Acupuncture in the Treatment of Fatigue in Parkinson's Disease
Paraules clau
Resum
Descripció
This will be a single centre, single blinded 2-group randomized controlled study, with participants receiving either verum acupuncture or placebo acupuncture.
A retractable non-invasive placebo needle will be used in the placebo arm. Both the real and placebo needles have a fine needle body and copy handle and look exactly the same. However, the placebo needle has a retractable shaft and blunt tip. When pressed onto the skin, it telescopes into the handle and the blunt tip stays on the skin instead of penetrating it. The plastic tube with adhesive foot-plate is placed on the skin to hold it in place. The real needle, on the other hand, has a normal sharp tip which allows it to pierce the skin.
The following acupoints will be needled: Stomach 36 (bilateral), Spleen 6 (bilateral), Kidney 3 (bilateral), Large Intestine 4 (bilateral), Pericardium 6 (bilateral), and Conception Vessel 6. These points were chosen based on Traditional Chinese Medicine theory (which attributed fatigue to deficiencies of spleen, kidney and qi).
Each acupuncture session will be based on a strict protocol, and conversation between acupuncturists and participants will be kept to a minimum.
Participants will be assessed at 3 intervals:
1. Week 0 (baseline)
2. Week 5 (completion of intervention)
3. Week 9 (4 weeks after completion of intervention
Dates
| Darrera verificació: | 03/31/2017 |
| Primer enviat: | 10/15/2015 |
| Inscripció estimada enviada: | 10/24/2015 |
| Publicat per primera vegada: | 10/26/2015 |
| Última actualització enviada: | 07/05/2017 |
| Publicació de l'última actualització: | 07/10/2017 |
| Data d'inici de l'estudi real: | 10/31/2015 |
| Data estimada de finalització primària: | 02/28/2017 |
| Data estimada de finalització de l’estudi: | 04/26/2017 |
Condició o malaltia
Intervenció / tractament
Device: Acupuncture
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Active Comparator: Verum acupuncture 10 sessions of verum acupuncture | |
| Placebo Comparator: Placebo acupuncture 10 sessions of placebo acupuncture via use of placebo acupuncture needles |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 21 Years Per a 21 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion Criteria: 1. Diagnosis of PD based on criteria developed by Gelb et al which is adopted by the National Institute of Neurological Disorders and Stroke, US National Institute of Health. 2. Age 21-85 years old 3. Presence of persistent fatigue of a moderate level for at least 4 weeks' duration. Moderate fatigue is defined as a score of ≥10 on the general fatigue domain of the Multidimensional Fatigue Inventory. 4. No acupuncture treatment in the past 6 months. Exclusion Criteria: 1. Significant cognitive, language or psychiatric illnesses which prevents the subject from understanding instructions and participating in the study. 2. Needle phobia 3. Comorbidity with a bleeding disorder 4. Known anemia with hemoglobin level less than 10g/dl. 5. Known congestive cardiac failure and/or end stage renal disease 6. Female subjects of childbearing age 7. Presence of symptomatic postural hypotension |
Resultat
Mesures de resultats primaris
1. General Fatigue score of the Multidimensional Fatigue Inventory [General Fatigue score of the Multidimensional Fatigue Inventory at week 5]
Mesures de resultats secundaris
1. General Fatigue score of the Multidimensional Fatigue Inventory [General Fatigue score of the Multidimensional Fatigue Inventory at week 9]
2. Unified Parkinson's Disease Rating Scale (UPDRS) [UPDRS score at week 5]
3. Unified Parkinson's Disease Rating Scale (UPDRS) [UPDRS score at week 9]
4. Parkinson's Disease Questionnaire-39 (PD 39). [PD 39 score at week 5]
5. Parkinson's Disease Questionnaire-39 (PD 39). [PD 39 score at week 9]
6. Geriatric Depression Scale (GDS) [GDS score at week 5]
7. Geriatric Depression Scale (GDS) [GDS score at week 9]
Altres mesures de resultats
1. Adverse events [Adverse events will be captured up to 9 weeks]
