Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504010
Status:
COMPLETED
Last Update Posted:
2009-01-07
First Post:
2007-07-17
Brief Title:
The Role of Arnica on Muscle Pain Following Eccentric Exercise
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
The Role of Arnica on Muscle Pain Following Eccentric Exercise
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Arnica
Brief Summary:
Arnica in a topical gel formulation will be compared to a placebo to determine whether it decreases muscle soreness following leg exercise when applied to the legs
Detailed Description:
Design The design is a randomized placebo-controlled double-blind trial Each participant will receive 2 containers of gel One container will be marked LEFT and one RIGHT One container will contain a commercially available arnica gel formulation and the other will contain a placebo gel identical in appearance to the arnica Subjects will not know which container contains which product Each participant will also be given a form containing an analog pain scale for each leg The participant will rate his or her pain in each leg separately on the day before exercise Each subject will then be asked to perform calf raises using the following protocol
The participant removes shoes
Active range of motion of the ankle is measured bilaterally using a goniometer
He or she places the metatarsal portion of his or her foot on a step that is 7 inches above the floor Handrails are provided for safety and comfort
He or she then performs heel lifts by rising up on the stair using the foot on the stair holds this for 2 seconds then maximally dorsiflexes the foot for a count of 2 seconds A metronome set to generate a tone every 2 seconds guides the pace of this
This is repeated 25 times or until the subject is unable to complete a full cycle
He or she then performs the same sequence using the other leg
A second set of 20 repetitions is performed in each leg followed by a final 15 repetitions
The gel is applied immediately after exercise to both lower legs Subjects are instructed not to wash off the leg for at least one hour after application
The pain score is completed for each leg 24 hours later and the gel is applied to each leg Again subjects are instructed to leave the gel undisturbed for at least one hour
Approximately 48 hours later the subject returns for measurement of ankle range of motion again completes a pain score and applies the gel for a final time Subjects are instructed to leave the gel on the legs for at least one hour
To measure muscle tenderness a 1cm sphere is placed on the subjects mid-calf and compressed by a standardized 5 pound weight The subject provides a tenderness score for each leg using the same pain score
A final pain score is completed by each subject at approximately 72 hours
Neither subjects nor the researchers doing the data collection or analysis will know which gel is associated with which formulation placebo vs Arnica Controls are within-subjects
The participant removes shoes
Active range of motion of the ankle is measured bilaterally using a goniometer
He or she places the metatarsal portion of his or her foot on a step that is 7 inches above the floor Handrails are provided for safety and comfort
He or she then performs heel lifts by rising up on the stair using the foot on the stair holds this for 2 seconds then maximally dorsiflexes the foot for a count of 2 seconds A metronome set to generate a tone every 2 seconds guides the pace of this
This is repeated 25 times or until the subject is unable to complete a full cycle
He or she then performs the same sequence using the other leg
A second set of 20 repetitions is performed in each leg followed by a final 15 repetitions
The gel is applied immediately after exercise to both lower legs Subjects are instructed not to wash off the leg for at least one hour after application
The pain score is completed for each leg 24 hours later and the gel is applied to each leg Again subjects are instructed to leave the gel undisturbed for at least one hour
Approximately 48 hours later the subject returns for measurement of ankle range of motion again completes a pain score and applies the gel for a final time Subjects are instructed to leave the gel on the legs for at least one hour
To measure muscle tenderness a 1cm sphere is placed on the subjects mid-calf and compressed by a standardized 5 pound weight The subject provides a tenderness score for each leg using the same pain score
A final pain score is completed by each subject at approximately 72 hours
Neither subjects nor the researchers doing the data collection or analysis will know which gel is associated with which formulation placebo vs Arnica Controls are within-subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None