Trial · NCT01562548
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline of Both AM and PM Spasm Assessment Scores | 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 | Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores | 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. |
| Secondary | Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores | 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. |
| Secondary | Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores | 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. |
| Secondary | Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores | 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. |
| Secondary | Muscle Relaxation Scores | 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. |
| Secondary | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | 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. |
| Secondary | Global Assessment of Treatment Helpfulness (GATH) | 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. |
| Secondary | Global Assessment of Sleep Disturbance (GASD) | 7 Days | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. |
| Secondary | Global Assessment of Headache Frequency (GAHF) | 7 Days | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. |
| Secondary | Global Assessment of Headache Intensity (GAHI) | 7 Days | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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