Spinal StenosisNCT01987622
Acupuncture for Lumbar Spinal Stenosis
A study testing Acupuncture in people with Spinal Stenosis, run by Korean Medicine Hospital of Pusan National University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Clinical Research Center, Korean Medicine Hospital, Pusan National University
Yangsan, Kyungsangnamdo, 626-770
About this study
Official title: Acupuncture for Lumbar Spinal Stenosis: a Parallel, Randomized Controlled Pilot Study With Usual Care Comparison
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.
Read more
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).
- Conditions
- Spinal Stenosis
- Being tested
- Acupuncture, Usual care
- Keywords
- lumbar spinal stenosis, claudication, low back pain, radiculopathy, acupuncture, Korean medicine, randomized controlled trial
- Medical subject headings
- Spinal Stenosis, Intermittent Claudication, Low Back Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
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.
Usual careProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | A series of acupuncture sessions within six weeks from the baseline Receives: Procedure: Acupuncture; Procedure: Usual care |
| Usual care | Active comparator | 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. Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (18)
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 3 weeks
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.
Measured: 6 weeks
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.
Measured: 3 weeks
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.
Measured: 6 weeks
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.
Measured: 3 months
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.
Measured: 6 weeks
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.
Measured: 3 months
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.
Measured: 6 weeks
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.
Measured: 3 months
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.
Measured: 6 weeks
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.
Measured: 3 months
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.
Measured: 6 weeks, 3 months
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).
Measured: 6 weeks, 3 months
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)
Measured: 6 weeks, 3 months
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.
Measured: 6 weeks, 3 months
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.
Measured: 6 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korean Medicine Hospital of Pusan National University
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine
- Responsible party
- Principal investigator, Gi Young Yang, Korean Medicine Hospital of Pusan National University
- Investigators
- Gi Young Yang, PhD, Principal investigator, Korean Medicine Hospital, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987622
- Sponsor's protocol ID
- Acustenosis
- Other IDs
- KIOM
- Status last verified
- Feb 2015
- First submitted
- 12 Nov 2013
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26953235
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Lumbar Spinal Stenosis: a Parallel, Randomized Controlled Pilot Study With Usual Care Comparison
- ClinicalTrials.gov ID
- NCT01987622
- Acronym / sponsor ID
- Acustenosis
- Conditions
- Spinal Stenosis
- Keywords
- lumbar spinal stenosis, claudication, low back pain, radiculopathy, acupuncture, Korean medicine, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Korean Medicine Hospital of Pusan National UniversityUniversity, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 19 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: Acupuncture, Procedure: Usual careA series of acupuncture sessions within six weeks from the baseline |
| Usual care | Active comparator | Procedure: Usual careAn intervention consisting of patient education for a healthier lifestyle, including diet, exercise, self-management of symptoms, and the use of other treatments as needed. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureThe 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. | Procedure or surgery | Acupuncture |
| Usual careUsual 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. | Procedure or surgery | Acupuncture, Usual care |
Primary outcome
Mid-term Back specific functional status
Time frame: 3 months
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.
18 secondary outcomes
Short-term Back specific functional status
Time frame: 6 weeks
Short-term low back pain bothersomeness
Time frame: 6 weeks
Mid-term low back pain bothersomeness
Time frame: 3 weeks
Short-term low back pain intensity
Time frame: 6 weeks
Mid-term low back pain intensity
Time frame: 3 weeks
Short-term leg pain bothersomeness
Time frame: 6 weeks
Mid-term leg pain bothersomeness
Time frame: 3 months
Short-term leg pain intensity
Time frame: 6 weeks
Mid-term leg pain intensity
Time frame: 3 months
Short-term pain-related quality of life
Time frame: 6 weeks
Mid-term pain-related quality of life
Time frame: 3 months
Short-term physical function-related quality of life
Time frame: 6 weeks
Mid-term physical function-related quality of life
Time frame: 3 months
Self-reported pain-free walking distance
Time frame: 6 weeks, 3 months
Patient satisfaction for treatment outcome
Time frame: 6 weeks, 3 months
Patient Global Assessment for treatment outcome
Time frame: 6 weeks, 3 months
Use of medication and healthcare resources
Time frame: 6 weeks, 3 months
Adverse events
Time frame: 6 weeks, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
- Derived from this study: PubMed 26953235Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gi Young Yang, PhD principal investigator
Korean Medicine Hospital, Pusan National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Spinal Stenosis, run by Korean Medicine Hospital of Pusan National University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mid-term Back specific functional status (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01987622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015.