Does adding an oral cortisone pill to the regular treatment of patients with rib cage pain and swelling improve their pain and quality of life?
| ISRCTN | ISRCTN11877533 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11877533 |
- Submission date
- 18/04/2022
- Registration date
- 30/04/2022
- Last edited
- 29/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Tietze syndrome is a rare form of chest wall inflammation with joint swelling which can cause significant chest pain and a decline in the ability of daily activities. It can be easily confused with other serious diseases that affect the heart, lung and chest wall. It can be a frequent cause for visiting the emergency department or outpatient clinic. There is no standardized treatment protocol. The aim of this study was to assess the efficacy of adding oral steroids in addition to other non-steroidal treatment in the improvement of pain and quality of life in patients with Tietze syndrome.
Who can participate?
Patients aged 12 to 60 years old presenting with anterior or posterior chest wall swelling and/or palpable tenderness upon examination without any significant past medical history, or with history of recurrent chest infection or multiple minor chest trauma.
What does the study involve?
Participants will be randomly allocated to receive treatment as usual or an oral corticosteroid in addition to treatment as usual for 3 weeks. Follow up is for up to 12 months.
What are the possible benefits and risks of participating?
Benefits include improvement in pain and quality of life with the intervention
Risks include the adverse effects of oral corticosteroids which will be monitored by the study
Where is the study run from?
Thoracic surgery department, Ain Shams University (Egypt)
When is the study starting and how long is it expected to run for?
February 2020 to April 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof Hany Hassan Elsayed, hanyhassan77@hotmail.com
Contact information
Principal Investigator
15 9th area buildings
sheraton heliopolis
Cairo
c236667
Egypt
 ORCID ID |
0000-0002-7597-6070 |
|---|---|
| Phone | +20 1227373270 |
| Hany.hassan@med.asu.ed.eg |
Study information
| Study design | Single center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | The efficacy of oral corticosteroids for treatment of Tietze syndrome: a pragmatic randomized controlled trial |
| Study acronym | OCTA |
| Study hypothesis | Oral corticosteroids may provide an additional benefit for patients with Tietze syndrome |
| Ethics approval(s) | Approved 15/02/2020, Ain Shams University hospital ethical committee (Abbasia square, Cairo C237765, Egypt; no telephone number provided; Ethicalcommitee@ainshams.edu.eg), ref: 08/ASU01/47 |
| Condition | Teitze syndrome: costochondritis of the chest wall with joint swelling |
| Intervention | The intervention group will have oral corticosteroid therapy for a short period in addition to all conventional methods of treatment. The control group will have only the conventional treatment Total duration of treatment = 3 weeks Follow up period for the steroid arm 1-12 months, median 5.5 months Follow up period for the NSAID arm 1-12 months, median 7 months Median follow up period 6.5 months Randomisation process by sealed envelope |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | oral prednisolone |
| Primary outcome measure | 1. Pain measured using the NRS at 1, 2, 3 weeks and follow up period 2. Quality of life measured using the EURO 5Q-5D-5L score at 3 weeks |
| Secondary outcome measures | Size of joint swelling measured by patient interview at 3 weeks and 6 months after treatment. |
| Overall study start date | 15/02/2020 |
| Overall study end date | 01/04/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 40 |
| Participant inclusion criteria | Patients aged 12 to 60 years old presenting with anterior or posterior chest wall swelling and/or palpable tenderness upon examination without any significant past medical history, or with history of recurrent chest infection or multiple minor chest trauma. Ultrasound of the sternocostal swellings was required to exclude other pathologies but no specific ultrasound finding was required to confirm the clinical diagnosis. Two senior thoracic surgeons were required to establish the diagnosis. |
| Participant exclusion criteria | 1. Patients diagnosed with myositis, coronary syndrome, chest wall tumors or mediastinal syndrome as diagnosed by clinical examination, CT chest, MRI chest or chest ultrasound. 2. Traumatic muscle pain, arthritis of sternoclavicular/sternomanubrial joints and fibromyalgia of costochondral junction. 3. Refused to be enrolled in the study or did not complete the full assessment at all time intervals. |
| Recruitment start date | 01/08/2020 |
| Recruitment end date | 01/03/2022 |
Locations
Countries of recruitment
- Egypt
Study participating centre
Cairo
C234
Egypt
Sponsor information
Not defined
15 9th area buildings
Cairo
C237776
Egypt
| Phone | +20 1227373270 |
|---|---|
| projectscenter@ainshams.edu.eg | |
| Website | http://www.asu.edu.eg/ |
"ROR" |
https://ror.org/00cb9w016 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Data is available upon request from hanyhassan77@hotmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 28/11/2022 | 29/11/2022 | Yes | No |
Editorial Notes
29/11/2022: Publication reference added.
03/05/2022: Internal review.
28/04/2022: Trial's existence confirmed by Ain Shams University
