Trial · NCT02909907
Comparison of Botulinum Toxin Injections in Forearm FLexor Plus EXtensor Muscles vs. Flexor Muscles Alone for Treatment of Essential Hand Tremor(FLEX-D ET)
NCT02909907, Not applicable, Completed, The Cleveland Clinic; results first posted 2019-04-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Botulinum Toxin Injections in Forearm FLexor Plus EXtensor Muscles vs. Flexor Muscles Alone for Treatment of Essential Hand Tremor(FLEX-D ET). Trials, record NCT02909907. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02909907
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Botulinum Toxin Injections in Forearm FLexor Plus EXtensor Muscles vs. Flexor Muscles Alone for Treatment of Essential Hand Tremor(FLEX-D ET)
- NCT number
- NCT02909907
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 21 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Essential Tremor
- Interventions
- Botulinum toxin, Placebo
- First posted
- 2016-09-21
- Last updated
- 2019-05-08
- Results first posted
- 2019-04-23
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in the 6 Week Post Injection Patient Global Impression of Improvement Scale (PGIS) Between Flexors Along and Flexors Plus Extensors Groups. | 6 weeks | 6 weeks post injection Clinician Global Impression if improvement Scale (CGIS) Assessment of improvement graded by the patient on a -4 to +4 scale * -4 = severe worsening * 0 = no change * +4 = complete abolishment of symptoms Higher scores represent better outcome. |
| Secondary | Difference in Tremor Rating Scale Score (TSR)Change From Baseline to Week 6 Between Flexors Alone and Flexors Plus Extensors Groups. | Baseline and 6 weeks | TRS: Tremor Rating Scale : scale composed of 6 items rated from 0-4. 0=none/normal and 4 = very severe/high level of disability. Total score is the sum of all items. Max score 24 ( maximal severity of tremor) Minimal score 0= no tremor/normal. |
| Secondary | Difference in the 6 Week Post Injection Clinician Global Impression of Improvement Scale (CGIS) Between Flexors Along and Flexors Plus Extensors Groups. | 6 weeks | 6 weeks post injection Clinician Global Impression if improvement Scale (CGIS) Assessment of improvement graded by clinician on a -4 to +4 scale * -4 = severe worsening * 0 = no change * +4 = complete abolishment of symptoms Higher scores represent better outcome. |
| Secondary | Difference of the Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 6 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group. | Baseline and 6 weeks | QUEST( Quality of Life in Essential Tremor Questionnaire ) is a 30-item, ET-specific quality of life scale . Items contribute to five dimensions. Physical/ADL (9 items ), Psychosocial (9 items), Communication (3 items), Hobbies/Leisure (3 items), and Work/Finances (6 items). The score on each scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. A total or summary index corresponds to the mean of the five domain scores. The total summary index corresponds to the mean of the five domain scores. Maximal score 100: worse quality of life. Minimal Score 0: best quality of life. This outcome represents the median of the differences between baseline and week 6 in QUEST summary index.Positive index change values indicate that the score increased and negative values indicate that the score decreased. |
| Secondary | Difference in the Post Injection Grip Strength Change Between Flexor Only Group and Flexor and Extensors Group at 6 Weeks. | 6 weeks | the median of the differences in grip strength between baseline and week 6, A negative value indicates a decrease in grip strength in Kg at week 6. |
| Secondary | 12 Weeks Post Injection Tremor Rating Scale for Flexors Group and Flexors Plus Extensors Group. | 12 weeks | TRS: Tremor Rating Scale : scale composed of 6 items rated from 0-4. 0=none or normal and 4 = very severe or high level of disability. Total score is the sum of all items. Max score 24 ( maximal severity of tremor) Minimal score 0= no tremor/normal. |
| Secondary | 12 Week Post Injection in Clinician Global Impression Scale-Improvement Subscale (CGIS) | 12 weeks | 12 week post injection in Clinician Global Impression Scale-Improvement Subscale (CGIS) Assessment of improvement graded by the clinician on a -4 to +4 scale * -4 = severe worsening * 0 = no change * +4 = complete abolishment of symptoms Higher scores represent better outcome. |
| Secondary | 12 Week Post Injection Patient Global Impression Scale-Improvement Subscale (PGIS) | 12 weeks | Patient Global Impression Scale-Improvement Subscale (PGIS) Assessment of improvement graded by patient on a -4 to +4 scale * -4 = severe worsening * 0 = no change * +4 = complete abolishment of symptoms Higher scores represent better outcome. |
| Secondary | Difference of Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 12 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group. | Baseline and 12 weeks. | QUEST( Quality of Life in Essential Tremor Questionnaire ) is a 30-item, ET-specific quality of life scale . Items contribute to five dimensions. Physical/ADL (9 items ), Psychosocial (9 items), Communication (3 items), Hobbies/Leisure (3 items), and Work/Finances (6 items). The score on each scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. A total or summary index corresponds to the mean of the five domain scores. The total summary index corresponds to the mean of the five domain scores. Maximal score 100: worse quality of life. Minimal Score 0: best quality of life. This outcome represents the median of the differences between baseline and week 6 in QUEST summary index. Positive index change values indicate that the score increased and negative values indicate that the score decreased. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference in the 6 Week Post Injection Patient Global Impression of Improvement Scale (PGIS) Between Flexors Along and Flexors Plus Extensors Groups. | 6 weeks | score on a scale | MEDIAN | |
| SECONDARY | Difference in Tremor Rating Scale Score (TSR)Change From Baseline to Week 6 Between Flexors Alone and Flexors Plus Extensors Groups. | Baseline and 6 weeks | score on a scale | MEDIAN | |
| SECONDARY | Difference in the 6 Week Post Injection Clinician Global Impression of Improvement Scale (CGIS) Between Flexors Along and Flexors Plus Extensors Groups. | 6 weeks | score on a scale | MEDIAN | |
| SECONDARY | Difference of the Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 6 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group. | Baseline and 6 weeks | score on a scale | MEDIAN | |
| SECONDARY | Difference in the Post Injection Grip Strength Change Between Flexor Only Group and Flexor and Extensors Group at 6 Weeks. | 6 weeks | Kilograms | MEDIAN | |
| SECONDARY | 12 Weeks Post Injection Tremor Rating Scale for Flexors Group and Flexors Plus Extensors Group. | 12 weeks | score on a scale | MEDIAN | |
| SECONDARY | 12 Week Post Injection in Clinician Global Impression Scale-Improvement Subscale (CGIS) | 12 weeks | score on a scale | MEDIAN | |
| SECONDARY | 12 Week Post Injection Patient Global Impression Scale-Improvement Subscale (PGIS) | 12 weeks | score on a scale | MEDIAN | |
| SECONDARY | Difference of Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 12 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group. | Baseline and 12 weeks. | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference in the 6 Week Post Injection Patient Global Impression of Improvement Scale (PGIS) Between Flexors Along and Flexors Plus Extensors Groups. | Flexors Alone | 1.2 | Inter-Quartile Range 1 to 3 | score on a scale | |
| Difference in the 6 Week Post Injection Patient Global Impression of Improvement Scale (PGIS) Between Flexors Along and Flexors Plus Extensors Groups. | Flexors Plus Extensors | 2.2 | Inter-Quartile Range 1.6 to 4 | score on a scale | |
| Difference in Tremor Rating Scale Score (TSR)Change From Baseline to Week 6 Between Flexors Alone and Flexors Plus Extensors Groups. | Flexors Alone | -5 | Inter-Quartile Range -6 to -4 | score on a scale | |
| Difference in Tremor Rating Scale Score (TSR)Change From Baseline to Week 6 Between Flexors Alone and Flexors Plus Extensors Groups. | Flexors Plus Extensors | -5 | Inter-Quartile Range -6 to -4 | score on a scale | |
| Difference in the 6 Week Post Injection Clinician Global Impression of Improvement Scale (CGIS) Between Flexors Along and Flexors Plus Extensors Groups. | Flexors Alone | 1 | Inter-Quartile Range 0 to 2 | score on a scale | |
| Difference in the 6 Week Post Injection Clinician Global Impression of Improvement Scale (CGIS) Between Flexors Along and Flexors Plus Extensors Groups. | Flexors Plus Extensors | 3 | Inter-Quartile Range 1 to 3 | score on a scale | |
| Difference of the Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 6 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group. | Flexors Alone | 1.1 | Inter-Quartile Range -1.7 to 5.6 | score on a scale | |
| Difference of the Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 6 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group. | Flexors Plus Extensors | -5.3 | Inter-Quartile Range -6.11 to 1.1 | score on a scale | |
| Difference in the Post Injection Grip Strength Change Between Flexor Only Group and Flexor and Extensors Group at 6 Weeks. | Flexors Alone | -6.2 | Inter-Quartile Range -15.3 to -5.3 | Kilograms | |
| Difference in the Post Injection Grip Strength Change Between Flexor Only Group and Flexor and Extensors Group at 6 Weeks. | Flexors Plus Extensors | -11 | Inter-Quartile Range -13.3 to 7.3 | Kilograms |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Flexors Alone | 10 | |
| Overall Study | STARTED | Flexors Plus Extensors | 10 | |
| Overall Study | COMPLETED | Flexors Alone | 10 | |
| Overall Study | COMPLETED | Flexors Plus Extensors | 9 | |
| Overall Study | NOT COMPLETED | Flexors Alone | 0 | |
| Overall Study | NOT COMPLETED | Flexors Plus Extensors | 1 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Finger Weakness | Nervous system disorders | Flexors Alone | 4 | 10 | |
| other | Finger Weakness | Nervous system disorders | Flexors Plus Extensors | 5 | 9 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Flexors Alone | 0 | 10 |
| Total, all-cause mortality | Flexors Plus Extensors | 0 | 9 |
| Total, other adverse events | Flexors Alone | 4 | 10 |
| Total, other adverse events | Flexors Plus Extensors | 5 | 9 |
| Total, serious adverse events | Flexors Alone | 0 | 10 |
| Total, serious adverse events | Flexors Plus Extensors | 0 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Flexors Alone vs Flexors Plus Extensors: deaths from any cause | Trial comparisons |
| Flexors Alone vs Flexors Plus Extensors: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02909907
GET https://conductscience.org/api/trials/v1/NCT02909907/registered