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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03118206
• Other study ID #: 20160804R
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: January 2020
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Physical Therapy
• Spinal Manipulation
• Spinal Stenosis
• Surgery

Intervention

Device:
• lumbar traction

Procedure:
• spinal manipulation

• surgery

Locations

Country	Name	City	State
Taiwan	ShinKongHospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS pain score	an 10-cm horizontal line will be used to assess average pain intensity in the last 1 week	Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
Secondary	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.	Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
Secondary	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.	Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
Secondary	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.	Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.
Secondary	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.	Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.