Upper Back PainNCT01562548

Exploratory Efficacy Study of Guaifenesin in Upper Back Pain

A study testing Guaifenesin in people with Upper Back Pain, run by GlaxoSmithKline at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Upper Back Pain
What is being tested?: Guaifenesin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 78 participants
Where: 5 sitesUnited States
Study dates: Feb 2012to May 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Radiant Research - Cincinnati
Cincinnati, Ohio, 45249
Med Investigations
Fair Oaks, California, 95628
J. Lewis Research
Salt Lake City, Utah, 84109
Radiant Research, Inc. - TX
San Antonio, Texas, 78229
San Diego Sports Medicine and Family Health Center
San Diego, California, 92120

Other trials in United States

About this study

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

Conditions: Upper Back Pain
Being tested: Guaifenesin, Placebo
Keywords: upper back/neck/shoulder muscle spasm
Medical subject headings: Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GuaifenesinDrug
high and low dose of Guaifenesin each given twice daily over a 4-day treatment period
PlaceboDrug
no active ingredient

Study groups in NCT01562548
Study group	Role	What they receive
Arm 1	Experimental	Guaifenesin 1 tablet BID Receives: Drug: Guaifenesin
Arm 2	Experimental	Guaifenesin 2 tablets BID Receives: Drug: Guaifenesin
Arm 3	Placebo comparator	Placebo 1 tablet BID Receives: Drug: Placebo
Arm 4	Placebo comparator	Placebo 2 tablets BID Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 7 Days

Secondary outcomes (10)

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.
Measured: 7 Days
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.
Measured: 7 Days
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.
Measured: 7 Days
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.
Measured: 7 Days
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.
Measured: 4 Days, 7 Days
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.
Measured: Before treatment, 4 Days, 7 Days
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.
Measured: 4 Days, 7 Days
Global Assessment of Sleep Disturbance (GASD)
Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Measured: 7 Days
Global Assessment of Headache Frequency (GAHF)
Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Measured: 7 Days
Global Assessment of Headache Intensity (GAHI)
Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Measured: 7 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012May 2013

First posted26 Mar 2012 (estimated)
Study startFeb 2012
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Upper Back PainStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01562548
Sponsor's protocol ID: A3940666
Status last verified: Mar 2014
First submitted: 22 Mar 2012
Last updated: 3 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Upper Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Proof of Principle Study to Explore the Utility of Guaifenesin in Upper Back Pain
ClinicalTrials.gov ID: NCT01562548
Acronym / sponsor ID: A3940666
Conditions: Upper Back Pain
Keywords: upper back/neck/shoulder muscle spasm
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 26 Mar 2012 (estimated)
Results: Posted 3 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Arm 1	Experimental	Drug: GuaifenesinGuaifenesin 1 tablet BID
Arm 2	Experimental	Drug: GuaifenesinGuaifenesin 2 tablets BID
Arm 3	Placebo comparator	Drug: PlaceboPlacebo 1 tablet BID
Arm 4	Placebo comparator	Drug: PlaceboPlacebo 2 tablets BID

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Paticipant presents with a new episode of acute upper back/neck/shoulder pain and muscle spasm that:
Paticipant has a normal neurological examination.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Guaifenesinhigh and low dose of Guaifenesin each given twice daily over a 4-day treatment period	Drug	Arm 1, Arm 2
Placebono active ingredient	Drug	Arm 3, Arm 4

Primary outcome

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.

10 secondary outcomes

Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores
Time frame: 7 Days
Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores
Time frame: 7 Days
Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores
Time frame: 7 Days
Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores
Time frame: 7 Days
Muscle Relaxation Scores
Time frame: 4 Days, 7 Days
Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores
Time frame: Before treatment, 4 Days, 7 Days
Global Assessment of Treatment Helpfulness (GATH)
Time frame: 4 Days, 7 Days
Global Assessment of Sleep Disturbance (GASD)
Time frame: 7 Days
Global Assessment of Headache Frequency (GAHF)
Time frame: 7 Days
Global Assessment of Headache Intensity (GAHI)
Time frame: 7 Days

Results and safety

Results posted to the registry on 3 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Guaifenesin 600mg	25	25
Placebo Matching Guaifenesin 600mg	15	15
Guaifenesin 1200mg	25	24
Placebo Matching Guaifenesin 1200mg	14	14

Primary outcome: Mean Change From Baseline of Both AM and PM Spasm Assessment Scores

Time frame: 7 Days. Mean (Standard Deviation). Unit: Score on a Scale

Measure	Guaifenesin 600mg n = 25	Placebo Matching Guaifenesin 600mg n = 15	Guaifenesin 1200mg n = 24	Placebo Matching Guaifenesin 1200mg n = 13
Value	1.66 (1.806)	1.87 (1.644)	1.91 (1.541)	1.54 (1.203)

Guaifenesin 600mg vs Placebo Matching Guaifenesin 600mg: Least Squares Means Difference: -0.21 (95% CI -1.23 to 0.80), p = 0.68, t-test, 2 sided
Guaifenesin 1200mg vs Placebo Matching Guaifenesin 1200mg: Least Squares Means Difference: 0.35 (95% CI -0.72 to 1.42), p = 0.52, t-test, 2 sided
Guaifenesin 600mg vs Guaifenesin 1200mg: Least Squares Means Difference: 0.24 (95% CI -0.64 to 1.13), p = 0.58, t-test, 2 sided

Population analysed: Efficacy analysis was conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment. Subjects were analyzed according to the treatment to which they were randomized.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Guaifenesin 600mg	0 of 25 (0%)	7 of 25 (28%)	Not reported
Placebo Matching Guaifenesin 600mg	0 of 15 (0%)	1 of 15 (6.7%)	Not reported
Guaifenesin 1200mg	0 of 24 (0%)	6 of 24 (25%)	Not reported
Placebo Matching Guaifenesin 1200mg	0 of 14 (0%)	3 of 14 (21.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Guaifenesin in people with Upper Back Pain, run by GlaxoSmithKline at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline of Both AM and PM Spasm Assessment Scores (time frame: 7 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01562548.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2014.