Status Approved
First Submitted Date
2021/01/29
Registered Date
2021/03/29
Last Updated Date
2021/03/12
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0006036 |
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Unique Protocol ID | CR-20-205-L |
Public/Brief Title | The effect of comprehensive and integrative medicine in patients with lumbar spinal stenosis - randomized control study (pilot study) |
Scientific Title | The effect of comprehensive and integrative medicine in patients with lumbar spinal stenosis - randomized control study (pilot study) |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | CR-20-205-L |
Approval Date | 2020-12-16 |
Institutional Review Board Name | Institutional Review Board of Daegu Catholic University |
Institutional Review Board Address | 33, Duryugongwon-ro 17-gil, Nam-gu, Daegu |
Institutional Review Board Telephone | 053-650-4423 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Gwak Sanggyu |
Title | assistant professor |
Telephone | +82-53-650-4724 |
Affiliation | Daegu Catholic University |
Address | 33, Duryugongwon-ro 17-gil, Nam-gu, Daegu, Republic of Korea |
Contact Person for Public Queries | |
Name | chung hyeonjung |
Title | associate professor |
Telephone | +82-53-670-5932 |
Affiliation | Daegu Oriental Hospital of Daegu Haany University |
Address | 136, Sincheondong-ro, Suseong-gu, Daegu, Republic of Korea |
Contact Person for Updating Information | |
Name | Kim Somi |
Title | CRC |
Telephone | +82-53-670-5981 |
Affiliation | Comprehensive & Integrative Medicine Hospital |
Address | 77 Duryu Park, Nam-gu, Daegu |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-01-21 Actual | |
Target Number of Participant | 30 | |
Primary Completion Date | 2021-11-30 , Anticipated | |
Study Completion Date | 2021-12-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Daegu Catholic University Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-01-21 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Health & Welfare |
Organization Type | Government |
Project ID | HI20C1753010220 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Daegu Catholic University Medical Center |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | <Background> Lumbar spinal stenosis is a typical degenerative disease of the spine that complains of lower extremities, back pain, hip joint pain, and walking disorders. The lower extremities and connections in the hips usually occur in the hip or waist area. This pain is a pain that radiates mainly to the thighs, calves, ankle joints, and soles, which is highly sensitive, with pain that seems to be stabbing, dull, burning, electrical, numb, or a bug crawling through. Many treatments have been presented to mitigate these radiations, mainly spinal therapy, physical therapy, massage, and a variety of drugs, including anti-inflammatory drugs, muscle relaxants, as well as the use of gabapentin and pregarine among these various drugs. In recent years, out-of-peritoneal injection therapy and neuromuscular blocking have been commonly performed as minimally invasive treatments. Among these, neuromuscular blocking is a method of relieving pain by injecting adrenal cortical hormones and local anesthetic agents into the compressed nerve muscles that cause radiation. Although there are differences over the ultimate treatment effectiveness of neuromuscular blocking, the prevailing view is that it is an effective treatment method, according to several researchers. Pedestrian disorder (parachute) is also a typical symptom caused by blood flow disorders in paralyzed areas, and various drugs, especially Limaprost, are mainly used as treatment agents. <Purpose> For spinal stenosis patients prescribed for neuromuscular blocking and limaprost, pregabalin, etc, acupuncture, cupping and manual therapy will be conducted three times a week for four weeks to evaluate the effectiveness of pain improvement, health condition change, and safety of comprehensive and integrative medical treatment. <The Method> For spinal stenosis patients who complains of radiating pain (LANSS > 7), who needs selective nerve root block with VAS of 3 or more, patients are devided two groups. The experimental group will be treated acupuncture, cupping and manual therapy and control group will be provided conventionl treatment excepting acupuncture, cupping and manual therapy. We would like to evaluate and compare short-term treatment (two weeks after treatment) with intermediate-term treatment effect (six weeks after treatment, 12 weeks after treatment). |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Others (comprehensive and integrative medcine) |
Intervention Description | The experimental group will be prescribed Limaprost, pregabalin and nerve root block, additionally acupuncture and cupping, and conduct a total of 12 massage three times a week for four weeks. On the other hand, the control group is prescribed Limaprost, pregabalin and performs nerve root block. The acupuncture treatment is performed three times a week for four weeks. The acupoints used in this study are BL23, BL24, BL25, BL26, GB30, GB31, BL40, KI3, BL60. Single use, disposable sterilized needle(stainless steel, 0.25*40mm, 0.30*60mm) will be used. The insertion depth is 10-50mm depending on the location of acupoints, and last for 25±5 minutes. Electrical stimulation at a frequency of 4Hz will be applied at BL23, BL25, GB30, GB31. The cupping method is to take baesuhyeol(배수혈) and maintain negative pressure for five minutes using an electric device. A total of 12 massage sessions will be conducted three times a week for four weeks. The therapist reduces pain caused by stenosis and seeks functional recovery of muscles and joints by applying fascia relaxation and massage or appropriate stretching treatment to induce relaxation of the surrounding muscles and ligament joints. |
Number of Arms | 2 |
Arm 1 |
Arm Label comprehensive and integrative medicine group |
Target Number of Participant 15 |
|
Arm Type Experimental |
|
Arm Description The experimental group will be prescribed Limaprost, pregabalin and nerve root block, additionally acupuncture and cupping, and conduct a total of 12 massage three times a week for four weeks. |
|
Arm 2 |
Arm Label control group |
Target Number of Participant 15 |
|
Arm Type Active comparator |
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Arm Description the control group is prescribed Limaprost, pregabalin and performs nerve root block. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M48.06)Spinal stenosis, lumbar region Patients diagnosed with lumbar spinal stenosis who complain of radial pain (LANSS 7 7) and require selective nerve root blockwith VAS 3 or more points. |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 20Year~80Year |
|
Description 1. under the age of 80 2. Patient diagnosed with lumbar spinal stenosis with symptoms and complaining of lower limb radial pain (LANSS > 7) 3. Patients requiring selective neuromuscular blockage with a degree of VAS 3 or higher 4. Patients who voluntarily consents to a written consent form. |
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Exclusion Criteria |
1. under the age of 20 2. Patients who are pregnant 3. Patients with secondary benefits (industrial accidents, auto insurance, etc.) 4. patients with severe comorbidity 5. Patients who are unable to administrate drugs. 6. Patients who were involved in an interventional study during the period of study 7. patients who suffer from a cancer-related pain caused by primary or metastatic cancer in the spine. 8. Patients who cannot communicate, such as questionnaires, etc. |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | VAS(Visual Analog Sacale) |
|
Timepoint | after each treatment |
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Secondary Outcome(s) 1 | ||
Outcome | SF-36 (Health Survey for Spine Patients) |
|
Timepoint | Two weeks before treatment, six weeks after treatment, 12 weeks after treatment. |
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Secondary Outcome(s) 2 | ||
Outcome | RMDQ (Revised Roland Disability Scale) |
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Timepoint | Two weeks before treatment, six weeks after treatment, 12 weeks after treatment. |
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Secondary Outcome(s) 3 | ||
Outcome | ODI (Oswestry Disability Index) |
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Timepoint | Two weeks before treatment, six weeks after treatment, 12 weeks after treatment. |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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