Trial Outcomes & Findings for A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain (NCT NCT06379893)

NCT ID: NCT06379893

Last Updated: 2026-01-20

Results Overview

The average minutes of MVPA were measured through a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on physical activity. A mixed model with repeated measures (MMRM) was used to analyse the change from Baseline in MVPA average minutes. Change from Baseline was calculated by subtracting the Baseline average MVPA value from the average MVPA value at Week 1. Baseline value was calculated as the sum of minutes of MVPA over the Baseline period divided by duration of Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement. Modified Intent-To-Treat (mITT) population included all participants who met the inclusion/exclusion criteria, who used study product at least once and had data from at least one post Baseline quality of life (QoL) questionnaire to support at least one of the secondary endpoint assessments.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 196 participants
• Primary outcome timeframe: Baseline and Week 1
• Results posted on: 2026-01-20

Participant Flow

This study was conducted at 2 centers in the United States (US) and 6 centers in the European Union (EU) (Poland).

A total of 214 participants were screened during study of which 196 participants were enrolled and received Voltaren Gel. A total of 194 participants completed the study.

Participant milestones

Measure	Voltaren Gel Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Overall Study STARTED	196
Overall Study COMPLETED	194
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Voltaren Gel Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Overall Study Withdrawal by Subject	1
Overall Study Sponsors' decision	1

Baseline Characteristics

A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain

Baseline characteristics by cohort

Measure	Voltaren Gel n=196 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Age, Continuous	61.8 years STANDARD_DEVIATION 9.33 • n=37 Participants
Sex: Female, Male Female	118 Participants n=37 Participants
Sex: Female, Male Male	78 Participants n=37 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=37 Participants
Race (NIH/OMB) Asian	0 Participants n=37 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants
Race (NIH/OMB) Black or African American	6 Participants n=37 Participants
Race (NIH/OMB) White	188 Participants n=37 Participants
Race (NIH/OMB) More than one race	1 Participants n=37 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants
Race/Ethnicity, Customized Hispanic or Latino	19 Participants n=37 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	20 Participants n=37 Participants
Race/Ethnicity, Customized Missing	157 Participants n=37 Participants

PRIMARY outcome

Timeframe: Baseline and Week 1

Population: mITT Population. This study was designed as a single-arm real-world evidence (RWE) study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the three formulations within the population; therefore, all participants were analyzed as a single group. The reported results apply to the entire study population ("all groups") because there were no separate Arms/Groups in the study design.

The average minutes of MVPA were measured through a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on physical activity. A mixed model with repeated measures (MMRM) was used to analyse the change from Baseline in MVPA average minutes. Change from Baseline was calculated by subtracting the Baseline average MVPA value from the average MVPA value at Week 1. Baseline value was calculated as the sum of minutes of MVPA over the Baseline period divided by duration of Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement. Modified Intent-To-Treat (mITT) population included all participants who met the inclusion/exclusion criteria, who used study product at least once and had data from at least one post Baseline quality of life (QoL) questionnaire to support at least one of the secondary endpoint assessments.

Outcome measures

Measure	Voltaren Gel n=188 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Change From Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1 Baseline	249.2 minutes Standard Deviation 92.99
Change From Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1 Change from Baseline at Week 1	14.2 minutes Standard Deviation 53.54

PRIMARY outcome

Timeframe: Baseline and Week 2

Population: mITT population. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the three formulations within the population; therefore, all participants were analyzed as a single group. The reported results apply to the entire study population ("all groups") because there were no separate Arms/Groups in the study design.

The average minutes of MVPA were measured through a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on physical activity. A MMRM was used to analyse the change from Baseline in MVPA average minutes. Change from Baseline was calculated by subtracting the Baseline average MVPA value from the average MVPA value at Week 2. Baseline value was calculated as sum of minutes of MVPA over the Baseline period divided by duration of Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement.

Outcome measures

Measure	Voltaren Gel n=188 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Change From Baseline in the Average Minutes of MVPA at Week 2 Baseline	249.2 minutes Standard Deviation 92.99
Change From Baseline in the Average Minutes of MVPA at Week 2 Change from Baseline at Week 2	10.7 minutes Standard Deviation 60.93

PRIMARY outcome

Timeframe: Baseline and Week 3

Population: mITT population. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the three formulations within the population; therefore, all participants were analyzed as a single group. The reported results apply to the entire study population ("all groups") because there were no separate Arms/Groups in the study design.

The average minutes of MVPA were measured through a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on physical activity. A MMRM was used to analyse the change from Baseline in MVPA average minutes. Change from Baseline was calculated by subtracting the Baseline average MVPA value from the average MVPA value at Week 3. Baseline value was calculated as sum of minutes of MVPA over the Baseline period divided by duration of Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement.

Outcome measures

Measure	Voltaren Gel n=188 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Change From Baseline in the Average Minutes of MVPA at Week 3 Baseline	249.2 minutes Standard Deviation 92.99
Change From Baseline in the Average Minutes of MVPA at Week 3 Change from Baseline at Week 3	-0.8 minutes Standard Deviation 71.08

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2 and Week 3

Population: mITT population. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the three formulations within the population; therefore, all participants were analyzed as a single group. The reported results apply to the entire study population ("all groups") because there were no separate Arms/Groups in the study design.

Daily average number of steps taken were measured through a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on functional mobility. MMRM was used to analyse the change from Baseline in daily average number of steps taken. Change from Baseline was calculated by subtracting the average number of steps taken at Baseline from the average number of steps taken at each indicated post-Baseline timepoint. Baseline value was calculated as the sum of steps taken over the Baseline period divided by duration of Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement.

Outcome measures

Measure	Voltaren Gel n=188 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Change From Baseline in Daily Average Number of Steps Taken at Weeks 1, 2 and 3 Baseline	13826.5 steps Standard Deviation 5076.05
Change From Baseline in Daily Average Number of Steps Taken at Weeks 1, 2 and 3 Change from Baseline at Week 1	602.3 steps Standard Deviation 2930.69
Change From Baseline in Daily Average Number of Steps Taken at Weeks 1, 2 and 3 Change from Baseline at Week 2	323.1 steps Standard Deviation 3515.66
Change From Baseline in Daily Average Number of Steps Taken at Weeks 1, 2 and 3 Change from Baseline at Week 3	-57.1 steps Standard Deviation 3826.57

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2 and Week 3

Population: mITT population. Number analyzed is the number of participants with non-missing data at the indicated timepoint. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the three formulations within the population; therefore, all participants were analyzed as a single group. The reported results apply to the entire study population ("all groups") as there were no separate Arms in the study design.

Sedentary/non-sedentary time was measured using a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on functional mobility. Ratio of sedentary/non-sedentary time was calculated as = Total number of minutes defined as sedentary behaviour divided by Total number of non-sedentary behaviour minutes where number of non-sedentary behaviour minutes in the day was derived as the sum of light activity and MVPA. Change from Baseline was calculated by subtracting the Baseline ratio of sedentary/non-sedentary time from the ratio at each indicated post-Baseline timepoint. Baseline was defined as the number of non-missing days between Day -6 and Day 0. A negative change from Baseline indicated improvement.

Outcome measures

Measure	Voltaren Gel n=188 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Change From Baseline in Ratio of Sedentary/Non-sedentary Time at Weeks 1, 2 and 3 Baseline	1.984 ratio Standard Deviation 1.1595
Change From Baseline in Ratio of Sedentary/Non-sedentary Time at Weeks 1, 2 and 3 Change from Baseline at Week 1	-0.028 ratio Standard Deviation 0.5376
Change From Baseline in Ratio of Sedentary/Non-sedentary Time at Weeks 1, 2 and 3 Change from Baseline at Week 2	0.003 ratio Standard Deviation 0.5571
Change From Baseline in Ratio of Sedentary/Non-sedentary Time at Weeks 1, 2 and 3 Change from Baseline at Week 3	0.089 ratio Standard Deviation 0.6121

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2 and Week 3

Population: mITT population. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the three formulations within the population; therefore, all participants were analyzed as a single group. The reported results apply to the entire study population ("all groups") because there were no separate Arms/Groups in the study design.

Gait was assessed through speed and step irregularity measured via cadence using a connected activity tracker (Actigraph device) worn by the participants. Change from Baseline was calculated as by subtracting the average cadence at Baseline from the cadence at each indicated post-Baseline timepoint. Baseline was defined as the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement.

Outcome measures

Measure	Voltaren Gel n=188 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Change From Baseline in Gait Assessed Through Speed and Step Irregularity Measured Via Cadence at Weeks 1, 2 and 3 Baseline	109.207 steps per minute Standard Deviation 6.8045
Change From Baseline in Gait Assessed Through Speed and Step Irregularity Measured Via Cadence at Weeks 1, 2 and 3 Change from Baseline at Week 1	-0.149 steps per minute Standard Deviation 6.3135
Change From Baseline in Gait Assessed Through Speed and Step Irregularity Measured Via Cadence at Weeks 1, 2 and 3 Change from Baseline at Week 2	-1.126 steps per minute Standard Deviation 11.7981
Change From Baseline in Gait Assessed Through Speed and Step Irregularity Measured Via Cadence at Weeks 1, 2 and 3 Change from Baseline at Week 3	-1.751 steps per minute Standard Deviation 14.7336

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2 and Week 3

Population: mITT population. Overall number analyzed is the number of participants with data available for analyses of this outcome measure. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the 3 formulations within the population; So, all participants were analyzed as a single group. The reported results apply to the entire study population (all groups) as there were no separate Arms in the study design.

Gait was assessed through speed and step irregularity measured via gait speed using a connected activity tracker (Actigraph device) worn by the participants. Change from Baseline was calculated by subtracting the average gait speed at Baseline from the Average gait speed at each indicated post-Baseline timepoint. Baseline was defined as the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement.

Outcome measures

Measure	Voltaren Gel n=177 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Change From Baseline in Gait Assessed Through Speed and Step Irregularity Measured Via Gait Speed at Weeks 1, 2 and 3 Change from Baseline at Week 1	-0.007 meters per second Standard Deviation 0.0809
Change From Baseline in Gait Assessed Through Speed and Step Irregularity Measured Via Gait Speed at Weeks 1, 2 and 3 Baseline	1.010 meters per second Standard Deviation 0.1385
Change From Baseline in Gait Assessed Through Speed and Step Irregularity Measured Via Gait Speed at Weeks 1, 2 and 3 Change from Baseline at Week 2	-0.016 meters per second Standard Deviation 0.1069
Change From Baseline in Gait Assessed Through Speed and Step Irregularity Measured Via Gait Speed at Weeks 1, 2 and 3 Change from Baseline at Week 3	-0.016 meters per second Standard Deviation 0.1401

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2 and Week 3

Population: mITT population. Overall number analyzed is the number of participants with data available for analyses of this outcome measure. Number analyzed is the number of participants with non-missing data at the indicated timepoint. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the 3 formulations within the population. The reported results apply to the entire study population ("all groups").

Indices of morning stiffness were assessed through levels of mobility 30 minutes post-wake. Functional mobility was measured through a connected activity tracker (Actigraph device) worn by the participants. Daily morning stiffness 30 minutes post-wake was defined as the total vector magnitude counts from Actigraph device 30 minutes post-wake. Change from Baseline was calculated as = (Average morning stiffness 30 minutes post-wake at each indicated post-Baseline timepoint minus Average Baseline morning stiffness 30 minutes post-wake). Baseline was defined as the number of non-missing days between Day -6 and Day 0. A negative change from Baseline indicated improvement.

Outcome measures

Measure	Voltaren Gel n=188 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Change From Baseline in Indices of Morning Stiffness Assessed Through Levels of Mobility 30 Minutes Post-wake at Weeks 1, 2 and 3 Baseline	75593.364 vector magnitude counts Standard Deviation 44958.5420
Change From Baseline in Indices of Morning Stiffness Assessed Through Levels of Mobility 30 Minutes Post-wake at Weeks 1, 2 and 3 Change from Baseline at Week 1	1969.758 vector magnitude counts Standard Deviation 28283.0182
Change From Baseline in Indices of Morning Stiffness Assessed Through Levels of Mobility 30 Minutes Post-wake at Weeks 1, 2 and 3 Change from Baseline at Week 2	2332.422 vector magnitude counts Standard Deviation 28420.8109
Change From Baseline in Indices of Morning Stiffness Assessed Through Levels of Mobility 30 Minutes Post-wake at Weeks 1, 2 and 3 Change from Baseline at Week 3	-1893.342 vector magnitude counts Standard Deviation 34458.1863

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2 and Week 3

Population: mITT Population. Here, overall number analyzed is the number of participants with data available for analyses of this outcome measure. Number analyzed is the number of participants with non-missing data at the indicated timepoint. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the 3 formulations within the population. The reported results apply to the entire study population ("all groups").

Indices of morning stiffness were assessed through levels of mobility 60 minutes post-wake. Functional mobility was measured through a connected activity tracker (Actigraph device) worn by the participants. Daily morning stiffness 60 minutes post-wake was defined as the total vector magnitude counts from Actigraph device 60 minutes post-wake. Change from Baseline was calculated as = (Average morning stiffness 60 minutes post-wake at each indicated post-Baseline timepoint minus Average Baseline morning stiffness 30 minutes post-wake). Baseline was defined as the number of non-missing days between Day -6 and Day 0. A negative change from Baseline indicated improvement.

Outcome measures

Measure	Voltaren Gel n=188 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Change From Baseline in Indices of Morning Stiffness Assessed Through Levels of Mobility 60 Minutes Post-wake at Weeks 1, 2 and 3 Baseline	149034.401 vector magnitude counts Standard Deviation 86661.4977
Change From Baseline in Indices of Morning Stiffness Assessed Through Levels of Mobility 60 Minutes Post-wake at Weeks 1, 2 and 3 Change from Baseline at Week 1	2891.276 vector magnitude counts Standard Deviation 45249.4973
Change From Baseline in Indices of Morning Stiffness Assessed Through Levels of Mobility 60 Minutes Post-wake at Weeks 1, 2 and 3 Change from Baseline at Week 2	2438.403 vector magnitude counts Standard Deviation 48859.7477
Change From Baseline in Indices of Morning Stiffness Assessed Through Levels of Mobility 60 Minutes Post-wake at Weeks 1, 2 and 3 Change from Baseline at Week 3	-6734.944 vector magnitude counts Standard Deviation 54957.9211

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2 and Week 3

Population: mITT Population. Overall number analyzed is the number of participants with data available for analyses of this outcome measure. Number analyzed is the number of participants with non-missing data at the indicated timepoint. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the 3 formulations within the population. The reported results apply to the entire study population ("all groups").

Participants completed the WOMAC questionnaire daily using eDiary. The WOMAC questionnaire consisted of 24 questions categorised in 3 subscales - Pain, Stiffness, Physical function. The physical function subscale consisted of 17 questions related to level of difficulty in performing functions, on average, during the last 48 hours scored on a 5-point Likert scale with scores ranging from 0 to 4, where score 0=none, 1=slight, 2=moderate, 3=severe, 4=extreme. Total WOMAC physical function subscale score was normalized on a 0 to 100 scale calculated as = (sum of raw score items)*1.47. Higher scores indicated more difficulty in performing physical functions. Change from Baseline was calculated by subtracting the normalized WOMAC subscale score at Baseline from the normalized WOMAC subscale score at each indicated post-Baseline timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement.

Outcome measures

Measure	Voltaren Gel n=176 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale Score at Week 1, 2 and 3 Baseline	48.702 score on a scale Standard Deviation 12.9284
Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale Score at Week 1, 2 and 3 Change from Baseline at Week 1	-8.677 score on a scale Standard Deviation 12.6188
Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale Score at Week 1, 2 and 3 Change from Baseline at Week 2	-11.926 score on a scale Standard Deviation 14.0764
Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale Score at Week 1, 2 and 3 Change from Baseline at Week 3	-15.644 score on a scale Standard Deviation 16.9641

SECONDARY outcome

Timeframe: Baseline up to Day 21

Population: mITT population. Number analyzed is the number of participants with non-missing data at the indicated timepoint. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the 3 formulations within the population; So, all participants were analyzed as a single group. The reported results apply to the entire study population (all groups) as there were no separate Arms in the study design.

The average minutes of MVPA on each day were measured through a connected activity tracker (Actigraph device) worn by the participants to assess the functional mobility. Baseline was calculated as the average of MVPA values collected during the Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0.

Outcome measures

Measure	Voltaren Gel n=188 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
MVPA on Each Day of the Study Day 8	264.2 minutes Standard Deviation 122.21
MVPA on Each Day of the Study Day 9	258.0 minutes Standard Deviation 126.33
MVPA on Each Day of the Study Baseline	249.2 minutes Standard Deviation 92.99
MVPA on Each Day of the Study Day 1	274.1 minutes Standard Deviation 119.79
MVPA on Each Day of the Study Day 2	268.4 minutes Standard Deviation 124.96
MVPA on Each Day of the Study Day 3	259.3 minutes Standard Deviation 124.79
MVPA on Each Day of the Study Day 4	270.8 minutes Standard Deviation 126.09
MVPA on Each Day of the Study Day 5	255.8 minutes Standard Deviation 115.05
MVPA on Each Day of the Study Day 6	255.1 minutes Standard Deviation 119.03
MVPA on Each Day of the Study Day 7	260.4 minutes Standard Deviation 112.45
MVPA on Each Day of the Study Day 10	266.5 minutes Standard Deviation 128.05
MVPA on Each Day of the Study Day 11	262.9 minutes Standard Deviation 124.18
MVPA on Each Day of the Study Day 12	252.0 minutes Standard Deviation 122.99
MVPA on Each Day of the Study Day 13	261.3 minutes Standard Deviation 122.89
MVPA on Each Day of the Study Day 14	254.3 minutes Standard Deviation 114.00
MVPA on Each Day of the Study Day 15	254.6 minutes Standard Deviation 124.49
MVPA on Each Day of the Study Day 16	250.3 minutes Standard Deviation 114.15
MVPA on Each Day of the Study Day 17	251.1 minutes Standard Deviation 122.16
MVPA on Each Day of the Study Day 18	253.8 minutes Standard Deviation 124.67
MVPA on Each Day of the Study Day 19	239.1 minutes Standard Deviation 118.63
MVPA on Each Day of the Study Day 20	244.0 minutes Standard Deviation 120.81
MVPA on Each Day of the Study Day 21	107.8 minutes Standard Deviation 85.88

SECONDARY outcome

Timeframe: Week 1, Week 2 and Week 3

Population: mITT population. Here, overall number analyzed is the number of participants with data available for analyses of this outcome measure. Number analyzed is the number of participants with non-missing data at the indicated timepoint. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the 3 formulations within the population. The reported results apply to the entire study population ("all groups").

Physical function subscale score of the WOMAC questionnaire was used to study participant's perceived ability to exercise more regularly. It consisted of 17 questions related to the level of difficulty in performing functions, on average, during the last 48 hours scored on a 5-point Likert scale with scores ranging from 0 to 4, daily using eDiary where score 0=none, 1=slight, 2=moderate, 3=severe, 4=extreme. Total WOMAC physical function subscale score was normalized on a 0 to 100 scale calculated as = (sum of raw score items)*1.47. Higher scores indicated more difficulty in performing physical functions.

Outcome measures

Measure	Voltaren Gel n=176 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
WOMAC Physical Function Subscale Score at Weeks 1, 2 and 3 Week 1	40.375 score on a scale Standard Deviation 14.7527
WOMAC Physical Function Subscale Score at Weeks 1, 2 and 3 Week 2	37.072 score on a scale Standard Deviation 15.9130
WOMAC Physical Function Subscale Score at Weeks 1, 2 and 3 Week 3	32.781 score on a scale Standard Deviation 17.2916

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2 and Week 3

Population: mITT Population. Here, overall number analyzed is the number of participants with data available for analyses of this outcome measure. Number analyzed is the number of participants with non-missing data at the indicated timepoint. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the 3 formulations within the population. The reported results apply to the entire study population ("all groups").

Participants rated the pain intensity experienced by them daily within the eDiary, using NRS. NRS is an 11-point scale with scores ranging from 0 to 10 where score 0 = no pain, 1 = slight pain, 2-3 = mild pain, 4-6 = moderate pain, 7 = severe pain, 8 to 9 = extreme pain, 10=pain as bad as it could be. Higher scores indicated greater pain intensity. Change from Baseline was calculated by subtracting the Baseline NRS score from the NRS score at each indicated post-Baseline timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement.

Outcome measures

Measure	Voltaren Gel n=176 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Change From Baseline in Self-reported Pain Intensity Assessed Through Numeric Rating Scale (NRS) at Weeks 1, 2 and 3 Baseline	5.7 score on a scale Standard Deviation 1.31
Change From Baseline in Self-reported Pain Intensity Assessed Through Numeric Rating Scale (NRS) at Weeks 1, 2 and 3 Change from Baseline at Week 1	-1.5 score on a scale Standard Deviation 1.54
Change From Baseline in Self-reported Pain Intensity Assessed Through Numeric Rating Scale (NRS) at Weeks 1, 2 and 3 Change from Baseline at Week 2	-1.9 score on a scale Standard Deviation 1.69
Change From Baseline in Self-reported Pain Intensity Assessed Through Numeric Rating Scale (NRS) at Weeks 1, 2 and 3 Change from Baseline at Week 3	-2.6 score on a scale Standard Deviation 1.96

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2 and Week 3

Population: mITT Population. Here, overall number analyzed is the number of participants with data available for analyses of this outcome measure. Number analyzed is the number of participants with non-missing data at the indicated timepoint. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the 3 formulations within the population. The reported results apply to the entire study population ("all groups").

Participants completed the WOMAC questionnaire daily. The WOMAC questionnaire consisted of 24 questions each scored on a 5-point scale: 0=none, 1=slight, 2=moderate, 3=severe, 4=extreme. The WOMAC questionnaire was categorized in 3 subscales - Pain (5 questions, score ranges 0-20), Stiffness (2 questions, score ranges 0-8), Physical function (17 questions, score ranges 0-68). Each subscale score was normalized on a 0 to 100 scale calculated as: Pain subscale score= (sum of raw score items in dimension)*5; Stiffness subscale score= (sum of raw score items in dimension)*12.5; Physical function subscale score= (sum of raw score items in dimension)*1.47. WOMAC Total score = sum of the 3 normalized WOMAC subscale scores. Thus, WOMAC total score ranges from 0 to 300 with 0 being the best and 300 being the worst. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated post-Baseline timepoint. A negative change from Baseline indicated improvement.

Outcome measures

Measure	Voltaren Gel n=176 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Change From Baseline in the WOMAC Total Score at Weeks 1, 2 and 3 Baseline	147.040 score on a scale Standard Deviation 38.1349
Change From Baseline in the WOMAC Total Score at Weeks 1, 2 and 3 Change from Baseline at Week 1	-27.359 score on a scale Standard Deviation 38.7623
Change From Baseline in the WOMAC Total Score at Weeks 1, 2 and 3 Change from Baseline at Week 2	-36.062 score on a scale Standard Deviation 42.4964
Change From Baseline in the WOMAC Total Score at Weeks 1, 2 and 3 Change from Baseline at Week 3	-47.852 score on a scale Standard Deviation 49.4526

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2 and Week 3

Population: mITT Population. Here, overall number analyzed is the number of participants with data available for analyses of this outcome measure. Number analyzed is the number of participants with non-missing data at the indicated timepoint. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the 3 formulations within the population. The reported results apply to the entire study population ("all groups").

The pain subscale of the WOMAC questionnaire consisted of 5 questions related to severity of pain experienced by the participant when walking, stair climbing, at night, at rest, weightbearing, on average, during the last 48 hours. Participants scored the questions on a 5-point Likert scale ranging from 0 to 4 daily using eDiary where score 0=none, 1=slight, 2=moderate, 3=severe, 4=extreme. The total pain subscale score was normalized on a 0 to 100 scale calculated as = (sum of raw score items in dimension)*5. Higher scores indicated more pain. Change from Baseline was calculated by subtracting the Baseline normalized WOMAC pain subscale score from the normalized score at each indicated post-Baseline timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement.

Outcome measures

Measure	Voltaren Gel n=176 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Change From Baseline in the WOMAC Pain Subscale Score at Weeks 1, 2 and 3 Baseline	48.196 score on a scale Standard Deviation 13.2952
Change From Baseline in the WOMAC Pain Subscale Score at Weeks 1, 2 and 3 Change from Baseline at Week 1	-9.458 score on a scale Standard Deviation 13.7044
Change From Baseline in the WOMAC Pain Subscale Score at Weeks 1, 2 and 3 Change from Baseline at Week 2	-12.422 score on a scale Standard Deviation 14.5893
Change From Baseline in the WOMAC Pain Subscale Score at Weeks 1, 2 and 3 Change from Baseline at Week 3	-16.383 score on a scale Standard Deviation 16.6274

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2 and Week 3

Population: mITT Population. Here, overall number analyzed is the number of participants with data available for analyses of this outcome measure. Number analyzed is the number of participants with non-missing data at the indicated timepoint. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the 3 formulations within the population. The reported results apply to the entire study population ("all groups").

The stiffness subscale of the WOMAC questionnaire consisted of 2 questions related to severity of stiffness experienced by the participant at morning and during the day, on average, during the last 48 hours. Participants scored the questions on a 5-point Likert scale with scores ranging from 0 to 4 daily using eDiary, where score 0=none, 1=slight, 2=moderate, 3=severe, 4=extreme. The total stiffness subscale score for was normalized on a 0 to 100 scale calculated as = (sum of raw score items in dimension)*12.5. Higher scores indicated more stiffness. Change from Baseline was calculated by subtracting the Baseline normalized WOMAC stiffness subscale score from the normalized score at each indicated post-Baseline timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement.

Outcome measures

Measure	Voltaren Gel n=176 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Change From Baseline in the WOMAC Stiffness Subscale Score at Weeks 1, 2 and 3 Baseline	50.142 score on a scale Standard Deviation 16.7965
Change From Baseline in the WOMAC Stiffness Subscale Score at Weeks 1, 2 and 3 Change from Baseline at Week 1	-9.242 score on a scale Standard Deviation 18.6173
Change From Baseline in the WOMAC Stiffness Subscale Score at Weeks 1, 2 and 3 Change from Baseline at Week 2	-11.719 score on a scale Standard Deviation 19.2063
Change From Baseline in the WOMAC Stiffness Subscale Score at Weeks 1, 2 and 3 Change from Baseline at Week 3	-15.680 score on a scale Standard Deviation 20.6853

SECONDARY outcome

Timeframe: Baseline, Day 7, Day 14, and Day 21

Population: mITT Population. Here, overall number analyzed is the number of participants with data available for analyses of this outcome measure. Number analyzed is the number of participants with non-missing data at the indicated timepoint. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the 3 formulations within the population. The reported results apply to the entire study population ("all groups").

KSS measured the subjective level of sleepiness/alertness during the day. Participants rated how sleepy or alert they were feeling using KSS with scores ranging from 1 to 9 where 1 = extremely alert, 2 = very alert, 3 = alert, 4 = fairly alert, 5 = neither alert nor sleepy, 6 = some signs of sleepiness, 7 = sleepy, but no efforts to keep alert, 8 = sleepy, some efforts to keep alert, 9 = very sleepy, great effort to keep alert, fighting sleep. Higher scores indicated greater sleepiness. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated post-Baseline timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement.

Outcome measures

Measure	Voltaren Gel n=176 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Change From Baseline in Sleep/Alertness Assessed Using Karolinska Sleepiness Scale (KSS) at Days 7, 14 and 21 Baseline	3.9 score on a scale Standard Deviation 1.60
Change From Baseline in Sleep/Alertness Assessed Using Karolinska Sleepiness Scale (KSS) at Days 7, 14 and 21 Change from Baseline at Day 7	-0.2 score on a scale Standard Deviation 1.56
Change From Baseline in Sleep/Alertness Assessed Using Karolinska Sleepiness Scale (KSS) at Days 7, 14 and 21 Change from Baseline at Day 14	-0.2 score on a scale Standard Deviation 1.70
Change From Baseline in Sleep/Alertness Assessed Using Karolinska Sleepiness Scale (KSS) at Days 7, 14 and 21 Change from Baseline at Day 21	-0.4 score on a scale Standard Deviation 1.66

SECONDARY outcome

Timeframe: Baseline, Days 7, 14 and 21

Population: mITT population. Here, overall number analyzed is the number of participants with data available for analyses of this outcome measure. Number analyzed is the number of participants with non-missing data at the indicated timepoint. This study was designed as a single-arm RWE study to evaluate the effectiveness of Voltaren gel. There was no intention to compare the effectiveness of the 3 formulations within the population. The reported results apply to the entire study population ("all groups").

Health-related QoL of participants was assessed using the EQ-5D-5L questionnaire. It consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with 5 response levels for each dimension where Level 1 = no problems, Level 2 = slight problems, Level 3 = moderate problems, Level 4 = severe problems, Level 5 = unable to perform activities/extreme problems. Participants were asked to indicate their health by ticking the box next to the most appropriate response level for each dimension. The response levels were used to derive a health index score based on the Crosswalk Value Set for the United States ranging from less than 0 (worst imaginable health) to 1 (best imaginable health) where higher scores indicated better health. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. Baseline was defined as Day 0. A positive change from Baseline indicated improvement.

Outcome measures

Measure	Voltaren Gel n=174 Participants Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Change From Baseline in Health-related QoL Assessed Using EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire at Days 7, 14, and 21 Baseline	0.67 score on a scale Standard Deviation 0.124
Change From Baseline in Health-related QoL Assessed Using EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire at Days 7, 14, and 21 Change from Baseline at Day 7	0.04 score on a scale Standard Deviation 0.098
Change From Baseline in Health-related QoL Assessed Using EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire at Days 7, 14, and 21 Change from Baseline at Day 14	0.05 score on a scale Standard Deviation 0.097
Change From Baseline in Health-related QoL Assessed Using EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire at Days 7, 14, and 21 Change from Baseline at Day 21	0.07 score on a scale Standard Deviation 0.111

Adverse Events

Voltaren Gel

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Voltaren Gel n=196 participants at risk Participants used Voltaren Gel containing diclofenac sodium, topically, applied daily as per label and leaflet instructions for up to 21 days. Participants were instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.
Musculoskeletal and connective tissue disorders Arthralgia	3.1% 6/196 • From signing of informed consent form up to end of study (up to approximately 28 days) An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A serious AE (SAE) was a particular category of an AE where the adverse outcome was serious.
Musculoskeletal and connective tissue disorders Muscle spasms	0.51% 1/196 • From signing of informed consent form up to end of study (up to approximately 28 days) An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A serious AE (SAE) was a particular category of an AE where the adverse outcome was serious.
Musculoskeletal and connective tissue disorders Myalgia	0.51% 1/196 • From signing of informed consent form up to end of study (up to approximately 28 days) An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A serious AE (SAE) was a particular category of an AE where the adverse outcome was serious.
Infections and infestations Ear infection	0.51% 1/196 • From signing of informed consent form up to end of study (up to approximately 28 days) An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A serious AE (SAE) was a particular category of an AE where the adverse outcome was serious.
Infections and infestations Sinusitis	0.51% 1/196 • From signing of informed consent form up to end of study (up to approximately 28 days) An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A serious AE (SAE) was a particular category of an AE where the adverse outcome was serious.
Infections and infestations Viral infection	0.51% 1/196 • From signing of informed consent form up to end of study (up to approximately 28 days) An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A serious AE (SAE) was a particular category of an AE where the adverse outcome was serious.
Infections and infestations Viral upper respiratory tract infection	0.51% 1/196 • From signing of informed consent form up to end of study (up to approximately 28 days) An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A serious AE (SAE) was a particular category of an AE where the adverse outcome was serious.
Nervous system disorders Headache	1.5% 3/196 • From signing of informed consent form up to end of study (up to approximately 28 days) An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A serious AE (SAE) was a particular category of an AE where the adverse outcome was serious.
Skin and subcutaneous tissue disorders Erythema	0.51% 1/196 • From signing of informed consent form up to end of study (up to approximately 28 days) An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A serious AE (SAE) was a particular category of an AE where the adverse outcome was serious.
Skin and subcutaneous tissue disorders Rash	0.51% 1/196 • From signing of informed consent form up to end of study (up to approximately 28 days) An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A serious AE (SAE) was a particular category of an AE where the adverse outcome was serious.
Gastrointestinal disorders Abdominal pain	0.51% 1/196 • From signing of informed consent form up to end of study (up to approximately 28 days) An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A serious AE (SAE) was a particular category of an AE where the adverse outcome was serious.
Immune system disorders Hypersensitivity	0.51% 1/196 • From signing of informed consent form up to end of study (up to approximately 28 days) An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A serious AE (SAE) was a particular category of an AE where the adverse outcome was serious.
Injury, poisoning and procedural complications Muscle strain	0.51% 1/196 • From signing of informed consent form up to end of study (up to approximately 28 days) An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A serious AE (SAE) was a particular category of an AE where the adverse outcome was serious.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.51% 1/196 • From signing of informed consent form up to end of study (up to approximately 28 days) An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A serious AE (SAE) was a particular category of an AE where the adverse outcome was serious.

Additional Information

Haleon Response Center

HALEON

Phone: +441932959500

Email: ww.clinical-trial-register@haleon.com

Results disclosure agreements

• Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER