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Acupuncture for Lumbar Spinal Stenosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Korean Medicine Hospital of Pusan National University
Sponsor:
Collaborator:
Korea Institute of Oriental Medicine
Information provided by (Responsible Party):
Gi Young Yang, Korean Medicine Hospital of Pusan National University
ClinicalTrials.gov Identifier:
NCT01987622
First received: November 12, 2013
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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:

  1. A set of acupuncture sessions in combination with usual care can provide greater functional improvements than usual care alone .
  2. 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).


Condition Intervention
Spinal Stenosis
Procedure: Acupuncture
Procedure: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Lumbar Spinal Stenosis: a Parallel, Randomized Controlled Pilot Study With Usual Care Comparison

Resource links provided by NLM:


Further study details as provided by Korean Medicine Hospital of Pusan National University:

Primary Outcome Measures:
  • Mid-term Back specific functional status [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks, 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks, 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks, 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks, 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks, 3 months ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Participant expectancy for allocated treatments [ Time Frame: Baseline, 6 weeks, 3 months ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 50
Study Start Date: November 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
A series of acupuncture sessions within six weeks from the baseline
Procedure: Acupuncture
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.
Procedure: Usual care
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.
Active Comparator: Usual care
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.
Procedure: Usual care
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987622

Contacts
Contact: Minjoo Kang, BcS 82553605907 syblkmj@hanmail.net
Contact: Kun Hyung Kim, PhD 821096333592 pdchrist@gmail.com

Locations
Korea, Republic of
National Clinical Research Center, Korean Medicine Hospital, Pusan National University Recruiting
Yangsan, Kyungsangnamdo, Korea, Republic of, 626-770
Contact: Kun Hyung , PhD    82553605971    pdchrist@gmail.com   
Contact: Dong Jin Kim, BcS    82553605902    djkim085@gmail.com   
Principal Investigator: Gi Young Yang, PhD         
Sponsors and Collaborators
Korean Medicine Hospital of Pusan National University
Korea Institute of Oriental Medicine
Investigators
Principal Investigator: Gi Young Yang, PhD Korean Medicine Hospital, Pusan National University
  More Information

No publications provided

Responsible Party: Gi Young Yang, Assistant Professor, Korean Medicine Hospital of Pusan National University
ClinicalTrials.gov Identifier: NCT01987622     History of Changes
Other Study ID Numbers: Acustenosis, KIOM
Study First Received: November 12, 2013
Last Updated: November 18, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Korean Medicine Hospital of Pusan National University:
lumbar spinal stenosis
claudication
low back pain
radiculopathy
acupuncture
Korean medicine
randomized controlled trial

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 30, 2014