Artigo Científico

Licciardone et al • Original Contribution JAOA • Vol 104 • No 5 • May 2004 • 193

Context: Preliminary study results suggest that osteopathic

manipulative treatment (OMT) may reduce pain, improve

ambulation, and increase rehabilitation efficiency in patients

undergoing knee or hip arthroplasty.

Objective: To determine the efficacy of OMT in patients

who recently underwent surgery for knee or hip

osteoarthritis or for a hip fracture.

Design: Randomized controlled trial involving hospital and

postdischarge phases.

Setting: Hospital-based acute rehabilitation unit.

Patients: A total of 42 women and 18 men who were hospitalized

between October 1998 and August 1999.

Intervention: Patients were randomly assigned to groups

that received either OMT or sham treatment in addition to

standard care. Manipulation was individualized and performed

according to study guidelines regarding frequency,

duration, and technique.

Main Outcome Measures: Changes in Functional Independence

Measure (FIM) scores and in daily analgesic use

during the rehabilitation unit stay; length of stay; rehabilitation

efficiency—defined as the FIM total score change per

rehabilitation unit day; and changes in Medical Outcomes

Study Short Form-36 scores from rehabilitation unit admission

to 4 weeks after discharge.

Results: Of 19 primary outcome measures, the only significant

difference between groups was decreased rehabilitation

efficiency with OMT (2.0 vs 2.6 FIM total score points per day;

P.01). Stratified analyses demonstrated that poorer OMT

outcomes were confined to patients with osteoarthritis who

underwent total knee arthroplasty (length of stay, 15.0 vs

8.3 days; P.004; rehabilitation efficiency, 2.1 vs 3.4 FIM

total score points per day; P.001).

Conclusion: The OMT protocol used does not appear to be

efficacious in this hospital rehabilitation population.

Spinal manipulation can be helpful for patients with acute

low back problems without radiculopathy when initiated

within the first month of symptoms.1 A clinical trial of

osteopathic manipulative treatment (OMT) in patients with

low back pain for at least 3 weeks, but less than 6 months,

failed to demonstrate a benefit in primary outcomes in 12

weeks. However, patients who received OMT required less

medication and less physical therapy than patients who

received standard care.2 Despite growing evidence on the

efficacy of OMT in certain acute and subacute musculoskeletal

conditions, the role of OMT in treating chronic conditions

remains largely unknown.

Osteopathic manipulative treatment has been advocated

as a therapy for patients with rheumatic diseases,3,4 though

definitive evidence of efficacy is lacking. In addition, manipulation

is believed to play an important part in the management

of each stage of osteoarthritis, from early conservative

to postsurgical treatment.5 Osteopathic manipulative treatment

has also been advocated in the treatment of patients with

hip fractures for pain control and to facilitate patients’ return

to a nonhospital environment in the geriatric population.6

The rehabilitation setting provides an opportunity to

learn more about the efficacy of OMT in patients with debilitating

conditions, such as osteoarthritis and hip fracture.

The two preliminary studies that suggest OMT’s efficacy in

the postsurgical period in patients undergoing knee or hip

arthroplasty are limited by methodologic shortcomings.7,8

In a clinical outcome study, decreases in pain perception and

increases in ambulation in patients who received OMT were

reported; however, it is not clear whether outcomes were

A Randomized Controlled Trial of Osteopathic Manipulative Treatment

Following Knee or Hip Arthroplasty

John C. Licciardone, DO, MS; Scott T. Stoll, DO, PhD; Kathryn M. Cardarelli, MPH;

Russell G. Gamber, DO; Jon N. Swift, Jr, DO; William B. Winn, DO

From the University of North Texas Health Science Center at Fort Worth–Texas

College of Osteopathic Medicine (Licciardone, Stoll, Gamber); the University

of Texas School of Public Health, Houston (Cardarelli); Mayo Clinic, Rochester,

Minn (Swift); and the College of Education and Health Professions, University

of Arkansas (Winn).

Supported by grants from the American Osteopathic Association, the

Osteopathic Health System of Texas Foundation, and the Carl Everett Charitable

Lead Trust Fund.

Address correspondence to John C. Licciardone, DO, MS, University of North

Texas Health Science Center at Fort Worth–Texas College of Osteopathic

Medicine, 3500 Camp Bowie Blvd, Fort Worth, TX 76107.

E-mail: jlicciar@hsc.unt.edu

ORIGINAL CONTRIBUTION

194 • JAOA • Vol 104 • No 5 • May 2004

measured by blinded investigators, and controls did not

receive any type of placebo.7 The other study found significant

improvements in locomotion and in rehabilitation efficiency

in patients who received OMT.8 Patients in the latter

study were not randomly assigned to groups, and controls—

selected from different hospitals than patients who received

OMT—did not receive a placebo intervention.

The purpose of the present study was to further assess

the efficacy of OMT in patients who recently underwent

knee or hip surgery for chronic osteoarthritis or hip fractures.

Methods

Experimental Design

This was a randomized, double-blind, placebo-controlled trial

of OMT in patients who recently underwent knee or hip

surgery for chronic osteoarthritis or a hip fracture. The study

was conducted between October 1998 and August 1999 in the

rehabilitation unit of the Osteopathic Medical Center of Texas,

Fort Worth. This hospital is a medical training site for the University

of North Texas Health Science Center.

The rehabilitation unit was managed by a proprietary

entity that administered acute inpatient facilities nationwide.

Licciardone et al • Original Contribution

Table 1

Description of Osteopathic Manipulative Treatment Techniques

Allowed in the Research Protocol*

Technique Description

Myofascial release Involves passive palpatory feedback by the

operator to achieve release of myofascial tissues.

This may involve a direct technique in which the

restrictive barrier is engaged and then loaded

with a constant force by the operator until

release occurs, or it may involve an indirect

technique in which myofascial tissue is guided

along the path of least resistance until release

occurs.

Strain/counterstrain Involves a gentle, passive force to inhibit

inappropriate strain reflexes that are manifested

by specific point tenderness.

Muscle energy Involves directed patient movement from a

precisely controlled position against a defined

resistance by the operator. This technique may be

used to mobilize restricted joints, stretch tight

muscles and fascia, improve local circulation, and

balance neuromuscular relationships to alter

muscle tone.

Soft tissue Involves tissues other than skeletal or arthrodial

elements. This usually involves lateral stretching,

linear stretching, deep pressure, traction, or

separation of muscle origin and insertion, while

monitoring tissue response and motion changes

by palpation.

High-velocity low-amplitude Involves the application of a passive force by the

operator over a short distance to mobilize a

restricted joint.

Craniosacral Involves the primary respiratory mechanism based

on the interdependent functions of the cranial

bones, brain and spinal cord, intracranial and

intraspinal membranes, cerebrospinal fluid, and

the sacrum.

*Adapted from the Glossary of Osteopathic Terminology, available at

http://www.osteopathic.org/index.cfm?PageID=ost_glossary.

ORIGINAL CONTRIBUTION

JAOA • Vol 104 • No 5 • May 2004 • 195

rules regarding frequency, dose, technique, and sequence of

OMT. Individual treatment was also used because patients

may respond to a given technique in different ways.11

Precoded cards in sealed envelopes were used to randomly

allocate patients to groups that received either OMT or

sham treatment, with both procedures performed by the same

undergraduate fellows according to the preceding guidelines.

Sham treatment consisted of range-of-motion activities and

light touch. These placebo techniques were applied to anatomic

regions identified in the osteopathic evaluation and treatment

plan; however, these manually applied forces were of substantially

decreased magnitude and were purposely aimed

at avoiding key areas of somatic dysfunction.

Measures and Outcomes

Baseline data, collected on admission to the rehabilitation unit,

included demographic characteristics, health insurance coverage,

medical diagnoses, type of surgery, health status before

admission, functional assessment, and daily analgesic medication

use. Demographic variables included age, gender, race,

and marital status.

Standardized health measures were derived using the

Medical Outcomes Study Short Form-36 (SF-36) and the Functional

Independence Measure (FIM). The SF-36 is a valid, reliable,

and widely used measure of health that provides scores

in eight health scales. These scales include physical functioning,

role limitations due to physical problems, bodily pain,

general health perceptions, vitality, social functioning, role

limitations due to emotional problems, and mental health.12 In

osteoarthritis patients, following total knee arthroplasty, SF-36

scores for physical functioning and role limitations due to

physical problems are significantly correlated with the condition-

specific Knee Society function score.13 The SF-36 is equal

or superior to the Sickness Impact Profile, a more established

and longer instrument, in detecting physical and global health

changes associated with hip arthroplasty.14

During the hospital phase of the study, the research coordinator

conducted SF-36 face-to-face interviews at admission

to and discharge from the rehabilitation unit. The discharge

interview addressed only general health perceptions, vitality,

and mental health, as the five remaining SF-36 health scales are

based on physical or social activities that cannot be done in a

hospital rehabilitation unit. The research coordinator subsequently

conducted SF-36 telephone interviews 4 weeks after

discharge from the rehabilitation unit. Patient responses were

transformed using established scoring algorithms to generate

standardized health scale scores ranging from 0 to 100 (worst

to best possible health).12

The FIM instrument is the functional assessment measure

of the Uniform Data System for Medical Rehabilitation.15,16

Because of its use in hospital rehabilitation settings, the instrument

was used in the current study to complement the SF-36’s

generic measures of health. The FIM includes 18 items that

measure functional independence in 6 subscales: self-care,

Therefore, all patients received care that was consistent with

the national standard for acute inpatient rehabilitation. The only

experimental intervention was the addition of either OMT or

sham treatment to standard care in rehabilitation. The institutional

review board of the University of North Texas Health

Science Center approved all procedures.

Patients

The admissions director of the rehabilitation unit screened

patients who were 50 years of age or older to determine

whether they met study inclusion criteria: (1) hospitalized

with a primary diagnosis of knee or hip osteoarthritis, or hip

fracture; and (2) underwent any of the following surgical procedures

within 1 week before rehabilitation unit admission:

arthroplasty for knee or hip osteoarthritis; arthroplasty for a hip

fracture; open reduction–internal fixation for a hip fracture; or

revision of a previous knee or hip arthroplasty. Patients who

met these screening criteria were interviewed by the research

coordinator. This evaluation included a review of the medical

record to confirm study eligibility and an assessment of cognitive

performance using the Mini-Mental State Examination.9

The research coordinator administered verbal and written

informed consent to all eligible patients judged to be mentally

competent to participate within 72 hours of admission.

Randomization and Interventions

Participants were evaluated by an OMT specialist to identify

areas of somatic dysfunction, defined as “impaired or altered

function of related components of the somatic (body framework)

system; skeletal, arthrodial, and myofascial structures;

and related vascular, lymphatic, and neural elements.”10 This

evaluation served as the basis for an individualized OMT plan

for the rehabilitation unit stay. These individualized plans

focused on the anatomic region surrounding the surgical site

but allowed for manipulation of secondary regions if indicated.

Treatments were performed by undergraduate fellows

within the Department of Osteopathic Manipulative Medicine

at the University of North Texas Health Science Center at Fort

Worth–Texas College of Osteopathic Medicine. Although these

select medical students complete an additional year of training

in osteopathic principles and OMT before receiving their osteopathic

medical degree, students were still in the training process

while providing OMT in this study.

These fellows provided OMT according to the following

guidelines: (1) 2 to 5 sessions weekly; (2) no more than 2 days

between sessions; (3) 10- to 30-minute sessions; (4) one or a combination

of the following techniques: myofascial release;

strain/counterstrain; muscle energy; soft tissue; high-velocity

low-amplitude (not at the surgical site); or craniosacral manipulation.

Treatment guidelines reflect an intensity of OMT that

may be available in most hospital rehabilitation units. These

techniques, described in Table 1, are well-accepted modes of

OMT.11 Treatment was individualized, as there are no absolute

Licciardone et al • Original Contribution

ORIGINAL CONTRIBUTION

196 • JAOA • Vol 104 • No 5 • May 2004

sphincter control, mobility, locomotion, communication, and

social cognition.17,18 Each item is rated on a seven-point scale

that represents different gradations of independence and

reflects the amount of assistance the patient requires to perform

a specific activity. Independence is categorized and scored as

complete independence, 7; modified independence, 6; requires

supervision or setup, 5; requires minimal contact assistance, 4;

requires moderate assistance, 3; requires maximal assistance,

2; and requires total assistance, 1.18

These ordinal-scale responses closely approximate intervalscale

data except at the endpoints of the scales.19 The scores on

each scale may be summed to generate a total score, and

changes over time may be used to measure rehabilitation outcomes.

19 Functional Independence Measure performance has

been validated in rehabilitation inpatients, including those

with orthopedic conditions.20 Trained rehabilitation unit personnel,

including nurses and speech, occupational, and physical

therapists, scored the FIM items on admission to and discharge

from the rehabilitation unit.

The primary outcome measures were changes in FIM

subscale and total scores and in daily analgesic use during

the rehabilitation unit stay; length of stay; rehabilitation efficiency—

defined as the FIM total score change per rehabilitation

unit day15; and changes in SF-36 health scale scores from

rehabilitation unit admission to 4 weeks after discharge. All

study personnel who were responsible for developing OMT

Licciardone et al • Original Contribution

ORIGINAL CONTRIBUTION

Table 2

Baseline Characteristics of Study Participants*

All Participants OMT Group Sham Treatment Group

Characteristic (n60) (n30) (n30) P

Age, y 69.2 (10.3) 68.2 (10.7) 70.2 (10.0) .46

Sex, No. (%) .57

Female 42 (70) 20 (67) 22 (73)

Male 18 (30) 10 (33) 8 (27)

Race, No. (%) .77

White 45 (75) 22 (73) 23 (77)

Nonwhite 15 (25) 8 (27) 7 (23)

Marital status, No. (%) .60

Married 26 (43) 14 (47) 12 (40)

Not married 34 (57) 16 (53) 18 (60)

Health insurance, No. (%) .42

Medicare 25 (42) 11 (37) 14 (47)

HMO or PPO 23 (38) 11 (37) 12 (40)

Other 12 (20) 8 (27) 4 (13)

Primary diagnosis, No. (%) .08

Osteoarthritis (knee or hip) 44 (73) 25 (8) 19 (63)

Hip fracture 16 (27) 5 (17) 11 (37)

Comorbidities, No. 4.2 (2.1) 4.2 (2.3) 4.2 (1.8) .95

Surgery, No. (%) .07

Knee arthroplasty 30 (50) 19 (63) 11 (37)

Hip arthroplasty 27 (45) 9 (30) 18 (60)

Open reduction-internal fixation 3 (5) 2 (7) 1 (3)

Hospital stay before rehabilitation, d 4.2 (3.7) 3.7 (2.1) 4.6 (4.8) .35

* Values are expressed as mean (SD) unless otherwise indicated. A higher score represents better health or

functioning on both the SF-36 and FIM scales. P values are for the differences between OMT and sham treatment groups.

OMT indicates osteopathic manipulative treatment; HMO, health maintenance organization; PPO, preferred provider organization.

(continued)

ORIGINAL CONTRIBUTION

JAOA • Vol 104 • No 5 • May 2004 • 197

variance, with Tukey’s post-hoc test, for continuous variables.

Differences between OMT and sham-treatment patients were

assessed using the chi-square test for categoric variables and

the Student t-test for continuous variables. As the SF-36 general

health perceptions, vitality, and mental health scales were

measured three times (at rehabilitation unit admission, discharge,

and 4 weeks after discharge), repeated measures analysis

of variance was used to assess these outcomes. Analysis

of covariance was used to adjust for potential confounding

of study outcomes. Stratified analyses were used to determine

the efficacy of OMT in patients with osteoarthritis or hip fracture

and for each surgical site among patients with

osteoarthritis.

plans or measuring primary outcomes were blinded to group

assignments. The only personnel aware of these assignments

were the undergraduate fellows who performed OMT and

sham treatments; however, they did not measure any of the

study outcomes.

Statistical Analysis

Baseline measures were summarized using descriptive statistics.

Comparisons of patients who completed the hospital

phase of the study, eligible patients who refused to participate

or who did not complete the hospital phase, and patients

who were ineligible because of dementia were made using

the chi-square test for categorical variables and analysis of

Licciardone et al • Original Contribution

Table 2

Baseline Characteristics of Study Participants* (continued)

All Participants OMT Group Sham Treatment Group

Characteristic (n60) (n30) (n30) P

Analgesic medication, mg/d†

Acetaminophen 2801 (1829) 2899 (1642) 2699 (2030) .68

Hydrocodone 30.1 (17.3) 31.0 (14.8) 29.0 (20.4) .71

SF-36 health scale score‡

Physical functioning 38.1 (27.1) 39.0 (27.6) 37.1 (27.1) .79

Role limitations, physical 19.9 (35.9) 21.7 (37.6) 18.1 (34.7) .71

Bodily pain 38.5 (31.6) 31.0 (27.5) 46.3 (34.2) .06

General health 61.2 (25.1) 60.7 (24.6) 61.8 (26.1) .86

Vitality 32.5 (22.2) 32.5 (20.7) 32.5 (24.0) .99

Social functioning 53.4 (30.9) 52.5 (30.4) 54.3 (31.9) .82

Role limitations, emotional 53.7 (47.1) 50.0 (47.7) 57.5 (47.1) .55

Mental health 67.6 (20.8) 62.1 (22.2) 73.1 (18.0) .04

FIM subscale score§

Self-care 4.5 (0.7) 4.6 (0.8) 4.4 (0.6) .35

Sphincter control 4.5 (1.8) 4.4 (1.8) 4.6 (1.8) .62

Mobility 3.4 (1.1) 3.4 (1.1) 3.4 (1.0) .91

Locomotion 1.5 (0.7) 1.3 (0.5) 1.8 (0.8) .01

Communication 6.6 (0.7) 6.7 (0.6) 6.6 (0.7) .77

Social cognition 6.6 (0.6) 6.6 (0.7) 6.6 (0.6) .58

FIM total score at admission§ 82.0 (11.3) 81.8 (11.9) 82.3 (10.9) .86

FIM total score discharge goal§ 108.5 (7.8) 107.7 (8.1) 109.3 (7.6) .45

* Values are expressed as mean (SD) unless otherwise indicated. A higher score represents better health or

functioning on both the SF-36 and FIM scales. P values are for the differences between OMT and sham treatment groups.

† Acetaminophen (29 patients in the OMT group, 28 patients in the sham treatment group) and hydrocodone

(25 patients in the OMT group, 20 patients in the sham treatment group) were the two analgesics used by most of the patients.

Most patients used multiple analgesics.

‡ The SF-36 health scales were scored from 0 to 100 (worst to best possible score).

§ The FIM subscales and total were scored from 1 to 7 and 18 to 126, respectively (worst to best possible score).

OMT indicates osteopathic manipulative treatment; HMO, health maintenance organization; PPO, preferred provider organization;

SF-36, Medical Outcomes Study Short Form 36; FIM, Functional Independence Measure.

198 • JAOA • Vol 104 • No 5 • May 2004

Based on well-established data, we estimated the sample

size to have 80% power in detecting 11- to 20-point or greater

group differences in the SF-36 health scales.12 Using more

preliminary experience,8 we estimated that the sample size

provided 80% power in detecting 9-point or greater group

differences in FIM total score change and 7-day or greater

group differences in length of stay. Any of these outcomes is

considered not only to be statistically significant, but also clinically

relevant.12,20 All hypotheses were tested at the .05 level

of significance using two-tailed statistics. Statistical analyses

were performed using SYSTAT 7.0 for Windows (Systat Software

Inc, Richmond, Calif).

Results

Recruitment and Follow-up of Patients

Patient flow and retention are summarized in the Figure. Of 96

potentially eligible patients, 16 were excluded because of

dementia. Among the remaining 80 patients, 11 refused to

Licciardone et al • Original Contribution

ORIGINAL CONTRIBUTION

Table 3

Primary Outcome Measures*

OMT Group Sham Treatment Group

Measure (n30) (n30) P

Change from rehabilitation unit

admission to discharge

FIM subscale score†

Self-care 1.6 (0.6) 1.7 (0.5) .33

Sphincter control 2.1 (1.6) 1.6 (1.7) .28

Mobility 2.3 (0.9) 2.3 (0.9) .93

Locomotion 2.9 (1.1) 2.8 (1.1) .64

Communication 0.0 (0.1) 0.1 (0.4) .47

Social cognition 0.1 (0.2) 0.0 (0.1) .39

FIM total score† 26.5 (7.0) 26.2 (6.5) .86

Analgesic medication, mg/d

Acetaminophen 741 (1471) 371 (1715) .39

Hydrocodone 9.9 (16.9) 8.0 (13.3) .68

At rehabilitation unit discharge

Length of stay, d 15.4 (6.6) 12.3 (7.4) .09

Rehabilitation efficiency‡ 2.0 (0.7) 2.6 (1.1) .01

Change from rehabilitation unit

admission to 4 weeks after discharge

SF-36 health scale score§

Physical functioning 10.0 (31.3) 15.0 (27.2) .55

Role limitations, physical 16.3 (42.4) 7.0 (37.9) .41

Bodily pain 22.9 (36.7) 13.3 (38.0) .37

General health 4.9 (19.9) 3.3 (17.9) .76

Vitality 9.2 (23.2) 9.0 (33.7) .98

Social functioning 16.4 (41.5) 1.0 (32.5) .15

Role limitations, emotional 24.4 (58.5) 22.7 (45.9) .91

Mental health 10.6 (23.4) 4.8 (12.7) .27

* Values are expressed as mean (SD). Positive changes on the SF-36 and FIM represent improvements.

Negative changes for analgesic medication represent decreased use.

† The FIM subscales and total were scored from 1 to 7 and 18 to 126, respectively (worst to best possible score).

‡ Rehabilitation efficiency was computed as the FIM total score change per rehabilitation unit day.

§ The SF-36 health scales were scored from 0 to 100 (worst to best possible score).

OMT indicates osteopathic manipulative treatment; FIM, Functional Independence Measure;

SF-36, Medical Outcomes Study Short Form 36.

JAOA • Vol 104 • No 5 • May 2004 • 199

rehabilitation unit for extraneous reasons (2 were transferred

because of inadequate health insurance coverage and 1 was

transferred because of a cardiac complication). Patients with

dementia were significantly older than those who completed

the hospital phase of the study (78.1 vs 69.2 years; P.01) and,

participate, 3 were admitted during nonrecruitment intervals

(holidays during which study personnel were not available),

3 were randomly assigned but discharged before initial osteopathic

evaluation or before receiving any treatment, and 3

were randomly assigned but prematurely transferred out of the

Licciardone et al • Original Contribution

ORIGINAL CONTRIBUTION

Table 4

Primary Outcome Measures in Osteoarthritis Patients*

All Osteoarthritis Patients Knee Osteoarthritis Patients

Sham Sham

OMT Treatment OMT Treatment

Group Group) Group Group

Measure (n25) (n19 P (n19) (n11) P

Change from rehabilitation

unit admission to discharge

FIM subscale score†

Self-care 1.6 (0.6) 1.6 (0.5) .95 1.5 (0.6) 1.7 (0.6) .43

Sphincter control 2.1 (1.6) 1.4 (1.7) .19 2.4 (1.5) 1.2 (1.8) .07

Mobility 2.3 (0.9) 2.3 (0.9) .95 2.3 (0.9) 2.5 (0.9) .62

Locomotion 3.1 (1.0) 3.2 (0.9) .70 2.9 (1.0) 3.3 (1.1) .42

Communication‡ 0.0 (0.1) 0.0 (0.0) NA 0.0 (0.1) 0.0 (0.0) NA

Social cognition‡ 0.1 (0.2) 0.0 (0.0) NA 0.1 (0.2) 0.0 (0.0) NA

FIM total score† 27.0 (7.3) 25.6 (7.7) .56 27.1 (7.8) 26.6 (8.1) .89

Analgesic medication, mg/d

Acetaminophen 782 (1574) 10 (1889) .15 857 (1617) 433 (1919) .07

Hydrocodone 10.1 (17.7) 6.7 (16.8) .59 11.4 (18.3) 9.2 (12.0) .79

At rehabilitation unit discharge

Length of stay, d 14.9 (6.4) 9.3 (3.4) .001 15.0 (6.7) 8.3 (3.0) .004

Rehabilitation efficiency§ 2.1 (0.7) 3.0 (1.0) .001 2.1 (0.8) 3.4 (1.0) .001

Change from rehabilitation

unit admission to 4 weeks

after discharge

SF-36 health scale score¶

Physical functioning 1.0 (26.3) 9.0 (26.6) .37 4.3 (28.9) 3.8 (28.9) .96

Role limitations, physical 9.5 (38.3) 5.0 (34.3) .25 15.0 (41.0) 9.4 (18.6) .13

Bodily pain 29.0 (29.0) 23.4 (31.0) .58 21.5 (28.4) 23.0 (26.7) .91

General health 7.5 (19.8) 5.8 (18.4) .80 2.5 (16.4) 5.3 (10.4) .67

Vitality 9.8 (21.2) 21.3 (33.4) .21 8.3 (19.2) 29.4 (29.9) .05

Social functioning 25.6 (40.1) 8.0 (27.7) .15 16.3 (41.9) 17.2 (25.9) .96

Role limitations, emotional 34.9 (57.2) 17.8 (45.2) .34 26.7 (45.8) 29.2 (51.8) .91

Mental health 14.3 (22.6) 4.0 (13.1) .11 14.4 (20.6) 3.0 (10.0) .16

* Values are expressed as mean (SD). All knee osteoarthritis patients had arthroplasty. Positive changes on the SF-36

and FIM represent improvements. Negative changes for analgesic medication represent decreased use.

† The FIM subscales and total were scored from 1 to 7 and 18 to 126, respectively (worst to best possible score).

‡ The t-test could not be performed because there were no changes reported by any of the patients

in the sham treatment group.

§ Rehabilitation efficiency was computed as the FIM total score change per rehabilitation unit day.

¶ The SF-36 health scales were scored from 0 to 100 (worst to best possible score).

OMT indicates osteopathic manipulative treatment; FIM, Functional Independence Measure; SF-36,

Medical Outcomes Study Short Form 36.

200 • JAOA • Vol 104 • No 5 • May 2004

consequently, were more likely to have Medicare insurance

(80% vs 42%; P.02), a primary diagnosis of hip fracture (81%

vs 27%; P.001), and surgery other than a knee or hip arthroplasty

(44% vs 5%; P.001).

There were no significant differences in any of the aforementioned

characteristics, nor in gender, race, marital status,

or number of comorbid conditions between the 20 eligible

patients who refused to participate or did not complete the hospital

phase of the study and the 60 participants who completed

the hospital phase. Four patients in each group were lost

to follow-up after discharge. When these lost patients were

compared on 36 baseline characteristics and rehabilitation

unit outcomes, they differed significantly only in the baseline

SF-36 vitality score, which favored OMT patients (35.0

vs 10.0; P.02).

Baseline Characteristics

The typical participant was 69 years old, female, white, and had

four comorbid conditions (Table 2). Osteoarthritis was the predominant

diagnosis (73%), with the knee being the surgical site

approximately twice as often as the hip. All patients with

knee osteoarthritis had undergone total knee arthroplasty.

The mean scores on all SF-36 health scales were significantly

below national norms12; however, the FIM total score was

identical to that reported for rehabilitation inpatients with

orthopedic conditions.20 Most patients used acetaminophen

(95%) and hydrocodone (75%) for analgesia at admission.

Patients with hip fractures had significantly longer rehabilitation

unit length of stay than patients with osteoarthritis

(17.6 vs 12.5 days; P.01). Rehabilitation efficiency was also

lower in patients with hip fracture (1.8 vs 2.5 FIM total score

points daily; P.02). Age was directly related to length of

stay (P.002) and inversely related to rehabilitation efficiency

Licciardone et al • Original Contribution

ORIGINAL CONTRIBUTION

Figure. Profile of the randomized controlled trial.

JAOA • Vol 104 • No 5 • May 2004 • 201

ference between groups was decreased rehabilitation efficiency

with OMT. In patients who underwent arthroplasty for

knee osteoarthritis, OMT resulted in significantly poorer outcomes

in length of stay, rehabilitation efficiency, and vitality.

The reasons for these findings are unclear, and none is

explained by demographic characteristics, health insurance

coverage, or number of comorbid conditions.

The methodologic aspects of our study were evaluated by

adapting two sets of criteria for assessing the quality of randomized

clinical trials of spinal manipulation for low back or

neck pain.21,22 Scores of 67 and 82 were achieved in the current

study using the criteria of Koes et al21 and Andersson et al,22

respectively. These scores exceed those of other studies of

manipulation reported in original papers,21,22 in derivative

works,23-25 and in a recent clinical trial of OMT.2

The major methodologic problems in the present study

identified through this process are its sample size and the

presence of a comprehensive, multidisciplinary treatment program

as a standard cointervention in the rehabilitation unit.

However, given the significantly poorer outcomes associated

with OMT in length of stay and rehabilitation efficiency, it

seems unlikely that greater sample size would have uncovered

significant benefits associated with our OMT protocol in this

rehabilitation population.

Intention-to-treat analysis was not used because our

unpublished data from a previous study indicated that only

one of 20 patients who received OMT in this setting discontinued

treatment. Further, using the criteria of Koes et al,21

intention-to-treat analysis is not considered to be critical in

our research methodology because there was no loss to followup

during the hospital phase of the study, which included 11

of the 19 primary outcomes. Lack of OMT efficacy cannot be

attributed to losses to follow-up after discharge because the

rehabilitation unit outcomes of lost patients in each group

were similar. Further, the number of patients lost to follow-up

were not excessive and were similar in magnitude to those

in a recent clinical trial of OMT.2 The benefits of sessions of

OMT lasting between 10 and 30 minutes 2 or 3 times weekly

may have been obscured by the other modes of rehabilitation

therapy that were provided to all patients several times daily.

The sample size in this study, while limited, allows us to

reasonably exclude moderate to large treatment effects

attributable to student-performed OMT. However, we cannot

rule out more subtle, yet clinically significant, effects. Such

effects may have been apparent had we used condition-specific

or surgical site–specific outcome measures. Such measures

include the Arthritis Impact Measurement Scales, the Western

Ontario and McMaster Universities Osteoarthritis Index, the

Knee Society clinical rating scale, and the Oxford Hip Score.26,27

Also, we cannot exclude the possibility that greater efficacy may

have been observed had OMT been provided more frequently,

for longer duration, or by more experienced practitioners.

It is known that experienced osteopathic physicians record

fewer, but more significant, diagnostic findings than trained stu-

(P.001). Sex, race, marital status, health insurance coverage,

and number of comorbid conditions had no significant associations

with primary outcomes.

Baseline characteristics favored the sham treatment group

in the SF-36 mental health scale (73.1 vs 62.1; P.04) and in the

FIM locomotion subscale (1.8 vs 1.3; P.01). Nevertheless, it

seems that patients were adequately randomized because

under the null hypothesis the likelihood of observing two or

more significant differences between groups in the 27 baseline

variables tested can be attributed to chance (P.39). There

was also a trend toward better health in the sham treatment

group in the SF-36 bodily pain scale (46.3 vs 31.0; P.06).

Outcomes

Patients in the OMT and sham treatment groups had a similar

number (5.4 vs 4.7; P.39) and frequency (2.4 vs 2.6 weekly;

P.18) of treatments. The mean change in FIM total score

exceeded that previously reported for orthopedic patients (26

vs 22 FIM total score points).20

Patients in both groups improved in all FIM subscales and

decreased their daily analgesic use during the rehabilitation

unit stay, though neither group had significantly greater

improvement than the other (Table 3). Similarly, both groups

improved to a comparable degree on the three SF-36 health

scales measured at discharge from the rehabilitation unit.

Osteopathic manipulative treatment was associated with

lower rehabilitation efficiency (2.0 vs 2.6 FIM total score points

daily; P.01) and a trend toward greater length of stay (15.4

vs 12.3 days; P.09). In the postdischarge phase, patients in

both groups had similar changes in SF-36 health scale scores

when compared with those at admission; scores in physical

functioning and role limitations due to physical problems

declined because of curtailment of work and other activities

in the postsurgical period. Osteopathic manipulative treatment

was not significantly better than sham treatment in any

primary outcome, even after simultaneously adjusting for

baseline group differences in the SF-36 mental health and

bodily pain scales and in the FIM locomotion subscale.

Among patients with osteoarthritis, OMT was associated

with greater length of stay (14.9 vs 9.3 days; P.001) and

lower rehabilitation efficiency (2.1 vs 3.0 FIM total score points

daily; P.001) (Table 4). These poorer outcomes were limited

to patients with knee osteoarthritis (length of stay, 15.0 vs 8.3

days, P.004; rehabilitation efficiency, 2.1 vs 3.4 FIM total

score points daily, P.001). Among patients with a hip fracture,

there were no significant differences in primary outcomes

between patients who received OMT or sham treatments.

Discussion

Two to three OMT sessions weekly, performed by undergraduate

fellows, were not efficacious in acute rehabilitation

patients who recently underwent surgery for knee or hip

osteoarthritis or a hip fracture. Overall, the only significant dif-

Licciardone et al • Original Contribution

ORIGINAL CONTRIBUTION

202 • JAOA • Vol 104 • No 5 • May 2004

dent examiners.28 Thus, predoctoral examiners using inefficient

filtering processes for palpatory data may translate into

less optimal treatment in a time-constrained environment.

Despite the additional cost factor, which was prohibitive in this

study, the use of osteopathic physicians with more experience

must be considered in future research involving the efficacy

of OMT.

Findings from the present study also support the theory

that a spectrum of conditions exists with varying degrees of

responsiveness to OMT. At one end of the spectrum, relatively

healthy patients with acute, uncomplicated medical

conditions seem to respond most favorably to OMT.1 Patients

with subacute conditions may respond less favorably. For

example, they may have only marginal improvements in primary

outcomes, but they may be maintained on less medication

or may use fewer ancillary services.2 Patients with chronic

musculoskeletal conditions who respond least favorably (ie, the

rehabilitation patients in the present study) may represent the

other end of the spectrum. Additional research should assess

the use of OMT at various stages in the natural history of disease

and as a complement to standard treatment over time.

Acknowledgment

The authors thank Kimberly Fulda, MPH, and David P. Russo,

DO, MPH, for their assistance in this study.

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