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

Shin Kong Wu Ho-Su Memorial Hospital

Status: Terminated

Conditions: Lumbar Spinal Stenosis; Surgery; Spinal Manipulation; Physical Therapy

Treatments: Device: lumbar traction; Procedure: surgery; Procedure: spinal manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03118206

20160804R

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 3 patient groups

Lumbar spinal manipulation

Active Comparator group

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.

Treatment:

Device: lumbar traction

Physical therapy

Active Comparator group

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.

Treatment:

Procedure: spinal manipulation

Surgery

Active Comparator group

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.

Treatment:

Procedure: surgery