Exploratory Efficacy Study of Guaifenesin in Upper Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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A Proof of Principle Study to Explore the Utility of Guaifenesin in Upper Back Pain

Conditions
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Upper Back Pain

Intervention / Treatment
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* Drug: Guaifenesin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Guaifenesin 1 tablet BID | Drug: Guaifenesin<br>* high and low dose of Guaifenesin each given twice daily over a 4-day treatment period<br>|
| Experimental: Arm 2<br>Guaifenesin 2 tablets BID | Drug: Guaifenesin<br>* high and low dose of Guaifenesin each given twice daily over a 4-day treatment period<br>|
| Placebo Comparator: Arm 3<br>Placebo 1 tablet BID | Drug: Placebo<br>* no active ingredient<br>|
| Placebo Comparator: Arm 4<br>Placebo 2 tablets BID | Drug: Placebo<br>* no active ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 4 Days, 7 Days | 
| Global Assessment of Sleep Disturbance (GASD) | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. | 7 Days | 
| Global Assessment of Headache Frequency (GAHF) | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. | 7 Days | 
| Global Assessment of Headache Intensity (GAHI) | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. | 7 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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upper back/neck/shoulder muscle spasm