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

• Sponsor: Southern California University of Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT03669354
• Collaborator: Dartmouth College (Other)
• Enrollment: 195
• Location: 1
• Actual Duration (Months): 14
• Patients Per Site Per Month: 13.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain

Detailed 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)

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 195 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Spinal Manipulation Services vs. Prescription Drug Therapy for Long-term Care of Aged Medicare Beneficiaries With Chronic Low Back Pain
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: Mar 6, 2020
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Self-reported QOL - Physical Health [Base line. The survey (outcome measure) will be administered at at day one.]

   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.

2. Satisfaction With Care [Base line.The survey (outcome measure) will be administered at day one.]

   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.

3. Beliefs Regarding Back Pain and Its Treatment [Base line.The survey (outcome measure) will be administered at at day one.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 64 Years to 84 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern California University of Health Sciences	Whittier	California	United States	90604

Sponsors and Collaborators

• Southern California University of Health Sciences
• Dartmouth College

Investigators

• Principal Investigator: Anupama Kizhakkeveettil, PhD, Southern California University of Health Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 2, 2018

More Information

Publications

None provided.

• Responsible Party: Anupama KizhakkeVeettil, Professor, Southern California University of Health Sciences
• ClinicalTrials.gov Identifier: NCT03669354
• Other Study ID Numbers: 1R15AT010035-01
• First Posted: Sep 13, 2018
• Last Update Posted: Sep 23, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Anupama KizhakkeVeettil, Professor, Southern California University of Health Sciences: Prescription Drugs; Spinal Manipulation
• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

Participant Flow

Arm/Group Title	Cohort SMT	Cohort OAT	SMTX	OATX
Arm/Group Description	Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT	Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT	Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management with OAT	Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT
Period Title: Overall Study
STARTED	73	22	47	53
COMPLETED	73	22	47	53
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Cohort SMT	Cohort OAT	Cohort SMTX	Cohort OATX	Total
Arm/Group Description	Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT	Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT	Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management with OAT	Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT	Total of all reporting groups
Overall Participants	73	22	47	53	195
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	78 (3.6)	78 (3.7)	78 (3.6)	77 (4.1)	78 (3.7)
Sex: Female, Male (Count of Participants)
Female	54 74%	0 0%	33 70.2%	0 0%	87 44.6%
Male	19 26%	0 0%	14 29.8%	0 0%	33 16.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	71 97.3%	19 86.4%	45 95.7%	50 94.3%	185 94.9%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Self-reported QOL - Physical Health
Description	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.
Time Frame	Base line. The survey (outcome measure) will be administered at at day one.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort SMT	Cohort OAT	Cohort SMTX	Cohort OATX
Arm/Group Description	Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT	Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT	Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management with OAT	Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT.
Measure Participants	73	22	47	53
Mean (Standard Deviation) [units on a scale]	41.7 (11.2)	28.8 (9.2)	31.8 (8.7)	32.9 (11.5)

2. Primary Outcome

Title	Satisfaction With Care
Description	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.
Time Frame	Base line.The survey (outcome measure) will be administered at day one.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort SMT	Cohort OAT	Cohort SMTX	Cohort OATX
Arm/Group Description	Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT	Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT	Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management with OAT	Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT
Measure Participants	73	22	47	53
Mean (Standard Deviation) [Score on a scale]	8.9 (1.7)	7.2 (2.5)	4.9 (3.33)	8.2 (2.5)

3. Primary Outcome

Title	Beliefs Regarding Back Pain and Its Treatment
Description	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.
Time Frame	Base line.The survey (outcome measure) will be administered at at day one.

Outcome Measure Data

Analysis Population Description

Not every participant responded to all the questions. Results account for missing data.

Arm/Group Title	Cohort SMT	Cohort OAT	Cohort SMTX	Cohort OATX
Arm/Group Description	Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT	Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT	Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management with OAT	Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT.
Measure Participants	71	21	46	51
Taking/having spinal manipulation for low back pain makes a lot of sense	68 93.2%	7 31.8%	33 70.2%	46 86.8%
Taking/having prescription drugs for low back pain makes a lot of sense	9 12.3%	19 86.4%	23 48.9%	16 30.2%
I think spinal manipulation is pretty useless for people with low back pain	5 6.8%	5 22.7%	41 87.2%	10 18.9%
I think taking prescription drugs are pretty useless for people with low back pain	34 46.6%	19 86.4%	14 29.8%	15 28.3%
I have concerns about taking/having spinal manipulation for my low back pain	49 67.1%	12 54.5%	6 12.8%	8 15.1%
I have concerns about taking/having prescription drugs for my low back pain	53 72.6%	5 22.7%	23 48.9%	29 54.7%
I am confident spinal manipulation would be suitable treatment for my low back pain	64 87.7%	5 22.7%	31 66%	41 77.4%
I am confident prescription drugs would be suitable treatment for my low back pain.	7 9.6%	19 86.4%	23 48.9%	12 22.6%

Adverse Events

Time Frame	"Adverse Events were not monitored/assessed"
Adverse Event Reporting Description	"Adverse Events were not monitored/assessed"
Arm/Group Title	Cohort SMT		Cohort OAT		Cohort SMTX		Cohort OATX
Arm/Group Description	Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT		Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT		Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management with OAT		Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT.
All Cause Mortality
	Cohort SMT		Cohort OAT		Cohort SMTX		Cohort OATX
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Cohort SMT		Cohort OAT		Cohort SMTX		Cohort OATX
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Cohort SMT		Cohort OAT		Cohort SMTX		Cohort OATX
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.