Chiropractic Spinal Manipulative Therapy for Acute Sciatica Secondary to Lumbar Disc Herniation

Lumbar Disc Herniation Clinical Trial

Official title:

Biology and Clinical Outcomes of Chiropractic Spinal Manipulative Therapy in the Treatment of Patients With Acute Inflammatory Radiculopathy Secondary to Lumbar Disc Herniation: a Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01552486
• Other study ID #: 1R21AT006773-01A1
• Status: Active, not recruiting
• Phase: N/A
• First received: February 29, 2012
• Last updated: November 2, 2016
• Start date: June 2012
• Est. completion date: June 2017

Study information

• Verified date: November 2016
• Source: Vancouver General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Comparisons of surgical and non-operative treatment of patients with acute sciatica secondary to lumbar intervertebral disc herniation (AS/LDH) have shown no appreciable difference in outcome. The composition of the non-operative treatment of this patient population remains poorly defined. Spinal manipulative therapy (SMT) has demonstrated value in the treatment of AS/LDH. Recent preliminary studies suggest that SMT provides therapeutic benefit through the modulation of in vivo inflammatory mediators. This feasibility study will define the key experimental variables required to conduct a large multicentre study that will clarify the biological and clinical outcomes of SMT in the treatment of patients with AS/LDH.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 60 Years

Eligibility

Inclusion Criteria:

• chief complaint of sciatica rather than lower back pain

• pain of up to 6 months' duration

• a McCulloch criteria score of 5/5 (two clinical symptoms and two clinical signs of sciatica, and diagnostic imaging confirming the presence of a herniated nucleus pulposus contacting a spinal nerve root at the appropriate level)

• fluency in spoken and written English to ensure subjects understand the content of questionnaires and consent

Exclusion Criteria:

• progressive neurological deficit

• spinal fracture

• spinal tumor

• spinal infection

• spinal nerve root motor score of less than 4/5

• spinal stenosis that is not attributable to a herniated disc

• any other significant spinal ailment or local or generalized co-morbidity ailment that could affect outcomes independently of SMT ( e.g. seronegative spondyloarthropathy, malignancy).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Acute Sciatica
• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation
• Radiculopathy
• Sciatica

Intervention

Other:
• Chiropractic Spinal Manipulative Therapy
Patients will receive a course high-velocity low-amplitude thrust spinal manipulation 3 times per week for 4 weeks.
• Usual Care
Patients will be under the care of the their general physician and will be allowed the following medications: gabapentin, pregabalin, nortriptyline, amitriptyline.

Locations

Country	Name	City	State
Canada	Integrated Spine Clinic, Blusson Spinal Cord Centre, Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Vancouver General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recruitment of eligible patients		The number of patients recruited per week for 19 months	No
Secondary	Cytokine and cytokine mRNA levels in serum.		Change from baseline cytokine and cytokine mRNA levels in serum 4 weeks prior to surgery or commencing chiropractic spinal manipulative therapy (CSMT).	No
Secondary	Cytokine and cytokine mRNA levels in serum		Change from baseline cytokine and mRNA levels in serum pre-surgery or following a 4-week course of CSMT.	No
Secondary	Cytokine and cytokine mRNA levels in serum		Change from baseline cytokine and mRNA levels in serum and 12 weeks post-surgery and/or post-CSMT	No
Secondary	Cytokine and cytokine mRNA levels in serum.		Change from baseline cytokine and mRNA levels in serum and 24 weeks post-surgery and/or post-CSMT	No
Secondary	Total mRNA levels (isolated from disc tissue and disc / periradicular lavage samples) of interleukins 1,10 and 11, MIP-1 beta TNF alpha, and chemotactic protein alpha.		Specimens will be harvested an average of 6 weeks post-randomization	No
Secondary	Modified Roland Disability Questionnaire (mRDQ) score and Visual Analogue Scale (VAS) pain scale.		Change from baseline and 4-weeks prior to surgery or commencing 4-weeks of CSMT.	No
Secondary	mRDQ and VAS		Change from baseline and pre-surgery or following a 4-week course of CSMT	No
Secondary	mRMQ and VAS		Change from baseline and 12 weeks post-surgery and/or post-CSMT	No
Secondary	mRDQ and VAS		Change from baseline and 24 weeks post-surgery and/or post-CSMT	No