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A study to compare the efficacy of two sublingual cannabinoid based medicine extracts with placebo in the treatment of chronic pain due to brachial plexus injury.
This study used a three way crossover study design. Eligible patients recorded their symptoms during a one to two week baseline period, then entered a three period, double blind, randomised crossover of GW-1000-02, GW-2000-02 and placebo. Each period lasted two weeks, with no washout between periods. There were six possible treatment sequences. The primary analysis was based on Box Scale-11 pain severity scores recorded throughout the study in patient daily diary booklets. Blood samples were taken from patient-volunteers at the beginning of each period, for measurement of plasma cannabinoid concentration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GW-1000-02 | Experimental | Active treatment. |
|
| GW-2000-02 | Experimental | Active treatment. |
|
| Placebo | Placebo Comparator | Placebo control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW-1000-02 | Drug | Contains delta-9-tetrahydrocannabinol (THC) (25 mg/ml) and cannabidiol (CBD) (25mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg and CBD 2.5 mg). The maximum daily exposure was set at 48 actuations per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Mean Box Scale-11 Pain Review Score at the End of Each Treatment Period (Each Lasting 14-20 Days) | Each day patients recorded in their patient diary, the severity of their pain during the previous 24 hours using a Box Scale-11 pain score ranging from zero "no pain at all" to 10 "pain as bad as you can imagine". The Box Scale-11 pain score endpoint for each assessment period was the average of all available data recorded during the seven whole days prior to the visit immediately subsequent to that period, but only including data from Day 8 onwards. A negative value indicates an improvement in pain score from baseline. | Up to 74 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Mean Sleep Disturbance Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | Each day patients recorded in their patient diary the number of times they were woken due to pain during the previous night. The results were recorded as "None", "Once", "Twice" and "More Than Twice" and converted to a four point scale, zero to three respectively. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A negative value indicates an improvement from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal National Orthopaedic Hospital | Middlesex | HA7 4LP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15561385 | Result | Berman JS, Symonds C, Birch R. Efficacy of two cannabis based medicinal extracts for relief of central neuropathic pain from brachial plexus avulsion: results of a randomised controlled trial. Pain. 2004 Dec;112(3):299-306. doi: 10.1016/j.pain.2004.09.013. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GW-1000-02 First, Then GW-2000-02, Then Placebo | GW-1000-02 first (14-20 days), then GW-2000-02 (14-20 days), then placebo (14-20 days). Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period). |
| FG001 | GW-2000-02 First, Then GW-1000-02, Then Placebo | GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days). Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period). |
| FG002 | Placebo First, Then GW-1000-02, Then GW-2000-02 | Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days). Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period). |
| FG003 | GW-1000-02 First, Then Placebo, Then GW-2000-02 | GW-1000-02 first (14-20 days), then placebo (14-20 days), then GW-2000-02 (14-20 days). Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period). |
| FG004 | Placebo First, Then GW-2000-02, Then GW-1000-02 | Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days). Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period). |
| FG005 | GW-2000-02 First, Then Placebo, Then GW-1000-02 | GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days). Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intenvention (14-20 Days) |
| |||||||||||||
| Second Intenvention (14-20 Days) |
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| Third Intenvention (14-20 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Treatments: GW-1000-02, GW-2000-02 and Placebo | As this was a crossover study design, all patients were to receive all study treatments: GW-1000-02, GW-2000-02 and placebo. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change From Baseline in the Mean Box Scale-11 Pain Review Score at the End of Each Treatment Period (Each Lasting 14-20 Days) | Each day patients recorded in their patient diary, the severity of their pain during the previous 24 hours using a Box Scale-11 pain score ranging from zero "no pain at all" to 10 "pain as bad as you can imagine". The Box Scale-11 pain score endpoint for each assessment period was the average of all available data recorded during the seven whole days prior to the visit immediately subsequent to that period, but only including data from Day 8 onwards. A negative value indicates an improvement in pain score from baseline. | All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Up to 74 days |
|
All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
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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 | GW-1000-02 | Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 4.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Richard Potts, Clinical Operations Director | GW Pharma Ltd. | 0044 1223 266800 | rp@gwpharm.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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|
|
| GW-2000-02 | Drug | Contains THC (25 mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg). The maximum daily exposure was set at 48 actuations per day. |
|
| Placebo | Drug | Contains peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum daily exposure was set at 48 actuations per day. |
|
| Up to 74 days |
| Change From Baseline in the Mean Box Scale-11 Sleep Quality Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | Each day patients recorded in their patient diary the quality of their sleep during the previous night using a Box Scale-11 sleep score ranging from zero "Worst Imaginable" to 10 "Best Imaginable". The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A positive value indicates an improvement from baseline. | Up to 74 days |
| Change From Baseline in the Mean McGill Pain Questionnaire Part 1 Score for 'Total Pain Intensity' at the End of Each Treatment Period (Each Lasting 14-20 Days) | Part 1 of the questionnaire related to the intensity of 15 different types of pain. Intensity was recorded separately for each type of pain on a zero to three scale, where zero = "None", one = "Mild", two = "Moderate" and three = "Severe". The total intensity was defined as the unweighted sum of the 15 scores, giving a minimum possible score of zero (lowest pain score) and a maximum possible score of 45 (highest pain score). The distribution of each of the 15 types of pain was summarised at baseline and for each treatment. A negative value indicates an improvement in pain from baseline. | Up to 74 days |
| Change From Baseline in the Mean McGill Pain Questionnaire Part 2 Score for 'Intensity of Pain' at the End of Each Treatment Period (Each Lasting 14-20 Days) | Part 2 of the questionnaire recorded the intensity of pain at present. Results were recorded on a VAS ranging from zero "No pain" to 100 "Worst possible pain". Intensity of pain was summarised and analysed in the same manner as the primary efficacy parameter of Box Scale-11 pain score. A negative value indicates an improvement from baseline. | Up to 74 days |
| Change From Baseline in the Number of Patients Who Reported 'No Pain' or 'Mild Pain' Using a McGill Pain Questionnaire Part 3 Score for 'Strength of Pain at Present' at the End of Each Treatment Period (Each Lasting 14-20 Days) | Part 3 of the questionnaire recorded the strength of pain at present. Results were recorded in six categories which were classified as "No Pain", "Mild", "Discomforting", "Distressing", "Horrible" and "Excruciating". The change from baseline in the number of patients who reported "No Pain" or "Mild Pain" at the end of the respective treatment periods is presented. An increase in number indicates an improvement from baseline. | Up to 74 days |
| Change From Baseline in the Mean Pain Disability Index Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | The Pain Disability Index consisted of seven assessments representing different aspects of disability due to pain. Each assessment was scored on a zero to 10 scale, where zero equated with "no disability" and 10 equated with "total disability". The total Pain Disability Index score was the unweighted sum of the seven pain scores, ranging from zero to 70. A negative value indicates an improvement from baseline. | Up to 74 days |
| Change From Baseline in the Mean 12-Item General Health Questionnaire Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | The 12-Item General Health Questionnaire consisted of 12 general health questions. Each question was scored on a zero to three scale, where zero represented the better assessment. The total score was the unweighted sum of the 12 scores, ranging from zero to 36. A negative value indicates an improvement from baseline. | Up to 74 days |
| Incidence of Adverse Events as a Measure of Patient Safety. | The number of patients who experienced an adverse event during the course of study is presented. | Up to 114 days |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | GW-2000-02 | Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours. |
| OG002 | Placebo | Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours. |
|
|
|
| Secondary | Change From Baseline in the Mean Sleep Disturbance Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | Each day patients recorded in their patient diary the number of times they were woken due to pain during the previous night. The results were recorded as "None", "Once", "Twice" and "More Than Twice" and converted to a four point scale, zero to three respectively. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A negative value indicates an improvement from baseline. | All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Up to 74 days |
|
|
|
|
| Secondary | Change From Baseline in the Mean Box Scale-11 Sleep Quality Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | Each day patients recorded in their patient diary the quality of their sleep during the previous night using a Box Scale-11 sleep score ranging from zero "Worst Imaginable" to 10 "Best Imaginable". The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A positive value indicates an improvement from baseline. | All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Up to 74 days |
|
|
|
|
| Secondary | Change From Baseline in the Mean McGill Pain Questionnaire Part 1 Score for 'Total Pain Intensity' at the End of Each Treatment Period (Each Lasting 14-20 Days) | Part 1 of the questionnaire related to the intensity of 15 different types of pain. Intensity was recorded separately for each type of pain on a zero to three scale, where zero = "None", one = "Mild", two = "Moderate" and three = "Severe". The total intensity was defined as the unweighted sum of the 15 scores, giving a minimum possible score of zero (lowest pain score) and a maximum possible score of 45 (highest pain score). The distribution of each of the 15 types of pain was summarised at baseline and for each treatment. A negative value indicates an improvement in pain from baseline. | All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Up to 74 days |
|
|
|
|
| Secondary | Change From Baseline in the Mean McGill Pain Questionnaire Part 2 Score for 'Intensity of Pain' at the End of Each Treatment Period (Each Lasting 14-20 Days) | Part 2 of the questionnaire recorded the intensity of pain at present. Results were recorded on a VAS ranging from zero "No pain" to 100 "Worst possible pain". Intensity of pain was summarised and analysed in the same manner as the primary efficacy parameter of Box Scale-11 pain score. A negative value indicates an improvement from baseline. | All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Up to 74 days |
|
|
|
|
| Secondary | Change From Baseline in the Number of Patients Who Reported 'No Pain' or 'Mild Pain' Using a McGill Pain Questionnaire Part 3 Score for 'Strength of Pain at Present' at the End of Each Treatment Period (Each Lasting 14-20 Days) | Part 3 of the questionnaire recorded the strength of pain at present. Results were recorded in six categories which were classified as "No Pain", "Mild", "Discomforting", "Distressing", "Horrible" and "Excruciating". The change from baseline in the number of patients who reported "No Pain" or "Mild Pain" at the end of the respective treatment periods is presented. An increase in number indicates an improvement from baseline. | All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis. | Posted | Number | participants | Up to 74 days |
|
|
|
|
| Secondary | Change From Baseline in the Mean Pain Disability Index Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | The Pain Disability Index consisted of seven assessments representing different aspects of disability due to pain. Each assessment was scored on a zero to 10 scale, where zero equated with "no disability" and 10 equated with "total disability". The total Pain Disability Index score was the unweighted sum of the seven pain scores, ranging from zero to 70. A negative value indicates an improvement from baseline. | All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Up to 74 days |
|
|
|
|
| Secondary | Change From Baseline in the Mean 12-Item General Health Questionnaire Score at the End of Each Treatment Period (Each Lasting 14-20 Days). | The 12-Item General Health Questionnaire consisted of 12 general health questions. Each question was scored on a zero to three scale, where zero represented the better assessment. The total score was the unweighted sum of the 12 scores, ranging from zero to 36. A negative value indicates an improvement from baseline. | All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Up to 74 days |
|
|
|
|
| Secondary | Incidence of Adverse Events as a Measure of Patient Safety. | The number of patients who experienced an adverse event during the course of study is presented. | All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis. | Posted | Number | participants | Up to 114 days |
|
|
|
| 1 |
| 46 |
| 34 |
| 46 |
| EG001 | GW-2000-02 | Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours. | 0 | 47 | 37 | 47 |
| EG002 | Placebo | Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours. | 0 | 48 | 20 | 48 |
| Somnolence | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
|
| Headache Not Otherwise Specified | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
|
| Dry Mouth | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
|
| Oral Discomfort | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
|
| Feeling Drunk | General disorders | MedDRA 4.0 | Systematic Assessment |
|
| Lethargy | General disorders | MedDRA 4.0 | Systematic Assessment |
|
| Pain Exacerbated | General disorders | MedDRA 4.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 4.0 | Systematic Assessment |
|
| Euphoric Mood | Psychiatric disorders | MedDRA 4.0 | Systematic Assessment |
|
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
|
| Paresthesia Oral | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
|
| Oral Pain | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
|
| Hypoaesthesia Oral | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 4.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 4.0 | Systematic Assessment |
|
| Panic Attack | Psychiatric disorders | MedDRA 4.0 | Systematic Assessment |
|
| Appetite Increased | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
|
GW will coordinate the dissemination of data from this study and may solicit input and assistance from the principal investigator. All publications, for example manuscripts, abstracts, oral/slide presentations or book chapters based on this study, must be submitted to GW for corporate review before release.
Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Period |
| ANOVA |
| <0.001 |
| Estimated mean treatment difference |
| -0.33 |
| 2-Sided |
| 95 |
| -0.49 |
| -0.16 |
| Superiority or Other (legacy) |
Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Period |
| ANOVA |
| 0.001 |
| Estimated mean treatment difference |
| 0.79 |
| 2-Sided |
| 95 |
| 0.33 |
| 1.24 |
| Superiority or Other (legacy) |
Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Period |
| ANOVA |
| 0.040 |
| Estimated mean treatment difference |
| -2.20 |
| 2-Sided |
| 95 |
| -4.29 |
| -0.10 |
| Superiority or Other (legacy) |
Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Period |
| ANOVA |
| 0.037 |
| Estimated mean treatment difference |
| -8.99 |
| 2-Sided |
| 95 |
| -17.41 |
| -0.57 |
| Superiority or Other (legacy) |
Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.
| Wilcoxon (Mann-Whitney) |
| 0.560 |
| Mann-Whitney U statistic |
| 1200.5 |
| 95 |
| Superiority or Other (legacy) |
Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Period |
| ANOVA |
| 0.739 |
| Estimated mean treatment difference |
| 0.43 |
| 2-Sided |
| 95 |
| -2.12 |
| 2.98 |
| Superiority or Other (legacy) |
|
12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Period |
| ANOVA |
| 0.178 |
| Estimated mean treatment difference |
| -1.21 |
| 2-Sided |
| 95 |
| -2.97 |
| 0.56 |
| Superiority or Other (legacy) |