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Study protocol
sheng Li
2nd clinical hospital of Guangzhou university of chinese medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0003-1401-0923
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Depression and Chronic musculoskeletal pain (CMSP) are the leading causes of global years lived with disability diseases. Moreover, they often commonly coexist, which made a great difficult to diagnosis and treatment. A safe and effective treatment was urgently need. Previous studies showed that acupuncture was a cost-effective treatment for simple depression or CMSP. But limited evidence showed that acupuncture was effective for depression comorbid CMSP.
Methods: This is a randomized, sham acupuncture-controlled trial with three arms: real acupuncture (RA), sham acupuncture (SA) and healthy control (HC). 48 depression combined CMSP participants and 12 healthy people will be recruited from GDTCM hospital and randomized 2:2:1 to RA, SA, HC group. The patients will receive RA or SA intervention for 8 weeks, and HC will not receive any intervention. Upon completion of the intervention, there is a 4 weeks follow-up. The primary outcome measures will be severity of depression and pain which assessed by Hamilton depression rating scale (HAMD-17) and brief pain inventory (BPI), respectively. The secondary outcome measures will be cognitive function, and quality of life which measured by Montreal cognitive assessment (MoCA), P300 and world health organization quality of life (WHOQOL-BREF). In addition, the correlation between brain derived neurotrophic factor (BDNF) and symptoms will also be determined.
Discussion: The aim of this study is to evaluate the clinic efficacy and underlying mechanism of acupuncture on depression comorbid CMSP. This study will provide a convenient and cost-effectively means for future prevention and treatment of combined depression and CMSP.
Trial registration: This study pre-registered at 2th Feb 2018, at Chinese Clinical Trail Registry (ChiCTR1800014754). The study is on the recruiting status.
Keywords
Acupuncture, depression, chronic musculoskeletal pain, HAMD, BDNF
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CURRENT STATUS: Under Review
Version 1
Posted 12 Jan, 2021
No community comments so far
Editorial decision: Major revision
On 08 Feb, 2021
Review #3 received
Received 06 Feb, 2021
Review #1 received
Received 05 Feb, 2021
Reviewer #3 agreed
On 30 Jan, 2021
Review #2 received
Received 30 Jan, 2021
Reviewer #2 agreed
On 17 Jan, 2021
Reviewers invited
Invitations sent on 15 Jan, 2021
Reviewer #1 agreed
On 15 Jan, 2021
Editor assigned
On 05 Jan, 2021
Submission checks complete
On 05 Jan, 2021
First submitted
On 26 Oct, 2020
Metrics
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A new preprint design is coming!
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
sheng Li
2nd clinical hospital of Guangzhou university of chinese medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0003-1401-0923
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 12 Jan, 2021
No community comments so far
Editorial decision: Major revision
On 08 Feb, 2021
Review #3 received
Received 06 Feb, 2021
Review #1 received
Received 05 Feb, 2021
Reviewer #3 agreed
On 30 Jan, 2021
Review #2 received
Received 30 Jan, 2021
Reviewer #2 agreed
On 17 Jan, 2021
Reviewers invited
Invitations sent on 15 Jan, 2021
Reviewer #1 agreed
On 15 Jan, 2021
Editor assigned
On 05 Jan, 2021
Submission checks complete
On 05 Jan, 2021
First submitted
On 26 Oct, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Depression and Chronic musculoskeletal pain (CMSP) are the leading causes of global years lived with disability diseases. Moreover, they often commonly coexist, which made a great difficult to diagnosis and treatment. A safe and effective treatment was urgently need. Previous studies showed that acupuncture was a cost-effective treatment for simple depression or CMSP. But limited evidence showed that acupuncture was effective for depression comorbid CMSP.
Methods: This is a randomized, sham acupuncture-controlled trial with three arms: real acupuncture (RA), sham acupuncture (SA) and healthy control (HC). 48 depression combined CMSP participants and 12 healthy people will be recruited from GDTCM hospital and randomized 2:2:1 to RA, SA, HC group. The patients will receive RA or SA intervention for 8 weeks, and HC will not receive any intervention. Upon completion of the intervention, there is a 4 weeks follow-up. The primary outcome measures will be severity of depression and pain which assessed by Hamilton depression rating scale (HAMD-17) and brief pain inventory (BPI), respectively. The secondary outcome measures will be cognitive function, and quality of life which measured by Montreal cognitive assessment (MoCA), P300 and world health organization quality of life (WHOQOL-BREF). In addition, the correlation between brain derived neurotrophic factor (BDNF) and symptoms will also be determined.
Discussion: The aim of this study is to evaluate the clinic efficacy and underlying mechanism of acupuncture on depression comorbid CMSP. This study will provide a convenient and cost-effectively means for future prevention and treatment of combined depression and CMSP.
Trial registration: This study pre-registered at 2th Feb 2018, at Chinese Clinical Trail Registry (ChiCTR1800014754). The study is on the recruiting status.
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
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