Exploratory Efficacy Study of Guaifenesin in Upper Back Pain

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

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 Overview

• Status: Completed
• Conditions: Upper Back Pain
• Intervention / Treatment: Drug: Guaifenesin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fair Oaks, California, United States, 95628
      • MED Investigations
    • San Diego, California, United States, 92120
      • San Diego Sports Medicine and Family Health Center
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research - Cincinnati
  • Texas
    • San Antonio, Texas, United States, 78229
      • Radiant Research, Inc. - TX
  • Utah
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Paticipant presents with a new episode of acute upper back/neck/shoulder pain and muscle spasm that:

  1. is at least 30 days from previous episode.
  2. has an onset occurred within 48 hours of Visit 1.
  3. has symptoms consistent with a clinical diagnosis as per the physical examination at Visit 1.
  4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: March 22, 2012
• First Posted (Estimate): March 26, 2012

Study Record Updates

• Last Update Posted (Estimate): June 3, 2014
• Last Update Submitted That Met QC Criteria: May 1, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: upper back/neck/shoulder muscle spasm
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Respiratory System Agents; Appetite Depressants; Anti-Obesity Agents; Sympathomimetics; Expectorants; Vasoconstrictor Agents; Nasal Decongestants; Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
• Other Study ID Numbers: A3940666