UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008934 |
|---|---|
| Receipt number | R000009831 |
| Scientific Title | Effect of long term intervention with acupuncture on COPD: A randomized controlled trial. |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2026/04/20 17:32:20 |
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Basic information
Public title
Effect of long term intervention with acupuncture on COPD: A randomized controlled trial.
Acronym
Long term intervention of acupuncture for COPD.
Scientific Title
Effect of long term intervention with acupuncture on COPD: A randomized controlled trial.
Scientific Title:Acronym
Long term intervention of acupuncture for COPD.
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease: COPD
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the improvement effect of QoL in stable COPD patients (GOLD classification II-IV) with acupuncture for 48 weeks treatments.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
QoL of COPD patients will be assessed before and after 52 weeks from baseline using the St George Respiratory Questionnaire (SGRQ total domain).
Key secondary outcomes
Secondary Endpoints
1. SGRQ (Total) will be assessed before and after 12 weeks from baseline.
2. SGRQ (Symptom, Activity, Impact) will be assessed before and after 12 and 52 weeks from baseline.
3. 6-minute walk test (dyspnea on exertion (modified Borg scale), walking distance, oxygen saturation (lowest), pulse rate (highest), and lower extremity fatigue (modified Borg scale)) will be assessed at 12 and 52 weeks from baseline.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients in the acupuncture group (AG) receive acupuncture treatment once a week for 48 weeks, in addition to usual care.
*In accordance with the COPD guidelines developed by the World Health Organization (WHO), the National Heart, Lung, and Blood Institute (NHLBI), and the Japanese Respiratory Society, physicians provide usual care to all patients in AG groups.
Interventions/Control_2
Patients in the usual care group(UG) receive which is an outpatient visit once a month for 48 weeks.
*In accordance with the COPD guidelines developed by the World Health Organization (WHO), the National Heart, Lung, and Blood Institute (NHLBI), and the Japanese Respiratory Society, physicians provide usual care to all patients in UG groups.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient diagnosed as COPD and able to visit as outpatient.
2. Patient whose COPD condition is considered stable by his/her physician in charge.
3. Patient who has dyspnea on exertion due to COPD with Grade1 or higher by MMRC.
4. Patient in stage II or higher by GOLD guideline.
"Stable" here means when a COPD patient has no sudden deterioration in his/her symptoms of coughing, expectoration, or dyspnea on exertion during the 3 months period prior to the study outset, and is under a constant medication both in quantity and contents.
5. patients who had not been receiving pulmonary rehabilitation in the previous 6 months.
Key exclusion criteria
1. Patient who has heart disease (except for cor pulmonale), collagen disease (such as RA, PM/DM, etc.), cancer, severe mental disorders, or other severe complications.
2. Patient who is currently under pulmonary rehabilitation.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Motonari |
| Middle name | |
| Last name | Fukui |
Organization
Kitano hospital, the tazuke kofukai medical research institute
Division name
Division of Respiratory Medicine, Respiratory Disease Center
Zip code
530-8480
Address
2-4-20 Ougi-machi, Kitaku, Osaka, Japan
TEL
06-6312-1221
mfukui@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | SUZUKI |
Organization
Kitano hospital, the tazuke kofukai medical research institute
Division name
Division of Respiratory Medicine, Respiratory Disease Center
Zip code
530-8480
Address
2-4-20 Ougi-machi, Kitaku, Osaka, Japan
TEL
06-6312-1221
Homepage URL
masuzuki@fmu.ac.jp
Sponsor or person
Institute
Division of respiratory Medicine respiratory disease center of kitano hospital the tazuke kofukai medical research institute
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for MedicalResearch and Development.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
National Hospital Organization Toneyama National Hospital.
Name of secondary funder(s)
The Japan society of acupuncture and moxibution.
Kitano hospital, the tazuke kofukai medical research institute
IRB Contact (For public release)
Organization
Kitano Hospital Medical Research Institute Ethics Committee
Address
2-4-20 Ougi-machi, Kitaku, Osaka, Japan
Tel
06-6131-2911
rinshou@kitano-hp.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
1720
Org. issuing International ID_1
National Hospital Organization Osaka Toneyama Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
田附興風会医学研究所北野病院呼吸器センター（大阪府）、医療法人池岡診療所（大阪府）、湊クリニック（大阪府）、独立行政法人国立病院機構(NHO)刀根山病院呼吸器内科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://publications.ersnet.org/content/erjor/11/3/00668-2024
Publication of results
Published
Result
URL related to results and publications
https://publications.ersnet.org/content/erjor/11/3/00668-2024
Number of participants that the trial has enrolled
45
Results
The 45 participants comprised 21 patients in the UG and 24 in the AG. At week 52, the SGRQ total score was significantly improved in the AG compared with the UG (mean (SD) change from baseline: -22.8 (19.0) in the AG vs. 6.8 (13.5) in the UG; between-group difference: -26.9, 95% CI -35.8 to -17.9).
No severe adverse events were reported.
Results date posted
| 2026 | Year | 04 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participant demographics were as follows: age was 73.1(4.5) years in the UG group and 73.0(5.7) years in the AG group; mRC was 2.9(0.8) points in the UG group and 2.7(1.0) points in the AG group; SGRQ total domain scores were 45.1(12.5) for the UG group and 51.6(20.1) for the AG group; respiratory function (FEV1) was 1.2(0.5) L for both the UG and AG groups.
Of the 5 participants who did not complete the study, all dropouts in the AG group withdrew before the 12-week assessment. Excluding the dropouts, patients in the AG group received an average of 45.2(1.4) acupuncture treatments per year. As a result, the final analysis (FAS) included a total of 40 patients:20 in the AG group (excluding 4 dropouts) and 20 in the UG group (excluding 1 dropout).
Participant flow
In this study, a total of 121 patients were screened at four facilities between January 8, 2013, and October 31, 2018. After excluding 76 patients, the remaining 45 patients were enrolled, with 24 patients in the AG group and 21 in the UG group.
Adverse events
Minor adverse reactions associated with acupuncture reported by patients during the study were fatigue (five patients), small subcutaneous haemorrhage (seven patients) and needle site pain (three patients). All events were minor reactions and the patients recovered quickly. No serious events due to acupuncture treatment were reported.
Outcome measures
he SGRQ total score improved from 50.1 (18.0) at baseline to 27.3 (10.1) at week 52 in the AG, whereas no improvement was observed in the UG (45.3 [12.8] at baseline and 52.1 [19.2] at week 52).
The magnitude of change in the SGRQ total score was significantly greater in the AG (-22.8 [19.0]) than in the UG (6.8 [13.5]), with a mean difference of -29.6 (95% CI, -40.2 to -19.0). ANCOVA yielded a regression coefficient of -26.9 (95% CI, -35.8 to -17.9).
Further analysis using multiple imputation produced similar results (regression coefficient -24.7; 95% CI, -34.3 to -15.2).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 14 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 29 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 17 | Day |
Last modified on
| 2026 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009831
