Osteopathic Manipulative Treatment for Inpatients With Pulmonary Exacerbations of Cystic Fibrosis: Effects on Spirometry Findings and Patient Assessments of Breathing, Anxiety, and Pain

Methods

Procedures

At enrollment, participants were randomly assigned to an OMT group or a sham therapy group using a random numbers generator. Assignments were clustered in blocks of 10 to ensure even distribution between the 2 groups over time. Demographic data including sex, age, and ethnicity were collected. At the time of enrollment, each participant was given a written questionnaire to complete before the first treatment session. Participants in both the OMT and sham therapy groups received 1 treatment or sham therapy session lasting approximately 15 minutes daily for a minimum of 4 days and a maximum of 7 days, depending on hospital length of stay. After the last OMT or sham therapy session, patients' breathing was measured again using spirometry and patients completed the written questionnaire a second time. During the hospital stay, the inpatient physician service dictated all other standard treatments including antibiotic treatment, pulmonary physiotherapy, massage therapy, and recreational therapy, as well as hospital length of stay. All physicians caring for the patients were blinded to the patients' group assignment. Trained respiratory technicians who were blinded to the participants' group assignment performed spirometry using a Collins CPL-Raptor spirometer (nSpire Health, Inc).

OMT

Three osteopathic physicians (D.A.S., G.T., and K.A.) administered a set of 5 standard OMT techniques, described previously by Noll et al.¹⁰ Patients remained in the supine position during all treatments. The OMT techniques were as follows:

• Rib raising: The physician stands to the side of the patient and places his or her hands under the patient's thoracic spine. Using the pads of his or her fingers, the physician applies gentle anterolateral pressure along the angles of the ribs and holds the pressure until soft tissue release is palpated. This procedure is repeated along the entire thoracic spine.

• Abdominal diaphragm release: The physician places the thenar eminence of his or her hands parallel to the costal margin of the patient's abdomen and positions his or her thumbs pointed to midline. Beginning laterally, the physician gently applies medial and lateral traction to the border of the patient's diaphragm, testing for direction of greatest ease. In concert with patient inspiration, the physician applies cephalad and medial or lateral traction against the direction that is the most restricted. The physician repeats this maneuver for both sides of the patient's diaphragm and along the costal margin until he or she palpates tissue release and determines that mobility of the diaphragm is equal bilaterally.

• Thoracic inlet myofascial release: The physician stands at the head of the table and places his or her hands on the patient's thoracic inlet, with the physician's thumbs positioned posteriorly along the angle of the first rib and his or her fingers positioned anteriorly over the clavicle. The physician uses passive motion testing to determine the directions of ease and restriction. He or she then takes the tissues to the direction of least ease, holds them there, and instructs the patient to inhale and exhale. While the patient is exhaling, the physician takes the soft tissues further in the direction of restriction. The physician repeats this maneuver until he or she palpates tissue release and left-right symmetry.

• Thoracic lymphatic pump: The physician stands at the head of the bed and places his or her thenar eminences just below the patient's clavicle and over the pectoralis muscle, with the physician's fingers directed laterally. Using a rhythmic pumping motion (approximately 45 repetitions per minute), the physician introduces motion into the thoracic cavity for approximately 2 minutes. The force is gentle but sufficient to force expiration and inspiration.

• Suboccipital decompression: The physician stands at the head of the bed and places the tips of his or her fingers along the occipital condyles on the base of the patient's head. Using gentle pressure, the physician releases the occipital joint with outward and cephalad traction. The physician applies the technique to both sides of the patient's head until he or she palpates symmetry of restriction.

Sham Therapy

Five sham therapy techniques were provided to participants in the control group. These techniques were administered with the physician and participant in the same positions as those used for the OMT techniques, with the physician using the following modifications:

• avoiding prolonged contact of any 1 body area

• using minimal pressure and body surface contact and attempting to direct most of the force of contact into adjacent bedding

• avoiding body areas involved in OMT (eg, the spine) and instead applying light touch to adjacent structures when possible

• avoiding focal areas of pressure by using flat, soft hand contact

Before the study, all 3 osteopathic physicians participated in a session to standardize the OMT techniques. The session lasted approximately 15 minutes per physician, during which each physician performed the techniques on an osteopathic physician who specializes in OMT. The osteopathic physician specialist (the same for all operators) provided feedback when he detected substantial variations in operator technique. No further standardization of OMT technique was carried out during the study.

Participant Questionnaires

Participants were asked to complete the same questionnaire before their first OMT or sham therapy session and after their last session (Figure 1). Questions asked patients to rate their quality of breathing, level of anxiety, and level of pain, as well as describe any adverse effects from the therapy.

Figure 1.

Questionnaire completed by inpatients with pulmonary exacerbations of cystic fibrosis before and after receiving osteopathic manipulative treatment or sham therapy (N=33).

Results

A total of 36 patients were enrolled in the study. Two patients (1 from each study group) declined to continue the study after 2 days, and 1 patient from the OMT group was discharged before treatment day 4. Therefore, 33 patients completed the study (Figure 2). Patient demographic data are shown in Table 1. There were more men in the sham therapy group and more women in the OMT group (χ²=4.05, P=.044). No statistically significant differences were found between the 2 groups for age or number of treatments received. All enrolled patients were white. There were no statistically significant changes in mean vital signs (data not shown). Although the OMT group had a larger pre- to posttreatment mean decrease in temperature than the sham therapy group, this difference was not statistically significant (P=.084). There were no statistically significant between-group differences in pre- to posttreatment mean changes in the other vital signs or in weight.

Figure 2.

Study flow diagram of inpatients with pulmonary exacerbations of cystic fibrosis assigned to receive osteopathic manipulative treatment (OMT) or sham therapy.

Participants in both the OMT and sham therapy groups exhibited improvement in pulmonary function. At baseline (day 1), no differences in spirometric measures were found between the 2 groups (data not shown). Changes in spirometry measurements in the OMT and sham therapy groups are shown in Table 2. The improvement in FEV₁% was not significantly different between the OMT and sham therapy groups (t= −0.29, P=.977). Analysis of other spirometric data similarly showed no statistically significant differences (data not shown).

Table 3 shows the patterns of responses among the OMT and sham therapy groups for questionnaire items on breathing, anxiety, and pain. For the questionnaire item “Please rate how you are breathing TODAY,” 15 of 16 participants in the OMT group and 8 of 16 participants in the sham therapy group answered in a pattern that showed improvement from day 1 to the last day of intervention. For the same questionnaire item, 1 of 16 participants in the OMT group and 6 of 16 participants in the sham therapy group indicated that their state of breathing was “about the same as usual” both at baseline and after the final intervention. The second questionnaire item asked the participants about their breathing compared with 1 week ago. In the OMT group, 8 of 16 participants answered in a pattern that showed improvement during the study period, whereas 7 of 16 replied that their breathing had improved on both instances (ie, “better than 1 week ago”). By comparison, 6 of 16 participants in the control group answered in a pattern that showed improvement, and 6 of 16 replied that their breathing had improved in both instances (ie, “better than 1 week ago”). For the question on adverse effects, 1 participant reported intravenous catheter pain and 1 participant reported shortness of breath before receiving OMT. At the end of treatment, 1 participant from the OMT group reported feeling mildly nauseous.

Discussion

To our knowledge, the current single-blind randomized controlled trial is the first to report on the effects of OMT on CF patients. In both the OMT and sham therapy groups, patients demonstrated an increase in FEV₁ from day 1 to the final day of intervention. No statistically significant differences were found between the 2 groups in the amount of improvement in FEV₁.

The current study involved a small number of patients in each group, and this sample size may have limited our ability to detect smaller differences in FEV₁ changes. In addition, the standard therapy for pulmonary exacerbation (eg, intravenous antibiotics, chest physiotherapy) given to patients in both study groups may have subsumed any benefit that OMT produced.

The lack of clinically significant improvement in spirometry observed in the current study (beyond that typically observed with standard CF therapy) could indicate a more prominent role for OMT in CF patients who have not yet reached the severity of disease as seen in the current study's population. Studies of OMT for CF patients in the outpatient setting or for patients with early exacerbations of CF disease may show more subtle, long-term benefits, such as fewer or shorter hospital stays and increased FEV₁ over time. As previously mentioned, studies^7,8 of inpatient adults with pneumonia found shortened duration of intravenous antibiotics and length of hospital stay in individuals who received OMT. Another study¹² of an asthmatic pediatric population demonstrated statistically significant improvement in peak expiratory flow rates of patients who received OMT compared with those who received sham therapy.

Given the chronic and unremitting nature of pulmonary disease in CF, it is also possible that OMT is unable to resolve the substantial dysfunction that CF propagates in the pulmonary system, especially in the setting of an exacerbation requiring hospitalization. The study by Noll et al⁵ that showed worsening in air trapping in elderly patients with COPD immediately after they received OMT supports the notion that chronic, progressive pulmonary illnesses may not respond well to OMT.

All but 1 participant in the treatment group (15 of 16) identified their breathing as being better at the conclusion of the study than at the beginning, compared with half of the participants in the sham therapy group (8 of 16). Although this assessment was subjective, it does support the possibility that a benefit of OMT was masked by the standard CF therapy or not measured by conventional spirometry. A sham therapy protocol similar to the one used in the present study has been reported to successfully mask OMT group assignment in at least 1 other study.¹³ On the basis of these findings, we believe that the current study's protocol was sufficient to mask group assignment from our participants, limiting any possible placebo effect in the questionnaire responses of the OMT group.

Limitations of the current study were its small sample size, its lack of blinding of physicians administering OMT, and the potentially confounding CF treatments administered to both the OMT and sham therapy groups. Osteopathic manipulative treatment is ideally administered in a nonstandardized fashion, with the physician using physical diagnosis to guide treatment techniques. Our treatment protocol may have been limited by its standardized approach. Finally, our study did not use any validated quality-of-life or disease-specific patient reporting instruments.¹⁴ Future research should examine OMT's effects on the quality of life and breathing in CF patients. Other areas of research should focus on OMT in the outpatient clinic setting, particularly in preventing and managing early CF exacerbations.

Conclusion

Although the benefit of OMT in other pulmonary diseases has been previously demonstrated, the current study did not show a benefit of OMT in CF patients, as measured using spirometry. Additional studies are needed to examine the potential benefit of OMT in the long-term outcomes of patients with CF, as well as in the quality of life for these patients. Given the substantial costs and morbidity associated with CF, uncovering tools that can prevent morbidity for these patients is an important task for researchers in this field.