Trial Outcomes & Findings for STRIPS: Shoulder Taping Reduces Injury and Pain in Stroke (NCT NCT01062308)

Results Overview

Visual analog scale (VAS) is an 11-point scale displayed on a 100 mm horizontal line, ranging from 0 ("No Pain") to 100 ("Worst Pain Imaginable") Shoulder pain and disability index (SPADI) is a 13-item questionnaire that consists of 2 subscales for pain (5 items) and disability (8 items), which is scored by taking an average of the 2 subscales. Scores range from 0 to 100, with higher scores indicating greater pain and disability

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

162 participants

Primary outcome timeframe

14 days and 30 days

Results posted on

2013-03-12

Participant Flow

Date of first Recruitment: Sep.2009 Date of Completion: March 2012

Participant milestones

Participant milestones
Measure	Taping Procedure for preventing shoulder injury	Sham Taping Sham Taping was applied without stretching the concerned muscles.
Overall Study STARTED	80	82
Overall Study COMPLETED	64	72
Overall Study NOT COMPLETED	16	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

STRIPS: Shoulder Taping Reduces Injury and Pain in Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Taping n=80 Participants Procedure for preventing shoulder injury	Sham Taping n=82 Participants Sham Taping was applied without stretching the concerned muscles.	Total n=162 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=5 Participants	59 Participants n=7 Participants	123 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	23 Participants n=7 Participants	39 Participants n=5 Participants
Age Continuous	56 years STANDARD_DEVIATION 13 • n=5 Participants	60 years STANDARD_DEVIATION 13 • n=7 Participants	58 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	33 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	49 Participants n=7 Participants	106 Participants n=5 Participants
Region of Enrollment India	80 participants n=5 Participants	82 participants n=7 Participants	162 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days and 30 days

Population: On the basis of complete follow up

Visual analog scale (VAS) is an 11-point scale displayed on a 100 mm horizontal line, ranging from 0 ("No Pain") to 100 ("Worst Pain Imaginable") Shoulder pain and disability index (SPADI) is a 13-item questionnaire that consists of 2 subscales for pain (5 items) and disability (8 items), which is scored by taking an average of the 2 subscales. Scores range from 0 to 100, with higher scores indicating greater pain and disability

Outcome measures

Outcome measures
Measure	Taping n=65 Participants Procedure for preventing shoulder injury	Sham Taping n=72 Participants Sham Taping was applied without stretching the concerned muscles.
Pain: Visual Analog Scale VAS Baseline to day 14	-2.3 mm Interval -9.3 to 4.7	1.4 mm Interval -5.3 to 8.0
Pain: Visual Analog Scale VAS baseline to day 30	-9.2 mm Interval -17.0 to -1.4	2.6 mm Interval -4.8 to 10.1

SECONDARY outcome

Timeframe: 14 days and 30 days

Population: On the basis of follow up completion

Passive range of motion (ROM) of shoulder was measured with full circle goniometer. The normal range of movement of flexion and abduction is 180 degree.

Outcome measures

Outcome measures
Measure	Taping n=64 Participants Procedure for preventing shoulder injury	Sham Taping n=72 Participants Sham Taping was applied without stretching the concerned muscles.
Passive Range of Motion (ROM) ROM baseline to day 14	2.9 degree Interval -3.5 to 9.4	-4.1 degree Interval -10.2 to 2.0
Passive Range of Motion (ROM) ROM baseline to day 30	4.9 degree Interval -1.8 to 11.7	-1.7 degree Interval -8.1 to 4.7

Adverse Events

Taping

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Taping

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeyaraj D Pandian

Christian Medical College and Hospital, Ludhiana, Punjab, India

Phone: 09915784750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place