Massage manipulation vs. low back muscle exercise for lumbar intervertebral instability: A preliminary randomized clinical trial

This is a preliminary randomized clinical trial on patients conducted at Wuxi Hospital Affiliated with


Introduction
Primary clinical manifestations of intervertebral instability include local pain and motion disorders (i.e., abnormal activity between vertebrae as revealed by passive lumbar extension test, instability catch sign, painful catch sign and apprehension sign). 1,2The presence of clinical symptoms of lumbar intervertebral instability, namely 'functional abnormality', is inescapably accompanied with abnormal lumbar motion, namely 'structural abnormality', but current imaging examinations only detect static abnormalities.Indeed, a plain X-ray, computed tomography (CT), and magnetic resonance imaging (MRI) film can reveal anatomical changes. 3Changes in flexion-extension on X-ray film are common findings.Whole-range dynamic observations and precise measurements of each irregular inter-segmental motion is a prerequisite for quantitative analysis of the motion property of the unstable lumbar spine.Quantitative fluoroscopy (QF) enables optimized noise reduction and results in lossless image editing to calculate the pattern of lumbar vertebral movement, hence, it overcomes various disadvantages of previous approaches.Low-dose X-ray acquires consecutive dynamic digital images of the subject in motion and automatically calculates them to achieve precise quantitative results. 4cording to the traditional Chinese medicine (TCM), massage manipulation is the key treatment for intervertebral instability. 5Manipulative adjustment of the vertebrae effectively improves abnormal stress distribution and reconstructs cervical stability. 6,7It remains unclear how manipulation helps lumbar stability, however, it could result from the relaxation of muscles that corrects the abnormal potential of paravertebral muscles. 8Another possibility is that manipulation improves clinical symptoms via the facilitation of the central nervous system to enhance central pain tolerance. 9Therefore, we aim to examine the changes in clinical features after manipulation for lumbar intervertebral instability.

Methods
This is a preliminary randomized clinical trial of patients with lumbar intervertebral instability, randomized 1:1 to formal manipulation or exercise (Wuxi Hospital Affiliated with Nanjing University of Chinese Medicine, Wuxi, China; from September 2015 to December 2016).According to preliminary experiments, it was assumed that the mean AZ value after treatment in the massage and exercise groups were -0.002 ± 0.02 and -0.03 ± 0.02, respectively; the mean BZ after treatment in the massage and exercise groups were -0.01 ± 0.03 and -0.06 ± 0.03, respectively; the mean RX of the massage and exercise groups were -0.02 ± 0.04 and 0.03 ± 0.04, respectively.Power was set at 1-β = 0.80 and alpha at 0.05.We used the inequality test for two means using differences (i.e., two-sample t-test) in the PASS 8.0 software.Based on the AZ, BZ, and RX values after treatment, the sample size was 10, 7, and 12 patients/group based on the calculations AZ (translation of lower point A in the Z direction), BZ (translation of lower point A in the Z direction), and RX (vertebral relaxation), respectively.Considering potential drop-out of 10%, we determined that the required sample size was 15 patients/group.Inclusion criteria were patients with age 40-65 years and symptoms of lumbar intervertebral instability for less than 3 months. 1Exclusion criteria were patients with either lumbar spondylolisthesis, structural scoliosis, severe osteoporosis (T-score above -2.5),history of spinal fractures or history of lumbar surgery.
Patients were recruited by their treating physicians when the patient was first consulted for low back pain and was simultaneously diagnosed with lumbar intervertebral instability.The physician then presented the study to the participant and allowed time for reading the informed consent form.If the patient agreed to participate in the study all his queries were addressed and the consent form was then signed.There was no monetary incentive, except that the study intervention (massage or exercise) was provided free of charge.
Patients were randomized 1:1 to the massage and exercise groups using sequential sealed envelopes prepared by an independent statistician.Massage techniques include loosening manipulation and fine-tuning techniques (Supplementary Material).All massage methods were performed by two professional massage therapists with more than 5 years of work experience at the hospital.
Low back muscle exercises for the treatment of lumbar intervertebral instability included standard exercises presented in the supplementary material.
Japanese Orthopaedic Association (JOA) score, Oswestry disability score, and quantitative fluoroscopy (QF) examinations were performed before and after treatment and at 1 and 3 months thereafter.
The JOA score for low back pain 10 and the Oswestry disability score 11 were used.QF examinations were performed routinely.

Observation indexes:
The JOA score for low back pain 7 and the Oswestry disability score 8 were used.QF examinations were performed routinely (Supplementary Material).

Statistical analysis:
Sample size estimation is presented in the supplementary material.All data were entered using EPIDATA 3.0 and analysed using SPSS 13.0.Oneway ANOVA and the Tukey's post hoc test were used for multi-group comparison.The student t-test was used for inter-group comparisons under normal distribution, while the rank-sum test was used for non-normal distribution.Two-sided p < 0.05 indicated statistical significance.S1).
There were no significant differences at baseline between the two groups (all p >0.05) in AZ, BZ, and RX of L4 and L5.On the other hand, changes were significantly better in the massage group compared to the exercise group (all p <0.05) (Supplementary Tables S2, S3).Supplementary Tables S4-S6 present the dynamic parameters of the two groups in extension.Supplementary Tables S7-S9 present the dynamic parameters of the two groups in flexion.Supplementary Tables S10-S12 present the dynamic parameters of the two groups in side bending.

Correlations analyses:
The correlations analyses showed that the changes in Oswestry disability scores and JOA scores correlated with changes in dynamic parameters in the massage group (all p < 0.05), but not in the exercise group (all p >0.05) (Supplementary Table S13-S18).

Discussion
The dynamic balance in lumbar motion is the key characteristic of lumbar stability.Clinical instability symptoms of pain and twisting are results of lumbar dynamic balance loss.Dynamic balance is not determined by a single factor but by multiple factors of lumbar facet joints, paravertebral muscles, and ligaments.Improvement of clinical symptoms by manipulation is potentially the result of reconstruction of the lumbar dynamic balance, and thus lumbar stability.Therefore, the mechanism of manipulation on lumbar intervertebral instability likely comprises correction of facet joint subluxation, improvement of irregular load on paravertebral muscles, and relaxation of paralumbar soft tissues.Nonetheless, eventual mechanism lies on the correction of irregular intervertebral motion and restoration of lumbar dynamic balance, leading to lumbar stability.The changes induced by manipulation or exercise may be small and precise methods like QF are necessary to quantify them.
Using QF, the present study showed that the massage treatment (Supplementary Material) was successful in improving all dynamic parameters at L4 and L5, while the exercise treatment, despite being performed 3 times daily for 15 days (compared with once a day for 6 days for massage) did not induce any improvement in dynamic parameters.In addition, these changes correlate with the improvements in JOA and Oswestry scores.These results are supported by previous studies that showed that manipulative adjustment of vertebrae effectively improves abnormal stress distribution and reconstructs cervical stability. 3,4Nevertheless, the present study adds to the literature by presenting quantitative data of dynamic improvements after massage manipulation.
The present study is not without limitations.Compared to X-ray films and CT examination, QF uses a lower radiation dose, but the drawback is that the images are less clear with more noise.Edge detection and enhancement were automatically performed by the software, but some issues need to be resolved, for instance automatic detection and calculation of vertebral corner in the coronal plane and poor tracking in the rotation state.These factors impact the study of lumbar coronal motion.Due to limitation of the vision field on the display of the electronic digital 3D C-arm X-ray system, this study selected only the L4-5 segments for investigation.In fact, occurrence of lumber intervertebral instability usually influences the adjacent segmental motion, which requires further study and improvement.In addition, the number of subjects included in the study were small and from a single centre.Finally, some data was not collected, including duration of symptoms, work description, drugs for pain relief, and active vs. sedentary lifestyle.Additional studies are necessary to address these issues.

Conclusion
The present study suggests that spinal massage manipulation is superior to low back muscle exercise in patients with lumbar intervertebral instability.The changes in intervertebral motion can be captured by QF, facilitating further illustration of the mechanism under spinal massage manipulation on lumbar intervertebral instability.

Supplementary Material
Massage manipulation: Massage techniques include loosening manipulation and fine-tuning techniques.
Loosening techniques included rolling, pressing, kneading and plucking.Patient was in the lateral position and relaxing as much as possible for fine-tuning manipulation.Practitioner used one elbow and arm to stabilize the patient's pelvis, and the feet and middle fingers were respectively placed on the upper and lower interval space of the spinous process of the dislocated vertebra, and the other hand slowly pulled the patient's lower shoulder forward to make the upper spine gradually bend forward until the feet finger placed on the upper interval space started to feel the upward movement of the adjacent upper spinous process along with flexion of the spine.Once the spinous process space was widened, forward movement of the shoulder was instantly stopped.Then, the upper shoulder of the patient was stabilized by the practitioner's elbow and arm originally used to pull the patient's shoulder.The feet and middle fingers were apart and placed respectively on the lower and upper interval space of the spinous process of the dislocated vertebra.The other hand slowly pulled the lower leg of the patient forward to gradually bend the hip joint, driving the pelvic backward tilt and lumbar flexion, until the feet finger placed on the lower interval space started to feel the downward movement of the adjacent lower spinous process.Once the spinous process space was widened, forward movement of the lower leg was instantly ended and the pelvis was stabilized by the elbow and arm to maintain the flexion range of the lower spine.Then, the feet and middle fingers pushed against the spinous process in displacement or scoliosis.According to the operating essentials of the oblique flip method, "nimble force in abrupt eruption" was imposed, and a sudden and rapid flip was made with increased amplitude.At the same time, the feet and middle fingers forcefully pushed the spinous process to induce reduction, usually with a clicking sound.After adjustment, the patient was placed in the lateral position, and lumbar and abdominal muscles were loosened at both sides of the transverse process.Relaxing the muscles of the affected limb was also performed before the end of the treatment.The treatment lasted 20 minutes, once every day for 6 days as a complete treatment course.
Low back muscle exercise: Low back muscle exercise for the treatment of lumbar intervertebral instability included the following methods.1) Five points support method: lying supine on the bed, with the five support points being the head, elbows, and feet, the patient body arched to make lumbar muscles contraction, 15 actions per session, and once every morning, noon, and evening.
2) Flying swallow touching water: lying prostrate on the bed, legs and arms straight on the sides, keeping the body straight, the head, upper limbs, and lower limbs of the patient were simultaneously lifted above the bed to achieve the purpose of posterior body arch, 15 actions per session, and once every morning, noon, and evening.A complete treatment course was 15 days.hips and knees.Images of lumbar vertebra positive side were acquired, centered on the L3 vertebral body.The subject rotated left and right at a uniform speed.The upright position being the neutral position, the rotation angle was 60°.The subject rotated from the neutral position to 60° left at a uniform speed within 10 s, and resumed position at the same speed.The same was done on the right.The images were captured at 10 frames per second (FPS).Therefore, about 300-400 consecutive lumbar motion images were obtained for each movement.
First, acquired images were enhanced through a filter to highlight the boundary of the lumber vertebral body in the soft tissues.Then, the enhanced images were put into the MATLAV image analysis software (Matrix Laboratory, MathWorks, USA).The Frobin method was applied to determine the midpoint and vertical axis of the vertebral body (Figure -1A). 9Vertebral rotation and displacement were measured on flexion extension images (Figure -1B).Vertebral rotation and displacement were measured on left and right lateral flexion images (Figure -1C).The specific heights were measured on flexion extension images in motion (Figure -1D).The relaxation degree of the lumbar spine was calculated as the ratio of the coronal rotation degree of each segment to the coronal rotation degree of the entire lumbar spine in lateral flexion while as the ratio of the sagittal rotation degree of each segment to the sagittal rotation degree of the entire lumbar spine in flexion extension.The higher the ratio, the greater the relaxation degree was.As shown in Figure -1E, taking the left flexion of L4/5 for an example, the left vertical axis displayed the coronal rotation degree of L4/5, the right vertical axis revealed the coronal rotation degree of the entire lumbar spine, and the horizontal axis reflected the frame number of images.L4/5 rotation degree was shown in the yellow line while the red line represented the lumbar rotation degree, and their ratio indicated the relaxation degree of L4/5 vertebral segments.Lateral flexion symmetry was quantitatively indicated by the root mean square (RMS) of the difference in coronal displacement and rotation between the two sides of the vertebral body (separated by the center of the vertebral body) in motion of left and right lateral flexion.Rotation symmetry was quantified by the ratio of the rotation degree between the two sides of the vertebral body (separated by the center of the vertebral body) in motion of left and right rotation.Vertebral rotation was evaluated by the Nash-Moe method, 10 which is regularly applied for the assessment of vertebral rotation in scoliosis.
Lateral flexion rotation axis was reflected by the instantaneous rotation axis geometrically calculated as the intersection point of the vertical middle lines of two lines, which were formed by connecting two vertebral apexes on the top of two sequentially adjacent images (A-A' and B-B') in motion of left and right lateral flexion.The flexion extension rotation axis was reflected by the instantaneous rotation axis geometrically calculated as the intersection point of the vertical middle lines of two lines, which were formed by connecting two vertebral apexes on two sequentially adjacent images, inferior position on the previous image and superior position on the following, in motion of forward flexion and backward extension.The calculation methods for lumbar dynamic balance comprised lateral flexion symmetry and rotation symmetry in lumbar motion, as well as symmetry of the lumbar instantaneous axis in motion of left and right lateral flexion.
Sample size estimation: According to preliminary experiments, it was assumed that the mean AZ value after treatment in the massage and exercise groups are -0.002± 0.02 and -0.03± 0.02, respectively; the mean BZ after treatment in the massage and exercise groups are -0.01 ± 0.03 and -0.06 ± 0.03, respectively; the mean RX of the massage and exercise groups were -0.02 ± 0.04 and 0.03 ± 0.04, respectively.The power was set to 1-β = 0.80 and alpha at 0.05.Sample size estimation was performed using the PASS 8.0 software according to the following formula: n1 = n2 = 2[(tα + tβ) 2 s / δ ] 2 According to the preset parameters, we used the inequality tests for two means using differences (i.e., twosample t-test) in the PASS 8.0 software Means menu to calculate the sample size.Based on the AZ, BZ and RX after treatment, sample size needed is 10, 7, and 12 cases/group when basing the calculations on AZ, BZ, and RX, respectively.Considering potential drop-out of 10%, we determined that the required sample was 15 cases per group.
Disclaimer: None to declare.

Quantitative fluoroscopy:
For QF examinations, the machine was an electronic digital three-dimensional Carm X-ray machine.Images were taken during motions of flexion extension, lateral flexion, and rotation in the standing and lying positions.The standing position was designed to simulate physiological activity while the lying position was to minimize the influence of muscular strength on movement.1) Flexion extension position.The patient was measured at both the standing and lying positions.The pelvis and knee joints were fixed with a special brace to prevent compensation.Lumbar lateral images were acquired centered at the L3 vertebral body.The subject performed flexion and extension motion at a uniform rate, with the upright position as the neutral position, in the range of 60° of flexion, and 20° of extension.The subject bent forward from the neutral position to 60° at a uniform rate within 10 s, then resumed from flexion to the neutral position at the same speed.The subject extended backward from the neutral position to 20° at a uniform rate within 5 s, then resumed from extension to the neutral position at the same speed.A complete flexion and extension motion cycle was about 30 s. 2) Left-right lateral flexion position.Imaging was performed in both the standing and supine positions.During imaging, the subject was secured to the pelvis to prevent the pelvis from tilting.Images of lumbar vertebra positive side were acquired centered on the L3 vertebral body.The subject was subjected to left and right lateral flexion at a uniform speed, with the upright position as the neutral position, and the left or right lateral flexion was 40°.The subject bent laterally from the neutral position to 40° left at a uniform speed within 10 s, and then resumed from left flexion to the neutral position at the same speed.The same way was used for right lateral flexion.3) Left-right rotation position.Imaging was performed in the standing position.The pelvis was immobilized during imaging to prevent rotation of the

Figure- 1 :
Figure-1: (A) Determination of the midpoint and vertical axis by the Frobin method.(B) Measurement of rotation and displacement in the sagittal plane of the vertebral body (RX referred to rotation, BZ and AZ referred to displacement).(C) Intervertebral rotation and displacement in the coronal plane.Distance between C and D at the X axis represented the displacement of the superior and inferior edges of the vertebral body.The angle between the CD line and the Y axis represented the angle of rotation.(D) Anterior and posterior heights of the intervertebral disk, marked in A and C. (E) The relaxation degree of the lumbar spine (taking L4/5 lateral flexion as an example).

Table - 1
: Characteristics of the patients.
J Pak Med Assoc 326 Z. Zhou, Y. Zhang, W. Chen, et al Supplementary

Table S1 :
Changes in vertebral sagittal rotation and displacement after massage or exercise treatment.
Supplementary TableS2: Intergroup comparison of L4 sagittal vertebral rotation and displacement between the two groups.AZ: translation of lower point A in the Z direction; BZ: translation of the upper point B in the Z direction; RX: angle of rotation around the X axis.Supplementary TableS3: Intergroup comparison of L5 sagittal vertebral rotation and displacement between the two groups.AZ: translation of lower point A in the Z direction; BZ: translation of the upper point B in the Z direction; RX: angle of rotation around the X axis.Supplementary

Table S4 :
Intergroup comparison of dynamic parameters in extension between the two groups before and after treatment.

Table S5 :
Changes in dynamic parameters in extension in the massage group.
AZ: translation of lower point A in the Z direction; BZ: translation of the upper point B in the Z direction; RX: angle of rotation around the X axis; HA: anterior height of the intervertebral disc; HC: posterior height of the intervertebral disc; IPX: instantaneous center of rotation in the X direction; IPY: instantaneous center of rotation in the Y direction.Supplementary TableS6: Changes in dynamic parameters in extension in the exercise group.AZ: translation of lower point A in the Z direction; BZ: translation of the upper point B in the Z direction; RX: angle of rotation around the X axis; HA: anterior height of the intervertebral disc; HC: posterior height of the intervertebral disc; IPX: instantaneous center of rotation in the X direction; IPY: instantaneous center of rotation in the Y direction.Supplementary

Table S7 :
Intergroup comparison of dynamic parameters in flexion between the two groups before and after treatment.
AZ: translation of lower point A in the Z direction; BZ: translation of the upper point B in the Z direction; RX: angle of rotation around the X axis; HA: anterior height of the intervertebral disc; HC: posterior height of the intervertebral disc; IPX: instantaneous center of rotation in the X direction; IPY: instantaneous center of rotation in the Y direction.Supplementary

Table S8 :
Changes in dynamic parameters in flexion in the massage group.: translation of lower point A in the Z direction; BZ: translation of the upper point B in the Z direction; RX: angle of rotation around the X axis; HA: anterior height of the intervertebral disc; HC: posterior height of the intervertebral disc; IPX: instantaneous center of rotation in the X direction; IPY: instantaneous center of rotation in the Y direction.
AZ: translation of lower point A in the Z direction; BZ: translation of the upper point B in the Z direction; RX: angle of rotation around the X axis; HA: anterior height of the intervertebral disc; HC: posterior height of the intervertebral disc; IPX: instantaneous center of rotation in the X direction; IPY: instantaneous center of rotation in the Y direction.Supplementary TableS9: Changes in dynamic parameters in flexion in the exercise group.AZ

Table S10 :
Intergroup comparison of dynamic parameters in side bending between the two groups before and after treatment.
AZ: translation of lower point A in the Z direction; BZ: translation of the upper point B in the Z direction; RX: angle of rotation around the X axis; HA: anterior height of the intervertebral disc; HC: posterior height of the intervertebral disc; IPX: instantaneous center of rotation in the X direction; IPY: instantaneous center of rotation in the Y direction.Supplementary

Table S11 :
Changes in dynamic parameters in side bending in the massage group.
AZ: translation of lower point A in the Z direction; BZ: translation of the upper point B in the Z direction; RX: angle of rotation around the X axis; HA: anterior height of the intervertebral disc; HC: posterior height of the intervertebral disc; IPX: instantaneous center of rotation in the X direction; IPY: instantaneous center of rotation in the Y direction.Supplementary

Table S12 :
Changes in dynamic parameters in side bending in the exercise group.
AZ: translation of lower point A in the Z direction; BZ: translation of the upper point B in the Z direction; RX: angle of rotation around the X axis; HA: anterior height of the intervertebral disc; HC: posterior height of the intervertebral disc; IPX: instantaneous center of rotation in the X direction; IPY: instantaneous center of rotation in the Y direction.Supplementary

Table S13 :
Correlations between the changes in the Oswestry disability score and changes in dynamic parameters in extension.

Table S14 :
Correlations between the changes in the JOA score and changes in dynamic parameters in extension.
AZ: translation of lower point A in the Z direction; BZ: translation of the upper point B in the Z direction; RX: angle of rotation around the X axis; HA: anterior height of the intervertebral disc; HC: posterior height of the intervertebral disc; IPX: instantaneous center of rotation in the X direction; IPY: instantaneous center of rotation in the Y direction.Supplementary

Table S15 :
Correlations between the changes in the Oswestry disability score and changes in dynamic parameters in flexion.

Table S16 :
Correlations between the changes in the JOA score and changes in dynamic parameters in flexion.

Table S17 :
Correlations between the changes in the Oswestry disability score and changes in dynamic parameters in side bending.
AZ: translation of lower point A in the Z direction; BZ: translation of the upper point B in the Z direction; RX: angle of rotation around the X axis; HA: anterior height of the intervertebral disc; HC: posterior height of the intervertebral disc; IPX: instantaneous center of rotation in the X direction; IPY: instantaneous center of rotation in the Y direction.Supplementary

Table S18 :
Correlations between the changes in the JOA score and changes in dynamic parameters in side bending.