Trial Outcomes & Findings for Acupuncture on Chemotherapy-induced Peripheral Neuropathy (NCT NCT03626220)
NCT ID: NCT03626220
Last Updated: 2025-01-20
Results Overview
The average pain severity was chosen as the primary assessment as neuropathy symptoms based on its ability to detect neuropathic pain in cancer patients, as well as its use to assess CIPN symptoms in other controlled clinical trials.The BPI-SF assesses pain when responding to the questionnaire (right now) and at its worst, least, and average pain severity in the last 24 h. The items range from 0 to 10 (0 = no pain; 10 = worst pain). The higher the pain severity scores, the worse the degree of pain experienced by the patient. We analyzed the data (1) within group analysis: compared the data at week 6 with baseline, and the data at week 9 with baseline from each group. (2) between group analysis: compared the acupuncture group and sham acupuncture group at week 6 and week 9. (3) the between group differences of the changes from week 6 to baseline and from week 9 to baseline.
COMPLETED
NA
20 participants
We measured the average pain severity 4 times within 9 weeks [at baseline (before the first treatment) and week 3, week 6, and week 9 during the protocol].
2025-01-20
Participant Flow
269 patients diagnosed with breast cancer were screened from June 2018 to July 2020. Of 61 potentially eligible patients, 20 (32.8%) were enrolled and randomized as 10 in the acupuncture group and 10 in the sham acupuncture group. 208 ineligible patients were excluded, and 41 patients declined to participate in our study.
Participant milestones
| Measure |
The Acupuncture Group
Acupuncture treatment will be performed for 9 weeks. The frequency of acupuncture will be twice a week for the first six weeks, and once a week for the following three weeks. 30 minutes needling at each treatment. Acupuncture points include Baihui(GV20), Qihai(CV6), Quchi(LI11), Hegu(LI4), Neiguan(P6), and Shenmen(HT7) for upper limbs. For palm numbness, choose two acupoints to use in turn; use Weizhong(BL40), Sanyinjiao(SP6), and Zusanli(ST36) for lower limbs. For the acupuncture points, Taixi(KI3) and Yongquan(K1) should be added for foot numbness. "De qi" sensation, such as soreness, numbness, pain, etc. will be achieved at each acupoints .
acupuncture: More than five years of experienced certified acupuncturists performed all treatments using the study protocol and administered to all participants. The acupoints selection principle was based on the Bi syndrome(the impediment disease) recorded in the Huangdi's Internal Classic, the Traditional Chinese medicine literature. Disposable sterile stainless steel needles (CASOON, Wuxi Jiajian Medical Instrument Company, LTD., Jiangsu, China) with 0.3mm in diameter and 40mm in length, were inserted into the prespecified acupoints
|
The Controlled Group
Acupuncture with superficial needling 0.5 cun (estimated 1cm with deviation depends on the body size of each participants) away from the acupoints, which only superficially penetrated the skin without feeling of "De Qi" sensation.
acupuncture: More than five years of experienced certified acupuncturists performed all treatments using the study protocol and administered to all participants. The acupoints selection principle was based on the Bi syndrome(the impediment disease) recorded in the Huangdi's Internal Classic, the Traditional Chinese medicine literature. Disposable sterile stainless steel needles (CASOON, Wuxi Jiajian Medical Instrument Company, Limited, Jiangsu, China) with 0.3mm in diameter and 40mm in length, were inserted into the prespecified acupoints
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
The Acupuncture Group
Acupuncture treatment will be performed for 9 weeks. The frequency of acupuncture will be twice a week for the first six weeks, and once a week for the following three weeks. 30 minutes needling at each treatment. Acupuncture points include Baihui(GV20), Qihai(CV6), Quchi(LI11), Hegu(LI4), Neiguan(P6), and Shenmen(HT7) for upper limbs. For palm numbness, choose two acupoints to use in turn; use Weizhong(BL40), Sanyinjiao(SP6), and Zusanli(ST36) for lower limbs. For the acupuncture points, Taixi(KI3) and Yongquan(K1) should be added for foot numbness. "De qi" sensation, such as soreness, numbness, pain, etc. will be achieved at each acupoints .
acupuncture: More than five years of experienced certified acupuncturists performed all treatments using the study protocol and administered to all participants. The acupoints selection principle was based on the Bi syndrome(the impediment disease) recorded in the Huangdi's Internal Classic, the Traditional Chinese medicine literature. Disposable sterile stainless steel needles (CASOON, Wuxi Jiajian Medical Instrument Company, LTD., Jiangsu, China) with 0.3mm in diameter and 40mm in length, were inserted into the prespecified acupoints
|
The Controlled Group
Acupuncture with superficial needling 0.5 cun (estimated 1cm with deviation depends on the body size of each participants) away from the acupoints, which only superficially penetrated the skin without feeling of "De Qi" sensation.
acupuncture: More than five years of experienced certified acupuncturists performed all treatments using the study protocol and administered to all participants. The acupoints selection principle was based on the Bi syndrome(the impediment disease) recorded in the Huangdi's Internal Classic, the Traditional Chinese medicine literature. Disposable sterile stainless steel needles (CASOON, Wuxi Jiajian Medical Instrument Company, Limited, Jiangsu, China) with 0.3mm in diameter and 40mm in length, were inserted into the prespecified acupoints
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
The Acupuncture Group
n=10 Participants
Acupuncture treatment will be performed for 9 weeks. The frequency of acupuncture will be twice a week for the first six weeks, and once a week for the following three weeks. 30 minutes needling at each treatment. Acupuncture points include Baihui(GV20), Qihai(CV6), Quchi(LI11), Hegu(LI4), Neiguan(P6), and Shenmen(HT7) for upper limbs. For palm numbness, choose two acupoints to use in turn; use Weizhong(BL40), Sanyinjiao(SP6), and Zusanli(ST36) for lower limbs. For the acupuncture points, Taixi(KI3) and Yongquan(K1) should be added for foot numbness. "De qi" sensation, such as soreness, numbness, pain, etc. will be achieved at each acupoints .
acupuncture: More than five years of experienced certified acupuncturists performed all treatments using the study protocol and administered to all participants. The acupoints selection principle was based on the Bi syndrome(the impediment disease) recorded in the Huangdi's Internal Classic, the Traditional Chinese medicine literature. Disposable sterile stainless steel needles (CASOON, Wuxi Jiajian Medical Instrument Company, LTD., Jiangsu, China) with 0.3mm in diameter and 40mm in length, were inserted into the prespecified acupoints
|
The Controlled Group
n=10 Participants
Acupuncture with superficial needling 0.5 cun (estimated 1cm with deviation depends on the body size of each participants) away from the acupoints, which only superficially penetrated the skin without feeling of "De Qi" sensation.
acupuncture: More than five years of experienced certified acupuncturists performed all treatments using the study protocol and administered to all participants. The acupoints selection principle was based on the Bi syndrome(the impediment disease) recorded in the Huangdi's Internal Classic, the Traditional Chinese medicine literature. Disposable sterile stainless steel needles (CASOON, Wuxi Jiajian Medical Instrument Company, LTD., Jiangsu, China) with 0.3mm in diameter and 40mm in length, were inserted into the prespecified acupoints
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.10 years
STANDARD_DEVIATION 11.07 • n=10 Participants
|
52.10 years
STANDARD_DEVIATION 11.18 • n=10 Participants
|
49.60 years
STANDARD_DEVIATION 11.13 • n=20 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Taiwan
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
|
Eastern Cooperative Group(ECOG) performance status
Grade 0
|
10 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
19 Participants
n=20 Participants
|
|
Eastern Cooperative Group(ECOG) performance status
Grade 1
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: We measured the average pain severity 4 times within 9 weeks [at baseline (before the first treatment) and week 3, week 6, and week 9 during the protocol].Population: * In the acupuncture group, one subject withdrew from the trial because of needle phobia after the third week of treatment, and another subject withdrew from the trial because of cellulitis in the radiation treatment site after completing the sixth week of treatment * In the placebo group, one subject did not record the scoring result after completing the sixth week of acupuncture treatment because of the omission to fill in this scale
The average pain severity was chosen as the primary assessment as neuropathy symptoms based on its ability to detect neuropathic pain in cancer patients, as well as its use to assess CIPN symptoms in other controlled clinical trials.The BPI-SF assesses pain when responding to the questionnaire (right now) and at its worst, least, and average pain severity in the last 24 h. The items range from 0 to 10 (0 = no pain; 10 = worst pain). The higher the pain severity scores, the worse the degree of pain experienced by the patient. We analyzed the data (1) within group analysis: compared the data at week 6 with baseline, and the data at week 9 with baseline from each group. (2) between group analysis: compared the acupuncture group and sham acupuncture group at week 6 and week 9. (3) the between group differences of the changes from week 6 to baseline and from week 9 to baseline.
Outcome measures
| Measure |
The Acupuncture Group
n=10 Participants
Acupuncture treatment will be performed for 9 weeks. The frequency of acupuncture will be twice a week for the first six weeks, and once a week for the following three weeks. 30 minutes needling at each treatment. Acupuncture points include Baihui(GV20), Qihai(CV6), Quchi(LI11), Hegu(LI4), Neiguan(P6), or Shenmen(HT7) for upper limbs. For plantar numbness, choose two acupoints to use in turn; use Weizhong(BL40), Sanyinjiao(SP6), or Zusanli(ST36) for lower limbs. If severe numbness occurred, Taixi(KI3) or Yongquan(K1) should be added for feet numbness. "De qi" sensation, such as soreness, numbness, pain, etc. will be achieved at each acupoints .
|
The Controlled Group
n=10 Participants
Acupuncture with superficial needling 0.5 cun (estimated 1cm with deviation depends on the body size of each participants) away from the acupoints, which only superficially penetrated the skin without feeling of "De Qi" sensation.
|
|---|---|---|
|
The Average Pain Severity in the Brief Pain Inventory-Short Form(BPI-SF)
Baseline
|
3.10 score on a scale
Standard Deviation 2.33
|
3.10 score on a scale
Standard Deviation 1.79
|
|
The Average Pain Severity in the Brief Pain Inventory-Short Form(BPI-SF)
Week 3
|
1.72 score on a scale
Standard Deviation 1.48
|
3.50 score on a scale
Standard Deviation 2.27
|
|
The Average Pain Severity in the Brief Pain Inventory-Short Form(BPI-SF)
Week 6
|
1.63 score on a scale
Standard Deviation 0.92
|
2.78 score on a scale
Standard Deviation 2.82
|
|
The Average Pain Severity in the Brief Pain Inventory-Short Form(BPI-SF)
Week 9
|
0.88 score on a scale
Standard Deviation 1.13
|
2.70 score on a scale
Standard Deviation 2.00
|
|
The Average Pain Severity in the Brief Pain Inventory-Short Form(BPI-SF)
Changes at week 6
|
-1.63 score on a scale
Standard Deviation 1.85
|
-0.11 score on a scale
Standard Deviation 2.71
|
|
The Average Pain Severity in the Brief Pain Inventory-Short Form(BPI-SF)
Changes at week 9
|
-2.38 score on a scale
Standard Deviation 2.39
|
-0.40 score on a scale
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: 4 times within 9 weeks: at baseline (before the first treatment) and week 3, week 6, and week 9 during the protocolPopulation: * In the acupuncture group, one subject withdrew from the trial because of needle phobia after the third week of treatment, and another subject withdrew from the trial because of cellulitis in the radiation treatment site after completing the sixth week of treatment * In the placebo group, one subject did not record the scoring result after completing the sixth week of acupuncture treatment because of the omission to fill in this scale
The 27-item FACT-G evaluated the quality of life of patients undergoing cancer therapy over the past 7 days. The question is rated on a five-point scale, from 0 to 4 (0= not at all; 4= very much) and summed ( total score range= 0-108). An increase in scores represents an improvement in the overall quality of life.The 13-item Ntx subscale measures the severity and impact of neurotoxicity symptoms over the past seven days. Items are rated on a five-point scale, scored from 0 to 4 and summed ( total score range= 0-52). Higher scores on the neurotoxicity scale indicate improvements in neurotoxic symptoms. The 40-item FACT/GOG-Ntx total score represents the sum of the FACT-G and Ntx subscale (total score range=0-160).The FACT/GOG-Ntx trial outcome index (TOI) contained the scores of the PWB, FWB, and FACT/GOG-Ntx subscale (total score range= 0-104).We analyzed the data (1) within group analysis(2) between group analysis(3) the changes between group analysis
Outcome measures
| Measure |
The Acupuncture Group
n=10 Participants
Acupuncture treatment will be performed for 9 weeks. The frequency of acupuncture will be twice a week for the first six weeks, and once a week for the following three weeks. 30 minutes needling at each treatment. Acupuncture points include Baihui(GV20), Qihai(CV6), Quchi(LI11), Hegu(LI4), Neiguan(P6), or Shenmen(HT7) for upper limbs. For plantar numbness, choose two acupoints to use in turn; use Weizhong(BL40), Sanyinjiao(SP6), or Zusanli(ST36) for lower limbs. If severe numbness occurred, Taixi(KI3) or Yongquan(K1) should be added for feet numbness. "De qi" sensation, such as soreness, numbness, pain, etc. will be achieved at each acupoints .
|
The Controlled Group
n=10 Participants
Acupuncture with superficial needling 0.5 cun (estimated 1cm with deviation depends on the body size of each participants) away from the acupoints, which only superficially penetrated the skin without feeling of "De Qi" sensation.
|
|---|---|---|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
NtxS-baseline
|
37.60 score on a scale
Standard Deviation 6.08
|
33.90 score on a scale
Standard Deviation 7.87
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
NtxS-week 3
|
37.89 score on a scale
Standard Deviation 6.01
|
33.62 score on a scale
Standard Deviation 6.52
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
NtxS-week 6
|
41.00 score on a scale
Standard Deviation 6.72
|
36.44 score on a scale
Standard Deviation 8.71
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
NtxS-week 9
|
40.88 score on a scale
Standard Deviation 7.72
|
35.90 score on a scale
Standard Deviation 5.92
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
NtxS-Changes at week 6
|
3.63 score on a scale
Standard Deviation 5.07
|
1.56 score on a scale
Standard Deviation 7.55
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
NtxS-Changes at wee 9
|
3.50 score on a scale
Standard Deviation 4.90
|
2.00 score on a scale
Standard Deviation 6.96
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
TOI-baseline
|
76.60 score on a scale
Standard Deviation 14.74
|
67.80 score on a scale
Standard Deviation 15.25
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
TOI-week 3
|
77.04 score on a scale
Standard Deviation 16.03
|
69.57 score on a scale
Standard Deviation 13.39
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
TOI-week 6
|
81.75 score on a scale
Standard Deviation 19.03
|
73.44 score on a scale
Standard Deviation 16.54
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
TOI-week 9
|
80.42 score on a scale
Standard Deviation 20.58
|
74.60 score on a scale
Standard Deviation 11.91
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
TOI-changes at week 6
|
6.63 score on a scale
Standard Deviation 7.41
|
3.00 score on a scale
Standard Deviation 14.34
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
TOI-changes at week 9
|
5.29 score on a scale
Standard Deviation 6.31
|
6.80 score on a scale
Standard Deviation 12.62
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
FACT-G score-baseline
|
79.70 score on a scale
Standard Deviation 16.35
|
69.73 score on a scale
Standard Deviation 14.19
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
FACT-G score-week 3
|
77.96 score on a scale
Standard Deviation 20.02
|
73.20 score on a scale
Standard Deviation 15.95
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
FACT-G score-week 6
|
80.08 score on a scale
Standard Deviation 19.80
|
73.49 score on a scale
Standard Deviation 16.16
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
FACT-G score-week 9
|
77.54 score on a scale
Standard Deviation 21.55
|
77.73 score on a scale
Standard Deviation 11.10
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
FACT-G score-changes at week 6
|
1.06 score on a scale
Standard Deviation 2.89
|
1.66 score on a scale
Standard Deviation 12.94
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
FACT-G score-changes at week 9
|
-1.48 score on a scale
Standard Deviation 5.51
|
8 score on a scale
Standard Deviation 10.31
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
FACT/GOG-Ntx total score-baseline
|
117.30 score on a scale
Standard Deviation 20.56
|
103.63 score on a scale
Standard Deviation 19.75
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
FACT/GOG-Ntx total score-week 3
|
115.85 score on a scale
Standard Deviation 23.80
|
106.82 score on a scale
Standard Deviation 18.34
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
FACT/GOG-Ntx total score-week 6
|
121.08 score on a scale
Standard Deviation 25.93
|
109.93 score on a scale
Standard Deviation 20.79
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
FACT/GOG-Ntx total score-week 9
|
118.42 score on a scale
Standard Deviation 28.55
|
113.43 score on a scale
Standard Deviation 12.80
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
FACT/GOG-Ntx total score-changes at week 6
|
4.69 score on a scale
Standard Deviation 7.39
|
3.21 score on a scale
Standard Deviation 18.40
|
|
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
FACT/GOG-Ntx total score-changes at week 9
|
2.02 score on a scale
Standard Deviation 8.01
|
9.80 score on a scale
Standard Deviation 14.30
|
SECONDARY outcome
Timeframe: We measured 2 times within 9 weeks: before and after treatmentPopulation: \- In the acupuncture group, one subject withdrew from the trial because of needle phobia after the third week of treatment, and another subject withdrew from the trial because of cellulitis in the radiation treatment site after completing the sixth week of treatment
WHOQOL-BREF Taiwan version was validated to be a good clinical tool across five kinds of Taiwanese cancer survivors. There are a total 28 items by adding 2 additional items to account for Taiwanese cultural adaptations. Item scores range from 1 to 5 (1 =the worst condition; 5=the best condition), except for 3 items (Ph1, Ph2, and Ps6), which are reverse coded. Each domain in the scale can be translated into two ranges of domain scores (0-100 and 4-20), and we used 0-100 scale in this study. The Higher scores in each domain indicate the better quality of life for patients with cancers We analyzed the data (1) within group analysis: compared post-treatment with baseline. (2) between group analysis: compared the acupuncture group and sham acupuncture group at week 9. (3) the between group differences of the changes from post-treatment to baseline.
Outcome measures
| Measure |
The Acupuncture Group
n=10 Participants
Acupuncture treatment will be performed for 9 weeks. The frequency of acupuncture will be twice a week for the first six weeks, and once a week for the following three weeks. 30 minutes needling at each treatment. Acupuncture points include Baihui(GV20), Qihai(CV6), Quchi(LI11), Hegu(LI4), Neiguan(P6), or Shenmen(HT7) for upper limbs. For plantar numbness, choose two acupoints to use in turn; use Weizhong(BL40), Sanyinjiao(SP6), or Zusanli(ST36) for lower limbs. If severe numbness occurred, Taixi(KI3) or Yongquan(K1) should be added for feet numbness. "De qi" sensation, such as soreness, numbness, pain, etc. will be achieved at each acupoints .
|
The Controlled Group
n=10 Participants
Acupuncture with superficial needling 0.5 cun (estimated 1cm with deviation depends on the body size of each participants) away from the acupoints, which only superficially penetrated the skin without feeling of "De Qi" sensation.
|
|---|---|---|
|
World Health Organization Quality of Life Scale(WHOQOL)-BREF (Taiwan Version)
Physical health-baseline
|
60.80 score on a scale
Standard Deviation 15.97
|
55.20 score on a scale
Standard Deviation 12.69
|
|
World Health Organization Quality of Life Scale(WHOQOL)-BREF (Taiwan Version)
Physical health-post-Tx
|
60.88 score on a scale
Standard Deviation 17.88
|
59.50 score on a scale
Standard Deviation 11.34
|
|
World Health Organization Quality of Life Scale(WHOQOL)-BREF (Taiwan Version)
Physical health-Changes at post-Tx
|
3.63 score on a scale
Standard Deviation 13.52
|
4.30 score on a scale
Standard Deviation 13.36
|
|
World Health Organization Quality of Life Scale(WHOQOL)-BREF (Taiwan Version)
Psychological-baseline
|
51.40 score on a scale
Standard Deviation 13.79
|
45.20 score on a scale
Standard Deviation 16.58
|
|
World Health Organization Quality of Life Scale(WHOQOL)-BREF (Taiwan Version)
Psychological-post-Tx
|
55.50 score on a scale
Standard Deviation 18.62
|
52.50 score on a scale
Standard Deviation 13.52
|
|
World Health Organization Quality of Life Scale(WHOQOL)-BREF (Taiwan Version)
Psychological-changes at post-Tx
|
6.13 score on a scale
Standard Deviation 11.79
|
7.30 score on a scale
Standard Deviation 8.14
|
|
World Health Organization Quality of Life Scale(WHOQOL)-BREF (Taiwan Version)
Social relationships-baseline
|
62.10 score on a scale
Standard Deviation 9.56
|
54.50 score on a scale
Standard Deviation 10.22
|
|
World Health Organization Quality of Life Scale(WHOQOL)-BREF (Taiwan Version)
Social relationships-post Tx
|
68.00 score on a scale
Standard Deviation 11.15
|
58.90 score on a scale
Standard Deviation 10.80
|
|
World Health Organization Quality of Life Scale(WHOQOL)-BREF (Taiwan Version)
Social relationships-changes at post-Tx
|
6.88 score on a scale
Standard Deviation 9.69
|
4.40 score on a scale
Standard Deviation 11.90
|
|
World Health Organization Quality of Life Scale(WHOQOL)-BREF (Taiwan Version)
Environment-baseline
|
61.90 score on a scale
Standard Deviation 8.20
|
61.40 score on a scale
Standard Deviation 13.02
|
|
World Health Organization Quality of Life Scale(WHOQOL)-BREF (Taiwan Version)
Environment-post Tx
|
61.75 score on a scale
Standard Deviation 10.33
|
66.30 score on a scale
Standard Deviation 11.84
|
|
World Health Organization Quality of Life Scale(WHOQOL)-BREF (Taiwan Version)
Environment-changes at post-Tx
|
-1.63 score on a scale
Standard Deviation 11.60
|
4.90 score on a scale
Standard Deviation 10.97
|
SECONDARY outcome
Timeframe: 2 times within 9 weeks: before and after treatmentPopulation: * In the acupuncture group, one subject withdrew from the trial because of needle phobia after the third week of treatment, and another subject withdrew from the trial because of cellulitis in the radiation treatment site after completing the sixth week of treatment * In the placebo group, one subject did not record the scoring result after completing the sixth week of acupuncture treatment because of the omission to fill in this scale
Measurements were performed using a set of 20 von Frey monofilaments(Semmes-Weinstein Von Frey Aesthesiometer, Stoelting Co. 620 Wheat Lane, Wood Dale, IL, U.S.A.), with evaluator size/target forces from 1.65/0.008 gto 6.65/300 g. Each monofilament was calibrated to a target force in grams (g) within a 5% standard deviation. Thresholds for categories of tactile perception were defined by the filament manufacturer as follows: normal ; diminished light touch; diminished protective sensation; loss of protective sensation; deep pressure sensation only . All tests were performed by an independent assessor who was unaware of the allocation of randomization. All the procedures followed the operation manual provided by the filament manufacturer. Measuring sites include: LHT(Left hand's middle fingertip);LHP(Left hand's palm);RHT(Right hand's middle fingertip);RHP(Right hand's palm);LFT(Left foot's big toe tip);LFP(Left foot's plantar);RFT(Right foot's big toe tip);RFP(Right foot's plantar)
Outcome measures
| Measure |
The Acupuncture Group
n=10 Participants
Acupuncture treatment will be performed for 9 weeks. The frequency of acupuncture will be twice a week for the first six weeks, and once a week for the following three weeks. 30 minutes needling at each treatment. Acupuncture points include Baihui(GV20), Qihai(CV6), Quchi(LI11), Hegu(LI4), Neiguan(P6), or Shenmen(HT7) for upper limbs. For plantar numbness, choose two acupoints to use in turn; use Weizhong(BL40), Sanyinjiao(SP6), or Zusanli(ST36) for lower limbs. If severe numbness occurred, Taixi(KI3) or Yongquan(K1) should be added for feet numbness. "De qi" sensation, such as soreness, numbness, pain, etc. will be achieved at each acupoints .
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The Controlled Group
n=10 Participants
Acupuncture with superficial needling 0.5 cun (estimated 1cm with deviation depends on the body size of each participants) away from the acupoints, which only superficially penetrated the skin without feeling of "De Qi" sensation.
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Touch Test Sensory Evaluator
LHT-baseline
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1.64 grams
Standard Deviation 1.87
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1.62 grams
Standard Deviation 1.41
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Touch Test Sensory Evaluator
LHT-post-Tx
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0.41 grams
Standard Deviation 0.66
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1.82 grams
Standard Deviation 2.28
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Touch Test Sensory Evaluator
LHT-changes at post-Tx
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-1.54 grams
Standard Deviation 2.12
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0.20 grams
Standard Deviation 2.51
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Touch Test Sensory Evaluator
LHP-baseline
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2.60 grams
Standard Deviation 4.69
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1.98 grams
Standard Deviation 2.89
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Touch Test Sensory Evaluator
LHP-post-Tx
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0.25 grams
Standard Deviation 0.23
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1.44 grams
Standard Deviation 1.99
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Touch Test Sensory Evaluator
LHP-changes at post-Tx
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-2.92 grams
Standard Deviation 5.20
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-0.54 grams
Standard Deviation 1.73
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Touch Test Sensory Evaluator
RHT-baseline
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1.52 grams
Standard Deviation 1.35
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1.74 grams
Standard Deviation 1.31
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Touch Test Sensory Evaluator
RHT-post-Tx
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0.37 grams
Standard Deviation 0.29
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1.25 grams
Standard Deviation 1.78
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|
Touch Test Sensory Evaluator
RHT-changes at post-Tx
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-1.43 grams
Standard Deviation 1.37
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-0.50 grams
Standard Deviation 2.20
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Touch Test Sensory Evaluator
RHP-baseline
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2.50 grams
Standard Deviation 4.53
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1.91 grams
Standard Deviation 1.85
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|
Touch Test Sensory Evaluator
RHP-post-Tx
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0.28 grams
Standard Deviation 0.20
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1.27 grams
Standard Deviation 1.77
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|
Touch Test Sensory Evaluator
RHP-changes at post-Tx
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-2.75 grams
Standard Deviation 5.06
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-0.64 grams
Standard Deviation 1.13
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Touch Test Sensory Evaluator
LFT-baseline
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14.02 grams
Standard Deviation 30.57
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10.30 grams
Standard Deviation 17.99
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Touch Test Sensory Evaluator
LFT-post-Tx
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2.50 grams
Standard Deviation 2.49
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3.50 grams
Standard Deviation 3.41
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|
Touch Test Sensory Evaluator
LFT-changes at post-Tx
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-14.87 grams
Standard Deviation 34.46
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-6.80 grams
Standard Deviation 16.04
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Touch Test Sensory Evaluator
LFP-baseline
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20.66 grams
Standard Deviation 56.17
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9.61 grams
Standard Deviation 18.09
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|
Touch Test Sensory Evaluator
LFP-post-Tx
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2.35 grams
Standard Deviation 5.13
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3.24 grams
Standard Deviation 4.60
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|
Touch Test Sensory Evaluator
LFP-changes at post-Tx
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-23.40 grams
Standard Deviation 57.43
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-6.36 grams
Standard Deviation 13.99
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Touch Test Sensory Evaluator
RFT-baseline
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12.80 grams
Standard Deviation 17.30
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5.28 grams
Standard Deviation 7.55
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|
Touch Test Sensory Evaluator
RFT-post-Tx
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2.43 grams
Standard Deviation 2.94
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4.94 grams
Standard Deviation 4.71
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|
Touch Test Sensory Evaluator
RFT-changes at post-Tx
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-12.45 grams
Standard Deviation 19.99
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-0.34 grams
Standard Deviation 7.15
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Touch Test Sensory Evaluator
RFP-baseline
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6.46 grams
Standard Deviation 6.53
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9.36 grams
Standard Deviation 18.01
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|
Touch Test Sensory Evaluator
RFP-post-Tx
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2.87 grams
Standard Deviation 5.06
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3.94 grams
Standard Deviation 3.77
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Touch Test Sensory Evaluator
RFP-changes at post-Tx
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-4.93 grams
Standard Deviation 6.11
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-5.41 grams
Standard Deviation 15.95
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OTHER_PRE_SPECIFIED outcome
Timeframe: 2 times within 9 weeks: before and after treatmentPopulation: Due to the difficulty of the execution in the hospital, the execution was abandoned
15 cc of blood samples will be drawn before and after 15 sessions of treatments from participants in both groups. The blood samples will be analyzed by enzyme-linked immunosorbent assay (ELISA) for tumor necrosis factor-alfa and interleukin- 6, interleukin-10 and brain-derived nuerotrophic factor to evaluate the differences in the inflammation state of peripheral nervous system within and between groups.
Outcome measures
Outcome data not reported
Adverse Events
The Acupuncture Group
The Controlled Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Chien-Chen Huang
An Nan Hospital, China Medical University, Tainan, Taiwan
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place