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

Sciatica Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03571503
• Other study ID #: JS-CT-2018-02
• Status: Completed
• Start date: July 9, 2018
• Est. completion date: September 20, 2019

Study information

• Verified date: November 2019
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 20, 2019
• Est. primary completion date: July 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• Inpatients with radiating leg pain distal to the gluteal fold with or without low back pain (LBP)

• Patients with onset of radiating leg pain occurrence within the last six months, and current pain intensity of numeric rating scale (NRS) =5

• Patients with disc protrusion or extrusion at the neural segment level with significant correlations with the radiating leg pain symptoms as identified on L-spine magnetic resonance imaging (MRI)

• Patients with plans of receiving Korean medicine treatment for herniated lumbar disc (HLD) through hospitalized care

• Patients who give voluntary written informed consent to study participation

Exclusion Criteria:

• Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation

• Surgery and surgical procedure in the last three weeks in areas of clinical relevance as a result of HLD

• Patients with soft tissue pathologies or pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, rheumatoid arthritis)

• Patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, serious diabetes with risk of infection, severe cardiovascular diseases, or other conditions deemed unsuitable for acupuncture treatment)

• Pregnant patients or patients planning pregnancy

• Patients with serious psychological disorders

• Participating in other clinical studies other than observational studies

• Patients unable to fill out study participation consent form

• Subjects deemed unsuitable for study participation as assessed by the researchers

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Radiculopathy
• Sciatic Radiculopathy
• Sciatica

Intervention

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.
• 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).
• 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).
• Acupuncture
Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
• Electroacupuncture
Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Daejeon Jaseng Hospital of Korean Medicine	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Numeric Rating Scale (NRS) of low back pain	Change in low back pain intensity at 2 weeks as measured using NRS. In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.	Baseline, 2 weeks post-baseline
Primary	Change in Numeric Rating Scale (NRS) of radiating leg pain	Change in radiating leg pain intensity at 2 weeks as measured using NRS. In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.	Baseline, 2 weeks post-baseline
Primary	Change in Oswestry Disability Index (ODI)	Functional disability questionnaire at 2 weeks as measured using ODI. The ODI is a 10-item questionnaire developed to assess level of disability due to low back pain (LBP). Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to LBP.	Baseline, 2 weeks post-baseline
Secondary	Numeric Rating Scale (NRS) of low back pain	Low back pain intensity as measured using NRS. In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Secondary	Numeric Rating Scale (NRS) of radiating leg pain	Radiating leg pain intensity as measured using NRS. In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Secondary	Oswestry Disability Index (ODI)	Functional disability questionnaire as measured using ODI. The ODI is a 10-item questionnaire developed to assess level of disability due to low back pain (LBP). Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to LBP.	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Secondary	Visual Analogue Scale (VAS) of radiating leg pain	Radiating leg pain intensity as measured using VAS. VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.	Baseline, 3, 7, 10, 14 days post-baseline
Secondary	Visual Analogue Scale (VAS) of low back pain	Low back pain intensity as measured using VAS. VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.	Baseline, 3, 7, 10, 14 days post-baseline
Secondary	EuroQol 5-Dimension (EQ-5D)	Health-related quality of life questionnaire as measured using SF-36. SF-36 consists of 36 items across 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. SF-36 is used to rate functional health and well-being in patients and healthy individuals. Higher scores indicate better HRQoL.	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Secondary	Patient Global Impression of Change (PGIC)	Global patient-reported outcome as measured using PGIC. PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse).	Baseline, 14, 30, 90 days post-baseline
Secondary	Drug Consumption (drug type)	Regarding recent use of medication, the type of prescription intake for medicine will be recorded.	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Secondary	Drug Consumption (drug intake frequency)	Regarding recent use of medication, the frequency of prescription intake for medicine will be recorded.	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Secondary	Drug Consumption (drug intake period)	Regarding recent use of medication, the period of prescription intake for medicine will be recorded.	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Secondary	Use of additional medical treatment (treatment type)	Regarding current use of medical services, the type of additional medical treatment received will be recorded.	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Secondary	Use of additional medical treatment (treatment frequency)	Regarding current use of medical services, the frequency of additional medical treatment received will be recorded.	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Secondary	Use of additional medical treatment (treatment period)	Regarding current use of medical services, the period of additional medical treatment received will be recorded.	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Secondary	Details of Doin conduction exercise sessions (type (region))	Administration details of Doin conduction exercise session type (region) will be recorded.	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Secondary	Details of Doin conduction exercise sessions (period)	Administration details of Doin conduction exercise sessions (period) will be recorded.	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Secondary	Lumbar range of movement (ROM)	Physical examination	Baseline, 3, 7, 10, 14 days post-baseline
Secondary	Straight leg raise (SLR) test	Physical examination	Baseline, 3, 7, 10, 14 days post-baseline
Secondary	Adverse events	Safety outcome	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline