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Exploratory Efficacy Study of Guaifenesin in Upper Back Pain
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01562548
First received: March 22, 2012
Last updated: May 1, 2014
Last verified: March 2014
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Purpose
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.
| Condition | Intervention |
|---|---|
| Upper Back Pain | Drug: Guaifenesin Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Participant) Primary Purpose: Treatment |
| Official Title: | A Proof of Principle Study to Explore the Utility of Guaifenesin in Upper Back Pain |
Resource links provided by NLM:
MedlinePlus related topics:
Back Pain
Drug Information available for:
Guaifenesin
Phenylpropanolamine hydrochloride
Triaminic
Phenylpropanolamine
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Mean Change From Baseline of Both AM and PM Spasm Assessment Scores [ Time Frame: 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:
- Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 7 Days ]Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
- Global Assessment of Headache Frequency (GAHF) [ Time Frame: 7 Days ]Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
- Global Assessment of Headache Intensity (GAHI) [ Time Frame: 7 Days ]Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
| Enrollment: | 78 |
| Study Start Date: | February 2012 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Guaifenesin 1 tablet BID
|
Drug: Guaifenesin
high and low dose of Guaifenesin each given twice daily over a 4-day treatment period
|
|
Experimental: Arm 2
Guaifenesin 2 tablets BID
|
Drug: Guaifenesin
high and low dose of Guaifenesin each given twice daily over a 4-day treatment period
|
|
Placebo Comparator: Arm 3
Placebo 1 tablet BID
|
Drug: Placebo
no active ingredient
|
|
Placebo Comparator: Arm 4
Placebo 2 tablets BID
|
Drug: Placebo
no active ingredient
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562548
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562548
Locations
| United States, California | |
| Med Investigations | |
| Fair Oaks, California, United States, 95628 | |
| San Diego Sports Medicine and Family Health Center | |
| San Diego, California, United States, 92120 | |
| United States, Ohio | |
| Radiant Research - Cincinnati | |
| Cincinnati, Ohio, United States, 45249 | |
| United States, Texas | |
| Radiant Research, Inc. - TX | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| J. Lewis Research | |
| Salt Lake City, Utah, United States, 84109 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01562548 History of Changes |
| Other Study ID Numbers: |
A3940666 |
| Study First Received: | March 22, 2012 |
| Results First Received: | March 6, 2014 |
| Last Updated: | May 1, 2014 |
Keywords provided by GlaxoSmithKline:
|
upper back/neck/shoulder muscle spasm |
Additional relevant MeSH terms:
|
Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Guaifenesin Phenylpropanolamine Chlorpheniramine, phenylpropanolamine drug combination Expectorants Respiratory System Agents Adrenergic alpha-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Appetite Depressants Anti-Obesity Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Nasal Decongestants Vasoconstrictor Agents |
ClinicalTrials.gov processed this record on June 23, 2017