Exploratory Efficacy Study of Guaifenesin in Upper Back Pain
- Registration Number
- NCT01562548
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
-
Paticipant presents with a new episode of acute upper back/neck/shoulder pain and muscle spasm that:
- is at least 30 days from previous episode.
- has an onset occurred within 48 hours of Visit 1.
- has symptoms consistent with a clinical diagnosis as per the physical examination at Visit 1.
- has a subject-rated muscle spasm score and a pain score of at least 40 out of 100 on a 100mm VAS.
-
Paticipant has a normal neurological examination.
- Medical history: a) Paticipant has a known or suspected intolerance or hypersensitivity to guaifenesin or methocarbamol (or closely related compounds) or any of their stated ingredients. b) Paticipant has history of upper back pain with active hypersensitive spots - trigger point in the muscles of upper back/neck/shoulder/maxillofacial regions. c) Paticipant has a current or recent history of liver and/or kidney disease, neck/back/shoulder injuries, spinal disc disease, myocardial infarction (<12 months from Visit 1) and osteoporosis. d) Subjects have history of other chronic pain e.g. headache, osteoarthritis, arthritis, lower back pain etc.
- Medications: a) Paticipant has used a muscle relaxant or narcotic within 2 weeks of Visit 1. b) Paticipant has used monoamine oxidase inhibitors or selegiline within 2 weeks of Visit 1 c) Currently using tricyclic antidepressants, lithium, anticoagulants, or tramadol.
- Paticipant is involved in a workers compensation case.
- Paticipant is unlikely to refrain from using analgesics, NSAIDs, and other muscle relaxants for the duration of the study, with the exception of cardioprotective doses of aspirin (i.e., ≤ 325 mg/day).
- Paticipant is unlikely to refrain from physical therapy, massage therapy, acupuncture, heat treatment, spas, etc for the duration of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 3 Placebo Placebo 1 tablet BID Arm 4 Placebo Placebo 2 tablets BID Arm 1 Guaifenesin Guaifenesin 1 tablet BID Arm 2 Guaifenesin Guaifenesin 2 tablets BID
- Primary Outcome Measures
Name Time Method Mean Change From Baseline of Both AM and PM Spasm Assessment Scores 7 Days 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.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores 7 Days 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.
Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores 7 Days 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.
Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores 7 Days 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.
Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores 7 Days 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.
Muscle Relaxation Scores 4 Days, 7 Days 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.
Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores Before treatment, 4 Days, 7 Days 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.
Global Assessment of Treatment Helpfulness (GATH) 4 Days, 7 Days Measured as an overall qualitative score on a 5 point categorical scale: 0-poor, 1-fair, 2-good, 3-very good and 4-excellent.
Global Assessment of Sleep Disturbance (GASD) 7 Days Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Global Assessment of Headache Frequency (GAHF) 7 Days Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Global Assessment of Headache Intensity (GAHI) 7 Days Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Trial Locations
- Locations (5)
Radiant Research, Inc. - TX
🇺🇸San Antonio, Texas, United States
Med Investigations
🇺🇸Fair Oaks, California, United States
J. Lewis Research
🇺🇸Salt Lake City, Utah, United States
San Diego Sports Medicine and Family Health Center
🇺🇸San Diego, California, United States
Radiant Research - Cincinnati
🇺🇸Cincinnati, Ohio, United States