Efficacy of Acupuncture in Macular Diseases

NCT ID: NCT02255981

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-11-30

Brief Summary

This is a single-arm study designed to assess the efficacy of acupuncture (Traditional Chinese Medicine) for chronic macular diseases of several types. All participants received acupuncture and massage and there is not a placebo group because it is not considered a good form to evaluate in Chinese Medicine due to, acupuncturing being a procedure is not as blind as is desired. As a control of the results in this trial, the outcomes could be contrasted against those reported in known medical publications and against expectations of the progress of the damage without treatment.

Detailed Description

Background.

WHO has included retinal diseases between conditions treatable by acupuncture and Traditional Chinese Medicine (TCM) has been used for retinal diseases in hospitals of China and in other parts of the world many years ago. Acupuncture and periocular massage act stimulating the vital energy to restore the normal function of the body.

Currently, most common treatments in Western Medicine, anti-VEGF, only are indicated for less than 10 percent of cases, which are the wet form or neovascular of AMD (NV-AMD) and they have restrictions for use, additionally, their cost and requirements are limiting for populations in all countries.

Objectives. The primary purpose of this study is to confirm the objective response among subjects with macular diseases treated with acupuncture and massage. The results of conventional treatment are published in similar trials and some of our patients have had intraocular injections previously.

It is important to feature the affordability of this therapy for low-income populations that do not have specialists or facilities nearby or for many governments that complain about the huge burden of the treatment of there diseases. In Colombia, the average cost of each intraocular injection by the time of this trial was about US 3.500 and it can be repeated every month, it requires a retina specialist and a surgical room, that is out of reach for many people in the country.

We did not calculate the costs of our treatment because the research team did voluntary labor, and the devices are at a very low cost, about US 0.50 in each session. Acupuncture treatment does not require special facilities as surgical rooms required in treatments with intraocular injections. The participants were not paid, they came from different economic conditions, some better, others from poorest neighborhoods or some from the rural areas.

This study includes 3 phases: Selection, Treatment, and Follow-up phases.

The selection phase included confirmed diagnosis by clinical register and OCT, Ophthalmologic assessment, and consent of the patient.

Macular diseases. In this trial, some patients had NV AMD in one or both eyes, dry AMD, myopic maculopathy or Stargardt disease. For TCM it is possible to treat all as damage of similar category.

Why no control group. There was no control group due to ethical reasons, leave the impairment without treatment in these mostly very sad persons. The second reason is the well-known difficulty to mask a procedure like acupuncture. another third reason is the possibility to contrast the results of this trial with those of similar studies conducted in eyes with conventional treatment.

In the phase of treatment, Patients received a session of acupuncture according to a standard protocol of points, and a periocular massage that was taught to the patient to be self-performed daily. The acupuncture sessions were scheduled every week initially, the evaluation of response was realized every 2 months by ophthalmologic exam and was asked to participants an optical coherence tomography (OCT) that would be realized every 6 months. Depending on the results of ophthalmologic assessment the sessions were extended gradually to every 2, 3, 5 until 13 weeks. Although tomographic assessments had been scheduled every 6 months, only a few of the participants accomplish with that due to economic limitations. Treatment continued until 24 months

All patients in the follow-up phase of this trial were monitored according to the Safety Follow-up protocol and the defined procedures and evaluations.

The final results were collected and analyzed.

Conditions

Age-related Macular Degeneration; Stargardt Disease; Macular Dystrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acupuncture group

Acupuncture and massage Therapy of Traditional Chinese Medicine (acupuncture and Massage) for 24 months

.

Group Type: EXPERIMENTAL

Acupuncture and massage

Intervention Type: OTHER

Treatment consists in to put needles on specific points of skin one day each week initially, then with longer spaces of time according to improvement.A total of 11 Chinese needles stainless steel, 25 x 40 were used by manual insertion and left for 12-15 minutes.

Periocular massage is taught and is practiced daily by the patient him or herself.

Interventions

Acupuncture and massage

Treatment consists in to put needles on specific points of skin one day each week initially, then with longer spaces of time according to improvement.A total of 11 Chinese needles stainless steel, 25 x 40 were used by manual insertion and left for 12-15 minutes.

Periocular massage is taught and is practiced daily by the patient him or herself.

Intervention Type: OTHER

Other Intervention Names

Traditional Chinese Medicine:( TCM); acupuncture chinese style

Eligibility Criteria

Inclusion Criteria

• • Clinical diagnosis of Macular Disease.

• The patient must accept treatment with acupuncture

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Escuela Neijing

OTHER

Sponsor Role: lead

Responsible Party

Dra. Luz Helena Gutiérrez C

Luz Gutierrez Physician, MPH, Escuela Neijing, Research Coordinator.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luz H Gutierrez, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Escuela Neijing Colombia

Jose L Padilla, MD

Role: STUDY_DIRECTOR

Hispano American Acupuncture Association-Beijing 84, Madrid, Spain

José R Gutiérrez, MD, Opht

Role: STUDY_CHAIR

Sociedad Colombiana de Oftalmología

Libia V Ferrer, Tech TCM

Role: STUDY_CHAIR

Escuela Neijing Colombia

Sergio L Pineda

Role: STUDY_CHAIR

Escuela Neijing Colombia

Locations

IPS Fundación Neijing

Guarne, Antioquia, Colombia

IPS Fundación Neijing

Medellín, Antioquia, Colombia

Countries

Colombia

References

Gutierrez L, Pineda S, Gutierrez R, Ferrer L. Acupuncture in Macular Diseases (AMAD) No published yet

Reference Type: RESULT

Other Identifiers

Neijing Ophthalmology

Identifier Type: -

Identifier Source: org_study_id