Trial Outcomes & Findings for Lower Extremity Splinting to Manage Pain and Sleep Disturbances Associated With HIV/AIDS Related Peripheral Neuropathy (NCT NCT01419314)
NCT ID: NCT01419314
Last Updated: 2013-01-03
Results Overview
A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.
COMPLETED
NA
46 participants
Week 3
2013-01-03
Participant Flow
The participants were randomized to use a night application of bilateral lower extremity splints (23 participants) or using the soft liners of the splints only (23 participants). One participant was excluded from the liner group as he failed to disclose a recent diabetes diagnosis.
One of the participants in the liner group was excluded from the study at the beginning as he developed type-II diabetes. The total number of participants in the liner group was thus 22 at baseline.
Participant milestones
| Measure |
Splinting Application
Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
|
Splint Liner Application
The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
|
|---|---|---|
|
Start of Study
STARTED
|
23
|
22
|
|
Start of Study
COMPLETED
|
23
|
22
|
|
Start of Study
NOT COMPLETED
|
0
|
0
|
|
Follow-up at Week 3 of the Trial
STARTED
|
23
|
22
|
|
Follow-up at Week 3 of the Trial
COMPLETED
|
17
|
21
|
|
Follow-up at Week 3 of the Trial
NOT COMPLETED
|
6
|
1
|
|
Follow-up at Week 6 of the Trial
STARTED
|
17
|
21
|
|
Follow-up at Week 6 of the Trial
COMPLETED
|
16
|
19
|
|
Follow-up at Week 6 of the Trial
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Splinting Application
Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
|
Splint Liner Application
The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
|
|---|---|---|
|
Follow-up at Week 3 of the Trial
Withdrawal by Subject
|
3
|
1
|
|
Follow-up at Week 3 of the Trial
Lost to Follow-up
|
3
|
0
|
|
Follow-up at Week 6 of the Trial
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Lower Extremity Splinting to Manage Pain and Sleep Disturbances Associated With HIV/AIDS Related Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
LE Splints Group
n=23 Participants
Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
|
Splint Liner Application
n=22 Participants
The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
|
Total
n=45 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
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
50.65 years
STANDARD_DEVIATION 8.04 • n=5 Participants
|
46.09 years
STANDARD_DEVIATION 7.71 • n=7 Participants
|
48.42 years
STANDARD_DEVIATION 8.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
CD4
|
586.13 cells/mm3
STANDARD_DEVIATION 233.64 • n=5 Participants
|
446.09 cells/mm3
STANDARD_DEVIATION 232.54 • n=7 Participants
|
517.67 cells/mm3
STANDARD_DEVIATION 241.07 • n=5 Participants
|
|
Log Viral load
|
2.25 Log (copies/ml)
STANDARD_DEVIATION 1.08 • n=5 Participants
|
1.96 Log (copies/ml)
STANDARD_DEVIATION 0.75 • n=7 Participants
|
2.10 Log (copies/ml)
STANDARD_DEVIATION 0.93 • n=5 Participants
|
|
Years living with HIV
|
11.30 years
STANDARD_DEVIATION 6.01 • n=5 Participants
|
10.32 years
STANDARD_DEVIATION 7.62 • n=7 Participants
|
10.82 years
STANDARD_DEVIATION 6.79 • n=5 Participants
|
|
Pain scores
|
61.35 Scores on a 0-100 scale.
STANDARD_DEVIATION 20.98 • n=5 Participants
|
60.16 Scores on a 0-100 scale.
STANDARD_DEVIATION 14.35 • n=7 Participants
|
60.77 Scores on a 0-100 scale.
STANDARD_DEVIATION 17.85 • n=5 Participants
|
|
Sleep Scores
|
14.13 Scores on a 0-21 scale
STANDARD_DEVIATION 3.89 • n=5 Participants
|
15.14 Scores on a 0-21 scale
STANDARD_DEVIATION 4.68 • n=7 Participants
|
14.62 Scores on a 0-21 scale
STANDARD_DEVIATION 4.28 • n=5 Participants
|
|
Function- Forward reach
|
35.31 Centimeters (cm)
STANDARD_DEVIATION 6.45 • n=5 Participants
|
36.88 Centimeters (cm)
STANDARD_DEVIATION 8.36 • n=7 Participants
|
36.07 Centimeters (cm)
STANDARD_DEVIATION 7.37 • n=5 Participants
|
|
Function-Walking Distance
|
246.00 Meters (m)
STANDARD_DEVIATION 133.71 • n=5 Participants
|
241.89 Meters (m)
STANDARD_DEVIATION 151.46 • n=7 Participants
|
243.99 Meters (m)
STANDARD_DEVIATION 141.04 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 3Population: The total number of participants returning for the first follow-up at week three with complete data.
A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.
Outcome measures
| Measure |
Lower Extremity Splinting Application
n=16 Participants
nighttime splint application to the lower extremities
|
Splint Liner
n=21 Participants
Night time application of lower extremity splint liner
|
|---|---|---|
|
Pain Scores at Week 3
|
50.53 units on a scale 0-100 (0= no pain)
Standard Deviation 16.48
|
53.76 units on a scale 0-100 (0= no pain)
Standard Deviation 15.41
|
PRIMARY outcome
Timeframe: Week 6Population: The total number of participants that completed the 6 week trial in each investigational group
A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.
Outcome measures
| Measure |
Lower Extremity Splinting Application
n=18 Participants
nighttime splint application to the lower extremities
|
Splint Liner
n=19 Participants
Night time application of lower extremity splint liner
|
|---|---|---|
|
Pain Scores
|
40.22 units on a scale 0-100 (0=no pain)
Standard Deviation 18.57
|
49.89 units on a scale 0-100 (0=no pain)
Standard Deviation 21.72
|
PRIMARY outcome
Timeframe: week 3Population: The number of participants returning for the first follow-up with complete data.
The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions.
Outcome measures
| Measure |
Lower Extremity Splinting Application
n=16 Participants
nighttime splint application to the lower extremities
|
Splint Liner
n=21 Participants
Night time application of lower extremity splint liner
|
|---|---|---|
|
Sleep Quality/Quantity Scores (PSQI)
|
13.13 Scores ranging 0-21, 0=no disturbances
Standard Deviation 4.51
|
14.29 Scores ranging 0-21, 0=no disturbances
Standard Deviation 4.58
|
PRIMARY outcome
Timeframe: week 6Population: The number of participants returning for the second follow-up
The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions. Buysse et al. reported sensitivity and specificity values of 89.6% and 86.5%, respectively for this scale in identifying good and poor sleepers.
Outcome measures
| Measure |
Lower Extremity Splinting Application
n=18 Participants
nighttime splint application to the lower extremities
|
Splint Liner
n=19 Participants
Night time application of lower extremity splint liner
|
|---|---|---|
|
Sleep Quality/Quantity Scores (PSQI)
|
12.06 Scores ranging 0-21, 0=no disturbances
Standard Deviation 4.84
|
11.95 Scores ranging 0-21, 0=no disturbances
Standard Deviation 5.57
|
SECONDARY outcome
Timeframe: week 3Population: The number of participants returning for the first follow-up. One participant in the liner group had baseline scores greater than 3 standard deviation difference from the mean and was excluded from the analysis.
Forward reach test For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed "to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor". The average distance of three reaching attempts was recorded and used in the analysis.
Outcome measures
| Measure |
Lower Extremity Splinting Application
n=16 Participants
nighttime splint application to the lower extremities
|
Splint Liner
n=20 Participants
Night time application of lower extremity splint liner
|
|---|---|---|
|
Function-Reach
|
38.76 Centimeters (cm)
Standard Deviation 6.76
|
38.35 Centimeters (cm)
Standard Deviation 7.04
|
SECONDARY outcome
Timeframe: week 6Population: The number of participants returning for the first follow-up. One participant in the liner group had baseline scores greater than 3 standard deviation difference from the mean and was excluded from the analysis.
Forward reach test For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed "to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor". The average distance of three reaching attempts was recorded and used in the analysis.
Outcome measures
| Measure |
Lower Extremity Splinting Application
n=18 Participants
nighttime splint application to the lower extremities
|
Splint Liner
n=18 Participants
Night time application of lower extremity splint liner
|
|---|---|---|
|
Function-Reach
|
40.00 Centimeters (cm)
Standard Deviation 6.22
|
39.34 Centimeters (cm)
Standard Deviation 6.22
|
SECONDARY outcome
Timeframe: week 3Population: The number of participants returning for the 3 week follow-up with complete data
Six minute walk test For this test the participants were instructed to: "Please walk as far, as fast and as safe as you can for up to six minutes". The walking test will be performed in a climate-controlled environment, on a level surface void of obstacles and with a pre-determined path of 68 feet (or approximately 20 m) per lap. The beginning and end of the 34-foot path were clearly marked with taped trapezoids to the non-skid floor.
Outcome measures
| Measure |
Lower Extremity Splinting Application
n=16 Participants
nighttime splint application to the lower extremities
|
Splint Liner
n=19 Participants
Night time application of lower extremity splint liner
|
|---|---|---|
|
Function-Walking Distance
|
255.84 Meters (m)
Standard Deviation 143.58
|
263.52 Meters (m)
Standard Deviation 156.74
|
SECONDARY outcome
Timeframe: week 6Population: The number of participants returning for the 6 week follow-up
Six minute walk test For this test the participants were instructed to: "Please walk as far, as fast and as safe as you can for up to six minutes". The walking test will be performed in a climate-controlled environment, on a level surface void of obstacles and with a pre-determined path of 68 feet (or approximately 20 m) per lap. The beginning and end of the 34-foot path were clearly marked with taped trapezoids to the non-skid floor.
Outcome measures
| Measure |
Lower Extremity Splinting Application
n=18 Participants
nighttime splint application to the lower extremities
|
Splint Liner
n=19 Participants
Night time application of lower extremity splint liner
|
|---|---|---|
|
Function-Walking Distance
|
279.52 Meters (m)
Standard Deviation 146.61
|
304.90 Meters (m)
Standard Deviation 137.63
|
Adverse Events
Lower Extremity Splinting Application
Splint Liner
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place