Acupuncture Treatment for Chronic Sciatica: the Neuroimaging Pain-network Study

NCT ID: NCT03489681

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-01-31

Brief Summary

Sciatica is a common pain disorder in the neurological clinic that typically present as low back or gluteal pain and may radiate to one leg with motor or sensory complaint. Sciatica has drawn more attention worldwide as a public health issue for its pain disability, high prevalence and significant medical and economic burden. A meta-analysis of sciatica treatment revealed discectomy, epidural injections, non-opioid analgesics, and acupuncture might relieve pain. However, the central effect of acupuncture-induced analgesia and its functional connectivities in various brain region remain unclear. Besides, the number of acupoints selection and its correlation in functional connectivity also need to be discussed. This clinical trial would collect the sciatica subjects assign by intent to treat, divided to acupuncture and non-acupuncture herbal control group. The treatment of acupuncture assigns randomized as high dose and low dose acupuncture group. The acupuncture will perform two times a week for four weeks. The primary outcomes are visual analog scale for pain and sciatica bothersomeness index; the secondary outcomes are Roland's disability questionnaire for sciatica, WHOQOL, and traditional Chinese medical constitutional scale. The functional magnetic resonance imaging scan would apply at the baseline and after four weeks' treatment. This study aims to explore the model of DMN in sciatica patients; it's central effect in different stimulation modality and to investigate the mechanism of the long-lasting, sustained impact in different acupuncture dosage.

Conditions

Therapy, Acupuncture; MRI, Functional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acupuncture, low dosage

treat as six acupoints

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: DEVICE

Low dose group:

Twenty patients will assign for low dose group treatment; as six acupoints as Shensu (BL 54), Huantiao (GB 30), Weizhong (BL 40), Yanglingquan (GB 34), Kunlun (BL 60), Juegu (GB 39).

High dose group:

Twenty patients will assign for high dose group treatment. These acupoints contains of eighteen acupoints, as Shenshu (BL 54), Dachangshu (BL 25) , Xiaochangshu (BL 27), Huantiao (GB 30), Yinmen (BL 37) , Zhibien (BL 54), Chengfu (BL 36), Fengshi (GB 31), Weizhong (BL 40), Zusanli (ST 36) Yanglingquan (GB 34), Yinlingquan (SP 9), Feiyang (BL 58), Sanyinjiao (SP 6), Juegu (GB 39), KunLun (BL 60), , Taixi (KI 3), Shenmai (BL 62).

Acupuncture, high dosage

treat as 18 acupoints

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: DEVICE

Low dose group:

Twenty patients will assign for low dose group treatment; as six acupoints as Shensu (BL 54), Huantiao (GB 30), Weizhong (BL 40), Yanglingquan (GB 34), Kunlun (BL 60), Juegu (GB 39).

High dose group:

Twenty patients will assign for high dose group treatment. These acupoints contains of eighteen acupoints, as Shenshu (BL 54), Dachangshu (BL 25) , Xiaochangshu (BL 27), Huantiao (GB 30), Yinmen (BL 37) , Zhibien (BL 54), Chengfu (BL 36), Fengshi (GB 31), Weizhong (BL 40), Zusanli (ST 36) Yanglingquan (GB 34), Yinlingquan (SP 9), Feiyang (BL 58), Sanyinjiao (SP 6), Juegu (GB 39), KunLun (BL 60), , Taixi (KI 3), Shenmai (BL 62).

Control group

no acupuncture treatment, healthy control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

acupuncture

Low dose group:

Twenty patients will assign for low dose group treatment; as six acupoints as Shensu (BL 54), Huantiao (GB 30), Weizhong (BL 40), Yanglingquan (GB 34), Kunlun (BL 60), Juegu (GB 39).

High dose group:

Twenty patients will assign for high dose group treatment. These acupoints contains of eighteen acupoints, as Shenshu (BL 54), Dachangshu (BL 25) , Xiaochangshu (BL 27), Huantiao (GB 30), Yinmen (BL 37) , Zhibien (BL 54), Chengfu (BL 36), Fengshi (GB 31), Weizhong (BL 40), Zusanli (ST 36) Yanglingquan (GB 34), Yinlingquan (SP 9), Feiyang (BL 58), Sanyinjiao (SP 6), Juegu (GB 39), KunLun (BL 60), , Taixi (KI 3), Shenmai (BL 62).

Intervention Type: DEVICE

Other Intervention Names

Ching Ming Mdical Device Co, Taipei, Taiwan, R.O.C

Eligibility Criteria

Inclusion Criteria

1. 35 - 70 y/o.

2. Low back or gluteal pain radiating into one leg.

3. Pain duration of at least two weeks.

Exclusion Criteria

1. Known or suspected severe spinal pathology (for example, cauda equina syndrome, or spinal fracture).

2. Pregnant or breastfeeding women.

3. Scheduled or being considered for spinal surgery or interventional procedures for sciatica during the 8-week treatment period.

4. Administration of sedative or analgesics within 24 h before the fMRI scan.

5. Comorbidities include systemic malignancy, bleeding tendency, rheumatic arthritis and other known autoimmune diseases.

6. Focal neurologic deficits with progressive or disabling symptoms

7. History of received acupuncture treatment in the past one month.

8. Any contraindication related to acupuncture and MRI.

9. Visual analog scale < 3.

10. Low back pain without sciatica.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lotung Poh-Ai Hospital

OTHER

Sponsor Role: collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Fang-Pey, Chen, MD

Role: CONTACT

fpchen@vghtpe.gov.tw

886-2-28757452 ext. 333

Facility Contacts

Fang-Pey, Chen, MD

Role: primary

fpchen@vghtpe.gov.tw

886-2-28757453 ext. 333

Ching-Hsiung Liu, MD

Role: backup

chl@mail.pohai.org.tw

886-3-954331 ext. 2253

References

Liu CH, Kung YY, Lin CL, Yang JL, Wu TP, Lin HC, Chang YK, Chang CM, Chen FP. Therapeutic Efficacy and the Impact of the "Dose" Effect of Acupuncture to Treat Sciatica: A Randomized Controlled Pilot Study. J Pain Res. 2019 Dec 31;12:3511-3520. doi: 10.2147/JPR.S210672. eCollection 2019.

Reference Type: DERIVED

PMID: 32021387 (View on PubMed)

Other Identifiers

2016-01-014A

Identifier Type: -

Identifier Source: org_study_id