Trial Outcomes & Findings for Acupuncture in Distal Radius Fracture Patients (NCT NCT02522403)
NCT ID: NCT02522403
Last Updated: 2018-10-19
Results Overview
The PRWE assesses pain and the inability to perform daily acitivities. Is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. It yields a score of 0 to 100, with lower scores indicanting better performance. Only the final results of the study are reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
6 weeks
Results posted on
2018-10-19
Participant Flow
Participant milestones
| Measure |
Rehabilitation
The investigators will be apply laser acupuncture for the rehabilitation of the wrist and hand of the patients, with the laser device in an off position, plus exercise of wrist flexion, extension, cubital and radial deviation, pronation and supination of the forearm. The investigators will be use ten different acupuncture points for treat this patients.
Rehabilitation: The investigators will be apply fake laser therapy in the patients with distal radius fracture, with the device in an off position; plus the patients will be teaching to do rehabilitation exercise in flexion, extension, pronation and supination of the wrist and forearm, and to do cubital and radial deviation exercise. The investigators delivered to all patients a graphic demonstration of the exercise
|
Low Lever Laser Acupuncture
The investigators will utilize an low level laser therapy device apply into each acupuncture point. Ten acupuncture points will be used. Each acupuncture point will be irradiated for 30 seconds at 8,000 Hz.
Low Lever Laser acupuncture: The investigators will be used a low lever laser device, to apply in ten selected acupuncture points, each point will be irradiated for 30 seconds at 8000 Hz, this therapy is useful for tissue regeneration and stimulate the acupuncture points, plus an antinociceptive effect.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
19
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Rehabilitation
The investigators will be apply laser acupuncture for the rehabilitation of the wrist and hand of the patients, with the laser device in an off position, plus exercise of wrist flexion, extension, cubital and radial deviation, pronation and supination of the forearm. The investigators will be use ten different acupuncture points for treat this patients.
Rehabilitation: The investigators will be apply fake laser therapy in the patients with distal radius fracture, with the device in an off position; plus the patients will be teaching to do rehabilitation exercise in flexion, extension, pronation and supination of the wrist and forearm, and to do cubital and radial deviation exercise. The investigators delivered to all patients a graphic demonstration of the exercise
|
Low Lever Laser Acupuncture
The investigators will utilize an low level laser therapy device apply into each acupuncture point. Ten acupuncture points will be used. Each acupuncture point will be irradiated for 30 seconds at 8,000 Hz.
Low Lever Laser acupuncture: The investigators will be used a low lever laser device, to apply in ten selected acupuncture points, each point will be irradiated for 30 seconds at 8000 Hz, this therapy is useful for tissue regeneration and stimulate the acupuncture points, plus an antinociceptive effect.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
Baseline Characteristics
Acupuncture in Distal Radius Fracture Patients
Baseline characteristics by cohort
| Measure |
Rehabilitation
n=13 Participants
The investigators will be apply laser acupuncture for the rehabilitation of the wrist and hand of the patients, with the laser device in an off position, plus exercise of wrist flexion, extension, cubital and radial deviation, pronation and supination of the forearm. The investigators will be use ten different acupuncture points for treat this patients.
Rehabilitation: The investigators will be apply fake laser therapy in the patients with distal radius fracture, with the device in an off position; plus the patients will be teaching to do rehabilitation exercise in flexion, extension, pronation and supination of the wrist and forearm, and to do cubital and radial deviation exercise. The investigators delivered to all patients a graphic demonstration of the exercise
|
Low Lever Laser Acupuncture
n=13 Participants
The investigators will utilize an low level laser therapy device apply into each acupuncture point. Ten acupuncture points will be used. Each acupuncture point will be irradiated for 30 seconds at 8,000 Hz.
Low Lever Laser acupuncture: The investigators will be used a low lever laser device, to apply in ten selected acupuncture points, each point will be irradiated for 30 seconds at 8000 Hz, this therapy is useful for tissue regeneration and stimulate the acupuncture points, plus an antinociceptive effect.
|
Total
n=26 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
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
54.8 years
STANDARD_DEVIATION 13.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Patiet-Rated Wrist Evaluation (PRWE)
|
70.9 units on a scale
STANDARD_DEVIATION 13.6 • n=5 Participants
|
69.1 units on a scale
STANDARD_DEVIATION 12.2 • n=7 Participants
|
70.1 units on a scale
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Visual Analog Scale (VAS)
|
5.0 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 1.7 • n=7 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Wrist Mobility
Flexion
|
33.3 degrees
STANDARD_DEVIATION 18.6 • n=5 Participants
|
34.2 degrees
STANDARD_DEVIATION 10.5 • n=7 Participants
|
33.8 degrees
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Wrist Mobility
Extension
|
14.9 degrees
STANDARD_DEVIATION 15.1 • n=5 Participants
|
22.0 degrees
STANDARD_DEVIATION 14.4 • n=7 Participants
|
18.5 degrees
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Wrist Mobility
Pronation
|
44.2 degrees
STANDARD_DEVIATION 23.2 • n=5 Participants
|
54.8 degrees
STANDARD_DEVIATION 25.2 • n=7 Participants
|
49.5 degrees
STANDARD_DEVIATION 24.4 • n=5 Participants
|
|
Wrist Mobility
Supination
|
40.3 degrees
STANDARD_DEVIATION 21.2 • n=5 Participants
|
42.6 degrees
STANDARD_DEVIATION 21.3 • n=7 Participants
|
41.5 degrees
STANDARD_DEVIATION 20.9 • n=5 Participants
|
|
Wrist Mobility
Ulnar Deviation
|
15.7 degrees
STANDARD_DEVIATION 6.8 • n=5 Participants
|
20.0 degrees
STANDARD_DEVIATION 7.6 • n=7 Participants
|
17.9 degrees
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Wrist Mobility
Radial Deviation
|
7.1 degrees
STANDARD_DEVIATION 5.5 • n=5 Participants
|
4.6 degrees
STANDARD_DEVIATION 4.1 • n=7 Participants
|
5.9 degrees
STANDARD_DEVIATION 5.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe PRWE assesses pain and the inability to perform daily acitivities. Is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. It yields a score of 0 to 100, with lower scores indicanting better performance. Only the final results of the study are reported.
Outcome measures
| Measure |
Rehabilitation
n=13 Participants
The investigators will be apply laser acupuncture for the rehabilitation of the wrist and hand of the patients, with the laser device in an off position, plus exercise of wrist flexion, extension, cubital and radial deviation, pronation and supination of the forearm. The investigators will be use ten different acupuncture points for treat this patients.
Rehabilitation: The investigators will be apply fake laser therapy in the patients with distal radius fracture, with the device in an off position; plus the patients will be teaching to do rehabilitation exercise in flexion, extension, pronation and supination of the wrist and forearm, and to do cubital and radial deviation exercise. The investigators delivered to all patients a graphic demonstration of the exercise
|
Low Lever Laser Acupuncture
n=13 Participants
The investigators will utilize an low level laser therapy device apply into each acupuncture point. Ten acupuncture points will be used. Each acupuncture point will be irradiated for 30 seconds at 8,000 Hz.
Low Lever Laser acupuncture: The investigators will be used a low lever laser device, to apply in ten selected acupuncture points, each point will be irradiated for 30 seconds at 8000 Hz, this therapy is useful for tissue regeneration and stimulate the acupuncture points, plus an antinociceptive effect.
|
|---|---|---|
|
Patient-Rated Wrist Evaluation (PRWE)
|
30.5 units on a scale
Standard Deviation 22.5
|
15.2 units on a scale
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: 6 weeksThe degrees of wrist mobility in flexion, extension, pronation, supination, and radial and ulnar deviation were measured in all patients. Only the final measures of movements of the study are reported.
Outcome measures
| Measure |
Rehabilitation
n=13 Participants
The investigators will be apply laser acupuncture for the rehabilitation of the wrist and hand of the patients, with the laser device in an off position, plus exercise of wrist flexion, extension, cubital and radial deviation, pronation and supination of the forearm. The investigators will be use ten different acupuncture points for treat this patients.
Rehabilitation: The investigators will be apply fake laser therapy in the patients with distal radius fracture, with the device in an off position; plus the patients will be teaching to do rehabilitation exercise in flexion, extension, pronation and supination of the wrist and forearm, and to do cubital and radial deviation exercise. The investigators delivered to all patients a graphic demonstration of the exercise
|
Low Lever Laser Acupuncture
n=13 Participants
The investigators will utilize an low level laser therapy device apply into each acupuncture point. Ten acupuncture points will be used. Each acupuncture point will be irradiated for 30 seconds at 8,000 Hz.
Low Lever Laser acupuncture: The investigators will be used a low lever laser device, to apply in ten selected acupuncture points, each point will be irradiated for 30 seconds at 8000 Hz, this therapy is useful for tissue regeneration and stimulate the acupuncture points, plus an antinociceptive effect.
|
|---|---|---|
|
Wrist Mobility
Flexion
|
39.8 degrees
Standard Deviation 18.1
|
60.2 degrees
Standard Deviation 18.9
|
|
Wrist Mobility
Extension
|
41.1 degrees
Standard Deviation 20.6
|
52.6 degrees
Standard Deviation 13.0
|
|
Wrist Mobility
Pronation
|
80.0 degrees
Standard Deviation 9.3
|
88.4 degrees
Standard Deviation 3.1
|
|
Wrist Mobility
Supination
|
67.6 degrees
Standard Deviation 22.5
|
76.1 degrees
Standard Deviation 13.7
|
|
Wrist Mobility
Cubital deviation
|
27.0 degrees
Standard Deviation 9.8
|
31.3 degrees
Standard Deviation 6.8
|
|
Wrist Mobility
Radial deviation
|
10.3 degrees
Standard Deviation 5.1
|
18.0 degrees
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: 6 weeksThe VAS has a score of 0 to 10. The lowest score (0) represents the absence of pain, while the highest score (10) corresponds to the maximum pain possible. Only the final results of the study are reported.
Outcome measures
| Measure |
Rehabilitation
n=13 Participants
The investigators will be apply laser acupuncture for the rehabilitation of the wrist and hand of the patients, with the laser device in an off position, plus exercise of wrist flexion, extension, cubital and radial deviation, pronation and supination of the forearm. The investigators will be use ten different acupuncture points for treat this patients.
Rehabilitation: The investigators will be apply fake laser therapy in the patients with distal radius fracture, with the device in an off position; plus the patients will be teaching to do rehabilitation exercise in flexion, extension, pronation and supination of the wrist and forearm, and to do cubital and radial deviation exercise. The investigators delivered to all patients a graphic demonstration of the exercise
|
Low Lever Laser Acupuncture
n=13 Participants
The investigators will utilize an low level laser therapy device apply into each acupuncture point. Ten acupuncture points will be used. Each acupuncture point will be irradiated for 30 seconds at 8,000 Hz.
Low Lever Laser acupuncture: The investigators will be used a low lever laser device, to apply in ten selected acupuncture points, each point will be irradiated for 30 seconds at 8000 Hz, this therapy is useful for tissue regeneration and stimulate the acupuncture points, plus an antinociceptive effect.
|
|---|---|---|
|
Visual Analogue Scale (VAS)
|
2.7 units on a scale
Standard Deviation 1.9
|
1.2 units on a scale
Standard Deviation 1.4
|
Adverse Events
Rehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Lever Laser Acupuncture
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place