Trial Outcomes & Findings for Study to Evaluate the Iovera° Device for Temporary Relief From Knee Pain (NCT NCT02260921)

NCT ID: NCT02260921

Last Updated: 2024-01-24

Results Overview

The WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions \[each question is presented in a numerical rating scale format with possible values between 0= No (best) to 10= Extreme (worst)\] with 5 questions regarding pain \[possible subscale score 0 to 50\], 2 questions regarding stiffness \[possible subscale score 0 to 20\] and 17 questions regarding function difficulty \[possible subscale score 0 to 170\]. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used for analyses.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 180 participants
• Primary outcome timeframe: Baseline to Day 30
• Results posted on: 2024-01-24

Participant Flow

Participant milestones

Measure	Iovera° Treatment Treatment with the iovera° device administered by a trained investigator to treat knee pain.	Sham Treatment Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
Overall Study STARTED	121	59
Overall Study Per-Protocol Population	112	56
Overall Study COMPLETED	107	55
Overall Study NOT COMPLETED	14	4

Reasons for withdrawal

Measure	Iovera° Treatment Treatment with the iovera° device administered by a trained investigator to treat knee pain.	Sham Treatment Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	4	3
Overall Study Withdraw Consent	4	1
Overall Study Death	1	0
Overall Study Prohibited Treatment for Knee Pain	4	0

Baseline Characteristics

Study to Evaluate the Iovera° Device for Temporary Relief From Knee Pain

Baseline characteristics by cohort

Measure	Iovera° Treatment n=121 Participants Treatment with the iovera° device administered by a trained investigator to treat knee pain.	Sham Treatment n=59 Participants Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.	Total n=180 Participants Total of all reporting groups
Age, Continuous	60.7 years n=5 Participants	61.3 years n=7 Participants	61.0 years n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants	40 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	19 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	110 Participants n=5 Participants	50 Participants n=7 Participants	160 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	121 participants n=5 Participants	59 participants n=7 Participants	180 participants n=5 Participants
Body Mass Index (BMI)	29.02 kg/m^2 n=5 Participants	29.99 kg/m^2 n=7 Participants	29.5 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 30

Population: Per-protocol Analysis Population included all participants who were randomized and underwent the assigned treatment where the treatment was successfully delivered as intended by the device and who are compliant with wash-out of pain medication prior to Baseline visit prior to study visit analyzed.

The WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions [each question is presented in a numerical rating scale format with possible values between 0= No (best) to 10= Extreme (worst)] with 5 questions regarding pain [possible subscale score 0 to 50], 2 questions regarding stiffness [possible subscale score 0 to 20] and 17 questions regarding function difficulty [possible subscale score 0 to 170]. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used for analyses.

Outcome measures

Measure	Iovera° Treatment n=112 Participants Treatment with the iovera° device administered by a trained investigator to treat knee pain.	Sham Treatment n=56 Participants Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
Absolute Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale Score at Day 30	-16.33 score on a scale Standard Error 1.15	-8.79 score on a scale Standard Error 1.63

SECONDARY outcome

Timeframe: Baseline to Day 30

Population: Per-Protocol Analysis Population included all participants who were randomized and underwent the assigned treatment where the treatment was successfully delivered as intended by the device and who are compliant with wash-out of pain medication prior to Baseline visit prior to study visit analyzed.

VAS pain assessment is a measure of pain intensity. The scale is made up of a 10 centimeter (cm) [100 millimeter (mm)] horizontal line. The far left of the horizontal line is labeled "no pain" while the far right of the horizontal line is labeled "worst imaginable pain". A negative change from Baseline indicates improvement. An ANCOVA model was used for analyses.

Outcome measures

Measure	Iovera° Treatment n=112 Participants Treatment with the iovera° device administered by a trained investigator to treat knee pain.	Sham Treatment n=56 Participants Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
Change From Baseline in Visual Analog Scale (VAS) at Day 30	-39.20 score on a scale Standard Error 2.74	-25.70 score on a scale Standard Error 3.89

SECONDARY outcome

Timeframe: Baseline to Day 30

Population: Per-Protocol Analysis Population included all participants who were randomized and underwent the assigned treatment where the treatment was successfully delivered as intended by the device and who are compliant with wash-out of pain medication prior to Baseline visit prior to study visit analyzed.

The WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions [each question is presented in a numerical rating scale format with possible values between 0= No (best) to 10= Extreme (worst)] with 5 questions regarding pain [possible subscale score 0 to 50], 2 questions regarding stiffness [possible subscale score 0 to 20] and 17 questions regarding function difficulty [possible subscale score 0 to 170]. The WOMAC total score was calculated by summing the 3 subscales for a total possible score of 0 to 240. A negative change from Baseline indicates improvement. An ANCOVA model was used for analyses.

Outcome measures

Measure	Iovera° Treatment n=112 Participants Treatment with the iovera° device administered by a trained investigator to treat knee pain.	Sham Treatment n=56 Participants Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
Change From Baseline in Total WOMAC Score at Day 30	-77.18 score on a scale Standard Error 5.38	-43.77 score on a scale Standard Error 7.61

SECONDARY outcome

Timeframe: Baseline to Day 60

Population: Per-Protocol Analysis Population included all participants who were randomized and underwent the assigned treatment where the treatment was successfully delivered as intended by the device and who are compliant with wash-out of pain medication prior to Baseline visit prior to study visit analyzed.

VAS pain assessment is a measure of pain intensity. The scale is made up of a 10 cm (100 mm) horizontal line. The far left of the horizontal line is labeled "no pain" while the far right of the horizontal line is labeled "worst imaginable pain". A negative change from Baseline indicates improvement. An ANCOVA model was used for analyses.

Outcome measures

Measure	Iovera° Treatment n=112 Participants Treatment with the iovera° device administered by a trained investigator to treat knee pain.	Sham Treatment n=56 Participants Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
Change From Baseline in VAS at Day 60	-37.46 score on a scale Standard Error 2.80	-28.82 score on a scale Standard Error 3.97

SECONDARY outcome

Timeframe: Day 30

Population: Per-Protocol Analysis Population included all participants who were randomized and underwent the assigned treatment where the treatment was successfully delivered as intended by the device and who are compliant with wash-out of pain medication prior to Baseline visit prior to study visit analyzed.

WOMAC Pain Score Responder Rate is defined as the percentage of participants with at least a 30% reduction in the WOMAC pain score at Day 30 compared to Baseline. WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions [each question is presented in a numerical rating scale format with possible values between 0= No to 10= Extreme] with the first 5 questions regarding pain [possible subscale score 0 (best) to 50 (worst)].

Outcome measures

Measure	Iovera° Treatment n=112 Participants Treatment with the iovera° device administered by a trained investigator to treat knee pain.	Sham Treatment n=56 Participants Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
WOMAC Pain Score Responder Rate at Day 30	67.9 percentage of participants	44.6 percentage of participants

SECONDARY outcome

Timeframe: Day 30

Population: Per-Protocol Analysis Population included all participants who were randomized and underwent the assigned treatment where the treatment was successfully delivered as intended by the device and who are compliant with wash-out of pain medication prior to Baseline visit prior to study visit analyzed.

VAS Responder Rate is defined as the percentage of participants with at least a 30% reduction in VAS at Day 30 compared to Baseline VAS pain assessment is a measure of pain intensity. The scale is made up of a 10 cm (100 mm) horizontal line. The far left of the horizontal line is labeled "no pain" while the far right of the horizontal line is labeled "worst imaginable pain".

Outcome measures

Measure	Iovera° Treatment n=112 Participants Treatment with the iovera° device administered by a trained investigator to treat knee pain.	Sham Treatment n=56 Participants Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
VAS Responder Rate at Day 30	67.9 percentage of participants	48.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Day 60

Population: Per-Protocol Analysis Population included all participants who were randomized and underwent the assigned treatment where the treatment was successfully delivered as intended by the device and who are compliant with wash-out of pain medication prior to Baseline visit prior to study visit analyzed.

The WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions [each question is presented in a numerical rating scale format with possible values between 0= No (best) to 10= Extreme (worst)] with 5 questions regarding pain [possible subscale score 0 to 50], 2 questions regarding stiffness [possible subscale score 0 to 20] and 17 questions regarding function difficulty [possible subscale score 0 to 170]. The WOMAC total score was calculated by summing the 3 subscales for a total possible score of 0 to 240. A negative change from Baseline indicates improvement.

Outcome measures

Measure	Iovera° Treatment n=112 Participants Treatment with the iovera° device administered by a trained investigator to treat knee pain.	Sham Treatment n=56 Participants Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
Change From Baseline in Total WOMAC Score at Day 60	-70.50 score on a scale Standard Error 5.52	-49.99 score on a scale Standard Error 7.81

SECONDARY outcome

Timeframe: Day 60

Population: Per-Protocol Analysis Population included all participants who were randomized and underwent the assigned treatment where the treatment was successfully delivered as intended by the device and who are compliant with wash-out of pain medication prior to Baseline visit prior to study visit analyzed.

VAS Responder Rate is defined as the percentage of participants with at least a 30% reduction in VAS at Day 60 compared to Baseline. VAS pain assessment is a measure of pain intensity. The scale is made up of a 10 cm (100 mm) horizontal line. The far left of the horizontal line is labeled "no pain" while the far right of the horizontal line is labeled "worst imaginable pain".

Outcome measures

Measure	Iovera° Treatment n=112 Participants Treatment with the iovera° device administered by a trained investigator to treat knee pain.	Sham Treatment n=56 Participants Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
VAS Responder Rate at Day 60	65.2 percentage of participants	55.4 percentage of participants

SECONDARY outcome

Timeframe: Day 60

Population: Per-Protocol Analysis Population included all participants who were randomized and underwent the assigned treatment where the treatment was successfully delivered as intended by the device and who are compliant with wash-out of pain medication prior to Baseline visit prior to study visit analyzed.

WOMAC Pain Score Responder Rate is defined as the percentage of participants with at least a 30% reduction in the WOMAC pain score at Day 60 compared to Baseline. WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions [each question is presented in a numerical rating scale format with possible values between 0= No (best) to 10= Extreme (worst)] with the first 5 questions regarding pain [possible subscale score 0 to 50].

Outcome measures

Measure	Iovera° Treatment n=112 Participants Treatment with the iovera° device administered by a trained investigator to treat knee pain.	Sham Treatment n=56 Participants Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
WOMAC Pain Score Responder Rate at Day 60	64.3 percentage of participants	48.2 percentage of participants

Adverse Events

Iovera° Treatment

Serious events: 2 serious events

Other events: 121 other events

Deaths: 1 deaths

Sham Treatment

Serious events: 1 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Measure	Iovera° Treatment n=121 participants at risk Treatment with the iovera° device administered by a trained investigator to treat knee pain.	Sham Treatment n=59 participants at risk Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
Cardiac disorders Myocardial infarction	0.83% 1/121 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.	0.00% 0/59 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.
Cardiac disorders Acute myocardial infarction	0.83% 1/121 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.	0.00% 0/59 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/121 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.	1.7% 1/59 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.83% 1/121 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.	0.00% 0/59 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.

Other adverse events

Measure	Iovera° Treatment n=121 participants at risk Treatment with the iovera° device administered by a trained investigator to treat knee pain.	Sham Treatment n=59 participants at risk Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
Skin and subcutaneous tissue disorders Administration site bruise	76.9% 93/121 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.	52.5% 31/59 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.
Skin and subcutaneous tissue disorders Administration site dysaesthesia	20.7% 25/121 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.	18.6% 11/59 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.
Skin and subcutaneous tissue disorders Administration site pain	21.5% 26/121 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.	18.6% 11/59 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.
Skin and subcutaneous tissue disorders Administration site paraesthesia	14.0% 17/121 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.	3.4% 2/59 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.
Skin and subcutaneous tissue disorders Administration site scab	5.0% 6/121 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.	5.1% 3/59 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.
Skin and subcutaneous tissue disorders Administration site swelling	40.5% 49/121 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.	27.1% 16/59 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.
Skin and subcutaneous tissue disorders Application site discolouration	0.83% 1/121 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.	0.00% 0/59 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.
Skin and subcutaneous tissue disorders Application site pruritus	5.8% 7/121 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.	3.4% 2/59 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.
Skin and subcutaneous tissue disorders Application site hypoaesthesia	52.1% 63/121 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.	54.2% 32/59 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.
Skin and subcutaneous tissue disorders Application site erythema	41.3% 50/121 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.	40.7% 24/59 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.
Skin and subcutaneous tissue disorders Application site pain	38.0% 46/121 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.	39.0% 23/59 • 6 Months Adverse Event (AE) data was collected over a 6 month period. Patients were followed until AE's were resolved.

Additional Information

Director of Clinical

Myoscience

Phone: 5109331541

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place