Explore the clinical efficacy of 7-day treatment regimens of guaifenesin in order to investigate the evidence that guaifenesin is an effective treatment for upper back/neck/shoulder muscle spasm/stiffness and pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
78
high and low dose of Guaifenesin each given twice daily over a 4-day treatment period
no active ingredient
Med Investigations
Fair Oaks, California, United States
San Diego Sports Medicine and Family Health Center
San Diego, California, United States
Radiant Research - Cincinnati
Cincinnati, Ohio, United States
Radiant Research, Inc. - TX
San Antonio, Texas, United States
Mean Change From Baseline of Both AM and PM Spasm Assessment Scores
The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no spasm to 10 - unbearable spasm.
Time frame: 7 Days
Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores
The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no stiffness to 10 - unbearable stiffness.
Time frame: 7 Days
Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores
The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no tension to 10 - unbearable tension.
Time frame: 7 Days
Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores
The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no pain to 10 - unbearable pain.
Time frame: 7 Days
Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores
The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no discomfort to 10 - unbearable discomfort.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
J. Lewis Research
Salt Lake City, Utah, United States
Time frame: 7 Days
Muscle Relaxation Scores
The score was measured as mean of both AM and PM assessment scores at Days 4 and 7. Measurements were based on a 5 categorical scale: 0 - no relaxation, 1- a little relaxation, 2 - fair relaxation, 3 - good relaxation, 4 - complete muscle relaxation.
Time frame: 4 Days, 7 Days
Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores
Vernon-Mior upper back/neck/shoulder components were assessed before the treatment and at Days 4 and 7. Each component (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation) was assessed based on a 6-point categorical scale (1 to 6), with 1 being the most positive and 6 being the worst.
Time frame: Before treatment, 4 Days, 7 Days
Global Assessment of Treatment Helpfulness (GATH)
Measured as an overall qualitative score on a 5 point categorical scale: 0-poor, 1-fair, 2-good, 3-very good and 4-excellent.
Time frame: 4 Days, 7 Days
Global Assessment of Sleep Disturbance (GASD)
Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Time frame: 7 Days
Global Assessment of Headache Frequency (GAHF)
Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Time frame: 7 Days
Global Assessment of Headache Intensity (GAHI)
Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Time frame: 7 Days