Effect of Acupuncture on Functional Capacity in Patients Undergoing Hemodialysis: A Patient-Assessor Blinded Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Design and Settings
2.2. Participants
2.3. Intervention
2.4. Outcome Measurement
2.4.1. Six-Minute Walk Test (6MWT)
2.4.2. Thirty-Second Sit-to-Stand (STS-30) Test
2.4.3. Handgrip Strength (HGS) Test
2.5. Randomization and Blinding
2.6. Quality Control and Data Collection
2.7. Statistical Analysis and Sample Size
3. Results
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Appendix A
Acupuncture Points | Location |
---|---|
KI3 (Taixi) | On the posteromedial aspect of the ankle, in the depression between the prominence of the medial malleolus and the calcaneal tendon. |
SP6 (Sanyinjiao) | On the tibial aspect of the leg, posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus. |
ST36 (Zusanli) | On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 cun inferior to ST35, on the tibialis anterior muscle. |
HT7 (Shenmen) | On the wrist, at the ulnar end of the transverse crease of the wrist, in the depression on the redial side of the tendon of m. flexor carpi ulnaris. |
CV4 (Guanyuan) | On the lower abdomen, 3 cun inferior to the center of the umbilicus, on the anterior median line. |
Non-Acupuncture Points | Location |
---|---|
Non-Acupuncture point 1 (NA1) | Located near KI3 (Taixi). On the posteromedial aspect of the ankle, at the midpoint of KI3 (Taixi) and KI7 (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. |
Non-Acupuncture point 2 (NA2) | Located near SP6 (Sanyinjiao). On the leg, at the midpoint of the medial side of the tibia, 1 cun distal from SP6 (Sanyinjiao). |
Non-Acupuncture point 3 (NA3) | Located near ST36 (Zusanli). 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. |
Non-Acupuncture point 4 (NA4) | Located near HT7 (Shenmen). On the wrist, at the transverse crease of the wrist, at the midpoint of HT7 (Shenmen) and PC7 (Daling), between the Pericardium Meridian and Heart Meridian. |
Non-Acupuncture point 5 (NA5) | Located near CV4 (Guanyuan). 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. |
Screening | Baseline | Treatment Period | Follow-Up Period | ||||
---|---|---|---|---|---|---|---|
0 Week | 1 Week | 3 Week | 9 Week | 12 Weeks after Treatment | |||
Patient | Eligibility | X | |||||
Informed Consent | X | ||||||
Demographics and clinical data | X | ||||||
Physical examination | X | ||||||
Randomization Laboratorial data | X X | ||||||
X | |||||||
Intervention | Verum Acupuncture Subgroup A | 9 Acupuncture treatments (3 sessions per week for 3 weeks) | X | ||||
Verum Acupuncture Subgroup B | 9 Acupuncture treatments (1 session per week for 9 weeks) | ||||||
Comparison | Sham Acupuncture Subgroup A | 9 Acupuncture treatments in non-acupuncture points (3 sessions per week for 3 weeks) | X | ||||
Sham Acupuncture Subgroup B | 9 Acupuncture treatments in non-acupuncture points (1 session per week for 9 weeks) | X | |||||
Non-Acupuncture Group 0 | Non-Acupuncture Treatment | X | |||||
Outcomes | 6MWT walked distance | X | X | X | X | ||
Lower Limbs Strength | X | X | X | X | |||
Handgrip Strength | X | X | X | X | |||
Assessment of blinding success. | X | X | |||||
Participant Safety | Adverse events | X | X | X | X |
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Experimental Group | Placebo Group | Control Group | ||||
---|---|---|---|---|---|---|
Verum Acupuncture (VA) | Sham Acupuncture (SA) | Waiting-List (WL) | ||||
DETAILS OF NEEDLING | Number of needles | 5 fixed acupoints and a total of 8 needle insertions per subject and session. | 5 fixed acupoints and a total of 8 needle insertions per subject and session. | No acupuncture treatment will be performed from the time of randomization until the end of the follow-up period. | ||
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. | Non-acupuncture points near the acupuncture points selected as described in Appendix A, Table A2. | ||||
Depth of insertion | CV4, ST36, KI3 and SP6 were inserted perpendicularly (15 to 20 mm depth) and HT7 was inserted slightly oblique (10 mm depth). | Superficial needling (5 mm depth) at non-acupuncture points abovementioned. | ||||
Response sought | De qi sensation (described as a compositional sensation including numbness, soreness, distention, heaviness) was achieved through lifting, thrusting and twirling manipulations. | No De qi sensation. | ||||
Needle stimulation | Manual stimulation. After generating needling sensation, needles were manipulated for one minute every ten minutes during needle retention. | No stimulation. | ||||
Needle retention time | 25 min. | 25 min. | ||||
Needle type | Sterilized stainless-steel needle (0.25 × 25 mm) Tewa, asia-med GmbH, Kirchplatz 182,049 Pullach, Germany. | Sterilized stainless-steel needle (0.25 × 25 mm) Tewa, asia-med GmbH, Kirchplatz 182,049 Pullach, Germany. | ||||
TREATMENT REGIMEN | Number of treatment sessions | 9 treatment sessions. | 9 treatment sessions. | Not applicable. | ||
Frequency of treatment sessions | VA subgroup A (VA.A) Three times a week for 3 weeks. (3 × 3) | VA subgroup B (VA.B) Once a week for 9 weeks. (1 × 9) | SA subgroup A (SA.A) Three times a week for 3 weeks. (3 × 3) | SA subgroup B (SA.B) Once a week for 9 weeks. (1 × 9) |
Variables | Total (n = 67) | Verum Acupuncture Group (n = 23) | Sham Acupuncture Group (n = 22) | Non-Acupuncture Group (n = 22) | p |
---|---|---|---|---|---|
Sociodemographic | |||||
Sex | |||||
Female | 26 (38.8%) | 9 (39.1%) | 8 (36.4%) | 9 (40.9%) | 1.000 (1) |
Male | 41 (61.2%) | 14 (60.9%) | 14 (63.6%) | 13 (59.1%) | |
Age | |||||
Minimum–Maximum | 56–91 | 60–84 | 57–91 | 56–87 | |
Mean (SD) | 71.6 (7.7) | 71.2 (5.1) | 72.6 (8.3) | 71.0 (9.4) | 0.764 (2) |
Residence | |||||
Urban | 24 (35.8%) | 9 (39.1%) | 8 (36.4%) | 7 (31.8%) | 0.948 (1) |
Rural | 43 (64.2%) | 14 (60.9%) | 14 (63.6%) | 15 (68.2%) | |
Education level | |||||
No literacy | 5 (7.5%) | 0 (0.0%) | 2 (9.1%) | 3 (13.6%) | 0.279 (1) |
1° Cycle (4 years) | 49 (73.1%) | 20 (87.0%) | 17 (77.3%) | 12 (54.5%) | |
2° Cycle (6 years) | 7 (10.4%) | 2 (8.7%) | 1 (4.5%) | 4 (18.2%) | |
3° Cycle (9 years) | 1 (1.5%) | 0 (0.0%) | 0 (0.0%) | 1 (4.5%) | |
High school (12 years) | 5 (7.5%) | 1 (4.3%) | 2 (9.1%) | 2 (9.1%) | |
Professional status | |||||
Employed | 4 (6.0%) | 0 (0.0%) | 2 (9.1%) | 2 (9.1%) | 0.481 (1) |
Self-employed | 4 (6.0%) | 2 (8.7%) | 0 (0.0%) | 2 (9.1%) | |
Unemployed | 2 (3.0%) | 1 (4.3%) | 1 (4.5%) | 0 (0.0%) | |
Retired | 57 (85.1%) | 20 (87.0%) | 19 (86.4%) | 18 (81.8%) | |
Clinical | |||||
CKD causes | |||||
Diabetes mellitus | 29 (43.3%) | 10 (43.5%) | 10 (45.5%) | 9 (40.9%) | 0.537 (1) |
Chronic rejection | 7 (10.4%) | 1 (4.3%) | 4 (18.2%) | 2 (9.1%) | |
Hypertensive nephropathy | 4 (6.0%) | 3 (13.0%) | 0 (0.0%) | 1 (4.5%) | |
High blood pressure | 2 (3.0%) | 0 (0.0%) | 1 (4.5%) | 1 (4.5%) | |
Glomerulonephritis | 2 (3.0%) | 1 (4.3%) | 0 (0.0%) | 1 (4.5%) | |
Polycystic disease | 2 (3.0%) | 0 (0.0%) | 0 (0.0%) | 2 (9.1%) | |
Interstitial tubular necrosis | 2 (3.0%) | 0 (0.0%) | 2 (9.1%) | 0 (0.0%) | |
Other | 5 (7.5%) | 3 (13.0%) | 1 (4.5%) | 1 (4.5%) | |
Unknown | 14 (20.9%) | 5 (21.7%) | 4 (18.2%) | 5 (22.7%) | |
Hemodialysis time | |||||
<12 months | 2 (3.0%) | 2 (8.7%) | 0 (0.0%) | 0 (0.0%) | 0.240 (1) |
12 to 120 months | 56 (83.6%) | 19 (82.6%) | 20 (90.9%) | 17 (77.3%) | |
>120 months | 9 (13.4%) | 2 (8.7%) | 2 (9.1%) | 5 (22.7%) | |
Vascular access | |||||
Arteriovenous fistula | 61 (91.0%) | 22 (95.7%) | 18 (81.8%) | 21 (95.5%) | 0.306 (1) |
Central venous catheter | 6 (9.0%) | 1 (4.3%) | 4 (18.2%) | 1 (4.5%) | |
Laboratorial | Mean (SD) | ||||
Hemoglobin | 10.93 (1.03) | 10.88 (0.94) | 10.86 (1.05) | 11.05 (1.12) | 0.797 (2) |
Potassium | 5.44 (0.81) | 5.52 (0.89) | 5.35 (0.81) | 5.45 (0.74) | 0.799 (2) |
Calcium | 9.11 (0.51) | 9.13 (0.55) | 9.10 (0.49) | 9.10 (0.51) | 0.970 (2) |
Phosphorus | 4.74 (1.13) | 4.71 (1.17) | 4.70 (1.25) | 4.80 (1.00) | 0.944 (2) |
Sodium | 138.1 (3.0) | 138.5 (2.9) | 138.6 (3.8) | 137.3 (2.0) | 0.296 (2) |
Albumin | 3.91 (0.28) | 3.98 (0.27) | 3.81 (0.27) | 3.95 (0.29) | 0.101 (2) |
Urea (before) | 152.6 (37.5) | 161.0 (37.9) | 145.3 (36.2) | 151.0 (38.3) | 0.369 (2) |
Creatinine | 9.94 (2.12) | 10.15 (2.26) | 9.51 (1.94) | 10.16 (2.16) | 0.514 (2) |
Parathyroid hormone | 418.0 (243.2) | 454.2 (256.9) | 358.2 (193.3) | 439.9 (271.5) | 0.370 (2) |
Cholesterol | 162.8 (37.1) | 166.0 (47.2) | 155.5 (35.8) | 166.6 (25.0) | 0.536 (2) |
Effects | 6MWT | STS-30 Test | HGS Test |
---|---|---|---|
Time | p = 0.001, η2p = 0.114 | p < 0.001, η2p = 0.240 | p = 0.004, η2p = 0.168 |
Interaction time*group | p < 0.001, η2p = 0.521 | p < 0.001, η2p = 0.600 | p = 0.032, η2p = 0.083 |
Interaction time*treatment frequency | p = 0.172, η2p = 0.028 | p = 0.438, η2p = 0.027 | p = 0.843, η2p = 0.002 |
Verum Acupuncture (VA) Group (n = 23) | Sham Acupuncture (SA) Group (n = 22) | Waiting-List (WL) Group (n = 22) | |
---|---|---|---|
Mean ± SD | Mean ± SD | Mean ± SD | |
6MWT, Walked distance (m) | |||
Baseline | 307.2 ± 80.1 a | 296.2 ± 97.8 a | 304.1 ± 119.3 a |
After treatment | 383.2 ± 70.7 b | 283.4 ± 95.2 a | 268.8 ± 113.8 b |
Follow-up | 368.9 ± 68.2 b | 262.5 ± 101.8 b | 241.7 ± 118.1 c |
ANOVA (1) | p < 0.001 | p < 0.001 | p < 0.001 |
Interaction time*group | p < 0.001, η2p = 0.509 | ||
STS-30 Test, Repetition number of sit-to-stand in 30 s | |||
Baseline | 9.7 ± 2.8 a | 9.1 ± 3.8 a | 9.1 ± 3.7 a |
After treatment | 11.5 ± 2.8 b | 7.9 ± 3.8 b | 7.9 ± 3.1 b |
Follow-up | 11.2 ± 3.0 b | 7.4 ± 3.6 b | 7.0 ± 3.7 c |
ANOVA (1) | p < 0.001 | p < 0.001 | p < 0.001 |
Interaction time*group | p < 0.001, η2p = 0.565 | ||
HGS Test, Isometric handgrip force (kgf) | |||
Baseline | 21.4 ± 5.5 a | 20.4 ± 4.7 a | 20.9 ± 6.5 a |
After treatment | 22.8 ± 5.7 b | 20.6 ± 5.1 a | 20.5 ± 6.1 a |
Follow-up | 21.7 ± 5.1 ab | 20.2 ± 5.6 a | 19.8 ± 5.9 a |
ANOVA (1) | p = 0.012 | p = 0.601 | p = 0.112 |
Interaction time*group | p = 0.043, η2p = 0.083 |
Participants’ Guess, n (%) | |||
---|---|---|---|
Groups | Verum Acupuncture | Sham Acupuncture | Do Not Know |
Verum Acupuncture (n = 23) | 7 (30.4%) | 0 (0.0%) | 16 (69.6%) |
Sham Acupuncture (n = 22) | 7 (31.8%) | 0 (0.0%) | 15 (68.2%) |
Total (n = 45) | 14 (31.1%) | 0 (0.0%) | 31 (68.9%) |
Blinding Index: 0.84 (95% Confidence Interval: 0.78–0.91) |
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Correia de Carvalho, M.; Nunes de Azevedo, J.; Azevedo, P.; Pires, C.; Laranjeira, M.; Machado, J.P. Effect of Acupuncture on Functional Capacity in Patients Undergoing Hemodialysis: A Patient-Assessor Blinded Randomized Controlled Trial. Healthcare 2022, 10, 1947. https://doi.org/10.3390/healthcare10101947
Correia de Carvalho M, Nunes de Azevedo J, Azevedo P, Pires C, Laranjeira M, Machado JP. Effect of Acupuncture on Functional Capacity in Patients Undergoing Hemodialysis: A Patient-Assessor Blinded Randomized Controlled Trial. Healthcare. 2022; 10(10):1947. https://doi.org/10.3390/healthcare10101947
Chicago/Turabian StyleCorreia de Carvalho, Marta, José Nunes de Azevedo, Pedro Azevedo, Carlos Pires, Manuel Laranjeira, and Jorge Pereira Machado. 2022. "Effect of Acupuncture on Functional Capacity in Patients Undergoing Hemodialysis: A Patient-Assessor Blinded Randomized Controlled Trial" Healthcare 10, no. 10: 1947. https://doi.org/10.3390/healthcare10101947