Ultrasound-guided steroid injection and rehabilitation exercises to ease shoulder pain in women who have undergone surgery for breast cancer

ISRCTN ISRCTN10358568
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Lorenzo Lippi
Principal Investigator

Via Venezia, 16
Alessandria
15121
Italy

Phone +39 3485908877
Email lorenzolippi.mt@gmail.com
Dr Lorenzo Lippi
Principal Investigator

Via Venezia, 16
Alessandria
15121
Italy

ORCiD logoORCID ID 0000-0001-9035-1485
Phone +39 3485908877
Email lorenzo.lippi@esterni.ospedale.al.it

Study information

Study designPilot randomized controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet 42239 PIS V1 8Feb2022.pdf
Scientific titleEfficacy of ultrasound-guided corticosteroid injection combined with personalized rehabilitation in breast cancer women with subacromial pain syndrome: A pilot randomized clinical study
Study objectivesRehabilitation 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) studiedSubacromial pain syndrome without tendon lesions following surgery for breast cancer
InterventionEnrolled 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 typeMixed
Primary outcome measurePain measured using the Numerical Pain Rating Scale at baseline (T0), after 1 week (T1), and after three months of follow-up (T2)
Secondary outcome measures1. 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 date01/04/2021
Completion date01/04/2023

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants20 patients (10 for each treatment arm)
Key inclusion criteria1. 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 criteria1. 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 enrolment10/03/2022
Date of final enrolment01/04/2323

Locations

Countries of recruitment

  • Italy

Study participating centre

National Hospital S.S. Antonio and Biagio and Cesare Arrigo
Via Venezia, 16
Alessandria
15121
Italy

Sponsor information

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
Hospital/treatment centre

Via Venezia, 16
Alessandria
15121
Italy

Phone +39 (0)131 206111
Email info@ospedale.al.it
Website http://www.ospedale.al.it/
ROR logo "ROR" https://ror.org/04yxyzj48

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date30/04/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe 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 planThe 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?
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

42239 protocol v1 08Feb2022.pdf
42239 PIS V1 8Feb2022.pdf

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).