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Colles´ FractureNCT02522403

Acupuncture in Distal Radius Fracture Patients

A study testing Rehabilitation and Low Lever Laser acupuncture in people with Colles´ Fracture and Radius Fracture, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colles´ Fracture, Radius Fracture
What is being tested?
Rehabilitation and Low Lever Laser acupuncture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteMexico
Study dates
Aug 2015to Jul 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • Universidad Autonoma de Nuevo Leon

    Monterrey, Nuevo León, 64480

Other trials in Mexico

About this study

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

Read the 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.

Being tested
Rehabilitation, Low Lever Laser acupuncture
Keywords
distal radius fracture, laser acupuncture, rehabilitation
Medical subject headings
Colles' Fracture, Radius Fractures, Wrist Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RehabilitationProcedure or surgery

    Also called Physical therapy

    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 acupunctureDevice

    Also called Chinese traditional medicine, Needles Diller & Diller

    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.

Study groups in NCT02522403
Study groupRoleWhat they receive
RehabilitationActive comparatorThe 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.
Receives: Procedure: Rehabilitation
Low Lever Laser acupunctureExperimentalThe 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.
Receives: Device: Low Lever Laser acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks

Secondary outcomes (2)
  1. 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.

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJun 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02522403
Sponsor's protocol ID
OR15-010
Status last verified
Dec 2017
First submitted
6 Aug 2015
Last updated
19 Oct 2018
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25143645
  • 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.

    PubMed 24600058
  • 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.

    PubMed 14770137
  • 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.

    PubMed 18972728
  • 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.

    PubMed 23291880

Questions about this trial

What is this clinical trial studying?

A study testing Rehabilitation and Low Lever Laser acupuncture in people with Colles´ Fracture and Radius Fracture, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-Rated Wrist Evaluation (PRWE) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02522403, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.

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