Foot PainNCT04894396
Orthotics, Pain & Fear of Falling
A study testing Aetrex L2305 Premium Memory Foam Orthotics W/ Metatarsal Support and Aetrex L2300 Premium Memory Foam Orthotics in people with Foot Pain and Foot Functionality, run by Talita Cumi Ltd. at 1 site in United Kingdom.
Trial summary
To investigate and compare the use of a prefabricated Orthotic, with and without a metatarsal pad in decreasing pain and fear of falling in older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Foot Pain, Foot Functionality, Fear of Falling
- What is being tested?
- Aetrex L2305 Premium Memory Foam Orthotics W/ Metatarsal Support and Aetrex L2300 Premium Memory Foam Orthotics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jul 2021to 15 Jan 2023
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A least 60 years of age
- Live in a community-based setting
- Are capable of ambulation
- Have some form of self-identified foot pain
Who cannot join
- Compromised skin integrity of the lower limbs
- Peripheral neuropathy and lack of sensation in the feet.
- Previous history of foot surgery and
- Inability to follow the instructions and procedures of the research protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Control Trial Comparing Prefabricated Orthotics With and Without Metatarsal Pad in Decreasing Pain and Fear of Falling in Older Adults
To investigate and compare the use of a prefabricated Orthotic, with and without a metatarsal pad in decreasing pain and fear of falling in older adults.
Read the detailed description
It is estimated that around 24% of community-dwelling adults over the age of 45 experience frequent foot pain. Falls and fear of falling are also significant issues in this population as both can result in avoidance of activities and decreased physical performance. In cases where fear of falling decreases physical performance and increases activity avoidance, it actually becomes a risk factor for falling itself.
Previous studies have shown that various types of Orthotic insoles improve balance and reduce lower-extremity pain in older adults. However, research which directly compares the effects of two different types of insoles is limited. Hence, this randomised control trial will investigate and compare the use of a prefabricated Orthotic, with and without a metatarsal pad, in decreasing pain and fear of falling in older adults.
This randomised control trial will be conducted over a 6-week period. The study population will include 206 participants who will be randomised into 2 groups (Group A and Group B). Participants in Group A will receive an Orthotic with a metatarsal pad and participants in Group B will receive a neutral Orthotic without the metatarsal pad. All participants will be required to continue with usual activities, using the Orthotic wherever possible for a period of 6 weeks. Participants will be asked to provide data in the form of completed surveys twice, once at the study onset and once at the end.
- Conditions
- Foot Pain, Foot Functionality, Fear of Falling
- Being tested
- Aetrex L2305 Premium Memory Foam Orthotics W/ Metatarsal Support, Aetrex L2300 Premium Memory Foam Orthotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aetrex L2305 Premium Memory Foam Orthotics W/ Metatarsal SupportDevice
An Orthotic insole to be inserted into shoes. Features Aetrex Arch Support to help biomechanically align the body \& help prevent common foot pain such as Plantar Fasciitis, Arch Pain and Metatarsalgia. For medium to high arches with forefoot pain, featuring a cupped heel to cushion and stabilize the back of foot and a metatarsal pad to redistribute weight to relieve ball-of-foot discomfort. With 43% more memory foam in the forefoot for those experiencing foot discomfort or fatigue.
Aetrex L2300 Premium Memory Foam OrthoticsDevice
An Orthotic insole to be inserted into shoes. Features Aetrex Arch Support to help biomechanically align the body \& help prevent common foot pain such as Plantar Fasciitis, Arch Pain and Metatarsalgia. With 43% more memory foam in the forefoot for those experiencing foot discomfort or fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Prefabricated Orthotics with metatarsal pad | Experimental | Participants in Group A will receive the Orthotic with the metatarsal pad (L 2305) according to participants shoe size (https://www.aetrex.com/search?q=l2305\&search-button=\&lang=en_US). When the investigators provide the Orthotics, an instruction sheet will also be provided, explaining how to use the orthotic. Alternatively, an online video tutorial on how to use the Orthotic will also be available throughout the study. Participants will be required to use the Orthotic wherever possible for a period of 6 weeks, whilst continuing with usual activities. Receives: Device: Aetrex L2305 Premium Memory Foam Orthotics W/ Metatarsal Support |
| Prefabricated Orthotics without metatarsal pad. | Active comparator | Participants in Group B will receive the neutral Orthotic with a cupped heel (L 2300) according to participants shoe size (https://www.aetrex.com/search?q=l2300\&search-button=\&lang=en_US). When the investigators provide the Orthotics, an instruction sheet will also be provided, explaining how to use the Orthotic. Alternatively, an online video tutorial on how to use the Orthotic will also be available throughout the study. Participants will be required to use the Orthotic wherever possible for a period of 6 weeks, whilst continuing with usual activities Receives: Device: Aetrex L2300 Premium Memory Foam Orthotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain as assessed by a Visual Analogue Scale (VAS)
Pain scores will be collected using the Visual Analogue Scale (VAS) as follows: Levels of pain on a 0 to 10 scale with 0 representing no pain, 2 - mild pain, 5 - moderate pain, 7 - severe pain, and 10 represents extremely severe pain. Utilization of this scale is in line with previous research [and will measure pain in the feet, ankles, knees, hips, and lower back.
Measured: Baseline and 6 weeks
Secondary outcomes (2)
Changes in foot pain & functionality as assessed by the Foot Health Status Questionnaire (FHSQ)
Foot Pain \& Functionality scores will be collected using the FHSQ or Foot Health Status Questionnaire. The Foot Health Status Questionnaire is designed to assess foot pain, foot health and its relation to quality of life. The questionnaire has four domains consisting of 13 key items. The four domains are; foot pain, foot function, footwear and general foot health. The current study will only use the 2 subsections of Foot Pain and Foot Function. In these subsections, participants will be required to rate foot pain in the last week from 1 (none) to 5 (severe), how often the participant experienced different types of foot pain during the last week from 1 (never) to 5 (always), how much the participants feet interfered with everyday activities in the last week from 1 (not at all) to 5 (extremely) and overall foot health from 1 (excellent) to 5 (poor). Previous research has found the FHSQ to exhibit a strong degree of context, criterion and construct validity with high retest reliability.
Measured: Baseline and 6 weeks
Fear of falling as assessed by the Falls Efficacy Scale International (FES-I) short.
Fear of falling will be measured using the Falls Efficacy Scale International (FES-I) short, The Falls Efficacy Scale-International (FES-I) (short) is a 7-item version of the FES-I. The questionnaire will ask participants to rate the concern about the possibility of falling when completing everyday tasks on a scale of 1 to 4 (where 1 = not at all concerned and 4 = very concerned). This version has been validated for community-dwelling older population. Furthermore, the short FES-I can predict future falls, muscle weakness, frailty and overall disability.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start23 Jul 2021
- Primary completion31 Aug 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Foot PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talita Cumi Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aetrex Worldwide Inc
- Responsible party
- Sponsor
- Investigators
- George Ampat, MBBS, MS, FRCS, Principal investigator, Talita Cumi Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894396
- Sponsor's protocol ID
- FFPETFETS003
- Status last verified
- May 2023
- First submitted
- 14 May 2021
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the study, data will be fully anonymised. Only non-identifiable, anonymised data will be archived along with the publication for use of other researchers. For instance, the age, sex, and study results of participants will be archived indefinitely as a supplementary document to the publication.
Publications
Menz HB. Chronic foot pain in older people. Maturitas. 2016 Sep;91:110-4. doi: 10.1016/j.maturitas.2016.06.011. Epub 2016 Jun 22.
PubMed 27451329Verma SK, Willetts JL, Corns HL, Marucci-Wellman HR, Lombardi DA, Courtney TK. Falls and Fall-Related Injuries among Community-Dwelling Adults in the United States. PLoS One. 2016 Mar 15;11(3):e0150939. doi: 10.1371/journal.pone.0150939. eCollection 2016.
PubMed 26977599Schoene D, Heller C, Aung YN, Sieber CC, Kemmler W, Freiberger E. A systematic review on the influence of fear of falling on quality of life in older people: is there a role for falls? Clin Interv Aging. 2019 Apr 24;14:701-719. doi: 10.2147/CIA.S197857. eCollection 2019.
PubMed 31190764Bennett PJ, Patterson C. The foot health status questionnaire (FHSQ): a new instrument for measuring outcomes of foot care. Australasian J Podiatr Med. 1998;32:55-9
Kempen GI, Yardley L, van Haastregt JC, Zijlstra GA, Beyer N, Hauer K, Todd C. The Short FES-I: a shortened version of the falls efficacy scale-international to assess fear of falling. Age Ageing. 2008 Jan;37(1):45-50. doi: 10.1093/ageing/afm157. Epub 2007 Nov 20.
PubMed 18032400Thomas MJ, Roddy E, Zhang W, Menz HB, Hannan MT, Peat GM. The population prevalence of foot and ankle pain in middle and old age: a systematic review. Pain. 2011 Dec;152(12):2870-2880. doi: 10.1016/j.pain.2011.09.019. Epub 2011 Oct 21.
PubMed 22019150Roddy E, Muller S, Thomas E. Onset and persistence of disabling foot pain in community-dwelling older adults over a 3-year period: a prospective cohort study. J Gerontol A Biol Sci Med Sci. 2011 Apr;66(4):474-80. doi: 10.1093/gerona/glq203. Epub 2010 Nov 24.
PubMed 21106703White EG, Mulley GP. Footcare for very elderly people: a community survey. Age Ageing. 1989 Jul;18(4):276-8. doi: 10.1093/ageing/18.4.275.
PubMed 2816562Friedman SM, Munoz B, West SK, Rubin GS, Fried LP. Falls and fear of falling: which comes first? A longitudinal prediction model suggests strategies for primary and secondary prevention. J Am Geriatr Soc. 2002 Aug;50(8):1329-35. doi: 10.1046/j.1532-5415.2002.50352.x.
PubMed 12164987Mulford D, Taggart HM, Nivens A, Payrie C. Arch support use for improving balance and reducing pain in older adults. Appl Nurs Res. 2008 Aug;21(3):153-8. doi: 10.1016/j.apnr.2006.08.006.
PubMed 18684409de Morais Barbosa C, Barros Bertolo M, Marques Neto JF, Bellini Coimbra I, Davitt M, de Paiva Magalhaes E. The effect of foot orthoses on balance, foot pain and disability in elderly women with osteoporosis: a randomized clinical trial. Rheumatology (Oxford). 2013 Mar;52(3):515-22. doi: 10.1093/rheumatology/kes300. Epub 2012 Nov 28.
PubMed 23192905Perry SD, Radtke A, McIlroy WE, Fernie GR, Maki BE. Efficacy and effectiveness of a balance-enhancing insole. J Gerontol A Biol Sci Med Sci. 2008 Jun;63(6):595-602. doi: 10.1093/gerona/63.6.595.
PubMed 18559634Riskowski JL, Hagedorn TJ, Hannan MT. Measures of foot function, foot health, and foot pain: American Academy of Orthopedic Surgeons Lower Limb Outcomes Assessment: Foot and Ankle Module (AAOS-FAM), Bristol Foot Score (BFS), Revised Foot Function Index (FFI-R), Foot Health Status Questionnaire (FHSQ), Manchester Foot Pain and Disability Index (MFPDI), Podiatric Health Questionnaire (PHQ), and Rowan Foot Pain Assessment (ROFPAQ). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S229-39. doi: 10.1002/acr.20554. No abstract available.
PubMed 22588747Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010 Mar;39(2):210-6. doi: 10.1093/ageing/afp225. Epub 2010 Jan 8.
PubMed 20061508
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial Comparing Prefabricated Orthotics With and Without Metatarsal Pad in Decreasing Pain and Fear of Falling in Older Adults
- ClinicalTrials.gov ID
- NCT04894396
- Acronym / sponsor ID
- FFPETFETS003
- Conditions
- Foot Pain, Foot Functionality, Fear of Falling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Talita Cumi Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Aetrex Worldwide Inc
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 20 May 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.
To investigate and compare the use of a prefabricated Orthotic, with and without a metatarsal pad in decreasing pain and fear of falling in older adults.
Detailed description
It is estimated that around 24% of community-dwelling adults over the age of 45 experience frequent foot pain. Falls and fear of falling are also significant issues in this population as both can result in avoidance of activities and decreased physical performance. In cases where fear of falling decreases physical performance and increases activity avoidance, it actually becomes a risk factor for falling itself.
Previous studies have shown that various types of Orthotic insoles improve balance and reduce lower-extremity pain in older adults. However, research which directly compares the effects of two different types of insoles is limited. Hence, this randomised control trial will investigate and compare the use of a prefabricated Orthotic, with and without a metatarsal pad, in decreasing pain and fear of falling in older adults.
This randomised control trial will be conducted over a 6-week period. The study population will include 206 participants who will be randomised into 2 groups (Group A and Group B). Participants in Group A will receive an Orthotic with a metatarsal pad and participants in Group B will receive a neutral Orthotic without the metatarsal pad. All participants will be required to continue with usual activities, using the Orthotic wherever possible for a period of 6 weeks. Participants will be asked to provide data in the form of completed surveys twice, once at the study onset and once at the end.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prefabricated Orthotics with metatarsal pad | Experimental | Device: Aetrex L2305 Premium Memory Foam Orthotics W/ Metatarsal SupportParticipants in Group A will receive the Orthotic with the metatarsal pad (L 2305) according to participants shoe size (https://www.aetrex.com/search?q=l2305\&search-button=\&lang=en_US). When the investigators provide the Orthotics, an instruction sheet will also be provided, explaining how to use the orthotic. Alternatively, an online video tutorial on how to use the Orthotic will also be available throughout the study. Participants will be required to use the Orthotic wherever possible for a period of 6 weeks, whilst continuing with usual activities. |
| Prefabricated Orthotics without metatarsal pad. | Active comparator | Device: Aetrex L2300 Premium Memory Foam OrthoticsParticipants in Group B will receive the neutral Orthotic with a cupped heel (L 2300) according to participants shoe size (https://www.aetrex.com/search?q=l2300\&search-button=\&lang=en_US). When the investigators provide the Orthotics, an instruction sheet will also be provided, explaining how to use the Orthotic. Alternatively, an online video tutorial on how to use the Orthotic will also be available throughout the study. Participants will be required to use the Orthotic wherever possible for a period of 6 weeks, whilst continuing with usual activities |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A least 60 years of age
- Live in a community-based setting
- Are capable of ambulation
- Have some form of self-identified foot pain
Key exclusion criteria (4 listed)
- Compromised skin integrity of the lower limbs
- Peripheral neuropathy and lack of sensation in the feet.
- Previous history of foot surgery and
- Inability to follow the instructions and procedures of the research protocol.
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 |
|---|---|---|
| Aetrex L2305 Premium Memory Foam Orthotics W/ Metatarsal SupportAn Orthotic insole to be inserted into shoes. Features Aetrex Arch Support to help biomechanically align the body \& help prevent common foot pain such as Plantar Fasciitis, Arch Pain and Metatarsalgia. For medium to high arches with forefoot pain, featuring a cupped heel to cushion and stabilize the back of foot and a metatarsal pad to redistribute weight to relieve ball-of-foot discomfort. With 43% more memory foam in the forefoot for those experiencing foot discomfort or fatigue. | Device | Prefabricated Orthotics with metatarsal pad |
| Aetrex L2300 Premium Memory Foam OrthoticsAn Orthotic insole to be inserted into shoes. Features Aetrex Arch Support to help biomechanically align the body \& help prevent common foot pain such as Plantar Fasciitis, Arch Pain and Metatarsalgia. With 43% more memory foam in the forefoot for those experiencing foot discomfort or fatigue. | Device | Prefabricated Orthotics without metatarsal pad. |
Primary outcome
Changes in pain as assessed by a Visual Analogue Scale (VAS)
Time frame: Baseline and 6 weeks
Pain scores will be collected using the Visual Analogue Scale (VAS) as follows: Levels of pain on a 0 to 10 scale with 0 representing no pain, 2 - mild pain, 5 - moderate pain, 7 - severe pain, and 10 represents extremely severe pain. Utilization of this scale is in line with previous research [and will measure pain in the feet, ankles, knees, hips, and lower back.
2 secondary outcomes
Changes in foot pain & functionality as assessed by the Foot Health Status Questionnaire (FHSQ)
Time frame: Baseline and 6 weeks
Fear of falling as assessed by the Falls Efficacy Scale International (FES-I) short.
Time frame: Baseline and 6 weeks
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 6 May 2023.
- Background: PubMed 27451329Menz HB. Chronic foot pain in older people. Maturitas. 2016 Sep;91:110-4. doi: 10.1016/j.maturitas.2016.06.011. Epub 2016 Jun 22.
- Background: PubMed 26977599Verma SK, Willetts JL, Corns HL, Marucci-Wellman HR, Lombardi DA, Courtney TK. Falls and Fall-Related Injuries among Community-Dwelling Adults in the United States. PLoS One. 2016 Mar 15;11(3):e0150939. doi: 10.1371/journal.pone.0150939. eCollection 2016.
- Background: PubMed 31190764Schoene D, Heller C, Aung YN, Sieber CC, Kemmler W, Freiberger E. A systematic review on the influence of fear of falling on quality of life in older people: is there a role for falls? Clin Interv Aging. 2019 Apr 24;14:701-719. doi: 10.2147/CIA.S197857. eCollection 2019.
- BackgroundBennett PJ, Patterson C. The foot health status questionnaire (FHSQ): a new instrument for measuring outcomes of foot care. Australasian J Podiatr Med. 1998;32:55-9
- Background: PubMed 18032400Kempen GI, Yardley L, van Haastregt JC, Zijlstra GA, Beyer N, Hauer K, Todd C. The Short FES-I: a shortened version of the falls efficacy scale-international to assess fear of falling. Age Ageing. 2008 Jan;37(1):45-50. doi: 10.1093/ageing/afm157. Epub 2007 Nov 20.
- Results publication: PubMed 22019150Thomas MJ, Roddy E, Zhang W, Menz HB, Hannan MT, Peat GM. The population prevalence of foot and ankle pain in middle and old age: a systematic review. Pain. 2011 Dec;152(12):2870-2880. doi: 10.1016/j.pain.2011.09.019. Epub 2011 Oct 21.
- Results publication: PubMed 21106703Roddy E, Muller S, Thomas E. Onset and persistence of disabling foot pain in community-dwelling older adults over a 3-year period: a prospective cohort study. J Gerontol A Biol Sci Med Sci. 2011 Apr;66(4):474-80. doi: 10.1093/gerona/glq203. Epub 2010 Nov 24.
- Results publication: PubMed 2816562White EG, Mulley GP. Footcare for very elderly people: a community survey. Age Ageing. 1989 Jul;18(4):276-8. doi: 10.1093/ageing/18.4.275.
- Results publication: PubMed 12164987Friedman SM, Munoz B, West SK, Rubin GS, Fried LP. Falls and fear of falling: which comes first? A longitudinal prediction model suggests strategies for primary and secondary prevention. J Am Geriatr Soc. 2002 Aug;50(8):1329-35. doi: 10.1046/j.1532-5415.2002.50352.x.
- Results publication: PubMed 18684409Mulford D, Taggart HM, Nivens A, Payrie C. Arch support use for improving balance and reducing pain in older adults. Appl Nurs Res. 2008 Aug;21(3):153-8. doi: 10.1016/j.apnr.2006.08.006.
- Results publication: PubMed 23192905de Morais Barbosa C, Barros Bertolo M, Marques Neto JF, Bellini Coimbra I, Davitt M, de Paiva Magalhaes E. The effect of foot orthoses on balance, foot pain and disability in elderly women with osteoporosis: a randomized clinical trial. Rheumatology (Oxford). 2013 Mar;52(3):515-22. doi: 10.1093/rheumatology/kes300. Epub 2012 Nov 28.
- Results publication: PubMed 18559634Perry SD, Radtke A, McIlroy WE, Fernie GR, Maki BE. Efficacy and effectiveness of a balance-enhancing insole. J Gerontol A Biol Sci Med Sci. 2008 Jun;63(6):595-602. doi: 10.1093/gerona/63.6.595.
- Individual participant dataSharing planned: Yes. At the end of the study, data will be fully anonymised. Only non-identifiable, anonymised data will be archived along with the publication for use of other researchers. For instance, the age, sex, and study results of participants will be archived indefinitely as a supplementary document to the publication.
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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.
George Ampat, MBBS, MS, FRCS principal investigator
Talita Cumi Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aetrex L2305 Premium Memory Foam Orthotics W/ Metatarsal Support and Aetrex L2300 Premium Memory Foam Orthotics in people with Foot Pain and Foot Functionality, run by Talita Cumi Ltd. at 1 site in United Kingdom.
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 4 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 6 May 2023. 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 Kingdom. 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.
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?
Changes in pain as assessed by a Visual Analogue Scale (VAS) (time frame: Baseline and 6 weeks). 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 NCT04894396, which also lists 14 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 6 May 2023.