NCT03571503

The Effectiveness of Doin (Conduction Exercise) of the Pelvic Joint for HLD With Radiating Leg Pain

The Effectiveness of Doin (Conduction Exercise) of the Pelvic Joint for Herniated Lumbar Disc (HLD) With Radiating Leg Pain: A Prospective Observational Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Jaseng Medical Foundation · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A prospective pilot study will be conducted to investigate the effectiveness and safety in herniated lumbar disc (HLD) patients receiving integrative Korean medicine treatment including Doin (conduction exercise) at a Korean medicine hospital through assessment of pain, functional disability, and quality of life.

Detailed description

A prospective single-center observational pilot study will be conducted to investigate the effectiveness and safety in herniated lumbar disc (HLD) patients with radiating leg pain receiving integrative Korean medicine treatment including Doin (conduction exercise) of the pelvic joint at Daejeon Jaseng Hospital of Korean Medicine through assessment of pain, functional disability, quality of life, satisfaction, and safety. The study is expected to be performed over a period of 6 months, during the former 3 months of the study period of which the Integrative Korean medicine treatment group will be recruited, and after a wash-out period of 2 weeks, during the latter 3 months of the study period of which the Doin with integrative Korean medicine will be recruited separately.

Conditions

• Intervertebral Disc Displacement
• Sciatica
• Sciatic Radiculopathy

Interventions

Type	Name	Description
PROCEDURE	Doin (conduction exercise)	An acupuncture physician will administer acupuncture at 4-8 acupoints in the low back and gluteal area (mandatory points: BL54, and GB30 ipsilateral to the dysfunctional site; and selective points: BL23, BL24, BL25, BL26, BL31, BL32, Ah-shi points, local acupuncture points and/or trigger points. Doin (conduction exercise) will be performed as active and passive movement with the needles in situ to the aim of effective treatment of pain and functional disability by increasing the hip joint range of motion (flexion and extension) with physician guidance and isometric resistance exercise (flexion and extension) as needed. Doin (conduction exercise) sessions will be performed 1 session/day for the duration of hospitalized treatment while the patient presents radiating leg pain (NRS≥1).
DRUG	Herbal medicine	Herbal medicine will be mainly administered in water-based decoction (120ml) and dried powder (2g) form (the ingredients are mainly, but not restricted to: Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
PROCEDURE	Chuna manual therapy	Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manipulation will be administered at the physician's discretion.
PROCEDURE	Bee venom pharmacopuncture	Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
PROCEDURE	Pharmacopuncture	Pharmacopuncture consisting of select herbal ingredients will be administered at Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
PROCEDURE	Acupuncture	Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
PROCEDURE	Electroacupuncture	Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
PROCEDURE	Cupping	Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
OTHER	Other intervention(s)	Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study.

Timeline

• Start date: 2018-07-09
• Primary completion: 2019-07-04
• Completion: 2019-09-20
• First posted: 2018-06-27
• Last updated: 2019-11-04

Locations

1 site across 1 country: South Korea