Spinal Manipulation Services vs. Prescription Drug Therapy for Long-term Care

Low Back Pain Clinical Trial

Official title:

Spinal Manipulation Services vs. Prescription Drug Therapy for Long-term Care of Aged Medicare Beneficiaries With Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669354
• Other study ID #: 1R15AT010035-01
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2021
• Source: Southern California University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Our overall objective is to assess the value of Spinal Manipulation Services as compared to Prescription Drug Therapy for long-term management of chronic Law back Pain (LBP). Our central hypothesis is that among aged Medicare beneficiaries with chronic LBP, utilization of SMS offers superior value (to both patient and payer) for long-term care as compared to PDT.

Description:

Research Design

This description applies to project specific aim 2.

Overview of Design and Methods: FFS Medicare beneficiaries will be surveyed and compared by cohort for differences in response. Subjects will be randomly sampled from each of the four cohorts (A, B, A2B & B2A) identified in SA1.

Survey Instrument and Question Formulation: A validated survey instrument will be used to collect subjective patient data. The survey will include questionnaires intended to evaluate 1) self-reported QOL, 2) satisfaction with care, and 3) beliefs regarding back pain and its treatment. For assessment of self-reported QOL a version of the SF12 (Ware '96) will be used and modified to account for time lapse between treatment for LBP and administration of the survey, and to elicit treatment-specific responses The SF -12 has been previously validated for measuring QOL among elderly patients, (Jakobsson '07) and patients using prescription drugs. (Naveiro-Rilo '14) For assessment of satisfaction with care a 0-10 numeric scale will be used. For assessment of beliefs a modified version of the validated LBP Treatment Beliefs Questionnaire will be used. (Dima '15). A pre- test of all the survey instruments will be conducted by distributing a prototype to a sample of 100 Medicare beneficiaries seen for LBP at the SCU Health Center in Whittier, CA. Responses to the survey pre-test will inform any need to edit the questionnaire for comprehensibility and ease of use, thus helping to ensure instrument face validity. For ease of comprehension by older subjects, the survey questions will be printed in large font and will be carefully worded to be brief, unambiguous, and free of bias.

Survey Methods: ResDAC will initiate contact with random samples of beneficiaries who meet criteria for inclusion in the cohorts identified in SA1. The Beneficiary Contact Service has reviewed the survey plan with the PIs and provided an official cost estimate for this service, which is routinely provided by the BCS with strict attention to patient protection. Initial contact will be in the form of a Beneficiary Notification Letter, signed by the CMS Privacy Officer. The letter will alert beneficiaries to the opportunity to voluntarily participate in a healthcare survey. Recipients will be informed that they may decline participation via enclosed reply forms, and will be given phone numbers to call CMS personnel for additional information. After three weeks, the Beneficiary Contact Service will supply the investigators with contact information for eligible beneficiaries (those who did not decline to participate). The survey will be commenced by mailing the printed survey, cover letter with informed consent form based on NCCIH guidelines, and a postage-paid return envelope with detailed information about the survey. Participants can contact study personnel if they have any questions. Follow up by phone after every two weeks or as needed will be used to increase the rate of response.

Outcomes Measurement and Statistical Analysis: Testing will be done for between-cohort differences in self-reported QOL, satisfaction with care, and beliefs about treatments for LBP. Survey responses between the four groups will be compared using Pearson chi-square tests and ANOVA. Demographic characteristics [e.g. sex as a biological variable, and age - because age-related cognitive decline can affect survey responses (Wolinsky '15)] will be controlled using linear regression for continuous survey items, proportional odds logistic regression for ordinal items and multinomial regression for categorical items. In the multivariable regression models equivalence between the four groups will be evaluated using likelihood ratio or Wald tests. Given the multiplicity of testing (e.g. multiple groups for multiple items), type I error inflation will be considered through used of Bonferonni corrections or approaches for false discovery rates. Parametric tests of numeric data can be used to yield unbiased answers when analyzing Likert scale responses. (Norman '10)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: June 30, 2020
• Est. primary completion date: March 6, 2020
• Gender: All
• Age group: 64 Years to 84 Years

Eligibility

Inclusion Criteria:

• Subjects will include Medicare Fee for Service beneficiaries (male or female), aged 65-84 years, residing in the US, and enrolled under Medicare Parts A, B, and D who have experienced an episode of chronic low back pain (defined as lasting three months or longer).

Exclusion Criteria:

• Subjects with diagnosis of cancer will be excluded from the study population to avoid confounding of the reason for use of prescription opioids. Subjects over the age of 85 will also be excluded.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Locations

Country	Name	City	State
United States	Southern California University of Health Sciences	Whittier	California

Sponsors (2)

Lead Sponsor	Collaborator
Southern California University of Health Sciences	Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported QOL - Physical Health	Self-reported Quality of Life; Scale range- There are 12 questions with scales of categorical values. Corresponding numeric values will be given to each category.; Value range from "0" to "100"; Higher scores reflecting better outcomes.	Base line. The survey (outcome measure) will be administered at at day one.
Primary	Satisfaction With Care	Satisfaction with the Care; The survey measured satisfaction for both SMT and PDT on a scale from 0-10, "0" being very dissatisfied and "10" being very satisfied. The patients were also given an option to select 'not applicable' if they never experienced either PDT or SMT.; Higher numerical values indicate more satisfaction.	Base line.The survey (outcome measure) will be administered at day one.
Primary	Beliefs Regarding Back Pain and Its Treatment	Beliefs about Treatments for Low Back Pain; Scale range- Categorical values of Strongly disagree, Disagree, Undecided, Agree, Strongly agree (corresponding to numeric value 1, 2, 3, 4, and 5).; For purposes of analysis, we combined the response options into the following three categories: "Disagree" (Strongly Disagree and Disagree), "Agree" (Strongly Agree and Agree), and "Undecided"(left as is).; For interpreting the results for this scale, we reported only the number of people who agreed with the statements.	Base line.The survey (outcome measure) will be administered at at day one.