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Acupuncture in Distal Radius Fracture Patients

Application of Laser Acupuncture in Rehabilitating Patients With Distal Radius Fracture

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02522403
Enrollment
36
Registered
2015-08-13
Start date
2015-08-31
Completion date
2016-07-31
Last updated
2018-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colles´ Fracture, Radius Fracture

Keywords

distal radius fracture, laser acupuncture, rehabilitation

Brief summary

The patients with distal radius fracture treated with immobilization (cast) and percutaneous pinning it will be to able to participate in this randomized trial. The investigators will be able to determine if the laser acupuncture is a good therapy for the rehabilitation in this type of patients. And if they are more comfortable to begin his rehabilitation exercise after the application of this therapy

Detailed description

Distal radius fractures are very common, ranging between 17 and 20% of all diagnosed fractures, and are the most common fractures treated by orthopedic surgeons in adult patients. It is defined as a fracture of the distal radius, which is less than 2.5 cm from the radiocarpal joint. Usually it is the result of falling on the outstretched hand. These fractures occur in all age groups and a bimodal distribution is observed with a peak incidence predominantly young adult patients and another peak in older women. In order to achieve successful functional results in distal radius fracture both an adequate treatment and timely and specific rehabilitation are required. The distal radius fracture guidelines generally indicate that rehabilitation therapy should begin at four to six weeks post injury or surgery after cast or external fixator is removed initiating passive/active ranges of motion exercises for the fingers, wrist and forearm. Patients are encouraged to use the wrist at home for light activities. At nine to 12 weeks post injury patients can initiate grip strengthening. There is limited available literature on the effect of acupuncture in the treatment of fractures. Two case reports claim to have achieved an acceleration of bone healing and pain management of patients with proximal humerus fracture when treated with a combination of acupuncture, electro-acupuncture and herbal medicine. Another study concluded that electroacupuncture plus radiation therapy with infrared rays and passive exercises was clearly superior to therapy with only exercises after surgery for humerus fracture. There is a modality of acupuncture using low level laser therapy, which is useful for tissue regeneration in general and to stimulate acupuncture points. Current clinical research has confirmed the therapeutic usefulness of laser acupuncture in and equine laminitis and in humans in treating myofascial pain, tennis elbow, knee osteoarthritis and other musculoskeletal diseases. The low level laser therapy, is a type of noninvasively phototherapy that has been shown to modulate various biological processes depending on the power density, wavelength and frequency. A recent study using rats showed that laser stimulation of acupuncture point (located in the leg) caused a significant antinociceptive effect controlling the behavior induced in rats caused by pain after peritoneal injection of acetic acid and injection of formalin in rat paws. The effect is mediated by activation of the opioidergic and serotoninergic systems (5HT-1 and 5HT-2A receptors). Investigators will try to determine whether laser acupuncture has a positive effect on the rehabilitation of patients with distal radius fracture and to establish a safe therapy without adverse effects that may alleviate pain and restore the functionality of the joint as soon as possible. This study will be a prospective, longitudinal, randomized, double-blind trial which will include 32 volunteers. All patients with a diagnosis of distal radius fracture type 23-A2, A3, B1, and B2 of the Orthopedic Trauma Association classification that comply with the inclusion criteria will be included. Patients will be randomly assigned to one of two groups: control or experimental group. The sessions will start as soon as the patient has their cast removed. Control group will receive conventional rehabilitation exercises and fake laser acupuncture (device turned off). Experimental group A will receive treatment with conventional rehabilitation plus real laser acupuncture on the following points: bilateral Hegu (IG4), ipsilateral Yangxi (IG5), ipsilateral Yangchi (SJ4), ipsilateral Yanggu (ID5), ipsilateral Waiguan (SJ15), ipsilateral Daling (PC7), contralateral Taixi (R3), contralateral Shenmai (V62) and contralateral Kunlun (V60). All patients will receive a total of 10 sessions with a frequency of 3 times a week. The laser that will be used in this study is a low level laser therapy device (980nm, 50 mW). Each acupuncture point will be irradiated for 30 seconds at 8,000 Hz. All patients will undergo clinical evaluation to assess improvement using the Patient-Rated Wrist Evaluation Scale. Patients also will be evaluated with the Visual Analogue Scale. The investigators will also measure improvement in range of motion of the wrist (flexion, extension, radial deviation, ulnar deviation, pronation and supination) and grip strength. The first assessment will be made right before starting rehabilitation and acupuncture, the day of the 5th session, again on the day of the 10th session and finally one week after completing the 10 sessions. All evaluations should be performed by blinded investigator. The investigators will compare the two groups to determine the degree of improvement with each treatment modality used.

Interventions

PROCEDURERehabilitation

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

DEVICELow 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.

Sponsors

Universidad Autonoma de Nuevo Leon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Distal radius fracture treated with percutaneous pinning and plaster * Type A2, A3, B1 and B2 of the Orthopedic Trauma Association classification

Exclusion criteria

* Rheumatoid arthritis * Ipsilateral fractures * Psychiatric illness * Previous wrist fracture or surgery * Cancer

Design outcomes

Primary

MeasureTime frameDescription
Patient-Rated Wrist Evaluation (PRWE)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.

Secondary

MeasureTime frameDescription
Wrist Mobility6 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.
Visual Analogue Scale (VAS)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.

Countries

Mexico

Participant flow

Participants by arm

ArmCount
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
13
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.
13
Total26

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up22
Overall StudyWithdrawal by Subject24

Baseline characteristics

CharacteristicRehabilitationTotalLow Lever Laser Acupuncture
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants4 Participants1 Participants
Age, Categorical
Between 18 and 65 years
10 Participants22 Participants12 Participants
Age, Continuous59.2 years
STANDARD_DEVIATION 14.7
54.8 years
STANDARD_DEVIATION 13.07
53.2 years
STANDARD_DEVIATION 9.7
Patiet-Rated Wrist Evaluation (PRWE)70.9 units on a scale
STANDARD_DEVIATION 13.6
70.1 units on a scale
STANDARD_DEVIATION 12.7
69.1 units on a scale
STANDARD_DEVIATION 12.2
Region of Enrollment
Mexico
13 participants26 participants13 participants
Sex: Female, Male
Female
9 Participants17 Participants8 Participants
Sex: Female, Male
Male
4 Participants9 Participants5 Participants
Visual Analog Scale (VAS)5.0 units on a scale
STANDARD_DEVIATION 2.2
5.5 units on a scale
STANDARD_DEVIATION 2
5.9 units on a scale
STANDARD_DEVIATION 1.7
Wrist Mobility
Extension
14.9 degrees
STANDARD_DEVIATION 15.1
18.5 degrees
STANDARD_DEVIATION 14.9
22.0 degrees
STANDARD_DEVIATION 14.4
Wrist Mobility
Flexion
33.3 degrees
STANDARD_DEVIATION 18.6
33.8 degrees
STANDARD_DEVIATION 14.9
34.2 degrees
STANDARD_DEVIATION 10.5
Wrist Mobility
Pronation
44.2 degrees
STANDARD_DEVIATION 23.2
49.5 degrees
STANDARD_DEVIATION 24.4
54.8 degrees
STANDARD_DEVIATION 25.2
Wrist Mobility
Radial Deviation
7.1 degrees
STANDARD_DEVIATION 5.5
5.9 degrees
STANDARD_DEVIATION 5
4.6 degrees
STANDARD_DEVIATION 4.1
Wrist Mobility
Supination
40.3 degrees
STANDARD_DEVIATION 21.2
41.5 degrees
STANDARD_DEVIATION 20.9
42.6 degrees
STANDARD_DEVIATION 21.3
Wrist Mobility
Ulnar Deviation
15.7 degrees
STANDARD_DEVIATION 6.8
17.9 degrees
STANDARD_DEVIATION 7.4
20.0 degrees
STANDARD_DEVIATION 7.6

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 13
other
Total, other adverse events
0 / 130 / 13
serious
Total, serious adverse events
0 / 130 / 13

Outcome results

Primary

Patient-Rated Wrist Evaluation (PRWE)

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.

Time frame: 6 weeks

ArmMeasureValue (MEAN)Dispersion
RehabilitationPatient-Rated Wrist Evaluation (PRWE)30.5 units on a scaleStandard Deviation 22.5
Low Lever Laser AcupuncturePatient-Rated Wrist Evaluation (PRWE)15.2 units on a scaleStandard Deviation 11.9
Secondary

Visual Analogue Scale (VAS)

The 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.

Time frame: 6 weeks

ArmMeasureValue (MEAN)Dispersion
RehabilitationVisual Analogue Scale (VAS)2.7 units on a scaleStandard Deviation 1.9
Low Lever Laser AcupunctureVisual Analogue Scale (VAS)1.2 units on a scaleStandard Deviation 1.4
Secondary

Wrist Mobility

The 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.

Time frame: 6 weeks

ArmMeasureGroupValue (MEAN)Dispersion
RehabilitationWrist MobilityPronation80.0 degreesStandard Deviation 9.3
RehabilitationWrist MobilityFlexion39.8 degreesStandard Deviation 18.1
RehabilitationWrist MobilityCubital deviation27.0 degreesStandard Deviation 9.8
RehabilitationWrist MobilityExtension41.1 degreesStandard Deviation 20.6
RehabilitationWrist MobilityRadial deviation10.3 degreesStandard Deviation 5.1
RehabilitationWrist MobilitySupination67.6 degreesStandard Deviation 22.5
Low Lever Laser AcupunctureWrist MobilityRadial deviation18.0 degreesStandard Deviation 5.9
Low Lever Laser AcupunctureWrist MobilityExtension52.6 degreesStandard Deviation 13
Low Lever Laser AcupunctureWrist MobilityPronation88.4 degreesStandard Deviation 3.1
Low Lever Laser AcupunctureWrist MobilitySupination76.1 degreesStandard Deviation 13.7
Low Lever Laser AcupunctureWrist MobilityCubital deviation31.3 degreesStandard Deviation 6.8
Low Lever Laser AcupunctureWrist MobilityFlexion60.2 degreesStandard Deviation 18.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026