Osteopathic Health Outcomes in Chronic Low Back Pain (OSTEOPATHIC) Trial

A Randomized Controlled Trial of Osteopathic Manipulative Treatment and Ultrasound Physical Therapy for Chronic Low Back Pain

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00315120

Enrollment

455

Registered

2006-04-17

Start date

2006-08-31

Completion date

2011-01-31

Last updated

2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Randomized controlled trial, Low back pain, Spinal manipulative therapy, Spinal manipulation, Osteopathic manipulation, Osteopathic medicine, Physical therapy modalities

Brief summary

The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain.

Detailed description

Interventions

PROCEDUREA. Active OMT and active UST

Active osteopathic manipulation (OMT) and active ultrasound physical therapy (UST)

PROCEDUREB. Sham OMT and active UST

Sham osteopathic manipulation (OMT) and active ultrasound physical therapy (UST)

PROCEDUREC. Active OMT and sham UST

Active osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)

PROCEDURED. Sham OMT and sham UST

Sham osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 69 Years

Healthy volunteers

Inclusion criteria

* Must give a positive response to the question: Have you had low back pain constantly or on most days for the last three months? * Must identify the low back as the primary site of pain * Must agree to not receive any of the following outside of the study during the period of participation: osteopathic manipulative treatment, chiropractic adjustment (including mobilization or manipulation), physical therapy * Women must not be pregnant or plan to become pregnant during the period of study participation (a negative pregnancy test and willingness to maintain an acceptable method of contraception will be required)

Exclusion criteria

* History of any of the following conditions which may be underlying causes of low back symptoms: cancer, spinal osteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, cauda equina syndrome * History of surgery involving the low back within the past year or planned low back surgery in the future * History of receiving Workers' Compensation benefits within the past three months * Involvement in current litigation relating to back problems * Current pregnancy or plan to become pregnant during the course of participation in the study * Any of the following that may limit a provider's choice of osteopathic manipulative treatment techniques or hamper compliance with the study protocol: angina or congestive heart failure symptoms that occur at rest or with minimal activity, history of a stroke or transient ischemic attack within the past year * Any of the following that may represent potential contraindications to receiving ultrasound physical therapy: implantation of a cardiac pacemaker, implantation of artificial joints or other biomedical devices, active bleeding or infection in the low back, pregnancy * Use of intravenous, intramuscular, or oral corticosteroids within the past month * History of osteopathic manipulative treatment, chiropractic adjustment, or physical therapy within the past three months or on more than three occasions during the past year * Practitioner or student of any of the following: osteopathic medicine (D.O.) allopathic medicine (M.D.), chiropractic (D.C.), physical therapy

Design outcomes

Primary

Measure	Time frame	Description
Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)	12 weeks	Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a better outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a worse outcome). However, only those better outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%).
Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)	12 weeks	Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a better outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a worse outcome). However, only those better outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%).

Secondary

Measure	Time frame	Description
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12)	12 weeks	Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Roland Morris Disability Questionnaire (UST and Sham UST - Week 4)	4 weeks	Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Roland Morris Disability Questionnaire (UST and Sham UST - Week 8)	8 weeks	Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Roland Morris Disability Questionnaire (UST and Sham UST - Week 12)	12 weeks	Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)	4 weeks	The general health scale ranges from 0 to 100, with higher scores representing better general health.
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)	8 weeks	The general health scale ranges from 0 to 100, with higher scores representing better general health.
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)	12 weeks	The general health scale ranges from 0 to 100, with higher scores representing better general health.
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)	4 Weeks	The general health scale ranges from 0 to 100, with higher scores representing better general health.
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)	8 Weeks	The general health scale ranges from 0 to 100, with higher scores representing better general health.
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)	12 Weeks	The general health scale ranges from 0 to 100, with higher scores representing better general health.
Work Disability (OMT and Sham OMT - Week 4)	4 weeks	Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4)	4 weeks	Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
Work Disability (OMT and Sham OMT - Week 12)	12 weeks	Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Work Disability (UST and Sham UST - Week 4)	4 weeks	Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Work Disability (UST and Sham UST - Week 8)	8 weeks	Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Work Disability (UST and Sham UST - Week 12)	12 weeks	Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Satisfaction With Back Care (OMT and Sham OMT - Week 4)	4 weeks	Subjects who reported being very satisfied with back care
Satisfaction With Back Care (OMT and Sham OMT - Week 8)	8 weeks	Subjects who reported being very satisfied with back care
Satisfaction With Back Care (OMT and Sham OMT - Week 12)	12 weeks	Subjects who reported being very satisfied with back care
Satisfaction With Back Care (UST and Sham UST - Week 4)	4 weeks	Subjects who reported being very satisfied with back care
Satisfaction With Back Care (UST and Sham UST - Week 8)	8 weeks	Subjects who reported being very satisfied with back care
Satisfaction With Back Care (UST and Sham UST - Week 12)	12 weeks	Subjects who reported being very satisfied with back care
Work Disability (OMT and Sham OMT - Week 8)	8 weeks	Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8)	8 weeks	Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.

Countries

United States

Participant flow

Recruitment details

A total of 455 participants were recruited from the Dallas-Fort Worth, Texas metroplex from August 2006 to September 2010 through newspaper advertisements, community agencies, and medical clinics, excluding OMT specialty clinics.

Pre-assignment details

Participants were randomized after their study eligibility was confirmed by both telephonic and clinical screening examinations.

Participants by arm

Arm	Count
OMT + UST Active osteopathic manipulation and active ultrasound physical therapy	115
Sham OMT + UST Sham osteopathic manipulation and active ultrasound physical therapy	118
OMT + Sham UST Active osteopathic manipulation and sham ultrasound physical therapy	115
Sham OMT + Sham UST Sham osteopathic manipulation and sham ultrasound physical therapy	107
Total	455

Baseline characteristics

Characteristic	Sham OMT + UST	OMT + Sham UST	OMT + UST	Sham OMT + Sham UST	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	3 Participants	4 Participants	2 Participants	10 Participants
Age, Categorical Between 18 and 65 years	117 Participants	112 Participants	111 Participants	105 Participants	445 Participants
Age, Continuous	39.19 years STANDARD_DEVIATION 11.9	41.97 years STANDARD_DEVIATION 12.58	40.50 years STANDARD_DEVIATION 13.05	41.38 years STANDARD_DEVIATION 12.99	40.74 years STANDARD_DEVIATION 12.63
Region of Enrollment United States	118 participants	115 participants	115 participants	107 participants	455 participants
Sex: Female, Male Female	68 Participants	78 Participants	66 Participants	72 Participants	284 Participants
Sex: Female, Male Male	50 Participants	37 Participants	49 Participants	35 Participants	171 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	6 / 115	5 / 118	4 / 115	3 / 107
serious Total, serious adverse events	1 / 115	2 / 118	5 / 115	1 / 107

Outcome results

Primary

Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)

Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a better outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a worse outcome). However, only those better outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%).

Time frame: 12 weeks

Arm	Measure	Value (NUMBER)
Active OMT	Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)	32 participants
Sham OMT	Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)	28 participants

p-value: 0.7295% CI: [0.7, 1.7]Chi-squared

Primary

Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)

Time frame: 12 weeks

Arm	Measure	Value (NUMBER)
Active OMT	Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)	40 participants
Sham OMT	Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)	20 participants

p-value: 0.00795% CI: [1.2, 3.2]Chi-squared

Secondary

Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)

The general health scale ranges from 0 to 100, with higher scores representing better general health.

Time frame: 12 weeks

Arm	Measure	Value (MEDIAN)
Active OMT	Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)	72 SF-36 General Health Score
Sham OMT	Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)	72 SF-36 General Health Score

Secondary

Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)

The general health scale ranges from 0 to 100, with higher scores representing better general health.

Time frame: 4 weeks

Arm	Measure	Value (MEDIAN)
Active OMT	Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)	71 SF-36 General Health Score
Sham OMT	Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)	72 SF-36 General Health Score

Secondary

Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)

The general health scale ranges from 0 to 100, with higher scores representing better general health.

Time frame: 8 weeks

Arm	Measure	Value (MEDIAN)
Active OMT	Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)	72 SF-36 General Health Score
Sham OMT	Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)	72 SF-36 General Health Score

Secondary

Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)

The general health scale ranges from 0 to 100, with higher scores representing better general health.

Time frame: 12 Weeks

Arm	Measure	Value (MEDIAN)
Active OMT	Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)	72 SF-36 General Health Score
Sham OMT	Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)	74 SF-36 General Health Score

Secondary

Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)

The general health scale ranges from 0 to 100, with higher scores representing better general health.

Time frame: 4 Weeks

Arm	Measure	Value (MEDIAN)
Active OMT	Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)	72 SF-36 General Health Score
Sham OMT	Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)	72 SF-36 General Health Score

Secondary

Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)

The general health scale ranges from 0 to 100, with higher scores representing better general health.

Time frame: 8 Weeks

Arm	Measure	Value (MEDIAN)
Active OMT	Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)	72 SF-36 General Health Score
Sham OMT	Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)	72 SF-36 General Health Score

Secondary