Radius Fracture Clinical Trial
Official title:
Application of Laser Acupuncture in Rehabilitating Patients With Distal Radius Fracture
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
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.
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