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This will be an open-label trial to describe the effects of cryoneurolysis with iovera° on symptom relief in patients with painful Kellgren-Lawrence (KL) grade 2-4 ankle osteoarthritis (OA). The Foot and Ankle Outcome Score (FAOS) subscales will be used to assess outcomes at 6, 12 and 24 weeks after treatment.
The aim of this study is to assess clinically significant long-term symptomatic relief with cryoneurolysis in people with unilateral ankle osteoarthritis (OA). The investigators will treat 1) the Superficial Fibular Nerve (SFN), Sural Nerve (SN) and Saphenous Nerve and/or 2) the Deep Fibular Nerve (DFN) with cryoneurolysis using the iovera° device. The primary study endpoint, clinically significant improvement in pain 12 weeks after each treatment, will be assessed using the FAOS pain subscale. If a participant is a non-responder (<20% improvement in pain within the 12 weeks following baseline), then the other treatment will be offered (e.g. if start with superficial group, then offer the DFN).
The secondary outcomes will be improvement in quality of life (FAOS-QoL), activities of daily living (FAOS-ADL) and Numerical Rating Scale (NRS) for pain.
The tertiary outcome will be improvement in physical performance measures (40m fast-paced walking test, standing balance test).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iovera | Experimental | The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iovera | Device | The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| FAOS - PAIN | FAOS-Pain is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | Change between baseline/screening and 12-weeks following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| NRS Pain Over Prior 7 Days | The Numeric Rating Scale (NRS) is a numeric scale to rates the pain from 0 (no pain) to 10 (worst pain). | change between baseline/screening and 6-weeks following treatment |
| FAOS - ADL(Activity of Daily Living) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 40m Fast Paced Walking Test (40m FPWT) Time Between Baseline/Screening and 6-weeks Following Treatment | The 40-meter walk test is one of the three OARSI (Osteoarthritis Research Society International) recommended minimal core set of performance-based outcome measures in OA research and clinical practice.The 40m FPWT will take approximately 2 minutes for each subject to complete. | change between baseline/screening and 6-weeks following treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil A Segal, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18312921 | Background | Ward ST, Williams PL, Purkayastha S. Intra-articular corticosteroid injections in the foot and ankle: a prospective 1-year follow-up investigation. J Foot Ankle Surg. 2008 Mar-Apr;47(2):138-44. doi: 10.1053/j.jfas.2007.12.007. | |
| 18830791 | Background | Valderrabano V, Horisberger M, Russell I, Dougall H, Hintermann B. Etiology of ankle osteoarthritis. Clin Orthop Relat Res. 2009 Jul;467(7):1800-6. doi: 10.1007/s11999-008-0543-6. Epub 2008 Oct 2. |
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Forty-three potentially eligible participants were screened. Of these two were found by radiographs or weight-bearing CT (WBCT) scan to not have tibiotalar osteoarthritis (KL=0) and were excluded. In addition, one participant was excluded due to an unstable ankle that resulted in bracing and opioid therapy. Subsequently, 40 participants with unilateral painful ankle OA were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iovera | The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Forty-three potentially eligible participants were screened. Of these, two were found by radiographs or weight-bearing CT (WBCT) scan to not have tibiotalar osteoarthritis (KL = 0) and were excluded. In addition, one participant was excluded due to an unstable ankle that resulted in bracing and opioid. Subsequently, 40 participants with unilateral painful ankle OA were recruited.
therapy. Subsequently, 40 participants with unilateral painful ankle OA were recruited.
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| ID | Title | Description |
|---|---|---|
| BG000 | Iovera | The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Least Squares 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 | FAOS - PAIN | FAOS-Pain is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | Twenty seven eligible participants completed 12-weeks follow-up treatment | Posted | Mean | Standard Error | score on a scale | Change between baseline/screening and 12-weeks following treatment |
|
All participants were followed for up to 24-weeks post cryoneurolysis treatment. Demographic and clinical characteristics for all participants were captured at baseline, 3, 6, 9, 12, 18 and 24-weeks follow-up.
Over the 24-week follow-up period following cryoneurolysis treatment, 19 participants reported a total of 42 adverse events. Of these, 2 were deemed to be unrelated to the intervention, 4 unlikely related, 18 possibly related, 14 probably related and 5 definitely related. The most frequently reported adverse events were index ankle arthralgia and paraesthesia. There were no serious adverse events.
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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 | Iovera | The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neil Segal, MD | University of Kansas Medical Center | 9135740961 | segal-research@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 25, 2019 | Feb 22, 2022 | Prot_SAP_000.pdf |
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|
FAOS - ADL(Activity of daily living) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - ADL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome.
| change between baseline/screening and 12-weeks following treatment |
| FAOS - ADL(Activity of Daily Living) | FAOS - ADL(Activity of daily living) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - ADL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | change between baseline/screening and 6-weeks following treatment |
| FAOS - ADL(Activity of Daily Living) | FAOS - ADL(Activity of daily living) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - ADL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | change between baseline/screening and 24-weeks following treatment |
| FAOS-QoL(Quality of Life) | FAOS-QoL(Quality of life) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - QoL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | change between baseline/screening and 12-weeks following treatment |
| FAOS-QoL(Quality of Life) | FAOS-QoL(Quality of life) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - QoL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | change between baseline/screening and 6-weeks following treatment |
| FAOS-QoL(Quality of Life) | FAOS-QoL(Quality of life) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - QoL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | change between baseline/screening and 24-weeks following treatment |
| FAOS - PAIN | FAOS-Pain is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | change between baseline/screening and 6-weeks following treatment |
| FAOS - PAIN | FAOS-Pain is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | change between baseline/screening and 24-weeks following treatment |
| NRS Pain Over Prior 7 Days | The Numeric Rating Scale (NRS) is a numeric scale to rates the pain from 0 (no pain) to 10 (worst pain). | change between baseline/screening and 24-weeks following treatment |
| NRS Pain Over Prior 7 Days | The Numeric Rating Scale (NRS) is a numeric scale to rates the pain from 0 (no pain) to 10 (worst pain). | change between baseline/screening and 12-weeks following treatment |
| Change in 40m Fast Paced Walking Test (40m FPWT) Time Between Baseline/Screening and 12-weeks Following Treatment | The 40-meter walk test is one of the three OARSI (Osteoarthritis Research Society International) recommended minimal core set of performance-based outcome measures in OA research and clinical practice.The 40m FPWT will take approximately 2 minutes for each subject to complete. | change between baseline/screening and 12-weeks following treatment |
| Change in 40m Fast Paced Walking Test (40m FPWT) Time Between Baseline/Screening and 24-weeks Following Treatment | The 40-meter walk test is one of the three OARSI (Osteoarthritis Research Society International) recommended minimal core set of performance-based outcome measures in OA research and clinical practice.The 40m FPWT will take approximately 2 minutes for each subject to complete. | change between baseline/screening and 24-weeks following treatment |
| 28231968 | Background | Repetto I, Biti B, Cerruti P, Trentini R, Felli L. Conservative Treatment of Ankle Osteoarthritis: Can Platelet-Rich Plasma Effectively Postpone Surgery? J Foot Ankle Surg. 2017 Mar-Apr;56(2):362-365. doi: 10.1053/j.jfas.2016.11.015. |
| 16880882 | Background | Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60. |
| 7326160 | Background | Evans PJ, Lloyd JW, Green CJ. Cryoanalgesia: the response to alterations in freeze cycle and temperature. Br J Anaesth. 1981 Nov;53(11):1121-7. doi: 10.1093/bja/53.11.1121. |
| 24023029 | Background | Golightly YM, Devellis RF, Nelson AE, Hannan MT, Lohmander LS, Renner JB, Jordan JM. Psychometric properties of the foot and ankle outcome score in a community-based study of adults with and without osteoarthritis. Arthritis Care Res (Hoboken). 2014 Mar;66(3):395-403. doi: 10.1002/acr.22162. |
| 25922461 | Background | Mani SB, Do H, Vulcano E, Hogan MV, Lyman S, Deland JT, Ellis SJ. Evaluation of the foot and ankle outcome score in patients with osteoarthritis of the ankle. Bone Joint J. 2015 May;97-B(5):662-7. doi: 10.1302/0301-620X.97B5.33940. |
| 25463444 | Background | Holzer N, Salvo D, Marijnissen AC, Vincken KL, Ahmad AC, Serra E, Hoffmeyer P, Stern R, Lubbeke A, Assal M. Radiographic evaluation of posttraumatic osteoarthritis of the ankle: the Kellgren-Lawrence scale is reliable and correlates with clinical symptoms. Osteoarthritis Cartilage. 2015 Mar;23(3):363-9. doi: 10.1016/j.joca.2014.11.010. Epub 2014 Nov 15. |
| 11642530 | Background | Roos EM, Brandsson S, Karlsson J. Validation of the foot and ankle outcome score for ankle ligament reconstruction. Foot Ankle Int. 2001 Oct;22(10):788-94. doi: 10.1177/107110070102201004. |
| 23965711 | Background | Hunt KJ, Hurwit D. Use of patient-reported outcome measures in foot and ankle research. J Bone Joint Surg Am. 2013 Aug 21;95(16):e118(1-9). doi: 10.2106/JBJS.L.01476. |
| 23680877 | Background | Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13. |
| 21310252 | Background | McDaniel G, Renner JB, Sloane R, Kraus VB. Association of knee and ankle osteoarthritis with physical performance. Osteoarthritis Cartilage. 2011 Jun;19(6):634-8. doi: 10.1016/j.joca.2011.01.016. Epub 2011 Feb 19. |
| 28336454 | Result | Radnovich R, Scott D, Patel AT, Olson R, Dasa V, Segal N, Lane NE, Shrock K, Naranjo J, Darr K, Surowitz R, Choo J, Valadie A, Harrell R, Wei N, Metyas S. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1247-1256. doi: 10.1016/j.joca.2017.03.006. Epub 2017 Mar 20. |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| NRS Pain Score | Pain in past 7 days | Mean | Standard Deviation | units on a scale |
|
| FAOS-Pain | Mean | Standard Deviation | units on a scale |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Index ankle joint, n (% right ) | Count of Participants | Participants |
|
| FAOS-ADL | Mean | Standard Deviation | units on a scale |
|
| FAOS-QOL | Mean | Standard Deviation | units on a scale |
|
| 40-meter fast-paced walking test | Mean | Standard Deviation | sec |
|
|
|
| Secondary | NRS Pain Over Prior 7 Days | The Numeric Rating Scale (NRS) is a numeric scale to rates the pain from 0 (no pain) to 10 (worst pain). | Thirty five eligible participants completed 6-weeks follow-up treatment | Posted | Mean | Standard Error | score on a scale | change between baseline/screening and 6-weeks following treatment |
|
|
|
| Secondary | FAOS - ADL(Activity of Daily Living) | FAOS - ADL(Activity of daily living) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - ADL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | Twenty seven eligible participants completed 12-weeks follow-up treatment | Posted | Mean | Standard Error | score on a scale | change between baseline/screening and 12-weeks following treatment |
|
|
|
| Secondary | FAOS - ADL(Activity of Daily Living) | FAOS - ADL(Activity of daily living) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - ADL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | Thirty five eligible participants completed 6-weeks follow-up treatment | Posted | Mean | Standard Error | score on a scale | change between baseline/screening and 6-weeks following treatment |
|
|
|
| Secondary | FAOS - ADL(Activity of Daily Living) | FAOS - ADL(Activity of daily living) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - ADL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | Twenty two eligible participants completed 24-weeks follow-up treatment | Posted | Mean | Standard Error | score on a scale | change between baseline/screening and 24-weeks following treatment |
|
|
|
| Secondary | FAOS-QoL(Quality of Life) | FAOS-QoL(Quality of life) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - QoL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | Twenty seven eligible participants completed 12-weeks follow-up treatment | Posted | Mean | Standard Error | score on a scale | change between baseline/screening and 12-weeks following treatment |
|
|
|
| Secondary | FAOS-QoL(Quality of Life) | FAOS-QoL(Quality of life) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - QoL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | Thirty five eligible participants completed 6-weeks follow-up treatment | Posted | Mean | Standard Error | score on a scale | change between baseline/screening and 6-weeks following treatment |
|
|
|
| Secondary | FAOS-QoL(Quality of Life) | FAOS-QoL(Quality of life) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - QoL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | Twenty two eligible participants completed 24-weeks follow-up treatment | Posted | Mean | Standard Error | score on a scale | change between baseline/screening and 24-weeks following treatment |
|
|
|
| Secondary | FAOS - PAIN | FAOS-Pain is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | Thirty five eligible participants completed 6-weeks follow-up treatment | Posted | Mean | Standard Error | score on a scale | change between baseline/screening and 6-weeks following treatment |
|
|
|
| Secondary | FAOS - PAIN | FAOS-Pain is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score.The sub scale ranges from 0 to 100 where higher values represents a better outcome. | Twenty two eligible participants completed 24-weeks follow-up treatment | Posted | Mean | Standard Error | score on a scale | change between baseline/screening and 24-weeks following treatment |
|
|
|
| Secondary | NRS Pain Over Prior 7 Days | The Numeric Rating Scale (NRS) is a numeric scale to rates the pain from 0 (no pain) to 10 (worst pain). | Twenty two eligible participants completed 24-weeks follow-up treatment | Posted | Mean | Standard Error | score on a scale | change between baseline/screening and 24-weeks following treatment |
|
|
|
| Secondary | NRS Pain Over Prior 7 Days | The Numeric Rating Scale (NRS) is a numeric scale to rates the pain from 0 (no pain) to 10 (worst pain). | Twenty seven eligible participants completed 12-weeks follow-up treatment | Posted | Mean | Standard Error | score on a scale | change between baseline/screening and 12-weeks following treatment |
|
|
|
| Other Pre-specified | Change in 40m Fast Paced Walking Test (40m FPWT) Time Between Baseline/Screening and 6-weeks Following Treatment | The 40-meter walk test is one of the three OARSI (Osteoarthritis Research Society International) recommended minimal core set of performance-based outcome measures in OA research and clinical practice.The 40m FPWT will take approximately 2 minutes for each subject to complete. | Thirty five eligible participants completed 6-weeks follow-up treatment | Posted | Mean | Standard Error | seconds | change between baseline/screening and 6-weeks following treatment |
|
|
|
| Other Pre-specified | Change in 40m Fast Paced Walking Test (40m FPWT) Time Between Baseline/Screening and 12-weeks Following Treatment | The 40-meter walk test is one of the three OARSI (Osteoarthritis Research Society International) recommended minimal core set of performance-based outcome measures in OA research and clinical practice.The 40m FPWT will take approximately 2 minutes for each subject to complete. | Twenty seven eligible participants completed 12-weeks follow-up treatment | Posted | Mean | Standard Error | seconds | change between baseline/screening and 12-weeks following treatment |
|
|
|
| Other Pre-specified | Change in 40m Fast Paced Walking Test (40m FPWT) Time Between Baseline/Screening and 24-weeks Following Treatment | The 40-meter walk test is one of the three OARSI (Osteoarthritis Research Society International) recommended minimal core set of performance-based outcome measures in OA research and clinical practice.The 40m FPWT will take approximately 2 minutes for each subject to complete. | Twenty two eligible participants completed 24-weeks follow-up treatment | Posted | Mean | Standard Error | seconds | change between baseline/screening and 24-weeks following treatment |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 19 |
| 40 |
| Bruising | Vascular disorders | Systematic Assessment |
|
| Bullous Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| fall | General disorders | Systematic Assessment |
|
| localized edema | Blood and lymphatic system disorders | Systematic Assessment |
|
| muscle cramp | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| pain ( 1st web space) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| paraesthesia | Nervous system disorders | Systematic Assessment |
|
| pruritus | Immune system disorders | Systematic Assessment |
|
| skin disorder - other (lump) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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