Management Strategies for Patients With Low Back Pain and Sciatica

NCT02391350 | Completed Results DMC

• 1 other identifier: R18HS022641
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain and sciatica is a common condition resulting in high costs and disability for society and affected individuals. Presently there is a lack of evidence for what treatments may help this condition early in the course of care. Improved early management could reduce risks for persistent disability and high costs. The goal of this project is to examine the clinical outcomes and costs associated with adding a physical therapy program to early management of patients with low back pain and sciatica within primary care.

Conditions

Low Back Pain; Sciatica; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Oswestry Disability Index

  Patient-reported disability due to low back pain. Scores range from 0-100 with higher scores indicating greater disability.

  Baseline, 4 weeks, 6 months, 1 year

Secondary Outcomes (2)

• Change From Baseline in Numeric Pain Ratings

  Baseline, 4 weeks, 6 months, 1 year

• Change From Baseline in EQ-5D

  Baseline, 4 weeks, 6 months, 1 year

Other Outcomes (3)

• Change From Baseline in Fear-Avoidance Beliefs

  Baseline, 4 weeks, 6 months, 1 year

• Change From Baseline in Pain Catastrophizing Scale

  Baseline, 4 weeks, 6 months, 1 year

• Number of Participants Utilizing Healthcare

  monthly throughout 12 month follow-up period

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.

Behavioral: Education and re-assurance

Early Intervention

EXPERIMENTAL

Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.

Behavioral: Education and re-assurance; Procedure: Physical Therapy

Interventions

Education and re-assurance BEHAVIORAL

Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.

Early Intervention; Usual Care

Physical Therapy PROCEDURE

Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.

Early Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Symptoms of pain and/or numbness between the 12th rib and buttocks, which, in the opinion of the primary care provider, are originating from tissues of the lumbar region.
• Symptoms of pain and/or numbness primarily into one leg that have extended below the knee in the last 72 hours, and correspond to a lower lumbar nerve root distribution (L4, L5, S1)
• Current symptoms present for 90 days or fewer
• Oswestry disability score \> 20%
• One or more of the following symptoms:
• Positive ipsilateral or contralateral straight leg raise test (reproduction of symptoms at \<70 degrees)
• Reflex, sensory, or strength deficits in a pattern consistent with lower lumbar nerve root

You may not qualify if:

• Any prior spine fusion surgery, or any surgery to the lumbosacral spine in the past year
• Current pregnancy
• Currently receiving treatment for LBP from another healthcare provider (e.g., chiropractic, massage therapy, injections, etc.) or any treatment for LBP in prior 6 months.
• Judgment of primary care provider of "red flags" of a potentially serious condition including cauda equina, major or rapidly progressing neurologic deficit, fracture, cancer, infection or systemic disease

Sponsors & Collaborators

• University of Utah: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

The University of Utah Healthcare System

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• Fritz JM, Lane E, McFadden M, Brennan G, Magel JS, Thackeray A, Minick K, Meier W, Greene T. Physical Therapy Referral From Primary Care for Acute Back Pain With Sciatica : A Randomized Controlled Trial. Ann Intern Med. 2021 Jan;174(1):8-17. doi: 10.7326/M20-4187. Epub 2020 Oct 6.

  PMID: 33017565 DERIVED

MeSH Terms

Conditions

Low Back Pain; Sciatica

Interventions

Educational Status; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Therapeutics; Rehabilitation

Results Point of Contact

• Title: Dr. Julie Fritz
• Organization: University of Utah

julie.fritz@utah.edu

8015872237

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: March 18, 2015
• Study Start: February 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 22, 2021
• Results First Posted: December 24, 2020

Record last verified: 2020-12

Locations

US (1)