Lumbar Disc Degenerative Disease
Conditions
Keywords
Lumbar disc degenerative disease, Methycobal
Brief summary
The purpose of this study is to observe the overall satisfaction of patients with degenerative disc disease after receiving triple therapy.
Detailed description
DDD (lumbar disc degenerative disease ) patients who have been prescribed triple therapy (MBL+ MYO+ NSAIDs) over 2 weeks of triple therapy were enrolled in the study. They were asked to assess their overall satisfaction degree on triple therapy.
Interventions
None listed
Sponsors
Eisai China Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. lumbar degenerative disc disease (DDD) 2. patients who have been prescribed over 2 weeks of triple therapy
Exclusion criteria
Patients who do not meet inclusion criteria for DDD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID). | 2 weeks | The measurement of overall satisfaction degree was in three scales, that was satisfactory, just so so and dissatisfactory. The measurement was estimated by both the physicians and the patients respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset Time of Symptom Relief. | 2 weeks | Kaplan-Meier Estimates for the Average Onset Time of Symptom Relief. In this case the onset time of symptom relief was defined as the days between the end of triple therapy and the symptom improvement reported by patients. |
| Safety Data During Triple Therapy. | 2 weeks | Percentage of participants with reported Adverse Events (AE) and Serious Adverse Event (SAE) |
| Japanese Orthopedic Association (JOA) Score | Baseline and 2 weeks | Each patient is Scored on JOA at baseline and two weeks. JOA is short for Japanese Orthopedic Association, which consists of 12 items: low back pain, lower extremity pain and numbness, walking ability, straight leg raising, muscle strength, sensory and etc. The first 3 item's scores are range from 0 to 3 and the others are from 0 to 2. Higher score means better condition. All of these items scores are combined for a total overall JOA score, which is range from 0 to 27. |
| Visual Analogue Scale (VAS) Score | Baseline and 2 weeks | Each patient is Scored on VAS at baseline and two weeks. VAS is the abbreviation of visual analogue score. There is no subscale in VAS. The maximum value of vas is 10 and the minimum is 0. This is self-evaluation method to present the severity of patient pain. More score number, more pain. |
Countries
China
Participant flow
Recruitment details
This study was recruited at 10 centers in China during the period of 09-Jun-2010 to 28-Sept-2010 .
Participants by arm
| Arm | Count |
|---|---|
| Lumbar Disc Degenerative Disease Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:
NSAID (diclofenac) 75 mg,: twice daily for two weeks | 478 |
| Total | 478 |
Baseline characteristics
| Characteristic | Lumbar Disc Degenerative Disease |
|---|---|
| Age Continuous | 50.34 years STANDARD_DEVIATION 12.63 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 478 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 252 Participants |
| Sex: Female, Male Male | 226 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 478 |
| serious Total, serious adverse events | 0 / 478 |
Outcome results
Primary
Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID).
The measurement of overall satisfaction degree was in three scales, that was satisfactory, just so so and dissatisfactory. The measurement was estimated by both the physicians and the patients respectively.
Time frame: 2 weeks
Population: The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lumbar Disc Degenerative Disease | Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID). | Estimation by Patients: dissatisfactory | 0.84 percentage of participants |
| Lumbar Disc Degenerative Disease | Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID). | Estimation by Physicians: satisfactory | 91.21 percentage of participants |
| Lumbar Disc Degenerative Disease | Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID). | Estimation by Physicians: just so so | 7.74 percentage of participants |
| Lumbar Disc Degenerative Disease | Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID). | Estimation by Physicians: dissatisfactory | 1.05 percentage of participants |
| Lumbar Disc Degenerative Disease | Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID). | Estimation by Patients: satisfactory | 86.4 percentage of participants |
| Lumbar Disc Degenerative Disease | Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID). | Estimation by Patients: just so so | 12.76 percentage of participants |
Secondary
Japanese Orthopedic Association (JOA) Score
Each patient is Scored on JOA at baseline and two weeks. JOA is short for Japanese Orthopedic Association, which consists of 12 items: low back pain, lower extremity pain and numbness, walking ability, straight leg raising, muscle strength, sensory and etc. The first 3 item's scores are range from 0 to 3 and the others are from 0 to 2. Higher score means better condition. All of these items scores are combined for a total overall JOA score, which is range from 0 to 27.
Time frame: Baseline and 2 weeks
Population: The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lumbar Disc Degenerative Disease | Japanese Orthopedic Association (JOA) Score | 2 weeks | 21.28 Scores on JOA | Standard Deviation 3.41 |
| Lumbar Disc Degenerative Disease | Japanese Orthopedic Association (JOA) Score | Baseline | 15.72 Scores on JOA | Standard Deviation 3.51 |
Secondary
Onset Time of Symptom Relief.
Kaplan-Meier Estimates for the Average Onset Time of Symptom Relief. In this case the onset time of symptom relief was defined as the days between the end of triple therapy and the symptom improvement reported by patients.
Time frame: 2 weeks
Population: The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumbar Disc Degenerative Disease | Onset Time of Symptom Relief. | 4.68 Average Days of Onset Time | Standard Deviation 2.61 |
Secondary
Safety Data During Triple Therapy.
Percentage of participants with reported Adverse Events (AE) and Serious Adverse Event (SAE)
Time frame: 2 weeks
Population: The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lumbar Disc Degenerative Disease | Safety Data During Triple Therapy. | AE | 2.7 Percentage of participants |
| Lumbar Disc Degenerative Disease | Safety Data During Triple Therapy. | SAE | 0 Percentage of participants |
Secondary
Visual Analogue Scale (VAS) Score
Each patient is Scored on VAS at baseline and two weeks. VAS is the abbreviation of visual analogue score. There is no subscale in VAS. The maximum value of vas is 10 and the minimum is 0. This is self-evaluation method to present the severity of patient pain. More score number, more pain.
Time frame: Baseline and 2 weeks
Population: The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lumbar Disc Degenerative Disease | Visual Analogue Scale (VAS) Score | Baseline | 6.23 Scores on VAS | Standard Deviation 1.38 |
| Lumbar Disc Degenerative Disease | Visual Analogue Scale (VAS) Score | 2 weeks | 2.61 Scores on VAS | Standard Deviation 1.7 |