Adhesive CapsulitisPhase 4DOXYNCT03479502
Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis
A Phase 4 study testing Methylprednisolone Injectable Product and Doxycycline Injection in people with Adhesive Capsulitis and Adhesive Capsulitis of Unspecified Shoulder, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
We will recruit a total of 40 patients from the Vanderbilt Sports Medicine Clinics who have been diagnosed with adhesive capsulitis and have not undergone any previous treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adhesive Capsulitis, Adhesive Capsulitis of Unspecified Shoulder, Frozen Shoulder
- What is being tested?
- Methylprednisolone Injectable Product and Doxycycline Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2018to 8 Feb 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older,
- diagnosis of stage II adhesive capsulitis as determined by clinical examination of the treating physician, and
- absence of abnormal findings on X-ray.
Who cannot join
- allergy to Doxycycline or Methylprednisolone,
- pregnancy,
- diagnosis,
- Inflammatory arthritis or diabetes,
- secondary adhesive capsulitis (history of significant trauma, rotator cuff tear injury, stroke)
- evidence of arthritis on x-ray,
- current infectious disease, and
- any previous treatment for the for adhesive capsulitis of the affected shoulder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Medical Center
Nashville, Tennessee, 37232
About this study
We will recruit a total of 40 patients from the Vanderbilt Sports Medicine Clinics who have been diagnosed with adhesive capsulitis and have not undergone any previous treatment. The 40 patients will be randomized, with 20 in the control group of 3 intra-articular injections of 40mg Methylprednisolone spaced every two weeks, and 20 in the experimental group of 3 intra-articular injection of 50mg doxycycline spaced every two weeks. Both groups will begin a standardized physical therapy program within a pain-free range of motion 4 weeks after the initiation of treatment. We will prospectively follow patients for one year, with follow-up at 6 weeks, 12 weeks, 6 months, and 12 months after the initiation of treatment.
Outcomes will be measured using the American Shoulder and Elbow Score (ASES) and objective measurements of shoulder range of motion, which will be collected by the treating physician. Both the patients and physicians participating in the study will be blinded.
Read the detailed description
Adhesive capsulitis, also known as frozen shoulder, is a common condition of the shoulder joint affecting 2-5% of the adult population and characterized by progressive, painful loss of both passive and active range of motion of shoulder [1,2]. Individuals affected by this condition find it increasingly difficult to perform activities of daily living that require overhead movement or rotation of the affected shoulder. The natural history of frozen shoulder follows a predictable progression of symptoms, lasting from 9-24 months before complete resolution, and results in significant loss of productivity and quality of life for those affected [3]. Despite the significant number of patients affected by adhesive capsulitis and the extensive literature focused on the progression and natural history of the condition, the true underlying etiology remains poorly understood. In light of this poor understanding of the condition, it is not surprising that a number of conservative and invasive modalities exist as accepted treatments. These include non-steroidal anti-inflammatory drugs (NSAIDS), oral steroids, intra-articular steroid injections, Physical Therapy (PT), and benign neglect as well as more invasive treatments such as hydroxylation, manipulation under anesthesia, and arthroscopic capsular release [2]. These treatments have all be shown to have short-term benefit in pain relief, but none have proven to be superior nor alter the long-term natural history of adhesive capsulitis.
Over the past decade, however, there has been a growing body of literature suggesting that Propionibacterium acnes infection may play a significant role in a variety of pathological conditions affecting the native shoulder, most notably frozen shoulder [4,5]. Our goal is to employ a treatment strategy focused on eradicating P acnes infection as a conservative treatment of adhesive capsulitis. Through this project, we aim to complete a prospective randomized pilot study to examine the hypothesis that administration of intra-articular antibiotics effective against P acnes will prove to be a superior treatment of adhesive capsulitis as compared to current gold standard of intraarticular steroid injection.
- Being tested
- Methylprednisolone Injectable Product, Doxycycline Injection
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone Injectable ProductDrug
Also called Prednisone
3 intra-articular injections of Methylprednisolone Injectable Product spaced every two weeks
Doxycycline InjectionDrug
Also called Doxy
3 intra-articular injections of Doxycycline Injection spaced every two weeks
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Active comparator | Patients meeting the inclusion criteria will be randomized into either the control group of intra-articular injection of 40mg Methylprednisolone once every 2 two weeks for 4 weeks (day 1, week 2, week 4) with 20 patients in each group. Injections will be administered by the treating physician. Receives: Drug: Methylprednisolone Injectable Product |
| Doxycycline | Active comparator | Patients meeting the inclusion criteria will be randomized or the experimental group of intraarticular injection of 50 mg doxycycline once every 2 two weeks for 4 weeks (day 1, week 2, week 4), with 20 patients in each group. Injections will be administered by the treating physician. Receives: Drug: Doxycycline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in American Shoulder and Elbow Score (ASES)
The American Shoulder and Elbow Score questionnaire was developed to provide a standardized method for evaluating shoulder function and has been validated in patients with any array of shoulder pathologies. ASES results are in the 0 to 100 range, where 0 indicates a worse shoulder condition and 100 indicates best shoulder condition, so the lower the score, the greater the level of shoulder disability. Transforming the pain and the ADLs domains into the final score relies on the following formulas: Pain = 5 x (10 - Score from question 7)
Measured: Baseline and 12 months
Change in Range of Motion(ROM) Measurements
The ROM measurements will include forward flexion, abduction, external rotation at the side and at 90 degrees abduction, and internal rotation at the side and at 90 degrees abduction recorded by the treating physician at follow up visits
Measured: Baseline and 12 months
Secondary outcomes (5)
Number of Medical Co-morbidities
number of medical co-morbidities per participant
Measured: Baseline
Duration of Symptoms
Length of time participants have experienced shoulder symptoms
Measured: Baseline
Changes in Pain
Number of participants with current dominant symptom and/or dominant symptom with disease onset
Measured: Baseline
Pain With Sitting
Number of patients that have pain while sitting or have ever had pain while sitting will be recorded using patient-reported survey and review of the patient's electronic medical record in Epic.
Measured: Baseline
Stiffness
Number of participants with current dominant symptom and/or dominant symptom with disease onset
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start5 Mar 2018
- Primary completion8 Feb 2022
- Study completion8 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients meeting the inclusion criteria will be randomized into either the control group of intra-articular injection of 40mg Methylprednisolone once every 2 two weeks for 4 weeks (day 1, week 2, week 4) or the experimental group of intraarticular injection of 50 mg doxycycline once every 2 two weeks for 4 weeks (day 1, week 2, week 4), with 20 patients in each group. Injections will be administered by the treating physician. The Vanderbilt Investigational Pharmacy will provide the doxycycline and the steroid solutions and will be in charge of patient randomization.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation
- Responsible party
- Principal investigator, John Kuhn, Vanderbilt University Medical Center
- Investigators
- John E Kuhn, MD, Study director, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479502
- Sponsor's protocol ID
- 172011
- Acronym
- DOXY
- Status last verified
- Jan 2024
- First submitted
- 20 Mar 2018
- Last updated
- 18 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hsu JE, Anakwenze OA, Warrender WJ, Abboud JA. Current review of adhesive capsulitis. J Shoulder Elbow Surg. 2011 Apr;20(3):502-14. doi: 10.1016/j.jse.2010.08.023. Epub 2010 Dec 16. No abstract available.
PubMed 21167743Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28.
PubMed 20110457Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000 Mar;(372):95-109.
PubMed 10738419Bunker TD, Boyd M, Gallacher S, Auckland CR, Kitson J, Smith CD. Association between Propionibacterium acnes and frozen shoulder: a pilot study. Shoulder Elbow. 2014 Oct;6(4):257-61. doi: 10.1177/1758573214533664. Epub 2014 May 27.
PubMed 27582943Levy O, Iyer S, Atoun E, Peter N, Hous N, Cash D, Musa F, Narvani AA. Propionibacterium acnes: an underestimated etiology in the pathogenesis of osteoarthritis? J Shoulder Elbow Surg. 2013 Apr;22(4):505-11. doi: 10.1016/j.jse.2012.07.007. Epub 2012 Sep 13.
PubMed 22981447Stirling A, Worthington T, Rafiq M, Lambert PA, Elliott TS. Association between sciatica and Propionibacterium acnes. Lancet. 2001 Jun 23;357(9273):2024-5. doi: 10.1016/S0140-6736(00)05109-6. No abstract available.
PubMed 11438138Dodson CC, Craig EV, Cordasco FA, Dines DM, Dines JS, Dicarlo E, Brause BD, Warren RF. Propionibacterium acnes infection after shoulder arthroplasty: a diagnostic challenge. J Shoulder Elbow Surg. 2010 Mar;19(2):303-7. doi: 10.1016/j.jse.2009.07.065. Epub 2009 Nov 1.
PubMed 19884021Athwal GS, Sperling JW, Rispoli DM, Cofield RH. Deep infection after rotator cuff repair. J Shoulder Elbow Surg. 2007 May-Jun;16(3):306-11. doi: 10.1016/j.jse.2006.05.013. Epub 2007 Feb 22.
PubMed 17321157Millett PJ, Yen YM, Price CS, Horan MP, van der Meijden OA, Elser F. Propionibacterium acnes infection as an occult cause of postoperative shoulder pain: a case series. Clin Orthop Relat Res. 2011 Oct;469(10):2824-30. doi: 10.1007/s11999-011-1767-4. Epub 2011 Jan 15.
PubMed 21240577Schneeberger AG, Yian E, Steens W. Injection-induced low-grade infection of the shoulder joint: preliminary results. Arch Orthop Trauma Surg. 2012 Oct;132(10):1387-92. doi: 10.1007/s00402-012-1562-z. Epub 2012 Jun 17.
PubMed 22707212Rollason J, McDowell A, Albert HB, Barnard E, Worthington T, Hilton AC, Vernallis A, Patrick S, Elliott T, Lambert P. Genotypic and antimicrobial characterisation of Propionibacterium acnes isolates from surgically excised lumbar disc herniations. Biomed Res Int. 2013;2013:530382. doi: 10.1155/2013/530382. Epub 2013 Aug 28.
PubMed 24066290Brandt KD, Mazzuca SA, Katz BP, Lane KA, Buckwalter KA, Yocum DE, Wolfe F, Schnitzer TJ, Moreland LW, Manzi S, Bradley JD, Sharma L, Oddis CV, Hugenberg ST, Heck LW. Effects of doxycycline on progression of osteoarthritis: results of a randomized, placebo-controlled, double-blind trial. Arthritis Rheum. 2005 Jul;52(7):2015-25. doi: 10.1002/art.21122.
PubMed 15986343Aydin O, Korkusuz F, Korkusuz P, Tezcaner A, Bilgic E, Yaprakci V, Keskin D. In vitro and in vivo evaluation of doxycycline-chondroitin sulfate/PCLmicrospheres for intraarticular treatment of osteoarthritis. J Biomed Mater Res B Appl Biomater. 2015 Aug;103(6):1238-48. doi: 10.1002/jbm.b.33303. Epub 2014 Oct 28.
PubMed 25350566Haerdi-Landerer MC, Suter MM, Steiner A. Intra-articular administration of doxycycline in calves. Am J Vet Res. 2007 Dec;68(12):1324-31. doi: 10.2460/ajvr.68.12.1324.
PubMed 18052736Cylwik J, Kita K, Barwijuk-Machala M, Reszec J, Klimiuk P, Sierakowski S, Sulkowski S. The influence of doxycycline on articular cartilage in experimental osteoarthrosis induced by iodoacetate. Folia Morphol (Warsz). 2004 May;63(2):237-9.
PubMed 15232785
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT03479502
- Acronym / sponsor ID
- DOXY / 172011
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Posted 27 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will recruit a total of 40 patients from the Vanderbilt Sports Medicine Clinics who have been diagnosed with adhesive capsulitis and have not undergone any previous treatment. The 40 patients will be randomized, with 20 in the control group of 3 intra-articular injections of 40mg Methylprednisolone spaced every two weeks, and 20 in the experimental group of 3 intra-articular injection of 50mg doxycycline spaced every two weeks. Both groups will begin a standardized physical therapy program within a pain-free range of motion 4 weeks after the initiation of treatment. We will prospectively follow patients for one year, with follow-up at 6 weeks, 12 weeks, 6 months, and 12 months after the initiation of treatment.
Outcomes will be measured using the American Shoulder and Elbow Score (ASES) and objective measurements of shoulder range of motion, which will be collected by the treating physician. Both the patients and physicians participating in the study will be blinded.
Detailed description
Adhesive capsulitis, also known as frozen shoulder, is a common condition of the shoulder joint affecting 2-5% of the adult population and characterized by progressive, painful loss of both passive and active range of motion of shoulder [1,2]. Individuals affected by this condition find it increasingly difficult to perform activities of daily living that require overhead movement or rotation of the affected shoulder. The natural history of frozen shoulder follows a predictable progression of symptoms, lasting from 9-24 months before complete resolution, and results in significant loss of productivity and quality of life for those affected [3]. Despite the significant number of patients affected by adhesive capsulitis and the extensive literature focused on the progression and natural history of the condition, the true underlying etiology remains poorly understood. In light of this poor understanding of the condition, it is not surprising that a number of conservative and invasive modalities exist as accepted treatments. These include non-steroidal anti-inflammatory drugs (NSAIDS), oral steroids, intra-articular steroid injections, Physical Therapy (PT), and benign neglect as well as more invasive treatments such as hydroxylation, manipulation under anesthesia, and arthroscopic capsular release [2]. These treatments have all be shown to have short-term benefit in pain relief, but none have proven to be superior nor alter the long-term natural history of adhesive capsulitis.
Over the past decade, however, there has been a growing body of literature suggesting that Propionibacterium acnes infection may play a significant role in a variety of pathological conditions affecting the native shoulder, most notably frozen shoulder [4,5]. Our goal is to employ a treatment strategy focused on eradicating P acnes infection as a conservative treatment of adhesive capsulitis. Through this project, we aim to complete a prospective randomized pilot study to examine the hypothesis that administration of intra-articular antibiotics effective against P acnes will prove to be a superior treatment of adhesive capsulitis as compared to current gold standard of intraarticular steroid injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients meeting the inclusion criteria will be randomized into either the control group of intra-articular injection of 40mg Methylprednisolone once every 2 two weeks for 4 weeks (day 1, week 2, week 4) or the experimental group of intraarticular injection of 50 mg doxycycline once every 2 two weeks for 4 weeks (day 1, week 2, week 4), with 20 patients in each group. Injections will be administered by the treating physician. The Vanderbilt Investigational Pharmacy will provide the doxycycline and the steroid solutions and will be in charge of patient randomization.
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Active comparator | Drug: Methylprednisolone Injectable ProductPatients meeting the inclusion criteria will be randomized into either the control group of intra-articular injection of 40mg Methylprednisolone once every 2 two weeks for 4 weeks (day 1, week 2, week 4) with 20 patients in each group. Injections will be administered by the treating physician. |
| Doxycycline | Active comparator | Drug: Doxycycline InjectionPatients meeting the inclusion criteria will be randomized or the experimental group of intraarticular injection of 50 mg doxycycline once every 2 two weeks for 4 weeks (day 1, week 2, week 4), with 20 patients in each group. Injections will be administered by the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older,
- diagnosis of stage II adhesive capsulitis as determined by clinical examination of the treating physician, and
- absence of abnormal findings on X-ray.
Key exclusion criteria (8 listed)
- allergy to Doxycycline or Methylprednisolone,
- pregnancy,
- diagnosis,
- Inflammatory arthritis or diabetes,
- secondary adhesive capsulitis (history of significant trauma, rotator cuff tear injury, stroke)
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 |
|---|---|---|
| Methylprednisolone Injectable ProductAlso: Prednisone3 intra-articular injections of Methylprednisolone Injectable Product spaced every two weeks | Drug | Methylprednisolone |
| Doxycycline InjectionAlso: Doxy3 intra-articular injections of Doxycycline Injection spaced every two weeks | Drug | Doxycycline |
Primary outcome
Change in American Shoulder and Elbow Score (ASES)
Time frame: Baseline and 12 months
The American Shoulder and Elbow Score questionnaire was developed to provide a standardized method for evaluating shoulder function and has been validated in patients with any array of shoulder pathologies. ASES results are in the 0 to 100 range, where 0 indicates a worse shoulder condition and 100 indicates best shoulder condition, so the lower the score, the greater the level of shoulder disability. Transforming the pain and the ADLs domains into the final score relies on the following formulas: Pain = 5 x (10 - Score from question 7)
Change in Range of Motion(ROM) Measurements
Time frame: Baseline and 12 months
The ROM measurements will include forward flexion, abduction, external rotation at the side and at 90 degrees abduction, and internal rotation at the side and at 90 degrees abduction recorded by the treating physician at follow up visits
5 secondary outcomes
Number of Medical Co-morbidities
Time frame: Baseline
Duration of Symptoms
Time frame: Baseline
Changes in Pain
Time frame: Baseline
Pain With Sitting
Time frame: Baseline
Stiffness
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21167743Hsu JE, Anakwenze OA, Warrender WJ, Abboud JA. Current review of adhesive capsulitis. J Shoulder Elbow Surg. 2011 Apr;20(3):502-14. doi: 10.1016/j.jse.2010.08.023. Epub 2010 Dec 16. No abstract available.
- Results publication: PubMed 20110457Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28.
- Results publication: PubMed 10738419Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000 Mar;(372):95-109.
- Results publication: PubMed 27582943Bunker TD, Boyd M, Gallacher S, Auckland CR, Kitson J, Smith CD. Association between Propionibacterium acnes and frozen shoulder: a pilot study. Shoulder Elbow. 2014 Oct;6(4):257-61. doi: 10.1177/1758573214533664. Epub 2014 May 27.
- Results publication: PubMed 22981447Levy O, Iyer S, Atoun E, Peter N, Hous N, Cash D, Musa F, Narvani AA. Propionibacterium acnes: an underestimated etiology in the pathogenesis of osteoarthritis? J Shoulder Elbow Surg. 2013 Apr;22(4):505-11. doi: 10.1016/j.jse.2012.07.007. Epub 2012 Sep 13.
- Results publication: PubMed 11438138Stirling A, Worthington T, Rafiq M, Lambert PA, Elliott TS. Association between sciatica and Propionibacterium acnes. Lancet. 2001 Jun 23;357(9273):2024-5. doi: 10.1016/S0140-6736(00)05109-6. No abstract available.
- Results publication: PubMed 19884021Dodson CC, Craig EV, Cordasco FA, Dines DM, Dines JS, Dicarlo E, Brause BD, Warren RF. Propionibacterium acnes infection after shoulder arthroplasty: a diagnostic challenge. J Shoulder Elbow Surg. 2010 Mar;19(2):303-7. doi: 10.1016/j.jse.2009.07.065. Epub 2009 Nov 1.
- Results publication: PubMed 17321157Athwal GS, Sperling JW, Rispoli DM, Cofield RH. Deep infection after rotator cuff repair. J Shoulder Elbow Surg. 2007 May-Jun;16(3):306-11. doi: 10.1016/j.jse.2006.05.013. Epub 2007 Feb 22.
- Results publication: PubMed 21240577Millett PJ, Yen YM, Price CS, Horan MP, van der Meijden OA, Elser F. Propionibacterium acnes infection as an occult cause of postoperative shoulder pain: a case series. Clin Orthop Relat Res. 2011 Oct;469(10):2824-30. doi: 10.1007/s11999-011-1767-4. Epub 2011 Jan 15.
- Results publication: PubMed 22707212Schneeberger AG, Yian E, Steens W. Injection-induced low-grade infection of the shoulder joint: preliminary results. Arch Orthop Trauma Surg. 2012 Oct;132(10):1387-92. doi: 10.1007/s00402-012-1562-z. Epub 2012 Jun 17.
- Results publication: PubMed 24066290Rollason J, McDowell A, Albert HB, Barnard E, Worthington T, Hilton AC, Vernallis A, Patrick S, Elliott T, Lambert P. Genotypic and antimicrobial characterisation of Propionibacterium acnes isolates from surgically excised lumbar disc herniations. Biomed Res Int. 2013;2013:530382. doi: 10.1155/2013/530382. Epub 2013 Aug 28.
- Results publication: PubMed 15986343Brandt KD, Mazzuca SA, Katz BP, Lane KA, Buckwalter KA, Yocum DE, Wolfe F, Schnitzer TJ, Moreland LW, Manzi S, Bradley JD, Sharma L, Oddis CV, Hugenberg ST, Heck LW. Effects of doxycycline on progression of osteoarthritis: results of a randomized, placebo-controlled, double-blind trial. Arthritis Rheum. 2005 Jul;52(7):2015-25. doi: 10.1002/art.21122.
- Individual participant dataSharing planned: Undecided
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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.
John E Kuhn, MD study director
Study Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone Injectable Product and Doxycycline Injection in people with Adhesive Capsulitis and Adhesive Capsulitis of Unspecified Shoulder, run by Vanderbilt University Medical Center at 1 site in United States.
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 3 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 18 Jan 2024. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in American Shoulder and Elbow Score (ASES) (time frame: Baseline and 12 months). The study lists 2 primary outcomes in all. 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 NCT03479502, which also lists 16 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 18 Jan 2024.