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
J. Lewis Research
Salt Lake City, Utah, 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.
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
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