Investigation of the Use of Acupuncture for the Treatment of Spasticity in Chronic Stroke Participants (HHSCSTROKEAC)
Background: Stroke is one of the leading causes of death and disability in Canada. There are approximately 50,000 new cases every year. Stroke victims often experience decreased mobility and significant disability as a result of impaired motor control and velocity-dependent muscle hypertonus (spasticity) in the lower extremity. Over the past 25 years, there has been an increasing interest in the use of acupuncture for the management of stroke-related neurological deficits.
Research questions: Is acupuncture more effective than sham treatment in reducing lower extremity spasticity, and improving gait speed in the chronic phase of stroke recovery?
Recruitment: Forty patients will be recruited from the out patient rehabilitation program of a university affiliated teaching hospital.
Group Assignment and Blinding:
The study design is a randomized double blind format. Once identified, interested patients will be screened for eligibility by an intake secretary and randomly assigned to sham (n=20) or acupuncture treatment (n=20) groups using a computer random-number-generation system. Sealed envelopes containing the group assignment will be delivered to acupuncture-trained therapists delivering sham or true acupuncture treatment. Treating therapists' interactions will be standardized to minimize therapist/participant interaction bias Treating therapists will remain blinded to outcome assessment results. Patients will be blinded to the receipt of true acupuncture or sham needles. Outcome measurements will be done by a single assessor who is blinded to the group assignment.
Intervention: Subjects will attend 4 acupuncture treatments sessions within a 3 week period. Needles will be applied to the following acupuncture points: Jiao's foot motor sensory scalp points (2 in total) and 2 additional standardized acupuncture points in the lower legs bilaterally based on Traditional Chinese Medicine (TCM) approach. Treatment needles are pre-sterilized single disposable type, 0.20 mm size and 40 mm in length. The locations of the acupuncture point will be cleaned with alcohol (99%) swab. Needles will be left in place for 20 minutes. In the true acupuncture group, needles will be inserted to a depth at which participants report a tingling sensation (as described De-qi in TCM approach). Subjects randomized to the control group will be treated with retractable needles to avoid transcutaneous insertion at the same acupuncture points.
Outcome Measures: The following outcome measures will be assessed by a blinded assessor. Primary outcome measures:2-minute walk test. Secondary outcome measures: ankle range of motion and self report soft tissue tightness. The outcome measures time frame is set at from baseline to the completion of the intervention period at 3 weeks.
Analysis: Descriptive statistics including mean, standard deviation and frequencies will be used to describe the study participants, as appropriate. Paired t-test will be used for the parametric variables, number of steps per minute, distance on a 2-minute walk test and dorsi-flexion range of motion. Significance is set at p smaller than 0.05. All statistical analysis will be two sided and performed with SPSS (V21).
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Investigation of the Use of Acupuncture for the Treatment of Spasticity in Chronic Stroke Participants|
- Change from baseline in 2 minute walk test [ Time Frame: Baseline to 3 weeks ] [ Designated as safety issue: No ]Two-minute walk tests (2MWT) - Participants are required to walk continuously for 2 minutes, using their regular aids or orthoses, but with no manual support. The walk will take place over a distance of 10m, and participants will be required to change direction of their own accord. The distance walked in a 2-minute interval will be recorded
- Change from baseline in self report ankle tightness [ Time Frame: Baseline to 3 weeks ] [ Designated as safety issue: No ]Participant report outcome measure (PROM) - ankle tightness - a self report outcome measures has been widely used for pain in a format of a 10-point visual analog scale (VAS). Recent studies showed the reliability of the adaption of PROM to cover other clinical outcomes and the re is extensive discussion on minimal detectable clinical improvement. Ankle tightness in Achilles tendon will be recorded as a PROM on a 10-point scale with 0 being no tightness and 10 is the most.
- Change from baseline in ankle range of motion [ Time Frame: Baseline to 3 weeks ] [ Designated as safety issue: No ]Participant in sitting position, active and passive ankle dorsi-flexion will be measured by a goniometer
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Single disposal needle to be used, 0.02 mm x 25 mm in length
Sham Comparator: Sham needle
Retractable acupuncture needles will be used. No true transcutaneous needling through the skin
Other: Sham needles
Retractable needle with no skin puncture
Please refer to this study by its ClinicalTrials.gov identifier: NCT02085642
|Contact: Patricia Hoover, PhD||905-389-4411 ext firstname.lastname@example.org|
|Hamilton Health Sciences||Not yet recruiting|
|Hamilton, Ontario, Canada, L8L 8E7|
|Contact: Enoch K Ho, MPh 905-389-4411 ext 42097 email@example.com|
|Principal Investigator: Enoch K Ho, MPh|
|Principal Investigator:||Enoch K Ho, MPh||Hamilton Health Sciences Corporation|