Cognitive Impairment Clinical Trial
Official title:
Clinical Trial, Randomized, Controlled, Parallel, to Evaluate the Effectiveness of Acupuncture as a Treatment in Patients Diagnosed With Chronic Fatigue Syndrome.
background: The Chronic Fatigue Syndrome (CFS) presents many disturbances multidimensional
affect holistically to people who have the disease and current management of fatigue, pain,
anxiety, depression and sleep disturbances present in this clinical entity is
unsatisfactory.
Hypothesis:
The hypothesis of this essay is to contrast that acupuncture is more useful than placebo.
The investigators suggest the use of a clinical study protocol (PEC), randomized,
placebo-controlled, acupuncture technique, aimed at increasing the patient's sense of
well-being, relief of pain and stiffness, acupuncture is effective to reduce fatigue,
anxiety, depression and sleep disorders in patients diagnosed with CFS.
Headline Goal.
Evaluate the effectiveness of true acupuncture (AV) compared to placebo-acupuncture or sham
acupuncture (AS) in improving symptoms of patients diagnosed with CFS.
Specific objectives:
- To assess whether, in patients diagnosed with Chronic Fatigue Syndrome, AV treatment,
compared to AS, is associated with a reduction in fatigue as measured by the scale FIS
(Fatigue impact Scale).
- Check the reduction of pain in patients diagnosed with CFS, following treatment with AS
versus AV as measured by the McGill.
- To verify the decrease in the use of analgesics in patients diagnosed with CFS, after
treatment with the AV versus AS, by counting these drugs.
- Evaluate reducing anxiety in patients diagnosed with CFS, following treatment with AS
AV against measured by HAD scale.
- Assess whether, in patients diagnosed with CFS, treatment with AV compared to AS, is
associated with a reduction in depressive symptoms, as measured by the HAD scale.
- To assess the improvement in sleep quality in patients diagnosed with CFS, after
treatment with AV compared to the AS, as measured by the Pittsburgh scale.
- Check the quality improvement of health-related life (HRQOL) in patients diagnosed with
CFS, after treatment with AV compared to the AS, as measured by the SF-36 (Short
Form-36).
Methodology.
Design.
Pilot clinical trial randomized, parallel group, placebo-controlled simulated acupuncture,
single-center, prospective, patient and assessor blind. 1:1 randomized trial, the principal
investigator unknown randomization to the time the patient is randomized.
Primary endpoint. Scores on the fatigue impact scale (FIS) after treatment with two
acupuncture techniques.
Study population and total number of patients. After signing the informed consent, we
included 60 patients diagnosed with CFS, 30 in the intervention group (IG) of real
acupuncture and 30 in the control group (CG) of sham acupuncture, applying an individualized
treatment plan customized according energy assessment of each patient.
Duration of treatment. 4 months.
Relevance.
This pilot study can demonstrate the effectiveness of acupuncture as a treatment for the
symptoms of CFS. The reduction in fatigue, anxiety, depression, pain and reduction in the
intake of analgesics with improved sleep quality, after treatment with real acupuncture
technique, i results in increased quality of life for the patient suffering from CFS.
Inclusion criteria.
- Patients must meet each of the following criteria for admission to the study:
- Patients of both sexes.
- Aged between 18 and 70 years.
- Patients diagnosed as having chronic fatigue syndrome according to the diagnostic
criteria Fukuda.
- Patients who have previously given their informed consent for participation in the
study.
Exclusion criteria.
- Patients who have had prior treatment with acupuncture.
- Pregnant or lactating.
- Women of childbearing potential not using an effective contraceptive method according
to medical criteria.
- Terminal clinical condition.
- History of allergy and / or hypersensitivity to the acupuncture needles.
- Patients who are on anticoagulant therapy.
- Use of investigational agents not registered in the 30 days prior to study entry.
- Patients who are participating in another clinical trial of the same or different
nature in the last 30 days prior to inclusion.
- Any individual who, in the opinion of the investigator, may not be able to follow
instructions or make a good filling of the therapeutic regimen.
- Subjects who do not grant written consent to participate in the study.
- Labor litigation for reasons of participation in the clinical trial of CFS.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02122198 -
Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women
|
N/A | |
Recruiting |
NCT04356924 -
Psychological Treatment to Support the Consequences of Cognitive Impairment
|
N/A | |
Suspended |
NCT05542238 -
The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury
|
N/A | |
Terminated |
NCT04493957 -
Evaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : ACCOMPAGNE
|
N/A | |
Recruiting |
NCT04792983 -
Cognition and the Immunology of Postoperative Outcomes
|
||
Completed |
NCT06029920 -
Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment
|
N/A | |
Not yet recruiting |
NCT05068323 -
Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients
|
N/A | |
Completed |
NCT04426838 -
Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
|
N/A | |
Completed |
NCT04713384 -
Remote Bimanual Virtual Rehabilitation Post CVD
|
N/A | |
Recruiting |
NCT06284213 -
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
|
||
Recruiting |
NCT06053775 -
Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP)
|
N/A | |
Completed |
NCT03698695 -
A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers
|
Phase 1 | |
Not yet recruiting |
NCT05552729 -
Effects of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03268109 -
COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
|
||
Completed |
NCT03301402 -
Air Purifier to Improve Endothelial Function and Carotid Intima Thickness
|
N/A | |
Completed |
NCT03187353 -
IMProving Executive Function Study
|
Phase 4 | |
Completed |
NCT05395559 -
Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
|
||
Recruiting |
NCT04907565 -
Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue
|
||
Recruiting |
NCT05030285 -
Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment
|
N/A | |
Recruiting |
NCT04897334 -
Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke
|
N/A |