Back to resultsAcupuncture for Lumbar Spinal Stenosis
Primary Purpose
Spinal Stenosis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acupuncture
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Stenosis focused on measuring lumbar spinal stenosis, claudication, low back pain, radiculopathy, acupuncture, Korean medicine, randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- Aged over 40
- Pain or bothersomeness of lower back or leg began at least three months ago (with at least 40 of pain or bothersomeness visual analogue intensity at the time of recruitment; 0 refers to no pain or bothersomeness and 100 to worst pain or bothersomeness imaginable)
- Clinical features of lumbar spinal stenosis, including neurological claudication or postural symptom changes
- Lumbar spinal stenosis confirmed by radiologic examination (e.g., computed tomography or magnetic resonance imaging) within the last two years
- Willingness to participate in the study
Exclusion Criteria:
- Congenital spinal stenosis
- Other spinal deformities, including spinal fractures and infections
- Participants who have received spinal surgeries, such as laminectomy, spinal fusion, and discectomy, due to lumbar spinal stenosis or other spinal diseases
- Other surgeries which might influence clinical features of lumbar spinal stenosis (e.g., total hip/knee replacements)
- Comorbid conditions which might interfere with the participant's active participation in the study (i.e., poorly controlled hypertension, poorly controlled diabetes mellitus, severe coronary artery disease, unstable asthma, cognitive function disorders, and other disabling conditions that interfere with self-ambulation, such as severe hip or knee arthritis)
- Past/present history of malignancy
- Began a new intervention for the management of lumbar spinal stenosis within the last one month
- Cauda equine syndrome (progressive lower extremity muscle weakness, loss of bowel/bladder control, and/or perianal numbness) and other urgent conditions which require immediate surgery
- Other conditions not appropriate for study participation
Sites / Locations
- National Clinical Research Center, Korean Medicine Hospital, Pusan National University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Acupuncture
Usual care
Arm Description
A series of acupuncture sessions within six weeks from the baseline
An intervention consisting of patient education for a healthier lifestyle, including diet, exercise, self-management of symptoms, and the use of other treatments as needed.
Outcomes
Primary Outcome Measures
Mid-term Back specific functional status
Participant-perceived reduction of pain and physical function will be measured with a 10-item questionnaire; change from baseline in the Oswestry Disability Index (ODI) scale will be used.
Secondary Outcome Measures
Short-term Back specific functional status
Participant-perceived reduction of pain and physical function will be measured by a 10-item questionnaire; change from baseline in the Oswestry Disability Index (ODI) scale will be used.
Short-term low back pain bothersomeness
Participant-perceived reduction of bothersomeness due to low back pain will be measured by visual analogue scale (VAS) with range of 0 (no bothersomeness) to 100 (worst possible bothersomeness). Change from baseline in VAS scale will be used.
Mid-term low back pain bothersomeness
Participant-perceived reduction of bothersomeness due to low back pain will be measured by visual analogue scale (VAS) with range of 0 (no bothersomeness) to 100 (worst possible bothersomeness). Change from baseline in VAS scale will be used.
Short-term low back pain intensity
Participant-perceived reduction of low back pain intensity will be measured by visual analogue scale (VAS) with range of 0 (no pain) to 100 (worst possible pain). Change from baseline in VAS scale will be used.
Mid-term low back pain intensity
Participant-perceived reduction of low back pain intensity will be measured by visual analogue scale (VAS) with range of 0 (no pain) to 100 (worst possible pain). Change from baseline in VAS scale will be used.
Short-term leg pain bothersomeness
Participant-perceived reduction of bothersomeness due to radicular pain in leg will be measured by visual analogue scale (VAS) with range of 0 (no bothersomeness) to 100 (worst possible bothersomeness). Change from baseline in VAS scale will be used.
Mid-term leg pain bothersomeness
Participant-perceived reduction of bothersomeness due to radicular pain in leg will be measured by visual analogue scale (VAS) with range of 0 (no bothersomeness) to 100 (worst possible bothersomeness). Change from baseline in VAS scale will be used.
Short-term leg pain intensity
Participant-perceived reduction of leg pain intensity will be measured by visual analogue scale (VAS) with range of 0 (no pain) to 100 (worst possible pain). Change from baseline in VAS scale will be used.
Mid-term leg pain intensity
Participant-perceived reduction of leg pain intensity will be measured by visual analogue scale (VAS) with range of 0 (no pain) to 100 (worst possible pain). Change from baseline in VAS scale will be used.
Short-term pain-related quality of life
Patient-perceived improvement of pain-related quality of life will be measured by 2-item questionnaire for the subdomain of bodily pain in the Short-Form 36 Rand Health Insurance study batteries (SF-36) questionnaire. Change from baseline in bodily pain subdomain scale will be used.
Mid-term pain-related quality of life
Patient-perceived improvement of pain-related quality of life will be measured by 2-item questionnaire for the subdomain of bodily pain in the Short-Form 36 Rand Health Insurance study batteries (SF-36) questionnaire. Change from baseline in bodily pain subdomain scale will be used.
Short-term physical function-related quality of life
Patient-perceived improvement of physical function-related quality of life will be measured by 10-item questionnaire for the subdomain of physical function in the Short-Form 36 Rand Health Insurance study batteries (SF-36) questionnaire. Change from baseline in physical function subdomain scale will be used.
Mid-term physical function-related quality of life
Patient-perceived improvement of physical function-related quality of life will be measured by 10-item questionnaire for the subdomain of physical function in the Short-Form 36 Rand Health Insurance study batteries (SF-36) questionnaire. Change from baseline in physical function subdomain scale will be used.
Self-reported pain-free walking distance
Patient-reported pain-free walking distance with providing the actual reference distance of 50 meters in the corridor of the research center.
Patient satisfaction for treatment outcome
Patients' satisfaction for allocated treatment outcomes will be measured by a single item with 7-point likert scale question (very much satisfied, much satisfied, a bit satisfied, just the same, a bit dissatisfied, much dissatisfied, very much dissatisfied).
Patient Global Assessment for treatment outcome
Patients' global assessment for overall treatment outcome will be measured by a single item with 5-point likert scale question (much improved, somewhat improved, just the same as baseline, somewhat worsened, much worsened)
Use of medication and healthcare resources
Information on the use of medication and other non-study healthcare resources will be collected by directly asking the patient at every visit. Patients in the control group who do not visit the research center to receive optional physical therapies will be contacted regularly by short-form message service and phone calling by study investigators. Examples of healthcare resources include analgesics, physical therapies, epidural injection, hospital visits for symptoms of lumbar spinal stenosis. Types and frequency of the use of healthcare resources will be assessed at 6 weeks and 3 months from baseline.
Adverse events
All expected or unexpected adverse events in both groups will be measured at the every study visit as well as by the telephone interview. Types and frequency of the occurrence of adverse events will be assessed at 6 weeks and 3 months from baseline.
Full Information
NCT ID
NCT01987622
First Posted
November 12, 2013
Last Updated
February 5, 2015
Sponsor
Korean Medicine Hospital of Pusan National University
Collaborators
Korea Institute of Oriental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01987622
Brief Title
Acupuncture for Lumbar Spinal Stenosis
Official Title
Acupuncture for Lumbar Spinal Stenosis: a Parallel, Randomized Controlled Pilot Study With Usual Care Comparison
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korean Medicine Hospital of Pusan National University
Collaborators
Korea Institute of Oriental Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Acupuncture is widely used to manage chronic low back pain. Mounting evidence suggests the beneficial effects of acupuncture for mitigating chronic low back pain with acceptable minor adverse events. However, little information exists regarding the effects and safety of acupuncture for degenerative lumbar spinal stenosis, one of the spinal disorders that present chronic low back and leg pain.
The investigators aimed to assess the overall effectiveness, safety, and feasibility of acupuncture in combination with usual care (as opposed to usual care alone) for patients with symptomatic degenerative lumbar spinal stenosis.
The hypotheses of this study are as follows:
A set of acupuncture sessions in combination with usual care can provide greater functional improvements than usual care alone .
A set of acupuncture sessions in combination with usual care can provide greater pain reduction than usual care alone .
The study aims to include 50 participants (25 in the acupuncture group and 25 in the usual care group).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis
Keywords
lumbar spinal stenosis, claudication, low back pain, radiculopathy, acupuncture, Korean medicine, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
A series of acupuncture sessions within six weeks from the baseline
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
An intervention consisting of patient education for a healthier lifestyle, including diet, exercise, self-management of symptoms, and the use of other treatments as needed.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
The patients in this group will receive individualized acupuncture prescribed by a certified Korean Medicine Doctor (KMD) with at least three years of clinical experience. The acupuncture formulas will be determined based on the individual patient's symptoms and at the KMD's discretion. The acupuncture treatment will be applied one to three times a week for six weeks (a total of 12 sessions and an additional four sessions are allowed). Acupuncture will be manually stimulated at first, and then electrical stimulation will be allowed at the KMD's discretion. Retention time will be equal to or less than 20 minutes. Examples of acupuncture points to be used might include LI4, LI11, TE5, SI3, TE3, ST36, SP6, SP9, LR3, GB34, Gb39, BL40, BL57, EX-B2, and BL23.
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
Usual care consists of patient education for a healthier lifestyle, including diet, exercise, self-management of symptoms, and the use of other treatments as needed. Participants will receive a three-page leaflet of patient education material. Optional regular physical therapies, including interferential current therapy (ICT) and local heat application, will be provided only for the control group at the participants' request . Physical therapy will be provided one to three times a week for six weeks (a total of 12 sessions and an additional four sessions are allowed). All kinds of conservative interventions for lumbar spinal stenosis, including analgesics and non-study physical treatments,will be allowed. However, surgical treatments, non-study acupuncture, or herbal medicine will not be allowed.
Primary Outcome Measure Information:
Title
Mid-term Back specific functional status
Description
Participant-perceived reduction of pain and physical function will be measured with a 10-item questionnaire; change from baseline in the Oswestry Disability Index (ODI) scale will be used.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Short-term Back specific functional status
Description
Participant-perceived reduction of pain and physical function will be measured by a 10-item questionnaire; change from baseline in the Oswestry Disability Index (ODI) scale will be used.
Time Frame
6 weeks
Title
Short-term low back pain bothersomeness
Description
Participant-perceived reduction of bothersomeness due to low back pain will be measured by visual analogue scale (VAS) with range of 0 (no bothersomeness) to 100 (worst possible bothersomeness). Change from baseline in VAS scale will be used.
Time Frame
6 weeks
Title
Mid-term low back pain bothersomeness
Description
Participant-perceived reduction of bothersomeness due to low back pain will be measured by visual analogue scale (VAS) with range of 0 (no bothersomeness) to 100 (worst possible bothersomeness). Change from baseline in VAS scale will be used.
Time Frame
3 weeks
Title
Short-term low back pain intensity
Description
Participant-perceived reduction of low back pain intensity will be measured by visual analogue scale (VAS) with range of 0 (no pain) to 100 (worst possible pain). Change from baseline in VAS scale will be used.
Time Frame
6 weeks
Title
Mid-term low back pain intensity
Description
Participant-perceived reduction of low back pain intensity will be measured by visual analogue scale (VAS) with range of 0 (no pain) to 100 (worst possible pain). Change from baseline in VAS scale will be used.
Time Frame
3 weeks
Title
Short-term leg pain bothersomeness
Description
Participant-perceived reduction of bothersomeness due to radicular pain in leg will be measured by visual analogue scale (VAS) with range of 0 (no bothersomeness) to 100 (worst possible bothersomeness). Change from baseline in VAS scale will be used.
Time Frame
6 weeks
Title
Mid-term leg pain bothersomeness
Description
Participant-perceived reduction of bothersomeness due to radicular pain in leg will be measured by visual analogue scale (VAS) with range of 0 (no bothersomeness) to 100 (worst possible bothersomeness). Change from baseline in VAS scale will be used.
Time Frame
3 months
Title
Short-term leg pain intensity
Description
Participant-perceived reduction of leg pain intensity will be measured by visual analogue scale (VAS) with range of 0 (no pain) to 100 (worst possible pain). Change from baseline in VAS scale will be used.
Time Frame
6 weeks
Title
Mid-term leg pain intensity
Description
Participant-perceived reduction of leg pain intensity will be measured by visual analogue scale (VAS) with range of 0 (no pain) to 100 (worst possible pain). Change from baseline in VAS scale will be used.
Time Frame
3 months
Title
Short-term pain-related quality of life
Description
Patient-perceived improvement of pain-related quality of life will be measured by 2-item questionnaire for the subdomain of bodily pain in the Short-Form 36 Rand Health Insurance study batteries (SF-36) questionnaire. Change from baseline in bodily pain subdomain scale will be used.
Time Frame
6 weeks
Title
Mid-term pain-related quality of life
Description
Patient-perceived improvement of pain-related quality of life will be measured by 2-item questionnaire for the subdomain of bodily pain in the Short-Form 36 Rand Health Insurance study batteries (SF-36) questionnaire. Change from baseline in bodily pain subdomain scale will be used.
Time Frame
3 months
Title
Short-term physical function-related quality of life
Description
Patient-perceived improvement of physical function-related quality of life will be measured by 10-item questionnaire for the subdomain of physical function in the Short-Form 36 Rand Health Insurance study batteries (SF-36) questionnaire. Change from baseline in physical function subdomain scale will be used.
Time Frame
6 weeks
Title
Mid-term physical function-related quality of life
Description
Patient-perceived improvement of physical function-related quality of life will be measured by 10-item questionnaire for the subdomain of physical function in the Short-Form 36 Rand Health Insurance study batteries (SF-36) questionnaire. Change from baseline in physical function subdomain scale will be used.
Time Frame
3 months
Title
Self-reported pain-free walking distance
Description
Patient-reported pain-free walking distance with providing the actual reference distance of 50 meters in the corridor of the research center.
Time Frame
6 weeks, 3 months
Title
Patient satisfaction for treatment outcome
Description
Patients' satisfaction for allocated treatment outcomes will be measured by a single item with 7-point likert scale question (very much satisfied, much satisfied, a bit satisfied, just the same, a bit dissatisfied, much dissatisfied, very much dissatisfied).
Time Frame
6 weeks, 3 months
Title
Patient Global Assessment for treatment outcome
Description
Patients' global assessment for overall treatment outcome will be measured by a single item with 5-point likert scale question (much improved, somewhat improved, just the same as baseline, somewhat worsened, much worsened)
Time Frame
6 weeks, 3 months
Title
Use of medication and healthcare resources
Description
Information on the use of medication and other non-study healthcare resources will be collected by directly asking the patient at every visit. Patients in the control group who do not visit the research center to receive optional physical therapies will be contacted regularly by short-form message service and phone calling by study investigators. Examples of healthcare resources include analgesics, physical therapies, epidural injection, hospital visits for symptoms of lumbar spinal stenosis. Types and frequency of the use of healthcare resources will be assessed at 6 weeks and 3 months from baseline.
Time Frame
6 weeks, 3 months
Title
Adverse events
Description
All expected or unexpected adverse events in both groups will be measured at the every study visit as well as by the telephone interview. Types and frequency of the occurrence of adverse events will be assessed at 6 weeks and 3 months from baseline.
Time Frame
6 weeks, 3 months
Other Pre-specified Outcome Measures:
Title
Participant expectancy for allocated treatments
Description
Each participant's expectancy for allocated treatment to reduce symptoms of lumbar spinal stenosis will be measured by a single-item questionnaire ("Do you think your allocated treatment will be [was] helpful to reduce your symptoms related to lumbar spinal stenosis?"). Possible answers will be 0 (not at all helpful) to 6 (very helpful).
Time Frame
Baseline, 6 weeks, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged over 40
Pain or bothersomeness of lower back or leg began at least three months ago (with at least 40 of pain or bothersomeness visual analogue intensity at the time of recruitment; 0 refers to no pain or bothersomeness and 100 to worst pain or bothersomeness imaginable)
Clinical features of lumbar spinal stenosis, including neurological claudication or postural symptom changes
Lumbar spinal stenosis confirmed by radiologic examination (e.g., computed tomography or magnetic resonance imaging) within the last two years
Willingness to participate in the study
Exclusion Criteria:
Congenital spinal stenosis
Other spinal deformities, including spinal fractures and infections
Participants who have received spinal surgeries, such as laminectomy, spinal fusion, and discectomy, due to lumbar spinal stenosis or other spinal diseases
Other surgeries which might influence clinical features of lumbar spinal stenosis (e.g., total hip/knee replacements)
Comorbid conditions which might interfere with the participant's active participation in the study (i.e., poorly controlled hypertension, poorly controlled diabetes mellitus, severe coronary artery disease, unstable asthma, cognitive function disorders, and other disabling conditions that interfere with self-ambulation, such as severe hip or knee arthritis)
Past/present history of malignancy
Began a new intervention for the management of lumbar spinal stenosis within the last one month
Cauda equine syndrome (progressive lower extremity muscle weakness, loss of bowel/bladder control, and/or perianal numbness) and other urgent conditions which require immediate surgery
Other conditions not appropriate for study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gi Young Yang, PhD
Organizational Affiliation
Korean Medicine Hospital, Pusan National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Clinical Research Center, Korean Medicine Hospital, Pusan National University
City
Yangsan
State/Province
Kyungsangnamdo
ZIP/Postal Code
626-770
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
26953235
Citation
Kim KH, Kim YR, Baik SK, Noh SH, Kim DH, Lee SW, Yang GY. Acupuncture for patients with lumbar spinal stenosis: a randomised pilot trial. Acupunct Med. 2016 Aug;34(4):267-74. doi: 10.1136/acupmed-2015-010962. Epub 2016 Mar 7.
Results Reference
derived
Learn more about this trial
Acupuncture for Lumbar Spinal Stenosis
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