Frozen ShoulderNCT06494657
Frozen Shoulder and Glucose Following Corticosteroid Injection
An observational study of Frozen Shoulder and Adhesive Capsulitis, run by Central London Community Healthcare NHS Trust.
Trial summary
The goal of this clinical study is to look at what happens to blood sugar levels in people who have a frozen shoulder, who do not have diabetes after a corticosteroid injection in people with frozen shoulder. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Frozen Shoulder, Adhesive Capsulitis
- What is being tested?
- Corticosteroid injection
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 16 Aug 2024to 30 Apr 2025
- Phase
- Observational
- 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 45 to 65 years
- All sexes
- Adult, Older adult
Study population: People with a Barnet borough GP and with a diagnosis of frozen shoulder
Who may be able to join
- Aged between 45 and 65
- Without diabetes or pre-diabetes
- Glenohumeral external rotation range is equally limited actively and passively by at least 50% compared to the contralateral side.
- Other glenohumeral movements are equally limited actively and passively compared to the contralateral side in one or more additional planes of movement (such as hand behind the back/shoulder flexion/abduction/scaption).
- The symptoms have been present for at least one month.
- No significant abnormality on plain radiographs.
- Ability to provide informed consent
Who cannot join
- Aged 44 and under and 66 and over
- People with frozen shoulder secondary to significant shoulder trauma (e.g., dislocation, fracture or full thickness tear requiring surgery) or other causes (e.g., recent breast cancer surgery or radiotherapy)
- People with prediabetes, type 1 and 2 diabetes
- A neurological disease affecting the shoulder
- Evidence of other shoulder disorders (e.g., inflammatory arthritis, rotator cuff disorders, glenohumeral joint instability) or with red flags consistent with the criteria set out by British Elbow and Shoulder Society (Rangan, 2015).
- Primary osteoarthritis of the glenohumeral joint on plain radiograph
Show all 15Show fewer
- Calcific tendinitis
- Who have received corticosteroid injection for shoulder pain in the last 12 weeks
- On long term steroids or a recent short course of oral steroids
- Currently being treated with coumarin anticoagulants, such as warfarin
- Who have participated in another research study involving an investigational medicinal product in the past 12 weeks
- Significant renal or hepatic impairment
- Any other significant disease which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study.
- Systemically unwell or with infection
- Pregnant or breastfeeding
Trial locations and contacts
No sites are listed yet.
Mindy Cairns, PhD contact
About this study
Official title: Frozen Shoulder: A Pragmatic Replicated N-of-1 Case Series Investigating Glucose Levels and Patient Reported Outcomes Following a Corticosteroid Injection.
The goal of this clinical study is to look at what happens to blood sugar levels in people who have a frozen shoulder, who do not have diabetes after a corticosteroid injection in people with frozen shoulder.
- The primary aim of this study will be to evaluate alterations in glucose levels for people without diabetes, following corticosteroid injection for frozen shoulder.
- The secondary aims are to observe a range of clinical, physiological, and psychosocial outcomes following corticosteroid injection for people with frozen shoulder.
Read more
Participants will wear a glucose measuring device, attached to the upper arm collecting readings of glucose levels for 14 days.
Participants will undergo a corticosteroid injection as part of usual care.
Read the detailed description
Frozen shoulder is regarded one of the most painful conditions to affect the shoulder. It is associated with substantial and prolonged pain that affects sleep and permeates into every aspect of daily function. Epidemiological research suggests the average onset is in the 6th decade, affecting up to 8% of men and 10% of women of working age may be affected. In people with diabetes this figure dramatically increases, with the incidence of frozen shoulder ranging from 10 to 59%.
Injection for frozen shoulder is a well-established treatment option, particularly in the early phase of the condition. The aim of this study is to assess glycaemic changes in a non-diabetic population following a corticosteroid injection. The cardiovascular risk factors associated with developing diabetes, which are increasing globally, because of ageing, smoking, poor diet and lack of physical activity, means there is good reason to understand better the impact of injection for frozen shoulder on the normo-glycaemic population.
A continuous glucose monitor worn on the upper arm, will collect glucose data at multiple timepoints for the 14 days it is worn both before and following the injection. The device is minimally invasive with the use of a small electrochemical sensor inserted under the skin and takes readings of interstitial (between cells, just below the skin).
In the N-of-1 design the 'N' represents a single participant. This design bridges the gap between evidence-based research and clinical care in health conditions. N-of-1 studies are patient centred as participants become more involved in their condition and treatment, setting outcomes due to the close monitoring of participants. When the 'N' is repeated, this may make the findings more generalisable. The CONSORT guidelines for RCTs were extended and the CENT 15 guidelines for N-of-1 trials were developed. A strength of N-of-1 studies as they are focussed on the individual and whilst their comorbidities are stable, they can be included in the study.
For this study, an A-B-A phase design will be used. The initial phase (A) is where repeated glucose measures are automatically obtained via the sensor and uploaded to the website and to check participants glucose levels do not go to the hyper/hypoglycaemic ranges on the day of the injection.
The next phase (B) is the intervention phase where participants will undergo a corticosteroid injection. The final phase (A) is where 'washout' will occur and this will be for the remainder of the life of the sensor. The term 'washout period' refers to ''a period in which no intervention is administered. A washout may be administered between different treatment periods or may act as a period in itself, as in a "reversal" design (to "wash out" the effects of a treatment….'' Glucose data is continually provided by the sensor to the website, which is around 14 days. It will be important to investigate glucose levels for the life of the CGM to assess if any individuals developed hyperglycaemia following the injection.
Day 1 is the day the CGM is attached to the participant. Data will be collected from day 1 but will not be used as part of the analysis as there is less available data collected by the device, resulting in less accurate readings.
Day 2 to day 5, is the pre-injection phase. Day 5 is the day of the injection and up until the point of the injection is included as pre-injection phase. Immediately following the injection is the early phase post injection up to day 8. Day 9 to day 14 is the late phase post injection.
Sampling technique
The process of sample selection will be as follows:
- Potential participants referred to the musculoskeletal physiotherapy department with a diagnosis of primary idiopathic frozen shoulder and fitting the inclusion criteria.
- Purposive sampling technique to include potential participants who may be under-represented, in the health-care setting, particularly if south Asian or black due to the increase incidence of frozen shoulder in these cohorts.
- The sample is derived from the electronic patient record system.
Potential participants will be recruited by their referring GP to the musculoskeletal service. The study aims to have a maximum of 10 completed participant data sets. A literature review of sample size for N-of-1 trials found the average sample size was 13 (range 2 - 428; IQR, 6.5 - 38.5). Other studies had sample sizes of 4 for mobility rehabilitation 8 for virtual reality exercises for neck pain and 4 participants with low back pain and exercise. There is no formal sample size calculation as there are unknown features for example size of the effect. This study is novel and to the best of the chief investigators knowledge there is no other similar study for comparison.
The primary outcome measures are glucose levels pre and post injection and the shoulder pain and disability index (SPADI). A Microsoft Teams channel will enable secure digital data collection and this data will be captured on 2 separate occasions: at baseline and at 3 weeks post-injection. The baseline data will be captured once at the start of participant involvement.
- Conditions
- Frozen Shoulder, Adhesive Capsulitis
- Being tested
- Corticosteroid injection
- Keywords
- Corticosteroid, Injection, Hyperglycemia
- Medical subject headings
- Bursitis, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid injectionOther
Corticosteroid injection for frozen shoulder
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean glucose levels
The primary biochemical outcome is mean glucose (mmol/dL) levels pre and post injection.
Measured: 3 weeks
Shoulder Pain and Disability Index
The primary clinical outcome is the functional questionnaire 'Shoulder Pain and Disability Index' before and after the injection. The SPADI is a 13-item patient completed instrument. Its categories include "pain" (5 items) and "disability" (8 items), with the total score often described as a percentage, resulting from the summation of each component. Overall total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction.
Measured: 3 weeks
Secondary outcomes (4)
Quick Disabilities of the Arm, Shoulder, and Hand
The Quick Disabilities of the Arm, Shoulder, and Hand questionnaire is a subset of 11 items from the 30-item Disabilities of the Arm, Shoulder, and Hand and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
Measured: 3 weeks
Pain Self Efficacy Questionnaire
The Pain Self Efficacy Questionnaire is a 10-item questionnaire, where patients rate their confidence from 0 points (not at all confident) to 6 points (completely confident). Total scores are calculated by summing the individual items with a range from 0 points (less self-efficacy) to 60 points (more self-efficacy)
Measured: 3 weeks
Pittsburgh Sleep Quality Index
The 19 items are grouped into 7 components, including (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction due to sleepiness, (5) sleep efficiency, (6) overall sleep quality, and (7) sleep medication use.
In scoring the Pittsburgh Sleep Quality Index, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: 3 weeks
Time in glucose range %
The time spent within various glucose ranges pre and post injection
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start16 Aug 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Frozen ShoulderStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central London Community Healthcare NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hertfordshire
- Responsible party
- Sponsor
- Investigators
- Simon Lewis, Study chair, Central London Community Healthcare NHS Trustr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494657
- Sponsor's protocol ID
- RD24.001
- Status last verified
- Aug 2024
- First submitted
- 2 Jul 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walker-Bone K, Palmer KT, Reading I, Coggon D, Cooper C. Prevalence and impact of musculoskeletal disorders of the upper limb in the general population. Arthritis Rheum. 2004 Aug 15;51(4):642-51. doi: 10.1002/art.20535.
PubMed 15334439Wong CK, Levine WN, Deo K, Kesting RS, Mercer EA, Schram GA, Strang BL. Natural history of frozen shoulder: fact or fiction? A systematic review. Physiotherapy. 2017 Mar;103(1):40-47. doi: 10.1016/j.physio.2016.05.009. Epub 2016 Jun 21.
PubMed 27641499Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
PubMed 29253607Vohra S, Shamseer L, Sampson M, Bukutu C, Schmid CH, Tate R, Nikles J, Zucker DR, Kravitz R, Guyatt G, Altman DG, Moher D; CENT Group. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ. 2015 May 14;350:h1738. doi: 10.1136/bmj.h1738. No abstract available.
PubMed 25976398Shamseer L, Sampson M, Bukutu C, Schmid CH, Nikles J, Tate R, Johnston BC, Zucker D, Shadish WR, Kravitz R, Guyatt G, Altman DG, Moher D, Vohra S; CENT group. CONSORT extension for reporting N-of-1 trials (CENT) 2015: explanation and elaboration. J Clin Epidemiol. 2016 Aug;76:18-46. doi: 10.1016/j.jclinepi.2015.05.018. Epub 2015 Aug 10.
PubMed 26272791Lobo MA, Moeyaert M, Baraldi Cunha A, Babik I. Single-Case Design, Analysis, and Quality Assessment for Intervention Research. J Neurol Phys Ther. 2017 Jul;41(3):187-197. doi: 10.1097/NPT.0000000000000187.
PubMed 28628553Punja S, Bukutu C, Shamseer L, Sampson M, Hartling L, Urichuk L, Vohra S. N-of-1 trials are a tapestry of heterogeneity. J Clin Epidemiol. 2016 Aug;76:47-56. doi: 10.1016/j.jclinepi.2016.03.023. Epub 2016 Apr 11.
PubMed 27079847de la Serna D, Navarro-Ledesma S, Alayon F, Lopez E, Pruimboom L. A Comprehensive View of Frozen Shoulder: A Mystery Syndrome. Front Med (Lausanne). 2021 May 11;8:663703. doi: 10.3389/fmed.2021.663703. eCollection 2021.
PubMed 34046418Deshmukh H, Wilmot EG, Gregory R, Barnes D, Narendran P, Saunders S, Furlong N, Kamaruddin S, Banatwalla R, Herring R, Kilvert A, Patmore J, Walton C, Ryder REJ, Sathyapalan T. Effect of Flash Glucose Monitoring on Glycemic Control, Hypoglycemia, Diabetes-Related Distress, and Resource Utilization in the Association of British Clinical Diabetologists (ABCD) Nationwide Audit. Diabetes Care. 2020 Sep;43(9):2153-2160. doi: 10.2337/dc20-0738. Epub 2020 Jul 15.
PubMed 32669277Dyer BP, Rathod-Mistry T, Burton C, van der Windt D, Bucknall M. Diabetes as a risk factor for the onset of frozen shoulder: a systematic review and meta-analysis. BMJ Open. 2023 Jan 4;13(1):e062377. doi: 10.1136/bmjopen-2022-062377.
PubMed 36599641Kooistra B, Dijkman B, Einhorn TA, Bhandari M. How to design a good case series. J Bone Joint Surg Am. 2009 May;91 Suppl 3:21-6. doi: 10.2106/JBJS.H.01573.
PubMed 19411496Millar NL, Meakins A, Struyf F, Willmore E, Campbell AL, Kirwan PD, Akbar M, Moore L, Ronquillo JC, Murrell GAC, Rodeo SA. Frozen shoulder. Nat Rev Dis Primers. 2022 Sep 8;8(1):59. doi: 10.1038/s41572-022-00386-2.
PubMed 36075904
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frozen Shoulder: A Pragmatic Replicated N-of-1 Case Series Investigating Glucose Levels and Patient Reported Outcomes Following a Corticosteroid Injection.
- ClinicalTrials.gov ID
- NCT06494657
- Acronym / sponsor ID
- RD24.001
- Conditions
- Frozen Shoulder, Adhesive Capsulitis
- Keywords
- Corticosteroid, Injection, Hyperglycemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Central London Community Healthcare NHS TrustOther government
- Collaborators
- University of Hertfordshire
- Study start
- 16 Aug 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 10 Jul 2024 (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 goal of this clinical study is to look at what happens to blood sugar levels in people who have a frozen shoulder, who do not have diabetes after a corticosteroid injection in people with frozen shoulder.
- The primary aim of this study will be to evaluate alterations in glucose levels for people without diabetes, following corticosteroid injection for frozen shoulder.
- The secondary aims are to observe a range of clinical, physiological, and psychosocial outcomes following corticosteroid injection for people with frozen shoulder.
Participants will wear a glucose measuring device, attached to the upper arm collecting readings of glucose levels for 14 days.
Participants will undergo a corticosteroid injection as part of usual care.
Detailed description
Frozen shoulder is regarded one of the most painful conditions to affect the shoulder. It is associated with substantial and prolonged pain that affects sleep and permeates into every aspect of daily function. Epidemiological research suggests the average onset is in the 6th decade, affecting up to 8% of men and 10% of women of working age may be affected. In people with diabetes this figure dramatically increases, with the incidence of frozen shoulder ranging from 10 to 59%.
Injection for frozen shoulder is a well-established treatment option, particularly in the early phase of the condition. The aim of this study is to assess glycaemic changes in a non-diabetic population following a corticosteroid injection. The cardiovascular risk factors associated with developing diabetes, which are increasing globally, because of ageing, smoking, poor diet and lack of physical activity, means there is good reason to understand better the impact of injection for frozen shoulder on the normo-glycaemic population.
A continuous glucose monitor worn on the upper arm, will collect glucose data at multiple timepoints for the 14 days it is worn both before and following the injection. The device is minimally invasive with the use of a small electrochemical sensor inserted under the skin and takes readings of interstitial (between cells, just below the skin).
In the N-of-1 design the 'N' represents a single participant. This design bridges the gap between evidence-based research and clinical care in health conditions. N-of-1 studies are patient centred as participants become more involved in their condition and treatment, setting outcomes due to the close monitoring of participants. When the 'N' is repeated, this may make the findings more generalisable. The CONSORT guidelines for RCTs were extended and the CENT 15 guidelines for N-of-1 trials were developed. A strength of N-of-1 studies as they are focussed on the individual and whilst their comorbidities are stable, they can be included in the study.
For this study, an A-B-A phase design will be used. The initial phase (A) is where repeated glucose measures are automatically obtained via the sensor and uploaded to the website and to check participants glucose levels do not go to the hyper/hypoglycaemic ranges on the day of the injection.
The next phase (B) is the intervention phase where participants will undergo a corticosteroid injection. The final phase (A) is where 'washout' will occur and this will be for the remainder of the life of the sensor. The term 'washout period' refers to ''a period in which no intervention is administered. A washout may be administered between different treatment periods or may act as a period in itself, as in a "reversal" design (to "wash out" the effects of a treatment….'' Glucose data is continually provided by the sensor to the website, which is around 14 days. It will be important to investigate glucose levels for the life of the CGM to assess if any individuals developed hyperglycaemia following the injection.
Day 1 is the day the CGM is attached to the participant. Data will be collected from day 1 but will not be used as part of the analysis as there is less available data collected by the device, resulting in less accurate readings.
Day 2 to day 5, is the pre-injection phase. Day 5 is the day of the injection and up until the point of the injection is included as pre-injection phase. Immediately following the injection is the early phase post injection up to day 8. Day 9 to day 14 is the late phase post injection.
Sampling technique
The process of sample selection will be as follows:
- Potential participants referred to the musculoskeletal physiotherapy department with a diagnosis of primary idiopathic frozen shoulder and fitting the inclusion criteria.
- Purposive sampling technique to include potential participants who may be under-represented, in the health-care setting, particularly if south Asian or black due to the increase incidence of frozen shoulder in these cohorts.
- The sample is derived from the electronic patient record system.
Potential participants will be recruited by their referring GP to the musculoskeletal service. The study aims to have a maximum of 10 completed participant data sets. A literature review of sample size for N-of-1 trials found the average sample size was 13 (range 2 - 428; IQR, 6.5 - 38.5). Other studies had sample sizes of 4 for mobility rehabilitation 8 for virtual reality exercises for neck pain and 4 participants with low back pain and exercise. There is no formal sample size calculation as there are unknown features for example size of the effect. This study is novel and to the best of the chief investigators knowledge there is no other similar study for comparison.
The primary outcome measures are glucose levels pre and post injection and the shoulder pain and disability index (SPADI). A Microsoft Teams channel will enable secure digital data collection and this data will be captured on 2 separate occasions: at baseline and at 3 weeks post-injection. The baseline data will be captured once at the start of participant involvement.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People with a Barnet borough GP and with a diagnosis of frozen shoulder
Key inclusion criteria (7 listed)
- Aged between 45 and 65
- Without diabetes or pre-diabetes
- Glenohumeral external rotation range is equally limited actively and passively by at least 50% compared to the contralateral side.
- Other glenohumeral movements are equally limited actively and passively compared to the contralateral side in one or more additional planes of movement (such as hand behind the back/shoulder flexion/abduction/scaption).
- The symptoms have been present for at least one month.
Key exclusion criteria (15 listed)
- Aged 44 and under and 66 and over
- People with frozen shoulder secondary to significant shoulder trauma (e.g., dislocation, fracture or full thickness tear requiring surgery) or other causes (e.g., recent breast cancer surgery or radiotherapy)
- People with prediabetes, type 1 and 2 diabetes
- A neurological disease affecting the shoulder
- Evidence of other shoulder disorders (e.g., inflammatory arthritis, rotator cuff disorders, glenohumeral joint instability) or with red flags consistent with the criteria set out by British Elbow and Shoulder Society (Rangan, 2015).
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 |
|---|---|---|
| Corticosteroid injectionCorticosteroid injection for frozen shoulder | Other | – |
Primary outcome
Mean glucose levels
Time frame: 3 weeks
The primary biochemical outcome is mean glucose (mmol/dL) levels pre and post injection.
Shoulder Pain and Disability Index
Time frame: 3 weeks
The primary clinical outcome is the functional questionnaire 'Shoulder Pain and Disability Index' before and after the injection. The SPADI is a 13-item patient completed instrument. Its categories include "pain" (5 items) and "disability" (8 items), with the total score often described as a percentage, resulting from the summation of each component. Overall total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction.
4 secondary outcomes
Quick Disabilities of the Arm, Shoulder, and Hand
Time frame: 3 weeks
Pain Self Efficacy Questionnaire
Time frame: 3 weeks
Pittsburgh Sleep Quality Index
Time frame: 3 weeks
Time in glucose range %
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Background: PubMed 15334439Walker-Bone K, Palmer KT, Reading I, Coggon D, Cooper C. Prevalence and impact of musculoskeletal disorders of the upper limb in the general population. Arthritis Rheum. 2004 Aug 15;51(4):642-51. doi: 10.1002/art.20535.
- Background: PubMed 27641499Wong CK, Levine WN, Deo K, Kesting RS, Mercer EA, Schram GA, Strang BL. Natural history of frozen shoulder: fact or fiction? A systematic review. Physiotherapy. 2017 Mar;103(1):40-47. doi: 10.1016/j.physio.2016.05.009. Epub 2016 Jun 21.
- Background: PubMed 29253607Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
- Background: PubMed 25976398Vohra S, Shamseer L, Sampson M, Bukutu C, Schmid CH, Tate R, Nikles J, Zucker DR, Kravitz R, Guyatt G, Altman DG, Moher D; CENT Group. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ. 2015 May 14;350:h1738. doi: 10.1136/bmj.h1738. No abstract available.
- Background: PubMed 26272791Shamseer L, Sampson M, Bukutu C, Schmid CH, Nikles J, Tate R, Johnston BC, Zucker D, Shadish WR, Kravitz R, Guyatt G, Altman DG, Moher D, Vohra S; CENT group. CONSORT extension for reporting N-of-1 trials (CENT) 2015: explanation and elaboration. J Clin Epidemiol. 2016 Aug;76:18-46. doi: 10.1016/j.jclinepi.2015.05.018. Epub 2015 Aug 10.
- Background: PubMed 28628553Lobo MA, Moeyaert M, Baraldi Cunha A, Babik I. Single-Case Design, Analysis, and Quality Assessment for Intervention Research. J Neurol Phys Ther. 2017 Jul;41(3):187-197. doi: 10.1097/NPT.0000000000000187.
- Background: PubMed 27079847Punja S, Bukutu C, Shamseer L, Sampson M, Hartling L, Urichuk L, Vohra S. N-of-1 trials are a tapestry of heterogeneity. J Clin Epidemiol. 2016 Aug;76:47-56. doi: 10.1016/j.jclinepi.2016.03.023. Epub 2016 Apr 11.
- Background: PubMed 34046418de la Serna D, Navarro-Ledesma S, Alayon F, Lopez E, Pruimboom L. A Comprehensive View of Frozen Shoulder: A Mystery Syndrome. Front Med (Lausanne). 2021 May 11;8:663703. doi: 10.3389/fmed.2021.663703. eCollection 2021.
- Background: PubMed 32669277Deshmukh H, Wilmot EG, Gregory R, Barnes D, Narendran P, Saunders S, Furlong N, Kamaruddin S, Banatwalla R, Herring R, Kilvert A, Patmore J, Walton C, Ryder REJ, Sathyapalan T. Effect of Flash Glucose Monitoring on Glycemic Control, Hypoglycemia, Diabetes-Related Distress, and Resource Utilization in the Association of British Clinical Diabetologists (ABCD) Nationwide Audit. Diabetes Care. 2020 Sep;43(9):2153-2160. doi: 10.2337/dc20-0738. Epub 2020 Jul 15.
- Background: PubMed 36599641Dyer BP, Rathod-Mistry T, Burton C, van der Windt D, Bucknall M. Diabetes as a risk factor for the onset of frozen shoulder: a systematic review and meta-analysis. BMJ Open. 2023 Jan 4;13(1):e062377. doi: 10.1136/bmjopen-2022-062377.
- Background: PubMed 19411496Kooistra B, Dijkman B, Einhorn TA, Bhandari M. How to design a good case series. J Bone Joint Surg Am. 2009 May;91 Suppl 3:21-6. doi: 10.2106/JBJS.H.01573.
- Background: PubMed 36075904Millar NL, Meakins A, Struyf F, Willmore E, Campbell AL, Kirwan PD, Akbar M, Moore L, Ronquillo JC, Murrell GAC, Rodeo SA. Frozen shoulder. Nat Rev Dis Primers. 2022 Sep 8;8(1):59. doi: 10.1038/s41572-022-00386-2.
- Individual participant dataSharing planned: No
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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.
Mindy Cairns, PhD contact
Simon Lewis study chair
Central London Community Healthcare NHS Trustr
Questions about this trial
What is this clinical trial studying?
An observational study of Frozen Shoulder and Adhesive Capsulitis, run by Central London Community Healthcare NHS Trust.
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 7 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Bilsborough Smith, MSc (07967631668, christinebilsborough@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean glucose levels (time frame: 3 weeks). 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 NCT06494657, which also lists 12 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 13 Aug 2024.