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

Primary Purpose

Lumbar Spinal Stenosis, Spinal Manipulation, Physical Therapy

Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
lumbar traction
spinal manipulation
surgery
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Lumbar spinal stenosis, spinal manipulation, physical therapy, surgery

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ShinKongHospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Lumbar spinal manipulation

Physical therapy

Surgery

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

VAS pain score
an 10-cm horizontal line will be used to assess average pain intensity in the last 1 week

Secondary Outcome Measures

Modified OswestryDisability Questionnaire (MODQ)
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.
Swiss Spinal Stenosis Questionnaire
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.
The Medical Outcome Survey Short Form (SF-36)
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.
Intermittent claudication
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.

Full Information

First Posted
April 7, 2017
Last Updated
January 20, 2020
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03118206
Brief Title
Comparison of the Effect of Lumbar Spinal Manipulation, Physical Therapy and Surgical Management in the Treatment of Lumbar Spinal Stenosis
Official Title
Comparison of the Effect of Lumbar Spinal Manipulation, Physical Therapy and Surgical Management in the Treatment of Lumbar Spinal Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Two authors changed their jobs.
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis, Spinal Manipulation, Physical Therapy, Surgery
Keywords
Lumbar spinal stenosis, spinal manipulation, physical therapy, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumbar spinal manipulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Physical therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
lumbar traction
Intervention Type
Procedure
Intervention Name(s)
spinal manipulation
Intervention Type
Procedure
Intervention Name(s)
surgery
Primary Outcome Measure Information:
Title
VAS pain score
Description
an 10-cm horizontal line will be used to assess average pain intensity in the last 1 week
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.
Secondary Outcome Measure Information:
Title
Modified OswestryDisability Questionnaire (MODQ)
Description
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.
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.
Title
Swiss Spinal Stenosis Questionnaire
Description
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.
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.
Title
The Medical Outcome Survey Short Form (SF-36)
Description
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.
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.
Title
Intermittent claudication
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 20 to 80 age years old Moderate to severe low back painand/or sciatica,and/or intermittent claudication (VAS>=4) Symptom duration is more than three months The diagnosis is proved by MRI Exclusion Criteria: Serious spinal pathologies including spinal tumor, infection, andinflammatory disease Progressive weakness, sensory loss or symptoms and signs suggesting cauda equine esion Concomitant serious medical conditions History of spinal surgery before Severe osteoporosis or instability of the lumbar spine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin-Fen Hsieh, M.D
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
ShinKongHospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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