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Back pain is a common secondary condition of both acute and chronic spinal cord injury (SCI). Current existing treatment including both pharmacologic and non-pharmacologic are limited by marginal efficacy or intolerable side effects. The purpose of this study is to evaluate the potential of subcutaneous injections of botulinum toxin A to provide pain relief in spinal cord injury patients with back pain near the level of injury in the spine. Botulinum toxin A has been shown in both pre-clinical and clinical studies to help with nerve pain. The researchers propose a double blinded placebo controlled crossover study to study the effects of subcutaneous botulinum injections to at--level SCI back pain in patients with spinal cord injury.
In this study, there will be 2 procedure performed. The first procedure will be named P1 and consists of subcutaneous injection of either placebo or Botulinum Toxin A. The second procedure will be the cross-over procedure named P2. For the cross-over procedure, the subjects who had initially received Botulinum Toxin A will receive placebo and the subjects who had initially received placebo will receive Botulinum Toxin A. This is a Randomized Double-Blinded Placebo Controlled Trial. Recruited subjects will be consented, enrolled and evaluated immediately prior to P1 (or during a visit prior to the visit for P1). After the initial pre-treatment evaluation, subjects will randomly receive either placebo or Botulinum Toxin A subcutaneously (P1). A telephone follow-up (or e-mail follow up) will be performed at 2 weeks and 8 weeks post- P1. An onsite follow up will be performed 4 weeks post P1 and 12 weeks post P1.
Cross-over Study: After the 3rd month on-site evaluation (12 weeks post P1), during the same visit, the subject will proceed to the cross-over study. At this time, the patient will have the option to receive a repeat subcutaneous injection of the cross-over agent. If they desire one, a subcutaneous injection of the cross-over agent will be performed at that same visit. If they wish to defer the repeat injection, they will be contacted and asked every 4 weeks - between 12 weeks and 24 weeks post P1 (no subject will receive P2 after week 24) if they would like to have the subcutaneous injection of the cross-over agent. If they desire one, a repeat injection will be scheduled for the following week.
The rationale for a variable length of time after the initial Botulinum Toxin A/Placebo injection (P1) is to document the variability of individuals' pain response after Botulinum Toxin A. It has been reported in literature, of the subjects that respond to subcutaneous Botulinum Toxin A injections for pain, most will return to their base-line pain score in 12--24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin A | Active Comparator | Each vial of botulin toxin (100U, BOTOX, Allergan) will be reconstituted with 4ml non-preserved saline solution (0.9%) as recommended by the manufacturer (concentration of 5 units Botulinum Toxin A/0.2ml). Each injection will be 0.2mL (BOTOX, 5 units), administered through a 25 gauge needle. The marked area will have subcutaneous injections, each separated by a radius of 1 cm, from the other injections into the marked area,(maximum of 80 injections, 400 Units). |
|
| Placebo | Placebo Comparator | Placebo consists of 0.9% normal saline. Each injection will be 0.2mL, administered with a 25 gauge needle subcutaneously into the affected area. The marked area will have subcutaneous injections (maximum of 80) each separated from the surrounding ones by a radius of 1 cm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin A | Drug | Subjects will receive subcutaneous Botulinum Toxin A injections into the marked painful region. The syringes will be prepared by a third party prior to the injection and the administrator of the procedure will be blinded to syringe content. This physician will be performing the injections under sterile conditions. Local anesthesia, EMLA (lignocaine/prilocaine eutectic mixture) cream, up to 4 grams, will be applied topically for local anesthesia. After 50 minutes, the cream will be cleaned off. Overlying skin will be sterilized with either betadine or alcohol solution. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | Participant rated pain intensity from 0-10, with higher score indicating more pain | up to 12 weeks post-injection, for a total of 24 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | Mean change from baseline. Participants are asked "Taking into account your pain level and how it affects your life, are you feeling better, the same or worse than when you started treatment?" and then to quantify the magnitude of the change. with the 7-Point guy Farrar which measures the global treatment effect from with scale from 0 to 6, higher score indicates worse outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Bryce, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12791431 | Background | Siddall PJ, McClelland JM, Rutkowski SB, Cousins MJ. A longitudinal study of the prevalence and characteristics of pain in the first 5 years following spinal cord injury. Pain. 2003 Jun;103(3):249-257. doi: 10.1016/S0304-3959(02)00452-9. | |
| 15520972 | Background | Cardenas DD, Bryce TN, Shem K, Richards JS, Elhefni H. Gender and minority differences in the pain experience of people with spinal cord injury. Arch Phys Med Rehabil. 2004 Nov;85(11):1774-81. doi: 10.1016/j.apmr.2004.04.027. |
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The following will be shared: demographic information, pain response to interventions, adverse events and functional outcomes. The above information will be obtain in the forms of questionnaires and surveys. The data will be available when the study concludes.
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin A Then Placebo | Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks, then Placebo 0.2mL of 0.9% normal saline for 12 weeks. |
| FG001 | Placebo Then Botulinum Toxin A | Placebo 0.2mL of 0.9% normal saline for 12 weeks, then Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First 12 Weeks |
| |||||||||||||
| Crossover Next 12 Weeks |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin A Then Placebo | Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks, then Placebo 0.2mL of 0.9% normal saline for 12 weeks. |
| BG001 | Placebo Then Botulinum Toxin A |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Numeric Pain Rating Scale (NPRS) | Participant rated pain intensity from 0-10, with higher score indicating more pain | only those who completed crossover were included | Posted | Mean | Standard Deviation | score on a scale | up to 12 weeks post-injection, for a total of 24 weeks from baseline |
|
24 weeks post injection
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Botulinum Toxin A | Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| thrombosed IVCF | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fever | Infections and infestations | MedDRA (10.0) | Systematic Assessment | Not close to time of injection |
Target number of participants needed to achieve target power and statistically reliable results not reached. Unsuccessful questionnaires post injection
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Bryce | Icahn School of Medicine at Mount Sinai | 212-241-6321 | thomas.bryce@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 29, 2015 | Feb 2, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 29, 2015 | Feb 2, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009437 | Neuralgia |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| Placebo | Drug | Subjects will receive subcutaneous placebo injections into the marked painful region. The syringes will be prepared by a third party prior to the injection and the administrator of the procedure will be blinded to syringe content. This physician will be performing the injections under sterile conditions. Local anesthesia, EMLA (lignocaine/prilocaine eutectic mixture) cream, up to 4 grams, will be applied topically for local anesthesia. After 50 minutes, the cream will be cleaned off. Overlying skin will be sterilized with either betadine or alcohol solution. |
|
| up to 12 weeks post-injection, for a total of 24 weeks from baseline |
| International Basic Pain Dataset - Pain Affecting Day-to-day Activities | The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting day-to-day activities subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes. | up to 12 weeks post-injection, for a total of 24 weeks from baseline |
| International Basic Pain Dataset - Pain Affecting Mood | The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting mood subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes. | up to 12 weeks post-injection, for a total of 24 weeks from baseline |
| International Basic Pain Dataset - Pain Affecting Sleep | The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting sleep subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes. | up to 12 weeks post-injection, for a total of 24 weeks from baseline |
| Static Mechanical Allodynia Testing | Mechanical allodynia is a characteristic of evoked pain in subjects with neuropathic pain. Static allodynia to mechanical stimuli will be defined as a sensation of pain evoked by the pressure of the end of a wooden stick. The end of a wooden stick will touch the affected region with enough pressure to indent the skin, for 10 seconds. Afterwards, the subject will be asked to rate the perceived pain on an 11-point NRS. | up to 12 weeks post-injection, for a total of 24 weeks from baseline |
| Dynamic Mechanical Allodynia Testing | Dynamic allodynia will be tested by stroking the affected region gently with a cotton swab, 4 times at a rate of 3-5cm per second over an area of 5cm. If there is an evoked clear sensation of pain, the subject is asked to rate the intensity of dynamic allodynia using the 11-point NRS. The region of static and dynamic allodynia, if present, will be marked and recorded | up to 12 weeks post-injection, for a total of 24 weeks from baseline |
| Patient-generated Index (PGI) | PGI measures activity affected by pain. Full score is 0 to 10000, with higher score indicating better function | up to 12 weeks post-injection, for a total of 24 weeks from baseline |
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| 22716282 | Background | Fabregat G, Asensio-Samper JM, Palmisani S, Villanueva-Perez VL, De Andres J. Subcutaneous botulinum toxin for chronic post-thoracotomy pain. Pain Pract. 2013 Mar;13(3):231-4. doi: 10.1111/j.1533-2500.2012.00569.x. Epub 2012 Jun 21. |
| 21076878 | Background | Zhang T, Adatia A, Zarin W, Moitri M, Vijenthira A, Chu R, Thabane L, Kean W. The efficacy of botulinum toxin type A in managing chronic musculoskeletal pain: a systematic review and meta analysis. Inflammopharmacology. 2011 Feb;19(1):21-34. doi: 10.1007/s10787-010-0069-x. Epub 2010 Nov 13. |
| 21134116 | Background | Argoff C. The emerging use of botulinum toxins for the treatment of neuropathic pain. Pain Med. 2010 Dec;11(12):1750-2. doi: 10.1111/j.1526-4637.2010.00997.x. No abstract available. |
| 18164334 | Background | Lew HL, Lee EH, Castaneda A, Klima R, Date E. Therapeutic use of botulinum toxin type A in treating neck and upper-back pain of myofascial origin: a pilot study. Arch Phys Med Rehabil. 2008 Jan;89(1):75-80. doi: 10.1016/j.apmr.2007.08.133. |
| 21958302 | Background | Jabbari B, Machado D. Treatment of refractory pain with botulinum toxins--an evidence-based review. Pain Med. 2011 Nov;12(11):1594-606. doi: 10.1111/j.1526-4637.2011.01245.x. Epub 2011 Sep 29. |
| 16712627 | Background | Jabbari B, Ney J, Sichani A, Monacci W, Foster L, Difazio M. Treatment of refractory, chronic low back pain with botulinum neurotoxin A: an open-label, pilot study. Pain Med. 2006 May-Jun;7(3):260-4. doi: 10.1111/j.1526-4637.2006.00147.x. |
| 1356988 | Background | McMahon HT, Foran P, Dolly JO, Verhage M, Wiegant VM, Nicholls DG. Tetanus toxin and botulinum toxins type A and B inhibit glutamate, gamma-aminobutyric acid, aspartate, and met-enkephalin release from synaptosomes. Clues to the locus of action. J Biol Chem. 1992 Oct 25;267(30):21338-43. |
| 10665805 | Background | Welch MJ, Purkiss JR, Foster KA. Sensitivity of embryonic rat dorsal root ganglia neurons to Clostridium botulinum neurotoxins. Toxicon. 2000 Feb;38(2):245-58. doi: 10.1016/s0041-0101(99)00153-1. |
| 14979881 | Background | Durham PL, Cady R, Cady R. Regulation of calcitonin gene-related peptide secretion from trigeminal nerve cells by botulinum toxin type A: implications for migraine therapy. Headache. 2004 Jan;44(1):35-42; discussion 42-3. doi: 10.1111/j.1526-4610.2004.04007.x. |
| 17666428 | Background | Meng J, Wang J, Lawrence G, Dolly JO. Synaptobrevin I mediates exocytosis of CGRP from sensory neurons and inhibition by botulinum toxins reflects their anti-nociceptive potential. J Cell Sci. 2007 Aug 15;120(Pt 16):2864-74. doi: 10.1242/jcs.012211. Epub 2007 Jul 31. |
| 15909179 | Background | Planells-Cases R, Garcia-Sanz N, Morenilla-Palao C, Ferrer-Montiel A. Functional aspects and mechanisms of TRPV1 involvement in neurogenic inflammation that leads to thermal hyperalgesia. Pflugers Arch. 2005 Oct;451(1):151-9. doi: 10.1007/s00424-005-1423-5. Epub 2005 May 21. |
| 15066994 | Background | Morenilla-Palao C, Planells-Cases R, Garcia-Sanz N, Ferrer-Montiel A. Regulated exocytosis contributes to protein kinase C potentiation of vanilloid receptor activity. J Biol Chem. 2004 Jun 11;279(24):25665-72. doi: 10.1074/jbc.M311515200. Epub 2004 Apr 5. |
| 18385327 | Background | Antonucci F, Rossi C, Gianfranceschi L, Rossetto O, Caleo M. Long-distance retrograde effects of botulinum neurotoxin A. J Neurosci. 2008 Apr 2;28(14):3689-96. doi: 10.1523/JNEUROSCI.0375-08.2008. |
| 22049408 | Background | Restani L, Antonucci F, Gianfranceschi L, Rossi C, Rossetto O, Caleo M. Evidence for anterograde transport and transcytosis of botulinum neurotoxin A (BoNT/A). J Neurosci. 2011 Nov 2;31(44):15650-9. doi: 10.1523/JNEUROSCI.2618-11.2011. |
| 15265242 | Background | Naumann M, Jankovic J. Safety of botulinum toxin type A: a systematic review and meta-analysis. Curr Med Res Opin. 2004 Jul;20(7):981-90. doi: 10.1185/030079904125003962. |
| 17112348 | Background | Naumann M, Albanese A, Heinen F, Molenaers G, Relja M. Safety and efficacy of botulinum toxin type A following long-term use. Eur J Neurol. 2006 Dec;13 Suppl 4:35-40. doi: 10.1111/j.1468-1331.2006.01652.x. |
| 15831014 | Background | Li M, Goldberger BA, Hopkins C. Fatal case of BOTOX-related anaphylaxis? J Forensic Sci. 2005 Jan;50(1):169-72. |
| 21353824 | Background | Forchheimer MB, Richards JS, Chiodo AE, Bryce TN, Dyson-Hudson TA. Cut point determination in the measurement of pain and its relationship to psychosocial and functional measures after traumatic spinal cord injury: a retrospective model spinal cord injury system analysis. Arch Phys Med Rehabil. 2011 Mar;92(3):419-24. doi: 10.1016/j.apmr.2010.08.029. |
| 16340590 | Background | Hanley MA, Jensen MP, Ehde DM, Robinson LR, Cardenas DD, Turner JA, Smith DG. Clinically significant change in pain intensity ratings in persons with spinal cord injury or amputation. Clin J Pain. 2006 Jan;22(1):25-31. doi: 10.1097/01.ajp.0000148628.69627.82. |
| 13271123 | Background | BEECHER HK. The powerful placebo. J Am Med Assoc. 1955 Dec 24;159(17):1602-6. doi: 10.1001/jama.1955.02960340022006. No abstract available. |
| 18521092 | Background | Widerstrom-Noga E, Biering-Sorensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. doi: 10.1038/sc.2008.64. Epub 2008 Jun 3. |
| 19786975 | Background | Jensen MP, Widerstrom-Noga E, Richards JS, Finnerup NB, Biering-Sorensen F, Cardenas DD. Reliability and validity of the International Spinal Cord Injury Basic Pain Data Set items as self-report measures. Spinal Cord. 2010 Mar;48(3):230-8. doi: 10.1038/sc.2009.112. Epub 2009 Sep 29. |
| 7967852 | Background | Ruta DA, Garratt AM, Leng M, Russell IT, MacDonald LM. A new approach to the measurement of quality of life. The Patient-Generated Index. Med Care. 1994 Nov;32(11):1109-26. doi: 10.1097/00005650-199411000-00004. |
| 10557665 | Background | Ruta DA, Garratt AM, Russell IT. Patient centred assessment of quality of life for patients with four common conditions. Qual Health Care. 1999 Mar;8(1):22-9. doi: 10.1136/qshc.8.1.22. |
| 3305931 | Background | Tugwell P, Bombardier C, Buchanan WW, Goldsmith CH, Grace E, Hanna B. The MACTAR Patient Preference Disability Questionnaire--an individualized functional priority approach for assessing improvement in physical disability in clinical trials in rheumatoid arthritis. J Rheumatol. 1987 Jun;14(3):446-51. |
| 9234873 | Background | Wright JG, Young NL. The patient-specific index: asking patients what they want. J Bone Joint Surg Am. 1997 Jul;79(7):974-83. doi: 10.2106/00004623-199707000-00003. |
| NOT COMPLETED |
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Placebo 0.2mL of 0.9% normal saline for 12 weeks, then Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| DN4 screen (neuropathic >4) | Number of participants scoring >4 on each question on the DN4. Douleur Neuropathique en 4 Questions (DN4) is a screening tool for neuropathic pain consisting of interview questions (DN4-interview) and physical tests. DN4 consists of 7 items related to symptoms and 3 related to clinical examination, total score from 0-10, with higher score indicating more symptom. | Count of Participants | Participants |
|
| SCIPI screen (neuropathic >=3) | Number of participants scoring >=3 on each item on the SCIPI. Spinal Cord Injury Pain Instrument is a 7 item instrument, total score from 0-7 with higher score indicating more pain. | Count of Participants | Participants |
|
|
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| Secondary | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | Mean change from baseline. Participants are asked "Taking into account your pain level and how it affects your life, are you feeling better, the same or worse than when you started treatment?" and then to quantify the magnitude of the change. with the 7-Point guy Farrar which measures the global treatment effect from with scale from 0 to 6, higher score indicates worse outcomes. | only those who completed crossover were included | Posted | Mean | Standard Deviation | score on a scale | up to 12 weeks post-injection, for a total of 24 weeks from baseline |
|
|
|
| Secondary | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting day-to-day activities subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes. | only those who completed crossover were included | Posted | Mean | Standard Deviation | units on a scale | up to 12 weeks post-injection, for a total of 24 weeks from baseline |
|
|
|
| Secondary | International Basic Pain Dataset - Pain Affecting Mood | The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting mood subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes. | only those who completed crossover were included | Posted | Mean | Standard Deviation | units on a scale | up to 12 weeks post-injection, for a total of 24 weeks from baseline |
|
|
|
| Secondary | International Basic Pain Dataset - Pain Affecting Sleep | The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting sleep subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes. | only those who completed crossover were included | Posted | Mean | Standard Deviation | units on a scale | up to 12 weeks post-injection, for a total of 24 weeks from baseline |
|
|
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| Secondary | Static Mechanical Allodynia Testing | Mechanical allodynia is a characteristic of evoked pain in subjects with neuropathic pain. Static allodynia to mechanical stimuli will be defined as a sensation of pain evoked by the pressure of the end of a wooden stick. The end of a wooden stick will touch the affected region with enough pressure to indent the skin, for 10 seconds. Afterwards, the subject will be asked to rate the perceived pain on an 11-point NRS. | Data initially collected incorrectly, then data not collected. | Posted | up to 12 weeks post-injection, for a total of 24 weeks from baseline |
|
|
| Secondary | Dynamic Mechanical Allodynia Testing | Dynamic allodynia will be tested by stroking the affected region gently with a cotton swab, 4 times at a rate of 3-5cm per second over an area of 5cm. If there is an evoked clear sensation of pain, the subject is asked to rate the intensity of dynamic allodynia using the 11-point NRS. The region of static and dynamic allodynia, if present, will be marked and recorded | Data initially collected incorrectly, then data not collected. | Posted | up to 12 weeks post-injection, for a total of 24 weeks from baseline |
|
|
| Secondary | Patient-generated Index (PGI) | PGI measures activity affected by pain. Full score is 0 to 10000, with higher score indicating better function | only those who completed crossover were included | Posted | Mean | Standard Deviation | score on a scale | up to 12 weeks post-injection, for a total of 24 weeks from baseline |
|
|
|
| 0 |
| 8 |
| 1 |
| 8 |
| 1 |
| 8 |
| EG001 | Placebo | Placebo 0.2mL of 0.9% normal saline for 12 weeks | 0 | 8 | 0 | 8 | 0 | 8 |
|
Recipient will have all rights to data resulting from the Study; provided, however, at least 30 calendar days prior to any submission...Recipient shall provide Allergan a copy of the proposed publication for review. Recipient agrees to delay submission for an additional 30 calendar days to allow Allergan the right to a) address any factual inaccuracies with the publisher as it relates to any Allergan materials or b) request redaction of information that Allergan deems confidential or proprietary
| D014947 | Wounds and Injuries |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| 4 week post injection |
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| 8 week post injection |
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| 12 week post injection |
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| crossover 2 week follow up |
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| crossover 4 week follow up |
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| crossover 8 week follow up |
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| crossover 12 week follow up |
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| 2 week post injection |
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| 4 week post injection |
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| 8 week post injection |
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| 12 week post injection |
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| crossover 2 week follow up |
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| crossover 4 week follow up |
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| crossover 8 week follow up |
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| crossover 12 week follow up |
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| 2 week post injection |
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| 4 week post injection |
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| 8 week post injection |
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| 12 week post injection |
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| crossover 2 week follow up |
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| crossover 4 week follow up |
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| crossover 8 week follow up |
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| crossover 12 week follow up |
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| 2 week post injection |
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| 4 week post injection |
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| 8 week post injection |
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| 12 week post injection |
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| crossover 2 week follow up |
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| crossover 4 week follow up |
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| crossover 8 week follow up |
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| crossover 12 week follow up |
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| 2 week post injection |
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| 4 week post injection |
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| 8 week post injection |
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| 12 week post injection |
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| crossover 2 week follow up |
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| crossover 4 week follow up |
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| crossover 8 week follow up |
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| crossover 12 week follow up |
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