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| ID | Type | Description | Link |
|---|---|---|---|
| 129586 | Registry Identifier | Integrated Reasearch Application System |
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| Name | Class |
|---|---|
| Queen Margaret University | OTHER |
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This study compares manipulative therapy to steroid injection in the treatment of Morton's Neuroma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| steroid injection | Active Comparator | 1 injection of 1mL methylprednisolone [40mg]with 1 mL 2% lignocaine |
|
| manual manipulation | Experimental | weekly manipulations to the metatarsophalangeal joints of the forefoot for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylprednisolone | Drug | a single injection of 1 mL methylprednisolone [40 mg] and 1 mL 2% lignocaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | pre treatment at each clinic visit and then 3,6,9 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | pre treatment at each clinic visit and then 3,6,9 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Foot function index questionnaire | A questionnaire to establish subjects level of function, pain and mobility changes over time | pre treatment at each clinic visit and then 3,6,9 and 12 months |
| Manchester Oxford Foot Pain Questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David G Cashley, BSc(Hons)Pod | Queen Margaret University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Podiatry Department NHS Lothian | Edinburgh | Lothian | EH3 9AU | United Kingdom |
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| ID | Term |
|---|---|
| D000070607 | Morton Neuroma |
| D009408 | Nerve Compression Syndromes |
| ID | Term |
|---|---|
| D037061 | Metatarsalgia |
| D005534 | Foot Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D000077555 | Methylprednisolone Acetate |
| D008012 | Lidocaine |
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| manual manipulation | Procedure | The lesser MTPJs of the affected foot will be manually manipulated using a high velocity, low amplitude thrust technique. |
|
|
Patient reported outcome measurement tool to measure changes in foot pain over time
| pre treatment at each clinic visit and then 3,6,9 and 12 months |
| Short Form 36 pain and disability Questionnaire | A quality of life questionnaire | pre treatment at each clinic visit and then 3,6,9 and 12 months |
| D009437 |
| Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |