Diabetic Peripheral NeuropathyNCT03195855
Foot and Ankle Mobilisation in Diabetic Peripheral Neuropathy
A study testing Manual therapy / joint mobilisations in people with Diabetic Peripheral Neuropathy and Limited Joint Mobility Syndrome, run by University of Plymouth at 1 site in United Kingdom.
Trial summary
Diabetes can affect the blood supply to the nerves in the legs. When this occurs a peripheral neuropathy can occur when the nerves carrying sensory information are affected. People with diabetic peripheral neuropathy have a high risk of foot ulceration and amputation which affects function and associated with high NHS… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Limited Joint Mobility Syndrome, Ankle Joint Range of Motion
- What is being tested?
- Manual therapy / joint mobilisations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 May 2018to 2 Jan 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type I or II diabetes with a moderate risk of foot ulceration as defined by i. Detection in less than <8/10 sites on the plantar aspect of the foot using a 10 g monofilament ii. Foot deformity defined and graded using a foot deformity score previously developed for people with diabetes (54) (Attached)
- Peripheral Neuropathy- This is defined according to NICE CG19 guidelines. Here, the ability to detect a 10g monofilament (Owen Mumford "neuropen", UK) at 5 sites per foot on the plantar aspect of the toes (1,3 and 5) and metatarsophalangeal joints (1 and 5) is tested. No feeling in less than 8 sites indicates increased risk of foot ulceration (55)
- Ankle joint stiffness: Static, non-weight bearing ankle dorsiflexion will be measured using goniometry (56). Ankle joint stiffness will be defined as 0 or less ankle dorsiflexion (14, 57) due to recent evidence that these patients are more likely to exhibit limited ankle dorsiflexion of <10 degrees during gait (58).
- Hallux joint stiffness (hallux limitus): Hallux dorsiflexion will be measured using goniometry and will be defined as <10 degrees of available dorsiflexion at the hallux during weight bearing (59, 60).
- Able to walk for 10 meters with or without using a walking aid
- Able to attend 6 sessions over a 6 week period
- Age >18 yrs
Who cannot join
- Plantar Ulceration: People with a current ulceration will be excluded from the study.
- Rheumatoid arthritis, ankle and 1st MTP osteoarthritis or Dupuytren's contractures as determined from medical notes and participants subjective response.
- Excessive distal lower limb oedema preventing mobilisation rated visually according to criteria (63). People with >+2 pitting oedema in whom it is not possible to palpate the joint line will also be excluded from the study.
- History of lower limb injury in the past three months, or leg fracture/surgery in last year
- Osteoporosis as determined by the medical notes
- Prolonged (>1 yr.) history of steroid use
Show all 10Show fewer
- Major amputation of lower limb
- Minor foot digits amputation
- Charcot arthropathy - both stages of acute (determined by the clinical signs of unilateral swelling, elevated skin temperature, erythema and joint effusion in the foot or ankle (61)) and chronic.
- Additional neurological or oncological conditions affecting the lower limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Foot and Ankle Joint Mobilisation Combined With a Home Programme of Ankle Stretches on Joint Range of Motion and Forefoot Peak Plantar Pressures in People With Diabetic Peripheral Neuropathy: a Randomized Controlled Trial
Diabetes can affect the blood supply to the nerves in the legs. When this occurs a peripheral neuropathy can occur when the nerves carrying sensory information are affected. People with diabetic peripheral neuropathy have a high risk of foot ulceration and amputation which affects function and associated with high NHS and social care costs. People with diabetes can also have reduced movement at joints caused by increased stiffness in connective tissue. Reductions in ankle and big toe movement leads to increases in the pressure over the sole on the front part of the foot (the forefoot) when walking; this is a risk factor for ulceration.
The study will to assess whether ankle and big toe joint mobilisations and home program of stretches in people with diabetic peripheral neuropathy improves joint range of motion and reduces forefoot peak pressures.
Read more
Fifty eight people with diabetic peripheral neuropathy and a moderate risk of plantar ulceration will be recruited from a local podiatry clinic. They will be randomly assigned to an intervention (29 people) or control group (29 people). We will control for between-group differences in age using a minimization process. The intervention will consist of a 6 week program of ankle and big toe joint mobilisation by a physiotherapist and home stretches. The control group will consist of usual care including podiatry interventions.
Outcome measures will be taken at baseline, post intervention and at 3 month follow up by an assessor who does not know the group allocation. Primary outcome will be ankle range while walking with secondary outcomes including big toe joint range, forefoot pressure while walking and balance.
Changes over time between the groups will be compared statistically and the relationship between ankle range of motion and peak plantar pressure will be analysed using linear regression.
- Conditions
- Diabetic Peripheral Neuropathy, Limited Joint Mobility Syndrome, Ankle Joint Range of Motion, Forefoot Peak Plantar Pressure, Foot and Ankle Mobilisations, Home Exercise Programme / Stretches
- Being tested
- Manual therapy / joint mobilisations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy / joint mobilisationsOther
Also called Home exercise programme / stretches
Manual therapy is a common form of treatment employed usually by physiotherapists, in order to help increase range of motion of a specific joint region by restoring the arthrokinematic accessory gliding and rolling movement that is associated with normal joint movement. The hypothesised mechanism of action for this is that improvements of gliding and rolling will normalise osteokinematic rotation and consequently enable the normalisation of active movements. Another possible mechanism of action of mobilisations includes increasing the extensibility of the noncontractile capsular and ligamentous tissues. The effectiveness of passive accessory gliding techniques to increase joint ROM has been widely explored in the literature; with some studies revealing an increase in ankle dorsiflexion and others no change in ankle dorsiflexion. However, the subjects taking part in these studies were people without diabetes and mostly people with ankle sprains or ankle instability.
| Study group | Role | What they receive |
|---|---|---|
| Ankle and big toe mobilisations combined with home stretches | Experimental | Intervention group (n=29):
This group will undertake talocural and 1st MTP joint mobilisations (x1/week for 6 weeks) and a 6 week home programme of stretching exercises.
1. Mobilisations: In our study, a traction intervention consisting of two, 2-min sets of Maitland grade II joint traction will precede 2-min sets of Maitland grade III mobilisations with one minute rest in between sets. Four sets will be performed for the ankle and two for the MTP. This protocol has been used previously (19, 43). The direction of mobilisation force will be parallel to the treatment plane and perpendicular to the treatment plane during traction (75).
2. Home Program: There will be 3 stretches prescribed (gastrocnemius, soleus and plantar fascia). Participants will be recommended to undertake three consecutive static stretches for 20-30s with a 1 minute rest period (76). Stretches will occur in standing. Receives: Other: Manual therapy / joint mobilisations |
| Control group of usual care including podiatry | No intervention | Control group (n=29): Usual care including regular monitoring of foot health by podiatrists as indicated by NICE (NG19) guidelines (78). A review of current clinical practice within the podiatry clinic indicates that people with moderate/intermediate risk are reviewed every 3 months. Interventions include nail care, callus debridement and foot care advice. In both groups, interventions delivered by podiatrists in the study period will be determined from the clinic notes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum ankle range of dorsiflexion in stance phase when both feet are in contact with the ground (double support phase).
Measured: The change of maximum dorsiflexion between immediate treatment effects (week 6) and at 3-months post intervention follow-up period (week 18).
Secondary outcomes (10)
Change in maximum ankle dorsiflexion during swing phase of walking as measured by 3D motion analysis.
Measured: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Change in total ankle range of motion during the stance phase of walking as measured by 3D motion analysis
Measured: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Walking forefoot peak plantar pressures will be measured using an in-shoe system (F Scan UK)
Measured: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Change in maximum static ankle dorsiflexion range
Measured: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Change in maximum 1st MTP dorsiflexion range in quiet standing
Measured: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Walking speed -maximal walking speed over 10 m
Measured: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Stride length
Measured: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Walking ability
12 item walking scale
Measured: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Change in postural sway
Postural sway will me measured with posturography
Measured: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Change in functional reach test
Functional reach test will be measured using a yardstick mounted on the wall at shoulder height
Measured: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start11 May 2018
- Primary completion4 Apr 2019
- Study completion2 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral NeuropathyStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr Vasileios Lepesis, University of Plymouth
- Investigators
- Vasileios Lepesis, Principal investigator, Plymouth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195855
- Sponsor's protocol ID
- FHHS-228115-VL-026
- Status last verified
- May 2022
- First submitted
- 13 Jun 2017
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lepesis V, Paton J, Rickard A, Latour JM, Marsden J. Effects of foot and ankle mobilisations combined with home stretches in people with diabetic peripheral neuropathy: a proof-of-concept RCT. J Foot Ankle Res. 2023 Dec 6;16(1):88. doi: 10.1186/s13047-023-00690-4.
PubMed 38057930
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Foot and Ankle Joint Mobilisation Combined With a Home Programme of Ankle Stretches on Joint Range of Motion and Forefoot Peak Plantar Pressures in People With Diabetic Peripheral Neuropathy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03195855
- Acronym / sponsor ID
- FHHS-228115-VL-026
- Conditions
- Diabetic Peripheral Neuropathy, Limited Joint Mobility Syndrome, Ankle Joint Range of Motion, Forefoot Peak Plantar Pressure, Foot and Ankle Mobilisations, Home Exercise Programme / Stretches
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Study start
- 11 May 2018 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 2 Jan 2022 (actual)
- First posted
- 22 Jun 2017 (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.
Diabetes can affect the blood supply to the nerves in the legs. When this occurs a peripheral neuropathy can occur when the nerves carrying sensory information are affected. People with diabetic peripheral neuropathy have a high risk of foot ulceration and amputation which affects function and associated with high NHS and social care costs. People with diabetes can also have reduced movement at joints caused by increased stiffness in connective tissue. Reductions in ankle and big toe movement leads to increases in the pressure over the sole on the front part of the foot (the forefoot) when walking; this is a risk factor for ulceration.
The study will to assess whether ankle and big toe joint mobilisations and home program of stretches in people with diabetic peripheral neuropathy improves joint range of motion and reduces forefoot peak pressures.
Fifty eight people with diabetic peripheral neuropathy and a moderate risk of plantar ulceration will be recruited from a local podiatry clinic. They will be randomly assigned to an intervention (29 people) or control group (29 people). We will control for between-group differences in age using a minimization process. The intervention will consist of a 6 week program of ankle and big toe joint mobilisation by a physiotherapist and home stretches. The control group will consist of usual care including podiatry interventions.
Outcome measures will be taken at baseline, post intervention and at 3 month follow up by an assessor who does not know the group allocation. Primary outcome will be ankle range while walking with secondary outcomes including big toe joint range, forefoot pressure while walking and balance.
Changes over time between the groups will be compared statistically and the relationship between ankle range of motion and peak plantar pressure will be analysed using linear regression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankle and big toe mobilisations combined with home stretches | Experimental | Other: Manual therapy / joint mobilisationsIntervention group (n=29): This group will undertake talocural and 1st MTP joint mobilisations (x1/week for 6 weeks) and a 6 week home programme of stretching exercises. 1. Mobilisations: In our study, a traction intervention consisting of two, 2-min sets of Maitland grade II joint traction will precede 2-min sets of Maitland grade III mobilisations with one minute rest in between sets. Four sets will be performed for the ankle and two for the MTP. This protocol has been used previously (19, 43). The direction of mobilisation force will be parallel to the treatment plane and perpendicular to the treatment plane during traction (75). 2. Home Program: There will be 3 stretches prescribed (gastrocnemius, soleus and plantar fascia). Participants will be recommended to undertake three consecutive static stretches for 20-30s with a 1 minute rest period (76). Stretches will occur in standing. |
| Control group of usual care including podiatry | No intervention | –Control group (n=29): Usual care including regular monitoring of foot health by podiatrists as indicated by NICE (NG19) guidelines (78). A review of current clinical practice within the podiatry clinic indicates that people with moderate/intermediate risk are reviewed every 3 months. Interventions include nail care, callus debridement and foot care advice. In both groups, interventions delivered by podiatrists in the study period will be determined from the clinic notes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of type I or II diabetes with a moderate risk of foot ulceration as defined by i. Detection in less than <8/10 sites on the plantar aspect of the foot using a 10 g monofilament ii. Foot deformity defined and graded using a foot deformity score previously developed for people with diabetes (54) (Attached)
- Peripheral Neuropathy- This is defined according to NICE CG19 guidelines. Here, the ability to detect a 10g monofilament (Owen Mumford "neuropen", UK) at 5 sites per foot on the plantar aspect of the toes (1,3 and 5) and metatarsophalangeal joints (1 and 5) is tested. No feeling in less than 8 sites indicates increased risk of foot ulceration (55)
- Ankle joint stiffness: Static, non-weight bearing ankle dorsiflexion will be measured using goniometry (56). Ankle joint stiffness will be defined as 0 or less ankle dorsiflexion (14, 57) due to recent evidence that these patients are more likely to exhibit limited ankle dorsiflexion of <10 degrees during gait (58).
- Hallux joint stiffness (hallux limitus): Hallux dorsiflexion will be measured using goniometry and will be defined as <10 degrees of available dorsiflexion at the hallux during weight bearing (59, 60).
- Able to walk for 10 meters with or without using a walking aid
Key exclusion criteria (10 listed)
- Plantar Ulceration: People with a current ulceration will be excluded from the study.
- Rheumatoid arthritis, ankle and 1st MTP osteoarthritis or Dupuytren's contractures as determined from medical notes and participants subjective response.
- Excessive distal lower limb oedema preventing mobilisation rated visually according to criteria (63). People with >+2 pitting oedema in whom it is not possible to palpate the joint line will also be excluded from the study.
- History of lower limb injury in the past three months, or leg fracture/surgery in last year
- Osteoporosis as determined by the medical notes
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 |
|---|---|---|
| Manual therapy / joint mobilisationsAlso: Home exercise programme / stretchesManual therapy is a common form of treatment employed usually by physiotherapists, in order to help increase range of motion of a specific joint region by restoring the arthrokinematic accessory gliding and rolling movement that is associated with normal joint movement. The hypothesised mechanism of action for this is that improvements of gliding and rolling will normalise osteokinematic rotation and consequently enable the normalisation of active movements. Another possible mechanism of action of mobilisations includes increasing the extensibility of the noncontractile capsular and ligamentous tissues. The effectiveness of passive accessory gliding techniques to increase joint ROM has been widely explored in the literature; with some studies revealing an increase in ankle dorsiflexion and others no change in ankle dorsiflexion. However, the subjects taking part in these studies were people without diabetes and mostly people with ankle sprains or ankle instability. | Other | Ankle and big toe mobilisations combined with home stretches |
Primary outcome
Change in maximum ankle range of dorsiflexion in stance phase when both feet are in contact with the ground (double support phase).
Time frame: The change of maximum dorsiflexion between immediate treatment effects (week 6) and at 3-months post intervention follow-up period (week 18).
10 secondary outcomes
Change in maximum ankle dorsiflexion during swing phase of walking as measured by 3D motion analysis.
Time frame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Change in total ankle range of motion during the stance phase of walking as measured by 3D motion analysis
Time frame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Walking forefoot peak plantar pressures will be measured using an in-shoe system (F Scan UK)
Time frame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Change in maximum static ankle dorsiflexion range
Time frame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Change in maximum 1st MTP dorsiflexion range in quiet standing
Time frame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Walking speed -maximal walking speed over 10 m
Time frame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Stride length
Time frame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Walking ability
Time frame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Change in postural sway
Time frame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
Change in functional reach test
Time frame: The following measure will be taken at across two time periods: i) immediate effects after the intervention (change between week 0-6) and ii) 3-month post intervention follow up period (change between week 0-18).
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 24 May 2022.
- Derived from this study: PubMed 38057930Lepesis V, Paton J, Rickard A, Latour JM, Marsden J. Effects of foot and ankle mobilisations combined with home stretches in people with diabetic peripheral neuropathy: a proof-of-concept RCT. J Foot Ankle Res. 2023 Dec 6;16(1):88. doi: 10.1186/s13047-023-00690-4.
- Individual participant dataSharing planned: No
Related trials for Diabetic Peripheral Neuropathy
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
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.
Vasileios Lepesis principal investigator
Plymouth 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 Manual therapy / joint mobilisations in people with Diabetic Peripheral Neuropathy and Limited Joint Mobility Syndrome, run by University of Plymouth 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 7 inclusion and 10 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 24 May 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 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?
Change in maximum ankle range of dorsiflexion in stance phase when both feet are in contact with the ground (double support phase). (time frame: The change of maximum dorsiflexion between immediate treatment effects (week 6) and at 3-months post intervention follow-up period (week 18).). 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 NCT03195855, which also lists 1 linked publication.
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 24 May 2022.