Last updated: 11/04/2018 04:21:24
Exploratory efficacy study of Guaifenesin in Upper Back Pain
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Proof of Principle Study to Explore the Utility of Guaifenesin in Upper Back Pain
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Mean change from baseline of both AM and PM spasm assessment scores
Timeframe: 7 Days
Secondary outcomes:
Mean change from baseline of both AM and PM NRS muscle stiffness assessment scores
Timeframe: 7 Days
Mean change from baseline of both AM and PM NRS tension assessment scores
Timeframe: 7 Days
Mean change from baseline of both AM and PM NRS pain assessment scores
Timeframe: 7 Days
Mean change from baseline of both AM and PM NRS discomfort assessment scores
Timeframe: 7 Days
Muscle relaxation scores
Timeframe: 4 Days, 7 Days
Upper back/neck/shoulder Pain Disability (Vernon-Mior) Index Scores
Timeframe: Before treatment, 4 Days, 7 Days
Global Assessment of Treatment Helpfulness (GATH)
Timeframe: 4 Days, 7 Days
Global Assessment of Sleep Disturbance (GASD)
Timeframe: 7 Days
Global Assessment of Headache Frequency (GAHF)
Timeframe: 7 Days
Global Assessment of Headache Intensity (GAHI)
Timeframe: 7 Days
Interventions:
Enrollment:
78
Primary completion date:
2013-31-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
upper back pain
Product
Not applicable
Collaborators
Not applicable
Study date(s)
February 2012 to May 2013
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Paticipant presents with a new episode of acute upper back/neck/shoulder pain and muscle spasm that:
- a. is at least 30 days from previous episode.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- Paticipant presents with a new episode of acute upper back/neck/shoulder pain and muscle spasm that: a. is at least 30 days from previous episode. b. has an onset occurred within 48 hours of Visit 1. c. has symptoms consistent with a clinical diagnosis as per the physical examination at Visit 1. d. 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.
Trial location(s)
Location
San Diego Sports Medicine and Family Health Center
San Diego, CA, United States, 92120
Status
Study Complete
Location
J. Lewis Research
Salt Lake City, UT, United States, 84109
Status
Terminated/Withdrawn
Location
Radiant Research, Inc. - TX
San Antonio, TX, United States, 78229
Status
Study Complete
Location
Radiant Research - Cincinnati
Cincinnati, OH, United States, 45249
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2013-31-05
Actual study completion date
2013-31-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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