Adhesive CapsulitisNCT04724317
Ultrasound Guided Shoulder Intra-Articular Ozone Injection Versus Pulsed Radiofrequency Application for Shoulder Adhesive Capsulitis
A study testing Steroid Group, Ozone Group and PRF Group in people with Adhesive Capsulitis and Shoulder Pain, run by Ahmed Foula at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the efficacy of the ultrasound guided shoulder intra-articular Ozone injection versus pulsed radiofrequency application in patients with shoulder adhesive capsulitis. Primary Outcome : Pain score using visual analogue scale during rest (VASr) and movement (VASm). Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Adhesive Capsulitis, Shoulder Pain
- What is being tested?
- Steroid Group, Ozone Group and PRF Group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2021to 10 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 30 to 65 years
- Either gender
- Diagnosed with Adhesive Capsulitis
- Inadequate response for conservative therapy (NSAIDs and physiotherapy) for four weeks
Who cannot join
- Patients diagnosed with central post-stroke neuropathic pain
- Patients with documented rheumatoid arthritis
- Patients with current shoulder fracture or trauma
- Known causes for secondary adhesive capsulitis (e.g., diabetes)
- Patients with local tumor at shoulder region
- Patients with local skin infection over shoulder region
- Patients with reported coagulopathy
- Patients with allergy to LA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Shoulder Intra-Articular Ozone Injection Versus Pulsed Radiofrequency Application for Shoulder Adhesive Capsulitis - A Randomized Controlled Clinical Study
The aim of this study is to evaluate the efficacy of the ultrasound guided shoulder intra-articular Ozone injection versus pulsed radiofrequency application in patients with shoulder adhesive capsulitis.
- Primary Outcome :
- Pain score using visual analogue scale during rest (VASr) and movement (VASm).
- Secondary Outcome :
- Quality of life using Shoulder Pain and Disability Index (SPADI). It assesses the overall functionality of the shoulder joint.
- Levels of serum ICAM -1, and serum high sensitive C-reactive protein (hs-CRP) are compared before and after treatment intervention.
Read the detailed description
After approval of the local ethical committee of Medical Research Institute - Alexandria University (IORG0008812), an informed written consent will be taken from all patients participating in the study. The study will be carried out on 45 adult patients (15 per group) of either gender, aged from 30 to 65 years. Eligible patients are those who were diagnosed with primary shoulder adhesive capsulitis according to the previously mentioned diagnostic criteria, with history of inadequate response to a trial of conservative therapy (NSAIDs and physiotherapy) for at least four weeks.
Patients will be assigned into three equal groups using computerized random blocks method:
- Steroid Group (S): [15 patients] Control group treated with intra-articular injection of 5 ml of Bupivacaine 0.125% added to triamcinolone 40 mg under the ultrasound guidance.
- Ozone Group (O3): [15 patients] Patients will be treated with intra-articular injection of 5 ml of Bupivacaine 0.125% followed by injection of 10 ml of Oxygen-Ozone mixture (15 μg/ml) under the ultrasound guidance.
- Pulsed radiofrequency Group (PRF): [15 patients] Patients will be treated with shoulder intra-articular injection of 5 ml of Bupivacaine 0.125% followed by pulsed radiofrequency application under the ultrasound guidance.
Patients' Evaluation and Preparation:
Patients' preparation starts with pre-intervention evaluation visit. Proper history taking and clinical examination will be carried out. Documentation of the range of motion and VAS score will be done after proper explanation. Patients will be asked to fill a SPADI score form.
Laboratory investigations will include complete blood count (CBC), prothrombin time (PT), and international normalized ratio (INR).
Baseline serum ICAM-1 level and hs-CRP level will be measured using 5 ml of patient's venous blood.
Patients will be asked to sign a consent form to participate in the study. Participants will be admitted to pain management ward. Random assignment will be carried out using computerized random blocks with variable block size.
All interventions will be carried out in the operating theatre (OR) for proper monitoring and sterilization procedures. A 20 G intravenous (IV) cannula will be inserted for all patients in the OR. Basic monitoring will be applied; continuous electrocardiogram (ECG) monitoring, arterial Oxygen saturation (SPO2) monitoring, and non-invasive blood pressure (NIBP) monitoring.
Intervention Methodology:
- Group S: Patients will be put in lateral semi-prone position with the affected shoulder facing up. Shoulder space will be opened by arm internal rotation and adduction across the chest. Under sterile conditions and proper draping of the affected shoulder, scanning will start using Sonosite® M- turbo™ ultrasound machine. A high frequency linear probe (7-14 MHz) will be put parallel and just inferior to spine of the scapula. Identification of humeral head, joint capsule, labrum, glenoid, and infraspinatus and deltoid muscles should be available in one image to avoid wrong needle positioning. The in-plane posterior approach for intra-articular injection will be used (Furman et al., 2017). Needle insertion (22 Gauge, 5 cm length) approach from inferomedial to superolateral direction towards the humeral head. The targeted needle path should avoid labrum puncture. The end point for injection is subcapsular and adjacent to the labrum. After confirmation of proper needle position, 5 ml of Bupivacaine 0.125% will be injected added to triamcinolone 40 mg (Babaei-Ghazani et al., 2019).
- Group O3: Under the previously described position and scanning technique, intra-articular injection of 5 ml of Bupivacaine 0.125% followed by 10 ml of Oxygen-Ozone mixture (15 μg/ml) will be done (Noori-Zadeh et al., 2019).
- Group PRF:
Under the previously described position and scanning technique, 5 ml of Bupivacaine 0.125% will be directly injected. Following, Intra-articular PRF will be applied with a 10 cm neurotherm needle with 10 mm active tip for 4 minutes to the glenohumeral joint (Ozyuvaci et al., 2011).
Post-Procedure Assessment:
All participants will be treated as day-case patients and will be observed in the recovery ward for 2 h after therapy. VAS, shoulder joint ROM, and any complication (e.g., hematoma formation, vasovagal attack, etc.) will be recorded before discharge.
Follow-up visits will be planned for all participants at week 1, 2, 4, 8 post-intervention. During these visits, reassessment will be done for VASr, VASm, SPADI score, and ROM.
- Pain score Using visual analogue scale during rest (VASr) and movement (VASm), pain will be categorized as mild (0-3), moderate (4-6), or severe (7-10). Improved pain score is considered significant when there is a categorical improvement in pain level.
- Quality of life Using Shoulder Pain and Disability Index (SPADI), improvement in quality of life is considered significant when there is 10% reduction in the final index.
During the last follow-up visit, samples for serum ICAM-1 and highly sensitive CRP levels will be obtained.
Statistical Analysis:
Data will be analyzed using descriptive statistical methods as well as comparison of the qualitative and quantitative data. Presentation will be carried out in the form of proper tables and graphical presentation.
- Conditions
- Adhesive Capsulitis, Shoulder Pain
- Being tested
- Steroid Group, Ozone Group, PRF Group
- Keywords
- adhesive capsulitis, soulder pain, triamcinolone, ozone, pulsed radiofrequency
- Medical subject headings
- Bursitis, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid GroupProcedure or surgery
Ultrasound guided shoulder intra-articular steroid injection
Ozone GroupProcedure or surgery
Ultrasound guided shoulder intra-articular Ozone injection
PRF GroupProcedure or surgery
Ultrasound guided shoulder intra-articular pulsed radiofrequency application
| Study group | Role | What they receive |
|---|---|---|
| Steroid Group | Sham comparator | shoulder intra-articular injection of 5 ml of Bupivacaine 0.125% added to triamcinolone 40 mg under the ultrasound guidance Receives: Procedure: Steroid Group |
| Ozone Group | Active comparator | shoulder intra-articular injection of 5 ml of Bupivacaine 0.125% followed by injection of 10 ml of Oxygen-Ozone mixture (15 µg/ml) under the ultrasound guidance Receives: Procedure: Ozone Group |
| PRF Group | Active comparator | shoulder intra-articular injection of 5 ml of Bupivacaine 0.125% followed by pulsed radiofrequency application under the ultrasound guidance Receives: Procedure: PRF Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score, using Visual Analogue Scale (VAS)
Visual analogue scale during rest (VASr) and movement (VASm), pain will be categorized as mild (0-3), moderate (4-6), or severe (7-10). Change in pain score is considered significant when there is a categorical shift in pain level.
Measured: Initial assessment visit + Immediate post-intervention + Follow-up visits will be planned at week 1, 2, 4, 8 post-intervention.
Secondary outcomes (3)
QOL improvement, using Shoulder Pain And Disability Index (SPADI)
Assesses the overall functionality of the shoulder joint. Using SPADI score, change in QOL is considered significant when there is 10% change in the final index.
Measured: Initial assessment visit + Immediate post-intervention + Follow-up visits will be planned at week 1, 2, 4, 8 post-intervention.
Systemic inflammatory markers, using serum Intracellular Adhesion Molecule (ICAM 1) level.
Levels of serum ICAM -1 are compared before intervention and at the end of follow-up period.
Measured: Immediate pre-intervention (baseline) + 8 weeks post-intervention (last follow-up visit).
Systemic inflammatory markers, using serum High Sensitive C Reactive Protein (hs-CRP) level.
Levels of serum high sensitive C Reactive Protein (hs-CRP) are compared before intervention and at the end of follow-up period.
Measured: Immediate pre-intervention (baseline) + 8 weeks post-intervention (last follow-up visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start5 Jan 2021
- Primary completion10 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Foula
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Foula, Alexandria University
- Investigators
- Laila S. Sabry, MD, Study director, Department of Anaesthesia and Pain Medicine - Medical Research Institute - Alexandria UniversityAhmed F. Elmulla, MD, Study director, Department of Anaesthesia and Pain Medicine - Medical Research Institute - Alexandria UniversityMaher A. Kamel, MD, Study director, Department of Biochemistry - Medical Research Institute - Alexandria UniversityAdel I. Hozein, MD, Study director, Department of Anaesthesia and Pain Medicine - Medical Research Institute - Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724317
- Sponsor's protocol ID
- 1216-4-010
- Status last verified
- Jul 2022
- First submitted
- 16 Jan 2021
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected can be shared with other researchers in other studies as decided by the main investigator. Personal data will never be shared.
Publications
Angst F, Schwyzer HK, Aeschlimann A, Simmen BR, Goldhahn J. Measures of adult shoulder function: Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) and its short version (QuickDASH), Shoulder Pain and Disability Index (SPADI), American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form, Constant (Murley) Score (CS), Simple Shoulder Test (SST), Oxford Shoulder Score (OSS), Shoulder Disability Questionnaire (SDQ), and Western Ontario Shoulder Instability Index (WOSI). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S174-88. doi: 10.1002/acr.20630. No abstract available.
PubMed 22588743Babaei-Ghazani A, Fadavi HR, Eftekharsadat B, Ebadi S, Ahadi T, Ghazaei F, Khabbaz MS. A Randomized Control Trial of Comparing Ultrasound-Guided Ozone (O2-O3) vs Corticosteroid Injection in Patients With Shoulder Impingement. Am J Phys Med Rehabil. 2019 Nov;98(11):1018-1025. doi: 10.1097/PHM.0000000000001240.
PubMed 31188145Bak K, Isaksson F. [Frozen shoulder]. Ugeskr Laeger. 2019 Feb 11;181(7):V03180207. Danish.
PubMed 30777592Basta M, Sanganeria T, Varacallo MA. Anatomy, Shoulder and Upper Limb, Suprascapular Nerve. 2022 Oct 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557880/
PubMed 32491803Binder AI, Bulgen DY, Hazleman BL, Roberts S. Frozen shoulder: a long-term prospective study. Ann Rheum Dis. 1984 Jun;43(3):361-4. doi: 10.1136/ard.43.3.361.
PubMed 6742896Chang LR, Anand P, Varacallo MA. Anatomy, Shoulder and Upper Limb, Glenohumeral Joint. 2025 Mar 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537018/
PubMed 30725703Franz A, Klose M, Beitzel K. [Conservative treatment of frozen shoulder]. Unfallchirurg. 2019 Dec;122(12):934-940. doi: 10.1007/s00113-019-00731-3. German.
PubMed 31650192Kim YS, Kim JM, Lee YG, Hong OK, Kwon HS, Ji JH. Intercellular adhesion molecule-1 (ICAM-1, CD54) is increased in adhesive capsulitis. J Bone Joint Surg Am. 2013 Feb 20;95(4):e181-8. doi: 10.2106/JBJS.K.00525.
PubMed 23426775Lipov EG, Navaie M, Rothfeld C, Kelzenberg B, Sharghi LH, Solomon DJ, Provencher MT. Use of intra-articular and intrabursal pulsed radiofrequency for the treatment of persistent arthrogenic shoulder pain. Pain Med. 2013 Apr;14(4):554-6. doi: 10.1111/pme.12073. Epub 2013 Mar 14. No abstract available.
PubMed 23489372Neviaser AS, Neviaser RJ. Adhesive capsulitis of the shoulder. J Am Acad Orthop Surg. 2011 Sep;19(9):536-42. doi: 10.5435/00124635-201109000-00004.
PubMed 21885699Noori-Zadeh A, Bakhtiyari S, Khooz R, Haghani K, Darabi S. Intra-articular ozone therapy efficiently attenuates pain in knee osteoarthritic subjects: A systematic review and meta-analysis. Complement Ther Med. 2019 Feb;42:240-247. doi: 10.1016/j.ctim.2018.11.023. Epub 2018 Nov 28.
PubMed 30670248Ozyuvaci E, Akyol O, Acikgoz A, Leblebici H. Intraarticular pulsed mode radiofrequency lesioning of glenohumeral joint in chronic shoulder pain: 3 cases. Korean J Pain. 2011 Dec;24(4):239-41. doi: 10.3344/kjp.2011.24.4.239. Epub 2011 Nov 30. No abstract available.
PubMed 22220248Su YD, Lee TC, Lin YC, Chen SK. Arthroscopic release for frozen shoulder: Does the timing of intervention and diabetes affect outcome? PLoS One. 2019 Nov 11;14(11):e0224986. doi: 10.1371/journal.pone.0224986. eCollection 2019.
PubMed 31710642Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.
PubMed 18467932Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.
PubMed 24049221
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Shoulder Intra-Articular Ozone Injection Versus Pulsed Radiofrequency Application for Shoulder Adhesive Capsulitis - A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04724317
- Acronym / sponsor ID
- 1216-4-010
- Conditions
- Adhesive Capsulitis, Shoulder Pain
- Keywords
- adhesive capsulitis, soulder pain, triamcinolone, ozone, pulsed radiofrequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ahmed FoulaUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the efficacy of the ultrasound guided shoulder intra-articular Ozone injection versus pulsed radiofrequency application in patients with shoulder adhesive capsulitis.
- Primary Outcome :
- Pain score using visual analogue scale during rest (VASr) and movement (VASm).
- Secondary Outcome :
- Quality of life using Shoulder Pain and Disability Index (SPADI). It assesses the overall functionality of the shoulder joint.
- Levels of serum ICAM -1, and serum high sensitive C-reactive protein (hs-CRP) are compared before and after treatment intervention.
Detailed description
After approval of the local ethical committee of Medical Research Institute - Alexandria University (IORG0008812), an informed written consent will be taken from all patients participating in the study. The study will be carried out on 45 adult patients (15 per group) of either gender, aged from 30 to 65 years. Eligible patients are those who were diagnosed with primary shoulder adhesive capsulitis according to the previously mentioned diagnostic criteria, with history of inadequate response to a trial of conservative therapy (NSAIDs and physiotherapy) for at least four weeks.
Patients will be assigned into three equal groups using computerized random blocks method:
- Steroid Group (S): [15 patients] Control group treated with intra-articular injection of 5 ml of Bupivacaine 0.125% added to triamcinolone 40 mg under the ultrasound guidance.
- Ozone Group (O3): [15 patients] Patients will be treated with intra-articular injection of 5 ml of Bupivacaine 0.125% followed by injection of 10 ml of Oxygen-Ozone mixture (15 μg/ml) under the ultrasound guidance.
- Pulsed radiofrequency Group (PRF): [15 patients] Patients will be treated with shoulder intra-articular injection of 5 ml of Bupivacaine 0.125% followed by pulsed radiofrequency application under the ultrasound guidance.
Patients' Evaluation and Preparation:
Patients' preparation starts with pre-intervention evaluation visit. Proper history taking and clinical examination will be carried out. Documentation of the range of motion and VAS score will be done after proper explanation. Patients will be asked to fill a SPADI score form.
Laboratory investigations will include complete blood count (CBC), prothrombin time (PT), and international normalized ratio (INR).
Baseline serum ICAM-1 level and hs-CRP level will be measured using 5 ml of patient's venous blood.
Patients will be asked to sign a consent form to participate in the study. Participants will be admitted to pain management ward. Random assignment will be carried out using computerized random blocks with variable block size.
All interventions will be carried out in the operating theatre (OR) for proper monitoring and sterilization procedures. A 20 G intravenous (IV) cannula will be inserted for all patients in the OR. Basic monitoring will be applied; continuous electrocardiogram (ECG) monitoring, arterial Oxygen saturation (SPO2) monitoring, and non-invasive blood pressure (NIBP) monitoring.
Intervention Methodology:
- Group S: Patients will be put in lateral semi-prone position with the affected shoulder facing up. Shoulder space will be opened by arm internal rotation and adduction across the chest. Under sterile conditions and proper draping of the affected shoulder, scanning will start using Sonosite® M- turbo™ ultrasound machine. A high frequency linear probe (7-14 MHz) will be put parallel and just inferior to spine of the scapula. Identification of humeral head, joint capsule, labrum, glenoid, and infraspinatus and deltoid muscles should be available in one image to avoid wrong needle positioning. The in-plane posterior approach for intra-articular injection will be used (Furman et al., 2017). Needle insertion (22 Gauge, 5 cm length) approach from inferomedial to superolateral direction towards the humeral head. The targeted needle path should avoid labrum puncture. The end point for injection is subcapsular and adjacent to the labrum. After confirmation of proper needle position, 5 ml of Bupivacaine 0.125% will be injected added to triamcinolone 40 mg (Babaei-Ghazani et al., 2019).
- Group O3: Under the previously described position and scanning technique, intra-articular injection of 5 ml of Bupivacaine 0.125% followed by 10 ml of Oxygen-Ozone mixture (15 μg/ml) will be done (Noori-Zadeh et al., 2019).
- Group PRF:
Under the previously described position and scanning technique, 5 ml of Bupivacaine 0.125% will be directly injected. Following, Intra-articular PRF will be applied with a 10 cm neurotherm needle with 10 mm active tip for 4 minutes to the glenohumeral joint (Ozyuvaci et al., 2011).
Post-Procedure Assessment:
All participants will be treated as day-case patients and will be observed in the recovery ward for 2 h after therapy. VAS, shoulder joint ROM, and any complication (e.g., hematoma formation, vasovagal attack, etc.) will be recorded before discharge.
Follow-up visits will be planned for all participants at week 1, 2, 4, 8 post-intervention. During these visits, reassessment will be done for VASr, VASm, SPADI score, and ROM.
- Pain score Using visual analogue scale during rest (VASr) and movement (VASm), pain will be categorized as mild (0-3), moderate (4-6), or severe (7-10). Improved pain score is considered significant when there is a categorical improvement in pain level.
- Quality of life Using Shoulder Pain and Disability Index (SPADI), improvement in quality of life is considered significant when there is 10% reduction in the final index.
During the last follow-up visit, samples for serum ICAM-1 and highly sensitive CRP levels will be obtained.
Statistical Analysis:
Data will be analyzed using descriptive statistical methods as well as comparison of the qualitative and quantitative data. Presentation will be carried out in the form of proper tables and graphical presentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Steroid Group | Sham comparator | Procedure: Steroid Groupshoulder intra-articular injection of 5 ml of Bupivacaine 0.125% added to triamcinolone 40 mg under the ultrasound guidance |
| Ozone Group | Active comparator | Procedure: Ozone Groupshoulder intra-articular injection of 5 ml of Bupivacaine 0.125% followed by injection of 10 ml of Oxygen-Ozone mixture (15 µg/ml) under the ultrasound guidance |
| PRF Group | Active comparator | Procedure: PRF Groupshoulder intra-articular injection of 5 ml of Bupivacaine 0.125% followed by pulsed radiofrequency application under the ultrasound guidance |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged from 30 to 65 years
- Either gender
- Diagnosed with Adhesive Capsulitis
- Inadequate response for conservative therapy (NSAIDs and physiotherapy) for four weeks
Key exclusion criteria (8 listed)
- Patients diagnosed with central post-stroke neuropathic pain
- Patients with documented rheumatoid arthritis
- Patients with current shoulder fracture or trauma
- Known causes for secondary adhesive capsulitis (e.g., diabetes)
- Patients with local tumor at shoulder region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steroid GroupUltrasound guided shoulder intra-articular steroid injection | Procedure or surgery | Steroid Group |
| Ozone GroupUltrasound guided shoulder intra-articular Ozone injection | Procedure or surgery | Ozone Group |
| PRF GroupUltrasound guided shoulder intra-articular pulsed radiofrequency application | Procedure or surgery | PRF Group |
Primary outcome
Pain score, using Visual Analogue Scale (VAS)
Time frame: Initial assessment visit + Immediate post-intervention + Follow-up visits will be planned at week 1, 2, 4, 8 post-intervention.
Visual analogue scale during rest (VASr) and movement (VASm), pain will be categorized as mild (0-3), moderate (4-6), or severe (7-10). Change in pain score is considered significant when there is a categorical shift in pain level.
3 secondary outcomes
QOL improvement, using Shoulder Pain And Disability Index (SPADI)
Time frame: Initial assessment visit + Immediate post-intervention + Follow-up visits will be planned at week 1, 2, 4, 8 post-intervention.
Systemic inflammatory markers, using serum Intracellular Adhesion Molecule (ICAM 1) level.
Time frame: Immediate pre-intervention (baseline) + 8 weeks post-intervention (last follow-up visit).
Systemic inflammatory markers, using serum High Sensitive C Reactive Protein (hs-CRP) level.
Time frame: Immediate pre-intervention (baseline) + 8 weeks post-intervention (last follow-up visit).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Background: PubMed 22588743Angst F, Schwyzer HK, Aeschlimann A, Simmen BR, Goldhahn J. Measures of adult shoulder function: Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) and its short version (QuickDASH), Shoulder Pain and Disability Index (SPADI), American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form, Constant (Murley) Score (CS), Simple Shoulder Test (SST), Oxford Shoulder Score (OSS), Shoulder Disability Questionnaire (SDQ), and Western Ontario Shoulder Instability Index (WOSI). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S174-88. doi: 10.1002/acr.20630. No abstract available.
- Background: PubMed 31188145Babaei-Ghazani A, Fadavi HR, Eftekharsadat B, Ebadi S, Ahadi T, Ghazaei F, Khabbaz MS. A Randomized Control Trial of Comparing Ultrasound-Guided Ozone (O2-O3) vs Corticosteroid Injection in Patients With Shoulder Impingement. Am J Phys Med Rehabil. 2019 Nov;98(11):1018-1025. doi: 10.1097/PHM.0000000000001240.
- Background: PubMed 30777592Bak K, Isaksson F. [Frozen shoulder]. Ugeskr Laeger. 2019 Feb 11;181(7):V03180207. Danish.
- Background: PubMed 32491803Basta M, Sanganeria T, Varacallo MA. Anatomy, Shoulder and Upper Limb, Suprascapular Nerve. 2022 Oct 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557880/
- Background: PubMed 6742896Binder AI, Bulgen DY, Hazleman BL, Roberts S. Frozen shoulder: a long-term prospective study. Ann Rheum Dis. 1984 Jun;43(3):361-4. doi: 10.1136/ard.43.3.361.
- Background: PubMed 30725703Chang LR, Anand P, Varacallo MA. Anatomy, Shoulder and Upper Limb, Glenohumeral Joint. 2025 Mar 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537018/
- Background: PubMed 31650192Franz A, Klose M, Beitzel K. [Conservative treatment of frozen shoulder]. Unfallchirurg. 2019 Dec;122(12):934-940. doi: 10.1007/s00113-019-00731-3. German.
- Background: PubMed 23426775Kim YS, Kim JM, Lee YG, Hong OK, Kwon HS, Ji JH. Intercellular adhesion molecule-1 (ICAM-1, CD54) is increased in adhesive capsulitis. J Bone Joint Surg Am. 2013 Feb 20;95(4):e181-8. doi: 10.2106/JBJS.K.00525.
- Background: PubMed 23489372Lipov EG, Navaie M, Rothfeld C, Kelzenberg B, Sharghi LH, Solomon DJ, Provencher MT. Use of intra-articular and intrabursal pulsed radiofrequency for the treatment of persistent arthrogenic shoulder pain. Pain Med. 2013 Apr;14(4):554-6. doi: 10.1111/pme.12073. Epub 2013 Mar 14. No abstract available.
- Background: PubMed 21885699Neviaser AS, Neviaser RJ. Adhesive capsulitis of the shoulder. J Am Acad Orthop Surg. 2011 Sep;19(9):536-42. doi: 10.5435/00124635-201109000-00004.
- Background: PubMed 30670248Noori-Zadeh A, Bakhtiyari S, Khooz R, Haghani K, Darabi S. Intra-articular ozone therapy efficiently attenuates pain in knee osteoarthritic subjects: A systematic review and meta-analysis. Complement Ther Med. 2019 Feb;42:240-247. doi: 10.1016/j.ctim.2018.11.023. Epub 2018 Nov 28.
- Background: PubMed 22220248Ozyuvaci E, Akyol O, Acikgoz A, Leblebici H. Intraarticular pulsed mode radiofrequency lesioning of glenohumeral joint in chronic shoulder pain: 3 cases. Korean J Pain. 2011 Dec;24(4):239-41. doi: 10.3344/kjp.2011.24.4.239. Epub 2011 Nov 30. No abstract available.
- Atlas of Image-Guided Spinal Procedures E-BookLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD collected can be shared with other researchers in other studies as decided by the main investigator. Personal data will never be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laila S. Sabry, MD study director
Department of Anaesthesia and Pain Medicine - Medical Research Institute - Alexandria University
Ahmed F. Elmulla, MD study director
Department of Anaesthesia and Pain Medicine - Medical Research Institute - Alexandria University
Maher A. Kamel, MD study director
Department of Biochemistry - Medical Research Institute - Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steroid Group, Ozone Group and PRF Group in people with Adhesive Capsulitis and Shoulder Pain, run by Ahmed Foula at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score, using Visual Analogue Scale (VAS) (time frame: Initial assessment visit + Immediate post-intervention + Follow-up visits will be planned at week 1, 2, 4, 8 post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04724317, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.