Clinical trial NCT02522403: Acupuncture in Distal Radius Fracture Patients
Official title: Application of Laser Acupuncture in Rehabilitating Patients With Distal Radius Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colles´ Fracture
Radius Fracture
Keywords: distal radius fracture
laser acupuncture
rehabilitation
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-Rated Wrist Evaluation (PRWE)
timeFrame: 6 weeks
Secondary outcomes:
measure: Wrist Mobility
timeFrame: 6 weeks
measure: Visual Analogue Scale (VAS)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Universidad Autonoma de Nuevo Leon
state: Nuevo Leon
Study officials:
affiliation: Universidad Autonoma de Nuevo Leon
name: Carlos Acosta-Olivo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tahririan MA, Javdan M, Motififard M. Results of pronator quadratus repair in distal radius fractures to prevent tendon ruptures. Indian J Orthop. 2014 Jul;48(4):399-403. doi: 10.4103/0019-5413.136275.
citation: Wei XM, Sun ZZ, Rui YJ, Song XJ. Minimally invasive plate osteosynthesis for distal radius fractures. Indian J Orthop. 2014 Jan;48(1):20-4. doi: 10.4103/0019-5413.125483.
citation: Smith DW, Brou KE, Henry MH. Early active rehabilitation for operatively stabilized distal radius fractures. J Hand Ther. 2004 Jan-Mar;17(1):43-9. doi: 10.1197/j.jht.2003.10.006.
citation: Luo KM, Hou Z, Yang L. [Observation on therapeutic effect of electroacupuncture on activity disturbance of the shoulder joint after operation of fracture]. Zhongguo Zhen Jiu. 2008 Oct;28(10):727-9. Chinese.
citation: Erthal V, da Silva MD, Cidral-Filho FJ, Santos AR, Nohama P. ST36 laser acupuncture reduces pain-related behavior in rats: involvement of the opioidergic and serotonergic systems. Lasers Med Sci. 2013 Sep;28(5):1345-51. doi: 10.1007/s10103-012-1260-7. Epub 2013 Jan 5.