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Comparison of the Effect of Lumbar Spinal Manipulation, Physical Therapy and Surgical Management in the Treatment of Lumbar Spinal Stenosis

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ClinicalTrials.gov Identifier: NCT03118206
Recruitment Status : Terminated (Two authors changed their jobs.)
First Posted : April 18, 2017
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Shin Kong Wu Ho-Su Memorial Hospital

Brief Summary:
To compare the effect of lumbar spinal manipulation, physical therapy and surgical management in the treatment of lumbar spinal stenosis.

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Spinal Manipulation Physical Therapy Surgery Device: lumbar traction Procedure: spinal manipulation Procedure: surgery Not Applicable

Detailed Description:

Low back pain (LBP) is a very common health problem which results in negative impact in daily life and burden especially in elderly. The global age-standardized point prevalence of LBP in 2010 was estimated to be 9.4%. Among the etiologies of low back pain, lumbar spinal stenosis is frequently encountered by physicians. In a large observational study, the prevalence of lumbar spinal stenosis was 23.6% in the general population and higher in patients more than 60 years-old. If untreated, the symptoms may persist in 70% of the patients over the 48-month observation period. On the other hand, previous studies have shown that surgery is more effective in pain relief, neurological symptoms and further functional status, however, conservative treatment still had favorable effect in patients with milder symptoms.

The role of spinal manipulation has been discussed in previous study which compared the clinical efficacy of spinal manipulation against microdiskectomy in patients with sciatica secondary to lumbar disc herniation. According to this study, the pain, disability and life quality of both groups in 12-week period had no significant difference that chiropractic spinal manipulative treatment could be considered as a primary treatment. However, comparison among the effect of spinal manipulation, physical therapy, and surgery has not been conducted before. Therefore, the purpose of this study is to compare the effect of spinal manipulation, physical therapy, and surgery in the treatment of lumbar spinal stenosis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Effect of Lumbar Spinal Manipulation, Physical Therapy and Surgical Management in the Treatment of Lumbar Spinal Stenosis
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lumbar spinal manipulation
Lumbar spinal manipulation will be performed up to 8 times within 1 month (no more than 2 times per week) by Dr. WangTso-Liang, who is a well-trained and experienced manual therapy doctor. If the symptoms subside before the end of 1 month' treatment, the manipulation is discontinued.
Device: lumbar traction
Active Comparator: Physical therapy
Physical therapy will include treatment with therapeutic exercise and modalities (lumbar traction, heattherapy, electric stimulation, and therapeutic exercise) for 2 month with frequency 3 times per week.
Procedure: spinal manipulation
Active Comparator: Surgery
General anesthesia, the patient will be put in the prone and abdomen-free position. A 4-cm midline longitudinal incision will be made over the spinous processes of the L3-5 levels. It will be deepened through the fat and fascia in line with the skin incision to reach the spinous processes.The paraspinous muscles will be dissected subperiosteally down the spinous processes and along the lamina to the facet joints. Laminectomy will be done carefully at the herniated disc level for posterior decompression. The ligamentum flavum will be excised to expose the dural sac.Using blunt dissection, the investigators carefully continue down the lateral side of the dura to the floor of the spinal canal; the investigators retract the dura and its nerve root medially. After the posterior aspect of the disc space is revealed, the affected disc will be removed and discotomy will be performed.The wound will be closed in the routine fashion after meticulous hemostasis and normal saline irrigation.
Procedure: surgery



Primary Outcome Measures :
  1. VAS pain score [ Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments. ]
    an 10-cm horizontal line will be used to assess average pain intensity in the last 1 week


Secondary Outcome Measures :
  1. Modified OswestryDisability Questionnaire (MODQ) [ Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments. ]
    For evaluation of disability related to LBP, Oswestry Disability Questionnaire (ODQ) is most widely used. ODQ is a 10-item self report instrument that evaluates perceived disability in 10 areas: pain intensity, ability to lift objects, ability to walk, ability to sit, ability to stand, ability to sleep, sex life, social life, traveling, and ability to complete personal hygiene activities. By using a 6-point Likert scale (0 = no limitation; 5 = severe limitation) , the total maximum scale is doubled and reported as a percentage of the patients perceived pain-related disability, with higher scores indicating greater disability.

  2. Swiss Spinal Stenosis Questionnaire [ Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments. ]
    The Swiss Spinal Stenosis Questionnaire is a disease-specific self-report outcome instrument commonly used in patients with lumbar spinal stenosis (LSS) for evaluation of outcomes of the treatment. It includes severity of symptoms, physical function characteristics, and patient's satisfaction after treatment. It was designed to complement existing generic measures of lumbar spine disability and health status in the evaluation of patients with LSS.

  3. The Medical Outcome Survey Short Form (SF-36) [ Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments. ]
    The Medical Outcome Survey Short Form (SF-36) was used to assess general health status. The SF-36 measures eight dimentions of health: general health perceptions, physical function, physical role, bodily pain, social functioning, mental health, emotional role, and vitality. The eight scales may be combined into two summary scores, the physical component summary(PCS) and the mental component summary(MCS). The SF-36 has well-established psychometric properties for the general population and individuals with LBP.

  4. Intermittent claudication [ Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments. ]
    For evaluation of intermittent claudication, self-reported duration of walking will be recorded. It divides into three levels to evaluate how long the patient can walk without resting. The duration includes less than 10 minutes, 11-20 minutes, 21-30 minutes and more than 30 minutes.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 20 to 80 age years old
  2. Moderate to severe low back painand/or sciatica,and/or intermittent claudication (VAS>=4)
  3. Symptom duration is more than three months
  4. The diagnosis is proved by MRI

Exclusion Criteria:

  1. Serious spinal pathologies including spinal tumor, infection, andinflammatory disease
  2. Progressive weakness, sensory loss or symptoms and signs suggesting cauda equine esion
  3. Concomitant serious medical conditions
  4. History of spinal surgery before
  5. Severe osteoporosis or instability of the lumbar spine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118206


Locations
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Taiwan
ShinKongHospital
Taipei, Taiwan
Sponsors and Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
Investigators
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Principal Investigator: Lin-Fen Hsieh, M.D Shin Kong Wu Ho-Su Memorial Hospital
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Responsible Party: Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier: NCT03118206    
Other Study ID Numbers: 20160804R
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:
Lumbar spinal stenosis
spinal manipulation
physical therapy
surgery
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases