Back to resultsExploratory Efficacy Study of Guaifenesin in Upper Back Pain
Primary Purpose
Upper Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guaifenesin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Upper Back Pain focused on measuring upper back/neck/shoulder muscle spasm
Eligibility Criteria
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.
Sites / Locations
- Med Investigations
- San Diego Sports Medicine and Family Health Center
- Radiant Research - Cincinnati
- Radiant Research, Inc. - TX
- J. Lewis Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
Guaifenesin 1 tablet BID
Guaifenesin 2 tablets BID
Placebo 1 tablet BID
Placebo 2 tablets BID
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Global Assessment of Sleep Disturbance (GASD)
Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Global Assessment of Headache Frequency (GAHF)
Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Global Assessment of Headache Intensity (GAHI)
Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01562548
Brief Title
Exploratory Efficacy Study of Guaifenesin in Upper Back Pain
Official Title
A Proof of Principle Study to Explore the Utility of Guaifenesin in Upper Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Back Pain
Keywords
upper back/neck/shoulder muscle spasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Guaifenesin 1 tablet BID
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Guaifenesin 2 tablets BID
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Description
Placebo 1 tablet BID
Arm Title
Arm 4
Arm Type
Placebo Comparator
Arm Description
Placebo 2 tablets BID
Intervention Type
Drug
Intervention Name(s)
Guaifenesin
Intervention Description
high and low dose of Guaifenesin each given twice daily over a 4-day treatment period
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
no active ingredient
Primary Outcome Measure Information:
Title
Mean Change From Baseline of Both AM and PM Spasm Assessment Scores
Description
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
Secondary Outcome Measure Information:
Title
Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores
Description
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
Title
Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores
Description
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
Title
Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores
Description
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
Title
Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores
Description
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
Title
Muscle Relaxation Scores
Description
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
Title
Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores
Description
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
Title
Global Assessment of Treatment Helpfulness (GATH)
Description
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
Title
Global Assessment of Sleep Disturbance (GASD)
Description
Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Time Frame
7 Days
Title
Global Assessment of Headache Frequency (GAHF)
Description
Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Time Frame
7 Days
Title
Global Assessment of Headache Intensity (GAHI)
Description
Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Time Frame
7 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Med Investigations
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
San Diego Sports Medicine and Family Health Center
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Radiant Research - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Radiant Research, Inc. - TX
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
J. Lewis Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
12. IPD Sharing Statement
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Exploratory Efficacy Study of Guaifenesin in Upper Back Pain
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