Effect of Acupuncture on Functional Capacity and Health-Related Quality of Life of Hemodialysis Patients: Study Protocol for a Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Setting
2.2. Recruitment
2.3. Eligibility Criteria
2.4. Randomization and Allocation
2.5. Blinding
2.6. Intervention
3. Outcome Measurement
3.1. Primary Outcome
3.2. Secondary Outcomes
3.3. Participant Timeline
3.4. Statistical Analysis and Sample size
3.5. Adverse Events Assessment
3.6. Quality Control and Data Collection
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Item | Detail | |
---|---|---|
1. Acupuncture Rationale | (1a) Style of acupuncture | Manual acupuncture. |
(1b) Reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references where appropriate. | The protocol treatment provided is based on traditional meridian theory, literature sources, clinical experience and consensus method of experts in Traditional Chinese Medicine, Acupuncture and Nephrology [25,26,27], members of research team. | |
(1c) Extent to which treatment was varied | Experimental (verum acupuncture) group will receive a total of 9 acupuncture treatments, however, will be divided into subgroups A and B. Experimental subgroup A will receive three acupuncture sessions per week over 3 weeks and subgroup B will receive one a week for 9 weeks. The same choice of acupuncture points will be applied to both experimental subgroups A and B. | |
2. Details of Needling | (2a) Number of needle insertions per subject per session | A total of 5 fixed acupoints and a total of 8 needle insertions per subject and per session. |
(2b) Names of points used | Taixi (KI3), bilateral; Sanyinjiao (SP6), bilateral; Zusanli (ST36), bilateral; Shenmen (HT7) unilateral, in the arm without arteriovenous fistula; Guanyuan (CV4), unilateral. Acupuncture points will be found according to the WHO points location method. | |
(2c) Depth of insertion, based on a specified unit of measurement, or on a particular tissue level | After local area disinfection with alcohol wipes, acupoints CV4, ST36, KI3 and SP6 will be inserted perpendicularly (15 to 20 mm depth) and HT7 inserted slightly obliquely (10 mm depth). | |
(2d) Response sought | De qi sensation (described as a compositional sensation including numbness, soreness, distention, heaviness) will be achieved through lifting, thrusting and twirling manipulations. | |
(2e) Needle stimulation | Manual stimulation. After generating a needling sensation, needles will be manipulated for one minute every ten minutes during needle retention. | |
(2f) Needle retention time | 25 min. | |
(2g) Needle type | Sterilized stainless-steel needle (0.25 × 25 mm) Tewa, asia-med GmbH, Kirchplatz 1, 82049 Pullach, Germany. | |
3. Treatment Regimen | (3a) Number of treatment sessions | A total of 9 treatment sessions for both groups. |
(3b) Frequency and duration of treatment sessions | Verum Acupuncture Subgroup A: three times a week for 3 weeks. Verum Acupuncture Subgroup B: once a week for 9 weeks. | |
4. Other Components of Treatment | (4a) Details of other interventions administered to the acupuncture group | Apart from the usual care routine for hemodialysis sessions, during the study period, no further intervention will be allowed. |
(4b) Setting and context of treatment, including instructions to practitioners, and information and explanations to patients | Treatment sessions will take place at the Hemodialysis Center of TECSAM Tecnologia e Serviços Médicos, SA, in Mirandela, during hemodialysis sessions. Participants will be informed about the entire procedure and a clarification meeting will also be held with the hemodialysis clinical team before treatments starts. | |
5. Practitioner Background | (5) Description of participating acupuncturists | M.C.d.C is a licensed specialist in Traditional Chinese Medicine with professional card number C-006513 issued by the Regulator of Health System Central Administration in Portugal, ACSS (Administração Central do Sistema de Saúde, I.P.); five years of professional experience; a Traditional Chinese Medicine Master’s degree from Instituto de Ciências Biomédicas Abel Salazar, Universidade do Porto, Portugal; completion of Advanced Chinese Medicine Course from Guangzhou University of Chinese Medicine, Guangzhou, P.R. China. |
6. Control or Comparator Interventions | (6a) Rationale for the control or comparator in the context of the research question, with sources that justify this choice | Participants will randomly be assigned to experimental group (verum acupuncture), placebo group (sham acupuncture) or control group (waiting list). |
(6b) Precise description of the control or comparator. If sham acupuncture or any other type of acupuncture-like control is used, provide details as for Items 1 to 3 above. | The placebo group (sham acupuncture) will receive a total of 9 acupuncture treatments, however, will be divided into subgroups A and B. Placebo subgroup A will receive three acupuncture sessions per week over 3 weeks and subgroup B will receive one a week for 9 weeks. Manual acupuncture will be performed as superficial needling (5 mm depth) at non-acupuncture points without an attempt to achieve a De qi sensation and without stimulation, lasting 25 min, using a sterilized stainless-steel needle (0.25 × 25 mm; Tewa, asia-med GmbH, Kirchplatz 1, 82049 Pullach, Germany).The control group (waiting list) will not receive any acupuncture treatment during the study period. List of Non-Acupuncture points used and their location In the present study, the non-acupuncture points selected will be the points located on the non-meridian but near the acupuncture points described above.
On the posteromedial aspect of the ankle, at the midpoint of KI3 (Taixi) and (Fuliu). KI7 (Fuliu) is located on the posteromedial aspect of the leg, anterior to the calcaneal tendon, 2 cun superior to the prominence of the medial malleolus.
On the leg, at the midpoint of the medial side of the tibia, 1 cun distal from SP6 (Sanyinjiao).
On the anterior aspect of the leg, at midpoint of ST37 (Shangjuxu) and the Gallbladder Meridian. ST37 (Shangjuxu) is located on the anterior aspect of the leg, on the line connecting ST35 with ST41, 6 cun inferior to ST35, on the tibialis anterior muscle.
On the wrist, at the transverse crease of the wrist, at the midpoint of HT7 (Shenmen) and PC7 (Daling), between the Pericardium Meridian and the Heart Meridian.
On the lower abdomen, 1 cun lateral from CV6 (Qihai). CV6 (Qihai) is located 1.5 cun inferior to the center of the umbilicus, on the anterior median line. |
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Correia de Carvalho, M.; Pereira Machado, J.; Laranjeira, M.; Nunes de Azevedo, J.; Azevedo, P. Effect of Acupuncture on Functional Capacity and Health-Related Quality of Life of Hemodialysis Patients: Study Protocol for a Randomized Controlled Trial. Healthcare 2022, 10, 2050. https://doi.org/10.3390/healthcare10102050
Correia de Carvalho M, Pereira Machado J, Laranjeira M, Nunes de Azevedo J, Azevedo P. Effect of Acupuncture on Functional Capacity and Health-Related Quality of Life of Hemodialysis Patients: Study Protocol for a Randomized Controlled Trial. Healthcare. 2022; 10(10):2050. https://doi.org/10.3390/healthcare10102050
Chicago/Turabian StyleCorreia de Carvalho, Marta, Jorge Pereira Machado, Manuel Laranjeira, José Nunes de Azevedo, and Pedro Azevedo. 2022. "Effect of Acupuncture on Functional Capacity and Health-Related Quality of Life of Hemodialysis Patients: Study Protocol for a Randomized Controlled Trial" Healthcare 10, no. 10: 2050. https://doi.org/10.3390/healthcare10102050