Trial Outcomes & Findings for Acupuncture With Manual and Electrical Stimulation to Reduce Labour Pain (NCT NCT01197950)
NCT ID: NCT01197950
Last Updated: 2022-09-21
Results Overview
Frequecy of epidural analgesia
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
303 participants
Primary outcome timeframe
From start of treatment until birth
Results posted on
2022-09-21
Participant Flow
Participant milestones
| Measure |
Manual Acupuncture
Manual stimulation
Manual Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour.
|
Electro Acupuncture
Electrical and manual stimulation
Electro Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold.
|
Standard Care
Standard Care No acupucture
|
|---|---|---|---|
|
Overall Study
STARTED
|
99
|
103
|
101
|
|
Overall Study
COMPLETED
|
83
|
87
|
83
|
|
Overall Study
NOT COMPLETED
|
16
|
16
|
18
|
Reasons for withdrawal
| Measure |
Manual Acupuncture
Manual stimulation
Manual Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour.
|
Electro Acupuncture
Electrical and manual stimulation
Electro Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold.
|
Standard Care
Standard Care No acupucture
|
|---|---|---|---|
|
Overall Study
Women's request (31), high workload (8), returned home (4), partus in one hour (1), other (6)
|
16
|
16
|
18
|
Baseline Characteristics
Acupuncture With Manual and Electrical Stimulation to Reduce Labour Pain
Baseline characteristics by cohort
| Measure |
Manual Acupuncture
n=99 Participants
Manual stimulation
Manual Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour.
|
Electro Acupuncture
n=103 Participants
Electrical and manual stimulation
Electro Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold.
|
Standard Care
n=101 Participants
No acupunture
|
Total
n=303 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
99 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
303 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
303 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Sweden
|
99 participants
n=5 Participants
|
103 participants
n=7 Participants
|
101 participants
n=5 Participants
|
303 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until birthFrequecy of epidural analgesia
Outcome measures
| Measure |
Manual Acupuncture
n=99 Participants
Manual stimulation
Manual Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour.
|
Electro Acupuncture
n=103 Participants
Electrical and manual stimulation
Electro Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold.
|
Standard Care
n=101 Participants
Standard care
|
|---|---|---|---|
|
Use of Epidural Analgesia
|
99 participants
|
103 participants
|
101 participants
|
Adverse Events
Manual Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 99 deaths
Electro Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 103 deaths
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 101 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Manual Acupuncture
n=99 participants at risk
Manual stimulation
Manual Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour.
|
Electro Acupuncture
n=103 participants at risk
Electrical and manual stimulation
Electro Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold.
|
Standard Care
n=101 participants at risk
Standard care - no acupuncture treatment at all
|
|---|---|---|---|
|
Infections and infestations
Only minor adverse events were expected
|
0.00%
0/99 • Three hours
We did not expected any adverse event except for infections in the injection area or after the acupuncture needles were removed.
|
0.00%
0/103 • Three hours
We did not expected any adverse event except for infections in the injection area or after the acupuncture needles were removed.
|
0.00%
0/101 • Three hours
We did not expected any adverse event except for infections in the injection area or after the acupuncture needles were removed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place