Clinical trial NCT01562548: Exploratory Efficacy Study of Guaifenesin in Upper Back Pain
Official title: A Proof of Principle Study to Explore the Utility of Guaifenesin in Upper Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Back Pain
Keywords: upper back/neck/shoulder muscle spasm
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Mean Change From Baseline of Both AM and PM Spasm Assessment Scores
timeFrame: 7 Days
Secondary outcomes:
measure: Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores
timeFrame: 7 Days
measure: Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores
timeFrame: 7 Days
measure: Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores
timeFrame: 7 Days
measure: Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores
timeFrame: 7 Days
measure: Muscle Relaxation Scores
timeFrame: 4 Days, 7 Days
measure: Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores
timeFrame: Before treatment, 4 Days, 7 Days
measure: Global Assessment of Treatment Helpfulness (GATH)
timeFrame: 4 Days, 7 Days
measure: Global Assessment of Sleep Disturbance (GASD)
timeFrame: 7 Days
measure: Global Assessment of Headache Frequency (GAHF)
timeFrame: 7 Days
measure: Global Assessment of Headache Intensity (GAHI)
timeFrame: 7 Days
Other outcomes:
Locations:
city: Fair Oaks
country: United States
facility: Med Investigations
state: California
city: San Diego
country: United States
facility: San Diego Sports Medicine and Family Health Center
state: California
city: Cincinnati
country: United States
facility: Radiant Research - Cincinnati
state: Ohio
city: San Antonio
country: United States
facility: Radiant Research, Inc. - TX
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research
state: Utah
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: