J. Acupunct. Tuina. Sci. 2010, 8 (3): 191-195 DOI: 10.1007/s11726-010-0404-1
Clinical Study
Clinical Study on Combined Tuina with Qi Zheng Qing Peng Paste for Herniation of the Lumbar Intervertebral Disc WANG Li-tong (王立童) 1, KOU Suo-tang (口锁堂) 1, ZHAN Hong-sheng (詹红生) 2, ZHU Wei-min (朱伟民) 3 1 Tianshan Hospital of Traditional Chinese Medicine, Changning District, Shanghai 200051, P. R. China 2 Shuguang Hospital Affiliated to the Shanghai University of Traditional Chinese Medicine, Shanghai 201203, P. R. China 3 No. 6 People’s Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200233, P. R. China
【摘要】目的：观察推拿手法结合奇正青鹏膏治疗腰椎间盘突出症的临床疗效。方法：将 568 例腰椎间盘突出症患者随机分为 3 组，观察组 189 例，采用推拿配合奇正青鹏膏治疗；对照Ⅰ 组 187 例，采用推拿配合双氯芬酸二乙胺乳剂治疗；对照Ⅱ组 192 例，采用推拿治疗。治疗 4 星期后比较各组疗效。结果：观察组总有效率为 89.9％，对照Ⅰ组为 86.6％，对照Ⅱ组为 84.9%， 观察组与对照Ⅱ组比较，总有效率差异有统计学意义（P＜0.05） 。结论：推拿手法结合奇正青 鹏膏剂对腰椎间盘突出症有良好的治疗作用。 【关键词】推拿；按摩；椎间盘移位；腰痛 【Abstract】Objective: To observe the clinical efficacy of combined tuina manipulations with Qi Zheng Qing Peng paste for herniation of the lumbar intervertebral disc. Method: All 568 cases were randomly allocated into an observation group (189 cases), control Ⅰ group (187 cases) and control Ⅱ group (192 cases). Combined tuina with Qi Zheng Qing Peng paste, combined tuina with diclofenac diethylamine emulsions and tuina alone were adopted in the above three groups respectively. The efficacies in the three groups were compared after 4 weeks of treatment. Results: The total effective rates in the observation group, control Ⅰ group and control Ⅱ group were 89.9%, 86.6% and 84.9% respectively, showing a significant difference (P＜0.05) . Conclusion: Combined tuina manipulations with Qi Zheng Qing Peng paste works well for herniation of the lumbar intervertebral disc. 【Key Words】Tuina; Massage; Intervertebral Disk Displacement; lower Back Pain 【CLC Number】R246.2 【Document Code】A The Qi Zheng Qing Peng paste acts to invigorate blood, unblock collaterals and relieve swelling and pain. Therefore, it is indicated for lower back pain as well as radiating and distending pain towards the lower limbs due to herniated lumbar intervertebral disc. This multi-center clinical study intends to evaluate the efficacy of combined tuina with Qi Zheng Qing Peng paste, coupled with the repeatability and safety of tuina manipulations, and thus, providing further guidance for clinical application. Fund Item: Training Project of the "Star of Tomorrow" by the Health System in Changning District, Shanghai Author: WANG Li-tong (1981- ), male, postgraduate for master degree Correspondence Author: ZHU Wei-min (1968- ), male, associate chief physician
1 Clinical Data 1.1 Diagnostic criteria, main signs and symptoms This is based on the Criteria of Diagnosis and Therapeutic Effects for TCM Diseases and Syndromes [1]. Patients may have a history of trauma, strain or attack by cold-dampness and present with lower back pain coupled with radiating pain to one or both legs. The pain can be aggravated by increased abdominal pressure (such as coughing or sneezing). Hyperesthesia or dysesthesia may occur in the affected innervations of the lower limbs. Muscular atrophy may also be present in those who have had a long duration. Other signs include a positive test for straight leg raising or augmented
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J. Acupunct. Tuina. Sci. 2010, 8 (3): 191-195
test, decrease or disappearance of knee or Achilles tendon reflex and weakness of dorsal expansion of the big toe and/or flexor muscle strength of toes. 1.2 Inclusive criteria Conform to the diagnostic criteria, mainly moderate severity and indicate for conservative therapy; aged from 15 to 65 years; discontinue other therapies during this study. 1.3 Exclusive criteria Aged below 15 or above 65 with concurrent lumbar spondylolisthesis, spinal disorders or sacroiliac or hip joint diseases; those with concurrent systemic collagen immune disease and administration of glucocorticoids for acute or chronic infection that may affect the evaluation; unwilling to join or cooperate in this study; drop out or loss of follow-up; persistent aggravation of the disease condition or in combination with severe complications; mental disorders 1.4 General data All568 cases with a history of lower back pain of at least one month were from the three centers, Tianshan TCM Hospital, Shuguang Hospital and No.6 People’s Hospital from September 2008 to January, 2010. The above cases were randomly allocated into three groups. Of 189 cases in the observation group, there are 93 males and 96 females aged from 43 to 65, with an average age of (53.24±4.33) years. Of 187 cases in control Ⅰ group, there are 90 males and 97 females aged from 44 to 65 (with an average age of 54.39±4.16 years). Of 192 cases in control Ⅱ group, there are 91 males and 101 females aged from 45 to 65, with an average age of (55.62±3.98) years. The duration in the three groups lasted from 2 months to 1 year. There was no statistical difference in general data of the three groups. 1.5 Statistical analysis The SPSS14.0 version was applied to perform statistical analysis (t-test was used for intra-group comparison and Ridit analysis for inter-group comparison). Statistical difference is expressed by P<0.05. Paired t-test was used for intra-group comparison for measurement data, Ridit analysis for ranked data in numeration data and χ2 test for inter-group recovery rate and effective rate. ●
2 Treatment Method This is based on the text of Principle and Practice of Acupuncture and Tuina edited by SHI Xue-min. Doctors from the three centers were trained with standard manipulations to increase the local circulation of qi and blood and thus alleviate the compression to the nerve root and relax the adhesion. Four weeks of treatment constitute one course of treatment. 2.1 Observation group 2.1.1 Tuina therapy Pushing the spine: Ask the patient to take a prone position. First, knead, press and pluck the tender spots; secondly, flex the thumb and middle finger to push the bilateral lines of the bladder meridian 3 times from top to bottom; then, pushing the bilateral sides of the spine using the base of the palm (from back to the hip joint) 3 times when the patient breaths in; next, press the tenderness spots using the base of the palm 3 times when the patient breaths out; and finally, tap the bilateral sides 5 times respectively using a hollow fist. Apply digital pressure to Huantiao (GB 30), Weizhong (BL 40), Chengshan (BL 57) and Ashi points using the thumb. Then conduct heavy pressure to the above points 3 times using the proximal interphalangeal joint process of the middle finger. Oblique pulling manipulation: Ask the patient to take a side-lying position and place the affected side above the healthy one. Standing behind the patient, place one hand on the lateral border of the patient’s hip bone and the other hand on the patient’s shoulder, then perform a forceful pulling by exerting pressure towards the opposite directions, often followed by a snap sound. Flex the knee and hip joint: Ask the patient to take a supine position, hold the patients’ knees to allow a maximum flexion degree of the hip and knee on the affected side to bring the knee joint close to the chest and bend the lower back 3 times. Back-to-back adjustment: The practitioner and patient stand back to back and cross the elbows. Then the practitioner slightly bends to support the patient up and stabilize the patient using the
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J. Acupunct. Tuina. Sci. 2010, 8 (3): 191-195
buttocks to shake 5-10 times. Finally the practitioner holds the patient’s lower back using the buttocks 3-4 times. Kneading and pressing using the Qi Zheng Qing Peng paste: Spread the paste on the lower back to the herniated segment as well as the radiated painful area. Then knead and press the local area until a warm sensation appears. 2.1.2 Qi Zheng Qing Peng paste The Qi Zheng Qing Peng paste was manufactured by Tibetan Qi Zheng Pharmaceutical Company. The specification of the paste covers 20 g per bottle. Major ingredients include Ji Dou (Crazyweed), Ya Da Huang (Asian Rhubarb), Tie Bang Chui (Radix Aconiti Penduli), He Zi (Fructus Chebulae), Mao He Zi (Fructus Terminaliae Billericae), Yu Gan Zi (Emblic Leafflower), An Xi Xiang (Chinese Benzoin), Kuan Jin Teng (Chinese Tinospora Stem) and She Xiang (Moschus). 2.2 Control Ⅰ group Same tuina manipulations were adopted, along with diclofenac diethylamine emulsions (manufactured by Norvatis Pharmaceutical Company, 20 g per bottle). 2.3 Control Ⅱ group Tuina manipulations alone were adopted. The Qi Zheng Qing Peng paste and diclofenac diethylamine emulsions were used once every night. Tuina manipulations were applied once every day. All cases were treated for 4 weeks.
3 Results 3.1 Therapeutic effect standard of the signs and symptoms The scores of signs and symptoms are calculated according to the Japanese Orthopedic Association, JOA. JOA improvement rate= (pre-treatment score－ post-treatment score)/pre-treatment score×100％. Recovery: JOA improvement rate≥50%; Improvement: JOA improvement rate≥30% and <50%; Failure: JOA improvement rate<30%. 3.2 Overall therapeutic effect standard This is based on the Criteria of Diagnosis and Therapeutic Effects for TCM Diseases and Syndromes[1] and Shanghai Diagnostic and Therapeutic Guidelines of Traditional Chinese Medicine[2], coupled with signs, symptoms and CT scans or MRI findings (collected, recorded, kept and analyzed by special personnel other than the clinical practitioner). Recovery: Lower back and leg pain as well as clinical signs disappeared, along with a normal labor force; Improved: Lower back and leg pain significantly alleviated, along with a decreased labor force; Failure: Lower back and leg pain remained unchanged or became worse, along with a loss of labor force. 3.3 Treatment result With the increase of the treatment times, the JOA signs and symptoms were gradually alleviated (table 1).
Table 1. Comparison on JOA symptoms and signs in three groups after 2, 3 and 4 weeks of treatment (Cases) Groups
Observation
Control Ⅰ
Control Ⅱ
n
189
187
192
Items
2 week s after treatment Recovery Improved
Failure
3 weeks after treatment Recovery Improved Failure
4 weeks after treatment Recovery Improved
Failure
1
64
103
22
82
88
19
142
29
18
2
64
99
26
80
86
23
139
30
20
3
67
98
24
77
91
21
136
34
19
1
59
105
23
73
92
22
138
27
22
2
60
99
28
72
90
25
134
31
22
3
69
91
27
74
90
23
135
32
20
1
52
112
28
83
82
27
133
35
24
2
61
101
30
79
87
26
136
31
25
3
72
88
32
75
89
28
138
28
26
Note: 1=Lower back and leg pain; 2=sensory disturbance; 3=motor dysfunction © Shanghai Research Institute of Acupuncture and Meridian and Springer-Verlag Berlin Heidelberg 2010︱● 193 \
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J. Acupunct. Tuina. Sci. 2010, 8 (3): 191-195
After 4 weeks of treatment, the total effective rates in the observation group, control Ⅰ group and control Ⅱ group were 89.9%, 86.6% and 84.9% respectively, showing a significant difference (P<0.05). There was no statistical difference between control Ⅰ group and control Ⅱ group (table 2). Table 2. Comparison of overall effect after 4 weeks of treatment (Cases) Groups
n
Recovery Improved Failure
TER (%)
Observation
189
139
31
19
89.91)
Control Ⅰ
187
130
32
25
86.6
Control Ⅱ
192
129
34
29
84.9
Note: TER=total effective rate. Compared with control group Ⅱ, 1) P<0.05
3.4 Adverse reactions No drug-related adverse reactions had been found in the three groups within the 4 weeks of treatment and 1-year follow up.
4 Discussion Herniation of the lumbar intervertebral disc often occurs as a result of degeneration of the disc, which may start after the age of 20[3]. Additionally, gradual decrease of water content in the nucleus pulposus, poor elasticity and load-bearing capability, coupled with compression and torsional stress may result in herniation of the degenerated nucleus pulposus out of the weak annulus fibrosus. This may further compress the nerve root, thus leading to congestion and inflammation, release of inflammatory medium such as histamine or interleukin, subluxation of facets, synovial interposing, and reflective muscle spasm. Tuina manipulations can relax the local muscle, increase the circulation of blood, adjust the vertebral position and therefore, restore spinal balance. Tuina manipulations have been proven as effective in alleviating the pressure to the posterolateral aspect of the disc, restoring the internal pressure and thus relieving the compression to the nerve root[4]. Furthermore, tuina manipulations can alleviate tension and compression via modifying the distance between the peak of the disc tissue and nerve root, increase microcirculation, speed up the absorption of inflammation, relieve the hypersensitive state of the nerve endings, increase the pain threshold and therefore, relieve inflammation and pain[5,6]. ●
The Qing Peng paste is a classic formula of the Tibetan nationality, which can be traced as early as the 16th century. This formula acts to alleviate pain and resolve swelling. Combined with modern techniques, the Qi Zheng Qing Peng paste is indicated for joint pain due to gout or Bi-impediment syndrome. Analyzing the chemical composition of the formula[7], the active components mainly include flavones, anthraquinones, alkaloids and polyhydric phenol. The paste generally acts to clear heat, remove toxins, invigorate blood, resolve stasis, dispel wind, resolve dampness, promote dieresis to relieve swelling, circulate qi, alleviate pain and reinforce qi and blood. The orifice-opening medicinal in the formula allows the potency to reach the garget directly for rapid absorption. In addition, He Zi (Fructus Chebulae), Yu Gan Zi (Emblica Officinalis) and Mao He Zi (Fructus Terminaliae Billericae) take effect through permeation and absorption of human microcirculation and then works on the entire body. Currently, herniation of the lumbar intervertebral disc can be treated by surgery or conservative therapy. However, conservative therapy is still the predominant option. Bone-setting manipulations including oblique pulling, lateral pulling and backto-back adjustment can correct the vertebral joint disorder as well as the abnormal anatomical position[8, 9]. Combined tuina manipulations with the Qi Zheng Qing Peng paste can invigorate blood, resolve stasis, dispel wind, resolve dampness and regulate the whole body, and therefore, obtain a better effect than tuina alone in terms of relaxing the adhesion of the nerve root, increasing the local circulation of blood and microcirculation and benefiting the repair and functional reconstruction of the lesion tissues. What’s more, this combined therapy can speed up the absorption of edema, stagnant blood and inflammation, relieve the stimulus to the nerve root and alleviate the symptoms. It is also important to advise the patients to take bed rest, postpone traction and avoid bending of the low back. On the other hand, it is advisable for the patients to walk with a raised head and straight chest by putting hands to the lateral sides of the lower back. This can help to relieve the lumbar muscle spasm, and speed repair of the peripheral
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tissues. When the condition becomes stable, functional exercise, appropriate traction and a waist belt should be combined together. As a preliminary clinical study, a large sample random controlled test is needed for the exact efficacy and safety evaluation of combined tuina and Qi Zheng Qing Peng paste for herniation of the lumbar intervertebral disc.
References [1] The State Administration of Traditional Chinese Medicine. Criteria of Diagnosis and Therapeutic Effects for TCM Diseases and Syndromes. Nanjing: Nanjing University Press, 1994: 201-202. [2] Shanghai Municipal Public Health Bureau. Shanghai Diagnostic and Therapeutic Guidelines of Traditional Chinese Medicine. Second Edition. Shanghai: Publishing House of Shanghai University of Traditional Chinese Medicine, 2003: 393-394. [3] LI Hai-Bo. Combined Chinese Herb and Pressing-vibrating Reduction for Herniation of the Lumbar Intervertebral Disc. Practical Clinical Journal of Integrated Traditional Chinese and Western Medicine, 2009, 9(3): 9-11. [4] FENG Yu, GAO Yan, ZHANG Guo-rong, et al. Experimental Study on Correlation between Vertebral
[5]
[6]
[7]
[8]
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Displacement and Pressure Change of Intervertebral Disc. China Journal of Orthopedics and Traumatology, 2001, 14(2): 83-84. ZHANG Lin-hui. Comparison of Curative Effect of Massage Manipulation for Protrusion of Lumbar Intervertebral Discs of Different Stages. Practical Journal of Clinical Medicine, 2009, 5(1): 49-50. WAN Xiao-qiang, Gong Xiao-ping. Tuina Manipulation and Herniation of the Lumbar Intervertebral Disc: Case Reports of 116 Cases. China Practical Medical, 2009, 4(16): 255-256. ZHONG Shi-hong, GU Rui, WANG Wen. Analysis of Prescription and Effective Components of QiZheng QingPeng Ointment for Joint Pain. Journal of Military Surgeon in Southwest China, 2007, 9(1):88-90. YU Dong, ZHANG Jun, TANG Dong-xin. SUN Shu-chun’s Experience in the Treatment of Herniation of the Lumbar Intervertebral Disc. Chinese Journal of Traditional Medical Traumatology & Orthopedics, 2007, 15(12): 65. GAO Zhen-xi. Tuina and Herniation of the Lumbar Intervertebral Disc. Guide of China Medicine, 2009, 7 (11): 100-101. Translator: HAN Chou-ping (韩丑萍) Received Date: January 10, 2010
● Related Link ●
Fully Automatic Extraction of Human Spine Curve from MR Images Using Methods of Efficient Intervertebral Disk Extraction and Vertebra Registration Purpose: A fully automatic method is proposed for extracting human spine curve which is required for gait modeling. By means of the gait modeling, origin of the gait pathology of patients could be found. Methods: Our method is composed of two parts. The first part is the extraction of intervertebral disk positions where an efficient method is proposed. At the beginning of this part, all possible positions of intervertebral disks are located using a gradient-based method. Then, non-intervertebral disks are filtered out by a graph-based and an active shape model-based method. In the second part, extracted disk positions are used by a vertebra registration method to segment spine vertebrae. Finally, spine curve is obtained by interpolating centers of segmented vertebrae using cubic spline. Results: We tested our method with 13 MR data sets of patients. All disk positions of each MR data set were correctly extracted in the first part. The mean deviation of centers of segmented vertebrae that were obtained in the second part and used to interpolate spine curve was around 1.4 mm. Conclusions: Our method achieves a fully automatic extraction of the spine curve. The extraction of intervertebral disk positions in the first part of our method when compared to model-based methods and manual selection which was proposed in other papers is highly efficient. In the second part including the vertebra registration, a new similarity measurement method, which is used to guide the vertebra atlas fitting process, is proposed to solve the problem of changes in overlap. Through our experiment, results of spine curves are at a highly accurate level. Selected from Tang Z, Pauli J. Fully Automatic Extraction of Human Spine Curve from MR Images Using Methods of Efficient Intervertebral Disk Extraction and Vertebra Registration. Int J Comput Assist Radiol Surg, 2010 Apr 27 [Epub ahead of print]. © Shanghai Research Institute of Acupuncture and Meridian and Springer-Verlag Berlin Heidelberg 2010︱● 195
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