Multiple Sclerosis
Conditions
Brief summary
Medical marijuana is commonly prescribed people with Multiple Sclerosis (MS) for symptom, e.g. spasticity and pain, management. Unfortunately not much is known about its effects outside the treatment for these 2 symptoms. Several previous studies have suggested people with MS using medical marijuana have lower levels of physical disability and improved walking abilities. A major limitation of these previous studies is that the investigators used subjective measures of motor function. In this proposed observational case-control study the investigators plan to objectively measure multiple domains of motor function, such as: fatigue, strength, and walking ability. No marijuana will be brought on to campus or given to participants.
Detailed description
To investigate the effects of medical marijuana usage on physical function the investigators will employ an observational case-control design. Cases (MS medical marijuana users) will be compared to age, sex, and disease duration matched controls (MS non-cannabis users).
Interventions
BEHAVIORALMedical Marijuana
To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design
Sponsors
William R. Shaffer, M.D.
Colorado State University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Medically diagnosed with MS, * 30-60 years of age, * Moderate disability (Patient Determined Disease Steps score 2-6).
Exclusion criteria
* Relapse with the last 60 days, * High risk for cardiovascular disease (American College of Sports Medicine risk classification), * Changes in disease modifying medications within the last 45 days, * Concurrent neurological/neuromuscular disease, * Hospitalization within the last 90 days, * Inability to understand/sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Through study completion, an average of 6 months. | Strength decline during fatiguing muscle contraction measured with force transducer |
| Muscle Strength | Through study completion, an average of 6 months. | Maximal muscle strength measured with force transducer |
| Postural Stability | Through study completion, an average of 6 months. | Timed up and go |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Regular Medical Marijuana Users People with MS that are regular Medical Marijuana users
Medical Marijuana: To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design | 13 |
| Non Users of Medical Marijuana People with MS that are non users of Medical Marijuana | 9 |
| Total | 22 |
Baseline characteristics
| Characteristic | Non Users of Medical Marijuana | Total | Regular Medical Marijuana Users |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 18 Participants | 11 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 9 participants | 22 participants | 13 participants |
| Sex: Female, Male Female | 6 Participants | 15 Participants | 9 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 9 |
| other Total, other adverse events | 0 / 13 | 0 / 9 |
| serious Total, serious adverse events | 0 / 13 | 0 / 9 |
Outcome results
Primary
Fatigue
Strength decline during fatiguing muscle contraction measured with force transducer
Time frame: Through study completion, an average of 6 months.
Population: Twenty Two participants were enrolled in the study. Analysis was performed on sixteen people with Multiple Sclerosis, eight cannabis users and age/sex matched non-users. Matching was only possible for 16 subjects. The remaining 6 subjects were not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular Medical Marijuana Users | Fatigue | 21 % decline | Standard Deviation 13 |
| Non Users of Medical Marijuana | Fatigue | 24 % decline | Standard Deviation 15 |
Primary
Muscle Strength
Maximal muscle strength measured with force transducer
Time frame: Through study completion, an average of 6 months.
Population: Twenty Two participants were enrolled in the study. Analysis was performed on sixteen people with Multiple Sclerosis, eight cannabis users and age/sex matched non-users.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular Medical Marijuana Users | Muscle Strength | 28.7 Newton | Standard Deviation 7.7 |
| Non Users of Medical Marijuana | Muscle Strength | 33.6 Newton | Standard Deviation 10.1 |
Primary
Postural Stability
Timed up and go
Time frame: Through study completion, an average of 6 months.
Population: Twenty Two participants were enrolled in the study. Analysis was performed on sixteen people with Multiple Sclerosis, eight cannabis users and age/sex matched non-users.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular Medical Marijuana Users | Postural Stability | 9.2 Seconds | Standard Deviation 3.4 |
| Non Users of Medical Marijuana | Postural Stability | 11.5 Seconds | Standard Deviation 13.5 |