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NCT Number: NCT01562548

Exploratory Efficacy Study 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.

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Key information

Conditions

Upper Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Med Investigations, Fair Oaks, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guaifenesin

Drug

high and low dose of Guaifenesin each given twice daily over a 4-day treatment period

Placebo

Drug

no active ingredient

Primary outcomes

  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 outcomes

  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'.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 26, 2012
Registry last updated
Jun 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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