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

NCT03669354 | Completed Results DMC

• 1 other identifier: 1R15AT010035-01
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain

Keywords

Prescription Drugs; Spinal Manipulation

Outcome Measures

Primary Outcomes (3)

• Self-reported QOL - Physical Health

  1. Self-reported Quality of Life 2. Scale range- There are 12 questions with scales of categorical values. Corresponding numeric values will be given to each category. 3. Value range from "0" to "100" 4. Higher scores reflecting better outcomes.

  Base line. The survey (outcome measure) will be administered at at day one.

• Satisfaction With Care

  1. Satisfaction with the Care 2. 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. 3. Higher numerical values indicate more satisfaction.

  Base line.The survey (outcome measure) will be administered at day one.

• Beliefs Regarding Back Pain and Its Treatment

  1. Beliefs about Treatments for Low Back Pain 2. Scale range- Categorical values of Strongly disagree, Disagree, Undecided, Agree, Strongly agree (corresponding to numeric value 1, 2, 3, 4, and 5). 3. 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). 4. 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.

Study Arms (4)

Cohort SMT

Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT

Cohort OAT

Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT

Cohort SMTX

Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management with OAT

Cohort OATX

Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT

Eligibility Criteria

• Age: 64 Years - 84 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target demographic is 65-84 year old Medicare beneficiaries who were treated for at least one episode of low back pain and were enrolled in Medicare Parts A, B, and D.

You may qualify if:

• \- 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern California University of Health Sciences: lead
• Dartmouth College: collaborator

Study Sites (1)

Southern California University of Health Sciences

Whittier, California, 90604, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The overall response rate was lower than expected and we observed an age difference between respondents and non-respondents. In addition, recall bias is a potential limitation.

Results Point of Contact

• Title: Anupama Kizhakkeveettil
• Organization: Southern California University Of Health Sciences

anu@scuhs.edu

(562) 475-5158

Study Officials

• Anupama Kizhakkeveettil, PhD

  Southern California University of Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: September 13, 2018
• Study Start: May 1, 2019
• Primary Completion: March 6, 2020
• Study Completion: June 30, 2020
• Last Updated: September 23, 2021
• Results First Posted: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)