Exploratory Efficacy Study of Guaifenesin in Upper Back Pain

• ClinicalTrials.gov Identifier: NCT01562548
• Recruitment Status: Completed
• First Posted: March 26, 2012
• Results First Posted: June 3, 2014
• Last Update Posted: June 3, 2014
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

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.

Condition or disease	Intervention/treatment	Phase
Upper Back Pain	Drug: Guaifenesin; Drug: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Proof of Principle Study to Explore the Utility of Guaifenesin in Upper Back Pain
• Study Start Date: February 2012
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: May 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. Global Assessment of Sleep Disturbance (GASD) [ Time Frame: 7 Days ]
   Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
9. Global Assessment of Headache Frequency (GAHF) [ Time Frame: 7 Days ]
   Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
10. Global Assessment of Headache Intensity (GAHI) [ Time Frame: 7 Days ]
    Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older 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:

  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.

Contacts and Locations

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
• Other Study ID Numbers: A3940666
• First Posted: March 26, 2012
• Results First Posted: June 3, 2014
• Last Update Posted: June 3, 2014
• Last Verified: March 2014

Keywords provided by GlaxoSmithKline:

upper back/neck/shoulder muscle spasm

Additional relevant MeSH terms:

Back Pain; Pain; Neurologic Manifestations; Phenylpropanolamine; Guaifenesin; 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