Persons aged 50 years and over with a history of COPD were recruited for the study. The inclusion criterion was an FEV1/FVC ratio of 70% or less of the predicted value. Potential subjects were identified by chart review or screening office spirometry. Exclusion criteria were osteopathic or chiropractic manipulation in the previous three months, acute illness, active respiratory tract infection, acute bone fracture, inability to cooperate, thoracic scoliosis greater than 25 degrees, or chest wall deformity. Study treatments were given in an outpatient office setting in the department of Internal Medicine at A.T. Still University's Kirksville College of Osteopathic Medicine in Kirksville, Missouri between June 2003 and January 2004. Individuals were recruited from the department's clinical practice, newspaper advertisement, and speaking engagements on local talk radio and with COPD support groups. Pulmonary function testing was conducted in the pulmonary function laboratory at Northeast Regional Medical Center. Subjects were transported by wheelchair through connecting indoor hallways between the office setting and the pulmonary function laboratory to avoid fatigue. The study was approved by the local institutional review board, and all subjects gave informed consent.
Subjects received 5 single session treatment protocols in random order until all 5 protocols had been given. The duration of each treatment protocol was 5 minutes, except the myofascial technique protocol which was 5 to 10 minutes in duration. Between each treatment session, there was a 4-week washout period. The standardized treatment protocols were administered as described below:
1) Minimal-touch control: The subject took five deep breaths while the physician auscultated the lungs; then the physician purposely auscultated the heart. No attempt was made to represent the minimal-touch protocol as an osteopathic manipulative technique. Throughout the treatment session, the physician engaged the subject in an empathetic discussion of issues related to health and COPD.
2) Thoracic lymphatic pump with activation: The physician's hands were placed on the thoracic wall with the thenar eminence of each hand over the pectoralis muscles just below the clavicles; the fingers were spread and angled toward the sides of the subject's body to evenly distribute contact pressure across the chest wall. The subject took a deep breath in and exhaled. During exhalation, rhythmic, pumping action was induced by alternating pressure on the chest wall. At the end of exhalation, some residual contact pressure was maintained on the chest wall, and the subject was told to take another deep breath. This procedure was repeated several times, each time building a little more pressure on the thoracic wall. On the fourth or fifth inhalation and during the first one-third of the inhalation, the hands were very briskly removed from the chest wall. This removal causes a sudden release of the pressure built up in the chest wall. The rib cage springs open, and a sudden increase in thoracic negative pressure produces a rush or sucking of air into the lungs.
3) Thoracic lymphatic pump without activation: The physician's hands were placed on the thoracic wall with the thenar eminence of each hand over the pectoralis muscles just below the clavicles; the fingers were spread and angled toward the sides of the subject's body to evenly distribute pressure across the chest wall. The subject took a deep breath in and exhaled. During exhalation, rhythmic, pumping action was induced by alternating pressure on the chest wall. At the end of exhalation, some pressure was maintained on the chest wall, and the subject was told to take another deep breath. Thus, inhalation was taken against some pressure on the chest wall. At the end of three or four breathing cycles, the hands were slowly withdrawn from the chest wall to avoid a sudden change in chest wall pressures.
4) Rib raising: This technique was done with the subject in the supine position. The physician stood or sat at the subject's side. The physician's hands were placed under the subject's thorax, contacting the rib angles with the pads of the fingers. The fingers were flexed, and traction was applied to the rib angle. While traction was maintained, the physician used their arm as a fulcrum and kept their wrists straight; rib angles were raised anteriorly. After this cycle was repeated a number of times and the ribs in that section had improved mobility, the hands were moved up the thoracic cage, and another section was treated. This procedure was repeated until all the ribs on one side of the subject were treated. The procedure was then repeated on the subject's alternate side.
5) Myofascial release: The physician treated any myofascial structural asymmetry or restriction found in the abdominal diaphragm, the thoracic rib cage, the thoracic inlet, or the cervical region with myofascial release. Myofascial release was performed by the physician placing their hands on the subject's body, palpating for the direction in which the tissues moved most easily, moving the tissues in that direction, and holding and feeling for a release or relaxation of the tissues. The duration of the myofascial protocol session was 5 to 10 minutes because the technique takes longer to administer compared to the other techniques.
Pulmonary function measures were obtained at baseline and 30-minutes posttreatment. Pulmonary function measures included forced vital capacity (FVC) in liters, forced expiratory volume in 1 second (FEV1) in liters, the FEV1/FVC ratio in percent, the average forced expiratory flow rate over the middle 50% of the FVC (FEF 25-75%) in L/s, the maximum forced expiratory flow rate (FEFmax) in L/s, expiratory time in seconds, and maximal voluntary volume (MVV) in L/min. Lung volume measures were slow vital capacity (SVC) in liters, inspiratory capacity (IC) in liters, expiratory reserve volume (ERV) in liters, total gas volume (TGV) in liters, residual volume (RV) in liters, total lung capacity (TLC) in liters, and the RV/TLC ratio as a percent. Airway resistance (Raw) in cm H2O/L/s was also measured. Subjects were surveyed regarding possible side effects and of treatment perceptions by telephone the day after each treatment session.
To ensure the quality of measurements, certified respiratory therapists conducted the pulmonary function tests and used the American Thoracic Society criteria for test reproducibility. Pulmonary function measures were obtained with a MedGraphics® 1085 Series™, which measures lung volumes using plethysmography. The two osteopathic physicians who administered the treatments reviewed and practiced the study techniques together prior to enrolling subjects.
The osteopathic physicians and subjects were not blinded to the order of the techniques assessed during the treatment sessions. Subjects were told that their participation as a volunteer would include five treatment sessions, each with before and after measures of pulmonary function, once every four weeks for approximately five months. They were told the purpose of the project was to determine the effectiveness of four manipulative treatment techniques for improving breathing and pulmonary function in persons with chronic obstructive pulmonary disease. Potential participants were told one of the sessions would be a minimal-touch treatment. It was explained that even minimal-touch may have beneficial effects, which is why it was included in the study. While no special effort was made to blind subjects to the treatment they received (since this was not practical), no treatment session was represented as being more beneficial than another. Individuals involved with collecting the data, conducting the pulmonary function testing, and performing the telephone survey were blinded to the specific technique performed during each testing session.
Sample size was determined using data from a previous study [11
]. The standard deviation of the total lung capacity percent predicted value was estimated to be 25%. Using a repeated measures analysis of variance (ANOVA), a sample size of 25 has power of 0.80 (α = 0.05) to detect a difference between two of the protocols of at least 9% or 0.36 standard deviations. The study statistician used blocked randomization to assign subjects to one of five treatment sequences, with randomization balanced after five subjects. Additionally, treatments were randomly assigned to one of two treatment providers. The treatment sequence assignment slips were placed in sealed envelopes and were opened by one of the treatment providers after enrollment of a new subject.
Wilcoxon signed rank tests were used to test for baseline to posttreatment changes on the actual pulmonary function measures and percent predicted values for each of the five techniques. To compare the five techniques on their immediate effects on pulmonary function measures, Friedman tests were used on the percent change from baseline to posttreatment with corresponding multiple comparisons when appropriate. Subjects were included in all comparisons for which they had complete data. P values less than .05 were considered statistically significant. Cohen's d was used to estimate effect sizes.