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Therapeutic Effect and Mechanism of Acupuncture Treating Chronic Pain and Major Depression Comorbidity

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ClinicalTrials.gov Identifier: NCT03328819
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Brief Summary:

Objectives: The effect of acupuncture as treatment for chronic pain and depression comorbidity is questionable because only a limited number of controlled clinical trials with sound methodologies have been conducted. The investigators will perform a well-designed crossover study including assessments of scales and blood sample analysis to investigate the efficacy of acupuncture as treatment for comorbidity of chronic pain and major depression disorder (MDD) and figure out the indicative biomarkers to predict or assess the comorbidity.

Methods: Patients with a recent major depression and chronic pain were randomized to receive acupuncture for depression group or acupuncture for chronic pain. They will receive 2~3 sessions per week over 6 consecutive weeks. Then patients accept another 6weeks sessions after two-week washout. During washout period, original western treatment will be maintained and acupuncture will be interrupted.

The primary outcome measure was change in 21-item Hamilton Depression Rating Scale (HAMD), pain with Brief Pain Inventory- Long form (BPI). Secondary outcome measures included changes in Beck Depression Inventory-II (BDI-II), Neurotoxicity Rating Scale (NTRS), WHO Quality of Life (WHOQoL), Clinical Global Impression (CGI), biomarkers such as neurotransmitter, kinase, protein, cytokine, DNA, mRNA related to comorbidity of chronic pain and major depression.


Condition or disease Intervention/treatment Phase
Chronic Pain Depression Other: Acupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Effect and Mechanism of Acupuncture Treating Chronic Pain and Major Depression Comorbidity: A Randomized, Subject and Investigator Double-Blind Controlled, and Crossover Study
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture for Depression/Acupuncture for pain Other: Acupuncture
Acupuncture is a form of alternative medicine in which thin needles are inserted into the body. It is a key component of traditional Chinese medicine (TCM). TCM theory and practice are not based upon scientific knowledge, and acupuncture is a pseudoscience. There are a diverse range of acupuncture theories based on different philosophies, and techniques vary depending on the country. The method used in TCM is likely the most widespread in the US. It is most often used for pain relief, though it is also used for a wide range of other conditions.

Experimental: Acupuncture for pain/Acupuncture for Depression Other: Acupuncture
Acupuncture is a form of alternative medicine in which thin needles are inserted into the body. It is a key component of traditional Chinese medicine (TCM). TCM theory and practice are not based upon scientific knowledge, and acupuncture is a pseudoscience. There are a diverse range of acupuncture theories based on different philosophies, and techniques vary depending on the country. The method used in TCM is likely the most widespread in the US. It is most often used for pain relief, though it is also used for a wide range of other conditions.




Primary Outcome Measures :
  1. The change of Hamilton Rating Scale for Depression (HAMD) [ Time Frame: At Week 0, 2, 4, 6, 8, 10, 12, 14. ]
    To analysis the efficacy of acupuncture on chronic pain

  2. The change of Brief Pain Inventory (BPI) [ Time Frame: At Week 0, 2, 4, 6, 8, 10, 12, 14. ]
    To analysis the efficacy of acupuncture on major depression disorder


Secondary Outcome Measures :
  1. The change of Beck Depressive Inventory (BDI-II) [ Time Frame: At Week 0, 2, 4, 6, 8, 10, 12, 14. ]
    To analysis the efficacy of acupuncture on major depression disorder

  2. The change of Neurotoxicity Rating Scale (NTRS) [ Time Frame: At Week 0, 2, 4, 6, 8, 10, 12, 14. ]
    To analysis the efficacy of acupuncture on chronic pain

  3. The change of WHO Quality of Life Questionnaire (WHOQoL) [ Time Frame: At Week 0, 2, 4, 6, 8, 10, 12, 14. ]
    To analysis the efficacy of acupuncture on comorbidity of chronic pain and major depression disorder

  4. The change of Clinical Global Inventory (CGI) [ Time Frame: At Week 0, 2, 4, 6, 8, 10, 12, 14. ]
    To analysis the efficacy of acupuncture on comorbidity of chronic pain and major depression disorder

  5. change of tumor necrosis factor α in plasma [ Time Frame: On Weeks 0 (baseline), 6 (first section finish), 8(before second section), and 14 (second section finish) ]
  6. change of Interferon gamma in plasma [ Time Frame: On Weeks 0 (baseline), 6 (first section finish), 8(before second section), and 14 (second section finish) ]
  7. change of interleukin-1β in plasma [ Time Frame: On Weeks 0 (baseline), 6 (first section finish), 8(before second section), and 14 (second section finish) ]
  8. change of interleukin-6 in plasma [ Time Frame: On Weeks 0 (baseline), 6 (first section finish), 8(before second section), and 14 (second section finish) ]
  9. change of interleukin-12 in plasma [ Time Frame: On Weeks 0 (baseline), 6 (first section finish), 8(before second section), and 14 (second section finish) ]
  10. change of interleukin-17 in plasma [ Time Frame: On Weeks 0 (baseline), 6 (first section finish), 8(before second section), and 14 (second section finish) ]
  11. change of interleukin-23 in plasma [ Time Frame: On Weeks 0 (baseline), 6 (first section finish), 8(before second section), and 14 (second section finish) ]
  12. change of gene amount: Serotonin Transporter Gene-Linked Polymorphism Region in plasma [ Time Frame: On Weeks 0 (baseline), 6 (first section finish), 8(before second section), and 14 (second section finish) ]
  13. change of gene amount: Tryptophan Hydroxylase 2 Gene in plasma [ Time Frame: On Weeks 0 (baseline), 6 (first section finish), 8(before second section), and 14 (second section finish) ]
  14. brain-derived neurotrophic factor (BDNF) in serum [ Time Frame: On Weeks 0 (baseline), 6 (first section finish), 8(before second section), and 14 (second section finish) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 20 years
  • they will be diagnosed with DSM-V as major depressive disorder
  • they will be rated ≥ 18 on the 21-item Hamilton Rating Scale
  • Clinical Global Impression: moderate
  • there will be no change of dosages or types of in medications or psychotherapy for more than 4 weeks before the enrolment
  • the pain persist more than 3 months and the score of 5th item of Brief Pain Inventory more than 4
  • patients never receive acupuncture and herbs within two weeks before enrollment (Whether the previous acupuncture or herbs will interfere the inclusion depends on the judgement of the therapists)

Exclusion Criteria:

  • Major depressive disorder caused by substance abuse or pregnancy
  • organic major depressive disorder
  • Major psychiatric depression other than major depression
  • first onset of major depressive disorder after 65 years old
  • Malignant pain caused by Cancer pain syndrome
  • Headache and visceral pain such as stomachache
  • referred pain such as back pain caused by pancreatitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328819


Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Hsien-Yin Liao, Master    +886-4-2205-2121    jamesliao1076@hotmail.com   
Contact: Kuan-Pin Su, PhD    +886-4-2205-2121    cobolsu@gmail.com   
Sponsors and Collaborators
China Medical University Hospital

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03328819     History of Changes
Other Study ID Numbers: CMUH106-REC1-077
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by China Medical University Hospital:
Acupuncture
Chronic pain
Major depressive disorder
Biomarkers
Gene
Comorbidity

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Chronic Pain
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms