com |
Principal Investigator
Via Venezia, 16
Alessandria
15121
Italy
0000-0001-9035-1485 | |
Phone | +39 3485908877 |
lorenzo.lippi@esterni.ospedale.al.it |
Study information
Study design | Pilot randomized controlled study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | 42239 PIS V1 8Feb2022.pdf |
Scientific title | Efficacy of ultrasound-guided corticosteroid injection combined with personalized rehabilitation in breast cancer women with subacromial pain syndrome: A pilot randomized clinical study |
Study objectives | Rehabilitation exercise combined with ultrasound-guided corticosteroids injection might provide additional benefits in pain relief and upper limb function for breast cancer patients with subacromial pain syndrome |
Ethics approval(s) | Approved 07/03/2022, Local Ethics Committee (Comitato Etico Interaziendale A.O. “SS. Antonio e Biagio e Cesare Arrigo” di Alessandria, Via Santa Caterina da Siena n° 30, 15121 Alessandria, Italy; +39 0131/206974-6627-6764; ecomitato@ospedale.al.it), ref: ASO.RRF.22.01 |
Health condition(s) or problem(s) studied | Subacromial pain syndrome without tendon lesions following surgery for breast cancer |
Intervention | Enrolled participants will be randomly assigned by a computer-generated randomization process with a 1:1 allocation without blocks. Participants randomized to Group A will undergo an interdisciplinary treatment including ultrasound (US)-guided percutaneous injections in the subacromial bursa (1 ml of 40 mg triamcinolone acetonide combined with 3 ml of 1% lidocaine), followed by a supervised rehabilitation program, including passive and active mobilization exercises, stretching exercises and myofascial release techniques followed by active extra- and intra-rotation exercises with elastic bands, exercises for the scapular stabilizing muscles and proprioceptive exercises. On the contrary, Group B will undergo only US-guided percutaneous injections in the subacromial bursa without any rehabilitative treatment. |
Intervention type | Mixed |
Primary outcome measure | Pain measured using the Numerical Pain Rating Scale at baseline (T0), after 1 week (T1), and after three months of follow-up (T2) |
Secondary outcome measures | 1. Isometric muscle strength measured using the Hand Grip Strength test (HGS) (Jamar hydraulic hand dynamometer Sammons Preston, Rolyon, Bolingbrook, IL, USA) at baseline (T0), after 1 week (T1), and after three months of follow-up (T2) 2. Shoulder function measured using the Oxford Shoulder Score (OSS) at baseline (T0), after 1 week (T1), and after three months of follow-up (T2) 3. Quality of Life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ - C30) at baseline (T0), after 1 week (T1), and after three months of follow-up (T2) 4. Patient satisfaction measured using the Global Perceived Effect (GPE) scale, after 1 week (T1), and after three months of follow-up (T2) 5. Safety measured using registering minor and major adverse events during the study period |
Overall study start date | 01/04/2021 |
Completion date | 01/04/2023 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | 20 patients (10 for each treatment arm) |
Key inclusion criteria | 1. Aged 18 years old and over 2. Female gender 3. Surgery for breast cancer 4. Subacromial pain syndrome 5. Numerical Pain Rating Scale (NPRS) > 5 6. Signed informed consent |
Key exclusion criteria | 1. Allergies to triamcinolone or lidocaine 2. Severe thrombocytopenia (<10,000plt) or bleeding disorders 3. Chemotherapy or radiotherapy in progress 4. Metastatic disease 5. Shoulder tendon lesions 6. Cognitive impairment or psychiatric disorders 7. Pregnancy or breastfeeding |
Date of first enrolment | 10/03/2022 |
Date of final enrolment | 01/04/2323 |
Locations
Countries of recruitment
- Italy
Study participating centre
Alessandria
15121
Italy
Sponsor information
Hospital/treatment centre
Via Venezia, 16
Alessandria
15121
Italy
Phone | +39 (0)131 206111 |
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info@ospedale.al.it | |
Website | http://www.ospedale.al.it/ |
https://ror.org/04yxyzj48 |
Funders
Funder type
Other
No information available
Results and Publications
Intention to publish date | 30/04/2024 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | The responsible for the dissemination strategy and the communication will be the supervisor of this cornerstone topic and will provide solutions for eventual issues and delay in information diffusion and circulation, defining a precise schedule for the dissemination of the study results. The dissemination will be guided by the sharing, transparency, and transferability of the results obtained and will contribute to the final goal of this project which is the transferability of the proposed intervention: this approach is the most suitable for achieving the project’s objectives. The key strategy of this proposal will be the widest possible spread of our results. This will be obtained through the largest involvement of the public with particular emphasis on diversification of interlocutors and transparency in order to help in improving knowledge in physicians, healthcare operators, patients, and caregivers. A strong involvement of the breast cancer associations, cancer patients, institutions, media and stakeholders will be performed to create and sustain a close communication of the new insights progressively provided by this project. The final step of this process will culminate in the involvement of the institutions in the communication of the results through local, national and European media and their involvement in the discussion of implementation of the results in the routine cancer patients care. |
IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Lorenzo Lippi, lorenzolippi.mt@gmail.com. Data are stored as an XLS database and will be available after the end of the study after appropriate request, for any type of analysis. All personal data will be processed in accordance with the General Regulation on the protection of personal data EU 2016/679 and Italian Legislative Decree 196/2003. Privacy will be guaranteed for any study participants. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Participant information sheet | version 1 | 08/02/2022 | 19/08/2022 | No | Yes |
Protocol file | version 1 | 08/02/2022 | 19/08/2022 | No | No |
Additional files
Editorial Notes
19/08/2022: Trial's existence confirmed by Intercompany Ethics Committee A.O. "SS. Antonio and Biagio and Cesare Arrigo" of Alessandria (Comitato Etico Interaziendale A.O. “SS. Antonio e Biagio e Cesare Arrigo” di Alessandria).