Neck pain continues. Criterion Validity Study of the Cervical Range of Motion (CROM) Device for Rotational Range of Motion on Healthy Adults

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1 Criterion Validity Study of the Cervical Range of Motion (CROM) Device for Rotational Range of Motion on Healthy Adults Michel Tousignant, PT, PhD 1 Cé cile Smeesters, PhD 2 Anne-Marie Breton, PT 3 É milie Breton, PT 3 Hé lène Corriveau, PT, PhD 1 Journal of Orthopaedic & Sports Physical Therapy Study Design: This study compared range of motion (ROM) measurements using a cervical range of motion device (CROM) and an optoelectronic system (OPTOTRAK). Objectives: To examine the criterion validity of the CROM for the measurement of cervical ROM on healthy adults. Background: Whereas measurements of cervical ROM are recognized as part of the assessment of patients with neck pain, few devices are available in clinical settings. Two papers published previously showed excellent criterion validity for measurements of cervical flexion/extension and lateral flexion using the CROM. Methods and Measures: Subjects performed neck rotation, flexion/extension, and lateral flexion while sitting on a wooden chair. The ROM values were measured by the CROM as well as the OPTOTRAK. Results: The cervical rotational ROM values using the CROM demonstrated a good to excellent linear relationship with those using the OPTOTRAK: right rotation, r = 0.89 (95% confidence interval, ), and left rotation, r = 0.94 (95% confidence interval, ). Similar results were also obtained for flexion/extension and lateral flexion ROM values. Conclusion: The CROM showed excellent criterion validity for measurements of cervical rotation. We propose using ROM values measured by the CROM as outcome measures for patients with neck pain. J Orthop Sports Phys Ther 2006;36(4): Key Words: measurement, neck, spine 1 Physiotherapist, Research Center on Aging, Sherbrooke Geriatric University Institute, Faculty of Medicine, Sherbrooke, Qué bec, Canada. 2 Engineer, Research Center on Aging, Sherbrooke Geriatric University Institute, Faculty of Engineering, Sherbrooke, Qué bec, Canada. 3 Physiotherapist, Faculty of Medicine, Université de Sherbrooke, Sherbrooke, Qué bec, Canada. The protocol for this study was approved by the Comité d é thique sur la recherche de l Institut universitaire de gé riatrie de Sherbrooke. The authors have no conflict of interest with the work presented in this manuscript. Address correspondence to Pr Michel Tousignant, Research Center on Aging, Sherbrooke Geriatric University Institute, 1036 Belvé dère Sud, Sherbrooke, Qué bec J1H 4C4, Canada. michel.tousignant@usherbooke.ca Neck pain continues to be a major health problem in industrialized countries. 3,5,10, 15,19,26,34 There is a need to improve the effectiveness of medical and rehabilitation interventions to decrease disability related to neck pain. Furthermore, the financial burden associated with neck pain disability within the current economical constraints urges us to develop outcome measures when assessing clinical progress of patients suffering from neck pain. 32 Because of the recognition of a relationship between range of motion (ROM) and impairment in patients with neck pain, 11,18,20,33 measurements of ROM are routinely included in spine and cervical spine disorder assessments. 1,2,16,30 Moreover, recent studies of the effectiveness of intervention for patients with neck pain 6,12,21,25,40-42 established that ROM was the best single estimator of handicap for acute whiplash syndrome. 20 As a consequence, need of measurements of cervical ROM are well established and 242 Journal of Orthopaedic & Sports Physical Therapy

2 norms have been developed for younger and older adults. 4,13,24,27,38 Whereas measurements of cervical ROM are recognized as part of the assessment of patients with neck pain, few devices to make those measurements are available in clinical settings. A device that has appeared on the market in the last decade is the cervical range of motion device (CROM; Performance Attainment Associates, St Paul, MN). This eye-glasses-like device combined with an inclinometer is easy to use and affordable. Moreover, intratester and intertester reliability of the CROM have been well established. 7,43,44 Two papers published previously showed excellent criterion validity for measurements of flexion and extension, 36 as well as for lateral flexion movements. 37 To our knowledge, no studies have investigated the validity of the CROM for rotational movements. Therefore, the primary objective of this study was to examine the criterion validity of the CROM for rotational ROM of the cervical spine using an optoelectronic system (OPTOTRAK; Northern Digital, Inc, Waterloo, ON) as the gold standard. Criterion validity for flexion/extension and lateral flexion ROM values was also examined to compare our results with those obtained previously with other methodologies. METHODS Subjects The sample was composed of 34 women and 21 men recruited in the community. The women were on average (SD) 59 (17) years old, ranging from 21 to 85 years, and the men were 56 (23) years old, ranging from 19 to 80 years. Inclusion criteria were (1) being 18 years of age or older and (2) being able to participate in a 1.5-hour assessment. Subjects with rheumatoid arthritis (possibility of C1-C2 instability) or recent trauma of the cervical spine that required medical attention were excluded. This project was approved by the Ethics Committee of the Institut universitaire de gé riatrie de Sherbrooke. Informed consent was obtained from all subjects. Instruments The CROM The CROM measures cervical ROM for rotation, flexion/extension, and lateral flexion using 3 separate inclinometers attached to a frame similar to eyeglasses (Figure 1): 1 inclinometer in the transverse plane for rotation, 1 inclinometer in the sagittal plane for flexion/extension, and 1 inclinometer in the frontal plane for lateral flexion. The rotation inclinometer has a magnetic needle, whereas the flexion/extension and the lateral flexion inclinometers have gravity needles. A magnetic necklace is worn by the subject to produce the magnetic field required to move the rotation inclinometer s needle when the head is rotated. A moveable ring on each inclinometer is used to set the zero position. Finally, all the inclinometers are marked in 2 increments. The OPTOTRAK System The OPTOTRAK/3020 system is a noninvasive optoelectronic motion measurement system that tracks infrared light-emitting diode markers in 3 dimensions with cameras (Northern Digital Inc, Ontario, Canada). 28 At a 2.25-m distance its root-mean-square accuracy is 0.10 to 0.15 mm ( ) and its 3-dimensional resolution is 0.01 mm (0.002 ). 28 However, good accuracy and resolution does not necessarily mean that the measurements are reproducible. To insure the reproducibility of the measurements, standardized procedures were used. The OPTOTRAK system is widely recognized as a good instrument for kinematics measurements, such as center-of-mass displacements, 8,9,39 gait analysis, 31 biomechanical analysis of lifting tasks, 29 and joint 17 and spine 14,22,23,45 displacements. The OPTOTRAK was preferred as the accepted standard of measurement because of the technical problems related to the calculation of rotational ROM using radiographic films. Indeed, exposure of the horizontal plane (over the cranium toward the feet) is required to measure rotational ROM on films. With this direction of exposure, because of the superposition of anatomical structures, it is impossible to precisely identify the specific landmarks required to calculate head rotation. Moreover, this direction of exposure can not be limited to the cranium and thus exposes genital organs to radiation. al Plane Inclinometer Transverse Plane Inclinometer Sagittal Plane Inclinometer Magnetic Necklace FIGURE 1. The CROM device has a transverse plane inclinometer to measure rotation (magnetic needle and necklace), a sagittal plane inclinometer to measure flexion/extension (gravity needle), and a frontal plane inclinometer to measure lateral flexion (gravity needle). RESEARCH REPORT J Orthop Sports Phys Ther Volume 36 Number 4 April

3 Z H Z R X R Y R 2 Y H X H 11 Z T 12 Journal of Orthopaedic & Sports Physical Therapy X H FIGURE 2. The subject wearing the swim cap and the cardboard shoulder pads on which the 12 OPTOTRAK markers were placed. The reference (R) rigid-body axes of the environment had its x r axis forward, its y r axis to the left and its z r axis perpendicular to the floor. Markers 1 to 6 defined the head (H) rigid-body axes, which had its origin at marker 3, its x H axis forward, its y h axis to the left, and its z h axis perpendicular to the floor. Markers 7 to 12 defined the trunk (T) rigid-body axes, which had its origin at marker 9, its x h axis forward, its y h axis to the left and its z h axis perpendicular to the floor. These 3 rigid-body axes were used to measure rotation, flexion/extension, and lateral flexion ranges of motion. Procedures 7 X T Staff Training A research assistant with a rehabilitation background was briefed on the research protocol and trained in the use of the CROM by the principal investigator for a total of 4 one-hour sessions. A technician was trained in the use of the OPTOTRAK by 2 of the coauthors specialized in the use of this system. 9 Rotation 4 X T 4 Y H Y T 8 10 Flexion / Extension Z H Z R X R X H Z R Y T Lateral Flexion Z H Y R Y H Data Collection Data collection took place at the Research Centre on Aging of the Institut universitaire de gé riatrie de Sherbrooke. By means of a questionnaire, the subjects were briefly assessed before and after the study to insure that they had no cervical spine pain or discomfort. The subjects sat on a wooden chair with a backrest. This chair was placed between the 2 OPTOTRAK (0 ) cameras, which were separated by a distance of 5 m. The subjects were 244 J Orthop Sports Phys Ther Volume 36 Number 4 April 2006

4 instructed to sit up straight, feet flat on the floor, with arms hanging at their sides. The trunk and shoulders were stabilized using straps. The subjects wore a swim cap and cardboard shoulder pads on which the OPTORAK markers were placed, with 6 markers on the swim cap and 6 markers on the shoulder pads (Figure 2). The motion of the markers was tracked by 2 position sensor cameras. Finally, the CROM and the magnetic necklace were placed on the subject. Each subject first performed 1 repetition of the 6 neck movements: right rotation, left rotation, flexion, extension, right lateral flexion, and left lateral flexion. Performing these movements had 2 goals: (1) to increase the flexibility of the neck structures and (2) to define the head and trunk rigid-body axes from the markers on the swim cap and shoulder pads, respectively (Figure 2). Using a random order for each subject, 2 trials were then performed for each of the 6 movements of the cervical spine: right rotation, left rotation, flexion, extension, right lateral flexion, and left lateral flexion. The first trial served as a practice trial. Only the data from the second trial were used for analysis. Using right rotation as an example, with the subject in the neutral position, the research assistant first recorded the initial rotation angle on the transverse plane inclinometer of the CROM. From this initial position, the subject was then asked to perform a right rotation as far as possible without pain, without moving the trunk or shoulders. This rotation was recorded by the OPTOTRAK while the research assistant stayed out of the field of view of the cameras. The subject then kept the final position for 5 seconds to allow the research assistant to record the final rotation angle on the transverse plane inclinometer of the CROM. The same procedure was followed for all the other movements using the transverse plane inclinometer to measure rotation, the sagittal plane inclinometer to measure flexion/extension, and the frontal plane inclinometer to measure lateral flexion. Data Analysis ROM Calculations For the CROM, the ROM values for each of the 3 pairs of movements were the final angle minus the initial angles in each of the 3 respective planes of motion. For the OPTOTRAK, the rotation ranges of motion were calculated as the average of the relative angles between the head and trunk rigid-body axes in the xy plane (Figure 2). The flexion/extension and lateral flexion ROM values were calculated as the average of the relative angles between the head and reference rigid-body axes in the xz and yz planes, respectively. These thus matched the magnetic and gravity referentials of the CROM. Statistical Analysis Descriptive statistics were reported for each of the cervical ROM planes of movement measured with both the CROM and the OPTOTRAK. A linear regression analysis was performed to estimate criterion validity between the 2 measurement methods for each of the planes of movement. Pearson product moment correlation coefficients (r) and 95% confidence intervals (CIs) were also calculated to determine the degree of association between measurement devices. RESULTS Cervical Rotation Cervical rotation ROM values measured with the CROM and the OPTOTRAK methods were very similar (Table 1). The average (SD) difference between paired measures was 2.2 (4.2 ) for right rotations and 1.7 (4.0 ) for left rotations. Data from 1 subject for right rotation using the CROM device, 10 subjects for right rotation using the OPTOTRAK, and 2 subjects for left rotation using the OPTOTRAK were missing. The Pearson product moment correlation coefficient (r) between the 2 measurement methods was 0.89 (95% CI, ) for right rotation and 0.94 (95% CI, ) for left rotation TABLE 1. Descriptive statistics for cervical ranges of motion in degrees (n = 55, unless otherwise indicated). CROM* OPTOTRAK Paired Difference Cervical Movement Means (SD) Range Means (SD) Range Means (SD) Right rotation 55.6 (10.3) (8.9) (4.2) rotation 56.1 (11.7) (10.3) (4.0) Flexion 46.6 (11.1) (10.8) (2.0) Extension 50.4 (14.4) (14.9) (2.4) Right lateral flexion 30.4 (9.1) (8.0) (3.8) lateral flexion 32.8 (8.6) (7.3) (4.0) * Cervical range of motion device. Data missing for 1 subject for the CROM device and 10 subjects for the OPTOTRAK. Data missing for 2 subjects for the OPTOTRAK. RESEARCH REPORT J Orthop Sports Phys Ther Volume 36 Number 4 April

5 TABLE 2. Pearson correlation coefficients (r) between measurements of cervical ranges of motion taken with the cervical range of motion device (CROM) and the OPTOTRAK. Cervical Movement r * 95% Confidence Intervals Right rotation (n = 44) rotation (n = 53) Flexion (n = 55) Extension (n = 55) Right lateral flexion (n = 55) lateral flexion (n = 55) * All correlation values were significant (P.05). (Table 2). The regression equations were y OPTOTRAK = x CROM for right rotation and y OPTOTRAK = x CROM for left rotation (Figure 3). Cervical Flexion/Extension and Lateral Flexion Measurements of cervical flexion/extension and lateral flexion ROM made with the CROM device and the OPTOTRAK also showed strong association with Pearson product moment correlation coefficients (r) ranging from 0.89 to 0.99 (Tables 1 and 2). DISCUSSION This study completes a research program to establish the validity of the measurements of cervical spine motion using the CROM device. The primary objective of this study was to examine the criterion validity of the CROM device for rotational movements using the OPTORAK as the gold standard. Moreover, criterion validity for flexion/extension and lateral flexion ROMs was also examined to compare our results with those from previous research. 36,37 Our results showed a very strong linear relationship between cervical rotation ROM values measured with the CROM device and those measured with the OPTOTRAK. Based on this strong linear relationship, the validity can be considered excellent. 35 To our knowledge, no study examining the validity of the CROM (or other clinical devices) for cervical rotation has been published to date. As a consequence, it is not possible to compare our results with previous studies. However, it is possible to compare our results with those previously obtained for measurements of cervical flexion (r = 0.97) and extension (r = 0.98), 36 as well as right (r = 0.84) and left lateral flexion (r = 0.82). 37 The validity coefficients found in our study (Table 2) are thus comparable to those obtained previously. 36,37 This coherence between studies using 2 different methodologies increases the confidence in the OPTOTRAK methodology for criterion validity studies of spine ROM. Some points regarding internal validity of the study merit attention. First, the higher proportion of missing data for the measurement of right versus left rotation using the OPTOTRAK is explained by the fact that the CROM sagittal plane inclinometer, located on the left side of the CROM, sometimes interfered with marker tracking by the OPTOTRAK when the subject made rotations to the right. Second, time was invested in properly training the research assistant in the use of the CROM and the technician in the use of the OPTOTRAK to standardize the data collection. Indeed, to insure accurate measurements in both research and clinical settings, it is important to minimize movements of the trunk with respect to the reference rigid-body axes in all 3 planes. Furthermore, to measure movement of the head with respect to the trunk rigid-body axes in a single plane (eg, rotation), it is also important to minimize movements of the head in the other 2 planes (eg, flexion/ extension and lateral flexion). For our study, trunk movements in all 3 planes were on average (SD) only 1.1 (1.1 ) and out-of-plane movements of the head were on average only 3.9 (5.6 ). In our research setting, minimizing trunk rotation was especially important to avoid loosing the OPTOTRAK markers at extreme ROMs. In a clinical setting where the CROM would be used, minimizing trunk rotation is less important because the magnetic referential of the CROM insures that rotational ROMs are not affected by trunk rotation. Some others points regarding generalization of our results also merit attention. First, the study was conducted on healthy subjects because of the time (5 seconds) the subjects needed to stay at the limit of their ROM to allow the research assistant to step into the field of view of the cameras and record the final rotation angle on the CROM. We must highlight that this choice was based on ethical considerations to decrease the possibility of increased pain for the subject. Furthermore, we must consider the limitation created by shoulder pads, which represented the shoulder and not the trunk itself, meaning that it does provide possibility of shoulder movement without necessary trunk movement. Theoretically, results should thus only be generalized to a healthy population. However, when the CROM is used by itself, the time required to record the rotation angle is only 1 second and its use on patients with neck pain should not add any technical difficulties. Indeed, placing the CROM on the head of symptomatic or asymptomatic subjects requires the same abilities from the examiner and imposes the same constraints on the subject. In this context, generalization could thus be extended to patients with neck pain. However, as shown by the 95% CI, the magnitude of the error may be slightly increased for movements in the lower ranges of motion. 246 J Orthop Sports Phys Ther Volume 36 Number 4 April 2006

6 Right Rotation R otatio n OPTOTRAK Angle (deg) y = 0.855x r 2 = 0.80 OPTOTRAK Angle (deg) y = 0.849x r 2 = CROM Angle (deg) CROM Angle (deg) FIGURE 3. Linear regression lines with 95% confidence intervals and coefficients of determination (r 2 ) for right and left cervical rotation range of motion values obtained with the cervical range of motion device (CROM) and the OPTOTRAK. Journal of Orthopaedic & Sports Physical Therapy CONCLUSION Based on our results, we believe that the CROM is a clinically useful and valid instrument to measure cervical rotational ROM in healthy subjects. In our nonrandom sample, the results revealed that cervical rotation measured using the CROM had a good to excellent linear relationship with those measured using the OPTOTRAK. Moreover, validity for flexion, extension, and lateral flexion ROMs, which had already been established in patients with neck pain, 36,37 was well reproduced in this study of healthy subjects. Therefore, we could argue that the CROM could also be used to measure cervical rotation ROM in patients with neck pain. However, future research is needed to confirm the validity of the CROM measurements for rotation and the relationship between ROM deficits and disability in patients with neck pain. ACKNOWLEDGMENTS We acknowledge the assistance of Franç ois Thenault who was involved in data analysis and Lise Trottier who was involved with statistical analysis. REFERENCES 1. American Medical Association. Guides to the Evaluation of Permanent Impairment. 3rd ed. Chicago, IL: American Medical Association; American Physical Therapy Association. Guide to Physical Therapist Practice. Second Edition. American Physical Therapy Association. Phys Ther. 2001;81: Andersen JH, Gaardboe O. Prevalence of persistent neck and upper limb pain in a historical cohort of sewing machine operators. Am J Ind Med. 1993;24: Bennett SE, Schenk RJ, Simmons ED. Active range of motion utilized in the cervical spine to perform daily functional tasks. J Spinal Disord Tech. 2002;15: Berglund A, Alfredsson L, Cassidy JD, Jensen I, Nygren A. The association between exposure to a rear-end collision and future neck or shoulder pain: a cohort study. J Clin Epidemiol. 2000;53: Bronfort G, Evans R, Nelson B, Aker PD, Goldsmith CH, Vernon H. A randomized clinical trial of exercise and spinal manipulation for patients with chronic neck pain. Spine. 2001;26: ; discussion Capuano-Pucci D, Rheault W, Aukai J, Bracke M, Day R, Pastrick M. Intratester and intertester reliability of the cervical range of motion device. Arch Phys Med Rehabil. 1991;72: Corriveau H, Hebert R, Raiche M, Dubois MF, Prince F. Postural stability in the elderly: empirical confirmation of a theoretical model. Arch Gerontol Geriatr. 2004;39: Corriveau H, Hebert R, Raiche M, Prince F. Evaluation of postural stability in the elderly with stroke. Arch Phys Med Rehabil. 2004;85: Cote P, Cassidy JD, Carroll L. The Saskatchewan Health and Back Pain Survey. The prevalence of neck pain and related disability in Saskatchewan adults. Spine. 1998;23: Dall Alba PT, Sterling MM, Treleaven JM, Edwards SL, Jull GA. Cervical range of motion discriminates between asymptomatic persons and those with whiplash. Spine. 2001;26: David J, Modi S, Aluko AA, Robertshaw C, Farebrother J. Chronic neck pain: a comparison of acupuncture treatment and physiotherapy. Br J Rheumatol. 1998;37: RESEARCH REPORT J Orthop Sports Phys Ther Volume 36 Number 4 April

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