Morton NeuromaNCT05707572
Morton's Neuroma: Manipulation Versus Steroid Injection
A study testing methylprednisolone and manual manipulation in people with Morton Neuroma, run by Dundee Podiatry Clinic at 1 site in United Kingdom.
Trial summary
This study compares manipulative therapy to steroid injection in the treatment of Morton's Neuroma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morton Neuroma
- What is being tested?
- methylprednisolone and manual manipulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to 30 Sep 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of morton's neuroma
- over 18 years of age
- presenting VAS score > 30mm
Who cannot join
- diabetes,
- rheumatoid arthritis
- fibromyalgia.
- Those currently taking Statins or analgesics
- previous neuroma surgery
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Podiatry Department NHS Lothian
Edinburgh, Lothian, EH3 9AU
About this study
Official title: Manipulation Versus Steroid Injection in the Treatment of Morton's Neuroma
This study compares manipulative therapy to steroid injection in the treatment of Morton's Neuroma.
Read the detailed description
The aim of this study is to establish whether manipulative therapy is an effective treatment for Morton's neuroma, a nerve entrapment in the foot. Steroid injection is the current gold standard conservative treatment for this condition. Therefore, a subject group shall be compared to a steroid injection intervention group. Outcomes will be compared using visual analogue pain scales -VAS, Foot Function Index questionnaires and algometric pressure threshold testing. An improvement in the manipulation group VAS of 20mm above the injection group shall be considered as the minimum worthwhile change as this has been identified as the minimum clinically important difference in pain between treatment groups in visual analogue pain scales.
- Conditions
- Morton Neuroma
- Being tested
- methylprednisolone, manual manipulation
- Keywords
- manipulation, plantar digital neuritis, morton's neuroma, nerve entrapment, foot
- Medical subject headings
- Morton Neuroma, Nerve Compression Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Depo-Medrone with Lidocaine (40mg + 10mg)/ml
a single injection of 1 mL methylprednisolone [40 mg] and 1 mL 2% lignocaine
manual manipulationProcedure or surgery
Also called adjustment
The lesser MTPJs of the affected foot will be manually manipulated using a high velocity, low amplitude thrust technique.
| Study group | Role | What they receive |
|---|---|---|
| steroid injection | Active comparator | 1 injection of 1mL methylprednisolone [40mg]with 1 mL 2% lignocaine Receives: Drug: methylprednisolone |
| manual manipulation | Experimental | weekly manipulations to the metatarsophalangeal joints of the forefoot for 6 weeks Receives: Procedure: manual manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue pain scale
Measuring changes in self reported pain over time. 100mm scale with anchored prompts of "no pain" at 0mm and "worst pain ever" at 100mm
Measured: pre treatment at each clinic visit and then 3,6,9 and 12 months
Secondary outcomes (1)
Algometric pressure threshold meter
Measuring changes in pressure tolerance over time. A meter which reads how much change in pressure a joint can withstand before it registers discomfort
Measured: pre treatment at each clinic visit and then 3,6,9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study startSep 2014
- Primary completionSep 2018
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morton NeuromaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dundee Podiatry Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Margaret University
- Responsible party
- Sponsor
- Investigators
- David G Cashley, BSc(Hons)Pod, Principal investigator, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707572
- Sponsor's protocol ID
- PDN001
- Other IDs
- 129586
- Status last verified
- Jan 2023
- First submitted
- 24 Jul 2018
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manipulation Versus Steroid Injection in the Treatment of Morton's Neuroma
- ClinicalTrials.gov ID
- NCT05707572
- Acronym / sponsor ID
- PDN001
- Conditions
- Morton Neuroma
- Keywords
- manipulation, plantar digital neuritis, morton's neuroma, nerve entrapment, foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Dundee Podiatry ClinicUniversity, hospital or other
- Collaborators
- Queen Margaret University
- Study start
- Sep 2014 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 1 Feb 2023 (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.
This study compares manipulative therapy to steroid injection in the treatment of Morton's Neuroma.
Detailed description
The aim of this study is to establish whether manipulative therapy is an effective treatment for Morton's neuroma, a nerve entrapment in the foot. Steroid injection is the current gold standard conservative treatment for this condition. Therefore, a subject group shall be compared to a steroid injection intervention group. Outcomes will be compared using visual analogue pain scales -VAS, Foot Function Index questionnaires and algometric pressure threshold testing. An improvement in the manipulation group VAS of 20mm above the injection group shall be considered as the minimum worthwhile change as this has been identified as the minimum clinically important difference in pain between treatment groups in visual analogue pain scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| steroid injection | Active comparator | Drug: methylprednisolone1 injection of 1mL methylprednisolone [40mg]with 1 mL 2% lignocaine |
| manual manipulation | Experimental | Procedure: manual manipulationweekly manipulations to the metatarsophalangeal joints of the forefoot for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of morton's neuroma
- over 18 years of age
- presenting VAS score > 30mm
Key exclusion criteria (5 listed)
- diabetes,
- rheumatoid arthritis
- fibromyalgia.
- Those currently taking Statins or analgesics
- previous neuroma surgery
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 |
|---|---|---|
| methylprednisoloneAlso: Depo-Medrone with Lidocaine (40mg + 10mg)/mla single injection of 1 mL methylprednisolone [40 mg] and 1 mL 2% lignocaine | Drug | steroid injection |
| manual manipulationAlso: adjustmentThe lesser MTPJs of the affected foot will be manually manipulated using a high velocity, low amplitude thrust technique. | Procedure or surgery | manual manipulation |
Primary outcome
Visual analogue pain scale
Time frame: pre treatment at each clinic visit and then 3,6,9 and 12 months
Measuring changes in self reported pain over time. 100mm scale with anchored prompts of "no pain" at 0mm and "worst pain ever" at 100mm
1 secondary outcome
Algometric pressure threshold meter
Time frame: pre treatment at each clinic visit and then 3,6,9 and 12 months
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 1 Feb 2023.
Related trials for Morton Neuroma
Not yet recruitingPhase 2
NAC-REPAIR for Post-surgical Pain
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Recruiting
Comparative Effectiveness of Cryoablation Versus Steroid and Lidocaine Alone for Treatment of Morton's Neuroma
Morton Neuroma
Enrolling by invitation
US and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma
Intermetatarsal Bursitis, Morton Neuroma
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.
David G Cashley, BSc(Hons)Pod principal investigator
Queen Margaret 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 methylprednisolone and manual manipulation in people with Morton Neuroma, run by Dundee Podiatry Clinic 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 3 inclusion and 5 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 1 Feb 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?
Visual analogue pain scale (time frame: pre treatment at each clinic visit and then 3,6,9 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2023.