Exploratory Efficacy Study of Guaifenesin in Upper Back Pain

Upper Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562548
• Other study ID #: A3940666
• Status: Completed
• Phase: N/A
• First received: March 22, 2012
• Last updated: May 1, 2014
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Upper Back Pain

Intervention

Drug:
• Guaifenesin
high and low dose of Guaifenesin each given twice daily over a 4-day treatment period
• Placebo
no active ingredient

Locations

Country	Name	City	State
United States	Radiant Research - Cincinnati	Cincinnati	Ohio
United States	Med Investigations	Fair Oaks	California
United States	J. Lewis Research	Salt Lake City	Utah
United States	Radiant Research, Inc. - TX	San Antonio	Texas
United States	San Diego Sports Medicine and Family Health Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Global Assessment of Sleep Disturbance (GASD)	Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.	7 Days	No
Secondary	Global Assessment of Headache Frequency (GAHF)	Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.	7 Days	No
Secondary	Global Assessment of Headache Intensity (GAHI)	Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.	7 Days	No