A traditional chinese medicine composition for treating heel pain and a method of using the same

Abstract

This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for treating heel pain and its method of use. It is composed of the following ingredients: tortoise shell, wolfberry, drynaria, psoralea, cistanche, achyranthes, epimedium, eucommia, astragalus, yam, prepared rehmannia, angelica, salvia miltiorrhiza, calcined dragon bone, calcined oyster shell, prepared licorice, codonopsis, and atractylodes macrocephala. The method of use involves a combined internal and external therapy: internally, a concentrated decoction is taken morning and evening; externally, the dregs are decocted again and used for foot baths. This invention, through the principles of "tonifying the liver and kidneys, strengthening tendons and bones, promoting blood circulation and removing blood stasis, and nourishing the spleen and controlling water," combined with the internal and external treatment approach, solves the technical problems of existing heel pain treatments, such as significant side effects, short-lasting efficacy, and limited therapeutic dimensions. Clinical trials have verified that this invention can significantly reduce patients' VAS pain scores and improve their AOFAS ankle-hindfoot scores, with high safety and no obvious toxic side effects, showing good prospects for clinical application and industrial promotion.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition for treating heel pain due to liver and kidney deficiency in middle-aged and elderly people and its method of use, and more particularly to a traditional Chinese medicine composition for treating heel pain and its method of use. Background Technology

[0002] Plantar fasciitis is a common foot and ankle surgical condition, belonging to the category of plantar pain syndromes. It is more prevalent in middle-aged and elderly individuals, with an even higher incidence in obese individuals. Currently identified causes include heel fat pad inflammation or atrophy, calcaneal spurs, and plantar fasciitis. Its onset is usually slow, although a few cases can have acute exacerbations. The core symptom is pain in the anterior and inferior position of the heel, which worsens upon waking or when standing up and walking after sitting for a while. There is often a significant tender point on the medial side of the weight-bearing area of ​​the heel. Some patients may experience mild swelling and erythema, which seriously affects the patient's walking function and quality of life.

[0003] From the perspective of Traditional Chinese Medicine (TCM), heel pain falls under the category of "Bi syndrome" or "Kidney Bi syndrome." The heel is connected to the Kidney Meridian. The Liver governs the tendons, and the Kidney governs the bones. Deficiency of the Liver and Kidney leads to insufficient production of Qi and Blood, allowing Wind, Cold, and Dampness to invade and obstruct the meridians. This impairs the flow of Qi and Blood, resulting in malnourishment of the tendons and bones, eventually leading to bone spurs. Therefore, this condition is a case of deficiency in the root and excess in the branch. The deficiency lies in Liver and Kidney deficiency, while the excess is due to the obstruction of the meridians by Wind, Cold, and Dampness. Thus, the core principles of TCM treatment for heel pain are to tonify the Liver and Kidney, dispel wind and cold, eliminate dampness and relieve pain, and promote blood circulation and remove blood stasis.

[0004] Currently, clinical treatments for heel pain in the elderly mainly include oral nonsteroidal anti-inflammatory drugs (NSAIDs), local corticosteroid injections, shockwave therapy, acupuncture, open surgery, and endoscopic surgery. Among these, local injection of corticosteroids is a widely used treatment method. Although it can relieve pain in the short term, its long-term efficacy is poor, and it carries potential risks such as infection, plantar fascia rupture, and fat pad necrosis. Oral NSAIDs are prone to causing gastrointestinal irritation and other side effects. Surgical treatment is highly invasive, has a long postoperative recovery period, and has low patient acceptance.

[0005] There are also various traditional Chinese medicine compositions for treating heel pain in the existing technology. For example, CN105168416A discloses a traditional Chinese medicine composition composed of chicken blood vine, salvia miltiorrhiza, gleditsia sinensis thorn, and ground beetle, which focuses on promoting blood circulation, removing blood stasis, and relieving pain, but does not take into account the fundamental pathogenesis of liver and kidney deficiency. CN102423344B discloses a traditional Chinese medicine composition containing stir-fried atractylodes macrocephala, achyranthes bidentata, and epimedium, which has a certain curative effect, but the total effective rate is only 83%, and the external adjuvant treatment method is not disclosed. CN104666881B discloses a traditional Chinese medicine composition containing white peony root, licorice, and yam, which has a complex formula and does not specify the specific weight ratio of each herb and clinical efficacy data.

[0006] In summary, existing treatments for heel pain suffer from drawbacks such as significant side effects, poor long-term efficacy, unreasonable formulations, and limited treatment methods. There is an urgent need for a scientifically formulated, effective, low-side-effect, and convenient traditional Chinese medicine composition and its application method to solve these technical problems. Summary of the Invention

[0007] The present invention aims to overcome the above-mentioned defects and provide a traditional Chinese medicine composition for treating heel pain.

[0008] To overcome the deficiencies in the prior art, the technical solution adopted by the present invention to solve its technical problem is as follows: This traditional Chinese medicine composition for treating heel pain is composed of the following raw materials in parts by weight: 14-16g of tortoise shell, 14-16g of wolfberry, 14-16g of drynaria rhizome, 14-16g of psoralea fruit, 14-16g of cistanche, 11-13g of achyranthes root, 14-16g of epimedium, 14-16g of eucommia bark, 11-13g of astragalus root, 11-13g of yam, 11-13g of prepared rehmannia root, 11-13g of angelica root, 11-13g of salvia root, 19-21g of calcined dragon bone, 19-21g of calcined oyster shell, 5-7g of prepared licorice root, 19-21g of codonopsis root, and 28-32g of atractylodes rhizome.

[0009] According to another embodiment of the present invention, the product further comprises, by weight, the following ingredients: 15g tortoise shell, 15g wolfberry, 15g drynaria rhizome, 15g psoralea fruit, 15g cistanche, 12g achyranthes root, 15g epimedium, 15g eucommia bark, 12g astragalus root, 12g yam, 12g prepared rehmannia root, 12g angelica root, 12g salvia root, 20g calcined dragon bone, 20g calcined oyster shell, 6g prepared licorice root, 20g codonopsis root, and 30g atractylodes rhizome.

[0010] The method of using this traditional Chinese medicine composition for treating heel pain includes the following steps:

[0011] Step 1, Preparation for oral administration: Take the Chinese herbal composition, add 400-450ml of water, bring to a boil over high heat, then simmer over low heat for 18-22 minutes until concentrated to 200-300ml, to obtain the decoction for oral administration;

[0012] Step 2, Oral administration: 1 dose per day, once in the morning and once in the evening, 100-150ml each time;

[0013] Step 3, preparation for external use: Take the dregs after decoction in step 1, add 25-35g of Atractylodes macrocephala and 18-22g of Clematis chinensis, add 300-350ml of water, decoct again for 15-20 minutes, filter and take the liquid to prepare the external foot bath liquid.

[0014] Step 4: Add warm water and 50ml of vinegar to the foot bath solution from step 3, and soak the affected foot in the foot bath solution for 20-25 minutes daily.

[0015] According to another embodiment of the present invention, the boiling temperature in the first step is 100°C and the simmering temperature is 80-90°C.

[0016] According to another embodiment of the present invention, the temperature of the water during the foot bath in the fourth step is 40-45°C.

[0017] The beneficial effects of this invention are:

[0018] 1. This invention is based on the core pathogenesis of heel pain syndrome in traditional Chinese medicine. It adopts the principle of "tonifying the liver and kidneys, promoting blood circulation and removing blood stasis, and strengthening the spleen and controlling water". It not only targets the root cause of deficiency of the liver, spleen and kidneys, but also relieves the symptoms of qi stagnation and blood stasis. The combination has strong synergy and can improve the pathogenesis of heel pain syndrome from the root.

[0019] 2. A combined internal and external treatment approach is adopted. Internal medication addresses the root cause, while external medication penetrates directly to the lesion through the skin. The medicine reaches the affected area directly, and the internal and external treatments work synergistically to significantly improve treatment efficiency and quickly relieve pain.

[0020] 3. Definite efficacy and supported by data: Clinical trials have verified that the VAS pain score, AOFAS ankle-hindfoot score, and Maryland foot score of the composition of this invention were significantly better than those of the control group treated with hormone injection on the second day of treatment, at 1 month and 3 months of treatment, and there were no side effects. The control group, on the other hand, experienced adverse reactions such as local swelling and tenderness, and rebound pain. The long-term efficacy and safety of this invention are more advantageous.

[0021] 4. The Chinese herbal raw materials used in this invention are all common medicinal materials, widely available and inexpensive. Compared with surgical treatment, shockwave therapy and other methods, the treatment cost is greatly reduced, making it suitable for use in primary medical institutions and ordinary patients, and has good prospects for clinical promotion. Detailed Implementation

[0022] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0023] A traditional Chinese medicine composition for treating heel pain, characterized in that, by weight, it comprises the following raw materials: 14-16g tortoise shell, 14-16g wolfberry, 14-16g drynaria rhizome, 14-16g psoralea fruit, 14-16g cistanche deserticola, 11-13g achyranthes bidentata, 14-16g epimedium, 14-16g eucommia bark, 11-13g astragalus root, 11-13g yam, 11-13g prepared rehmannia root, 11-13g angelica sinensis, 11-13g salvia miltiorrhiza, 19-21g calcined dragon bone, 19-21g calcined oyster shell, 5-7g prepared licorice root, 19-21g codonopsis root, and 28-32g atractylodes macrocephala.

[0024] Raw material specifications for the traditional Chinese medicine composition:

[0025] Tortoise shell, the dried carapace and plastron of the turtle (Tortoise scutellariae), is sweet and salty in taste, slightly cold in nature, and enters the liver, kidney, and heart meridians. Its functions include nourishing yin and suppressing yang, tonifying the kidneys and strengthening bones, nourishing blood and replenishing the heart, and consolidating menstruation and stopping uterine bleeding. It is mainly used to treat symptoms such as yin deficiency with tidal fever, night sweats, dizziness, internal wind due to deficiency, weakness of muscles and bones, forgetfulness due to heart deficiency, and metrorrhagia.

[0026] Goji berries, the dried, ripe fruit of the Solanaceae plant *Lycium barbarum*, are sweet in taste and neutral in nature, entering the liver and kidney meridians. They are effective in nourishing the liver and kidneys, replenishing essence, and improving eyesight. They are primarily used to treat conditions such as general weakness and deficiency of essence, lower back and knee pain, dizziness and tinnitus, impotence and seminal emission, internal heat and thirst, blood deficiency and chlorosis, and blurred vision.

[0027] Drynaria fortunei, the dried rhizome of the plant Drynaria fortunei (family Polypodiaceae), is bitter and warm in nature, and enters the liver and kidney meridians. It is effective in tonifying the kidneys and strengthening bones, promoting healing of injuries and relieving pain. Externally, it is used to dispel wind and remove blemishes. It is primarily used to treat kidney deficiency causing lower back pain, tinnitus and deafness, loose teeth, sprains and strains, and fractures; externally, it is used to treat alopecia areata, vitiligo, and other conditions.

[0028] Psoralea corylifolia, the dried, mature fruit of the legume Psoralea corylifolia, is pungent and bitter in taste, warm in nature, and enters the kidney and spleen meridians. Its functions include warming the kidneys and tonifying yang, regulating qi and relieving asthma, and warming the spleen and stopping diarrhea; externally, it is used to dispel wind and remove blemishes. It is primarily used to treat kidney yang deficiency, impotence, seminal emission, enuresis, frequent urination, cold pain in the lower back and knees, asthma due to kidney deficiency, and early morning diarrhea; externally, it is used to treat vitiligo, alopecia areata, and other conditions.

[0029] Cistanche deserticola, the dried, fleshy stem with scaly leaves of Cistanche deserticola or Cistanche tubulosa, both belonging to the Orobanchaceae family, has a sweet and salty taste, is warm in nature, and enters the kidney and large intestine meridians. It is effective in tonifying kidney yang, nourishing essence and blood, and moistening the intestines to relieve constipation. It is mainly used to treat symptoms such as kidney yang deficiency, deficiency of essence and blood, impotence and infertility, soreness and weakness of the lower back and knees, weakness of muscles and bones, and constipation due to intestinal dryness.

[0030] Achyranthes bidentata, the dried root of the plant Achyranthes bidentata (family Amaranthaceae), is sweet and slightly bitter in taste, neutral in nature, and enters the liver and kidney meridians. It is effective in removing blood stasis and promoting menstruation, facilitating joint movement, and promoting urination. It is primarily used to treat amenorrhea, retained placenta, injuries from falls, rheumatic pain, weakness and muscle spasms in the feet, hematuria, and other related conditions.

[0031] Epimedium, the dried leaves of Epimedium, Epimedium sagittatum, Epimedium pubescens, or Epimedium koreanum (all belonging to the Berberidaceae family), has a pungent and sweet taste, is warm in nature, and enters the liver and kidney meridians. It is effective in tonifying kidney yang, strengthening tendons and bones, and dispelling wind and dampness. It is primarily used to treat kidney yang deficiency, impotence, seminal emission, weakness of tendons and bones, rheumatic pain, numbness, and contractures.

[0032] Eucommia bark, the dried bark of the Eucommia ulmoides tree (Eucommia ulmoides), is sweet in taste and warm in nature, and enters the liver and kidney meridians. It is effective in tonifying the liver and kidneys, strengthening muscles and bones, and calming the fetus. It is primarily used to treat symptoms such as liver and kidney deficiency, lower back and knee pain, weakness of muscles and bones, dizziness, threatened miscarriage, and fetal restlessness.

[0033] Astragalus root, the dried root of *Astragalus mongholicus* or *Astragalus membranaceus*, belongs to the legume family. It is sweet in taste and slightly warm in nature, and enters the spleen and lung meridians. Its functions include tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, generating fluids and nourishing blood, promoting circulation and relieving pain, promoting pus drainage and detoxification, and promoting wound healing and tissue regeneration. It is mainly used to treat qi deficiency and fatigue, poor appetite and loose stools, qi sinking, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, internal heat and thirst, blood deficiency and chlorosis, hemiplegia, numbness and pain, carbuncles that are difficult to heal, and chronic ulcers that do not heal.

[0034] Yam, the dried rhizome of the Dioscorea opposita plant (Dioscorea opposita), is sweet in taste and neutral in nature, and enters the spleen, lung, and kidney meridians. It is effective in tonifying the spleen and stomach, promoting body fluid production and benefiting the lungs, and tonifying the kidneys and astringing essence. It is primarily used to treat symptoms such as poor appetite due to spleen deficiency, chronic diarrhea, cough and asthma due to lung deficiency, seminal emission due to kidney deficiency, leukorrhea, frequent urination, and thirst due to deficiency heat.

[0035] Rehmannia glutinosa, or prepared rehmannia root, is the tuberous root of Rehmannia glutinosa (a plant in the Scrophulariaceae family) that has been processed by steaming and drying. It has a sweet taste and slightly warm nature, and enters the liver and kidney meridians. Its functions include nourishing blood and yin, replenishing essence and marrow. It is mainly used to treat symptoms such as blood deficiency and chlorosis, palpitations, irregular menstruation, metrorrhagia, liver and kidney yin deficiency, soreness and weakness of the lower back and knees, bone steaming fever, night sweats, seminal emission, internal heat and thirst, dizziness, tinnitus, and premature graying of hair.

[0036] Angelica sinensis, the dried root of the plant Angelica sinensis (family Apiaceae), has a sweet and pungent taste, is warm in nature, and enters the liver, heart, and spleen meridians. It is effective in nourishing and invigorating blood, regulating menstruation and relieving pain, and moistening the intestines to promote bowel movements. It is primarily used to treat conditions such as blood deficiency and chlorosis, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic pain, injuries from falls and blows, carbuncles and sores, and constipation due to intestinal dryness.

[0037] Salvia miltiorrhiza, the dried root and rhizome of the plant Salvia miltiorrhiza (Lamiaceae family), is bitter in taste and slightly cold in nature, entering the heart and liver meridians. Its functions include promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the heart and relieving irritability, cooling the blood and reducing swelling. It is mainly used to treat chest pain, abdominal and hypochondriac pain, abdominal masses, painful arthralgia due to heat, insomnia, irregular menstruation, dysmenorrhea, amenorrhea, sores and swelling, and other ailments.

[0038] Calcined dragon bone is a fossilized bone or tusk of ancient mammals such as three-toed horses, rhinoceroses, deer, cattle, and elephants. After calcination, it has a sweet and astringent taste, is neutral in nature, and enters the heart, liver, and kidney meridians. Its functions include calming the nerves, soothing the liver, suppressing yang, and astringing. It is used to treat restlessness, palpitations, insomnia, epilepsy, mania, liver yang hyperactivity, dizziness, spontaneous sweating, night sweats, seminal emission, enuresis, frequent urination, metrorrhagia, leukorrhea, chronic diarrhea, and dysentery. Externally, it is used to astringe and heal sores.

[0039] Calcined oyster shell, the shell of the Pacific oyster, Dalian Bay oyster, or Lithops licheniformis, is salty and slightly cold in nature after calcination. It enters the liver, gallbladder, and kidney meridians. Its functions include calming the mind, nourishing yin and suppressing yang, softening and dispersing masses, astringing and consolidating, and neutralizing acid and relieving pain. It is used to treat palpitations, insomnia, dizziness, tinnitus, scrofula, abdominal masses, spontaneous sweating, night sweats, seminal emission, metrorrhagia, leukorrhea, stomach pain, and acid reflux.

[0040] Prepared licorice root, made from the dried root and rhizome of the legume licorice root through honey-processing, is sweet in taste and neutral in nature. It enters the heart, lung, spleen, and stomach meridians. Its functions include tonifying the spleen and replenishing qi, clearing heat and detoxifying, relieving spasms and pain, and harmonizing other herbs. It is primarily used to treat spleen and stomach weakness, fatigue, palpitations, shortness of breath, cough with excessive phlegm, abdominal and limb spasms and pain, carbuncles and boils, and to alleviate the toxicity and harshness of other medications.

[0041] Codonopsis pilosula, the dried root of Codonopsis pilosula, Codonopsis lanceolata, or Codonopsis chuanxiong, is a plant in the Campanulaceae family. It is sweet in taste, neutral in nature, and enters the spleen and lung meridians. Its functions include strengthening the spleen and lungs, nourishing blood and promoting body fluid production. It is primarily used to treat symptoms such as spleen and lung qi deficiency, poor appetite and fatigue, cough and wheezing, qi and blood deficiency, sallow complexion, palpitations and shortness of breath, thirst due to fluid depletion, and internal heat and thirst.

[0042] Atractylodes macrocephala, the dried rhizome of the plant Atractylodes macrocephala (family Asteraceae), is bitter and sweet in taste, warm in nature, and enters the spleen and stomach meridians. Its functions include strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. It is mainly used to treat symptoms such as poor appetite due to spleen deficiency, abdominal distension and diarrhea, phlegm retention, dizziness and palpitations, edema, spontaneous sweating, and threatened abortion. Heel pain syndrome is caused by bone marrow hyperplasia. According to the theory of the five elements' mutual generation and restraint, earth can control water; if the spleen is weak and unable to control water, kidney water will overflow.

[0043] Clematis chinensis, the dried root and rhizome of Clematis chinensis, Clematis armandii, or Clematis davidii (all belonging to the Ranunculaceae family), has a pungent and salty taste, is warm in nature, and enters the bladder meridian. It is effective in dispelling wind and dampness, clearing the meridians, and relieving bone stuck in the throat. It is mainly used to treat rheumatic pain, numbness of limbs, muscle contractures, difficulty in flexion and extension, and bone stuck in the throat.

[0044] Vinegar is an acidic liquid condiment made from grains such as glutinous rice, wheat, sorghum, millet, and corn, or from distiller's grains, through fermentation. It has a sour and sweet taste, is neutral in nature, and enters the liver and stomach meridians. Its functions include dispersing blood stasis and eliminating accumulations, stopping bleeding, expelling roundworms, and detoxifying. It is mainly used to treat postpartum dizziness, abdominal masses, hematemesis, epistaxis, hematochezia, abdominal pain due to intestinal parasites, poisoning from fish, meat, or vegetables, carbuncles, boils, and other ailments. It is also frequently used in processing traditional Chinese medicine to guide the medicine to the liver, enhance its efficacy, and moderate its effects.

[0045] Example 1:

[0046] A traditional Chinese medicine composition for treating heel pain, by weight, consists of the following ingredients: 15g tortoise shell, 15g wolfberry, 15g drynaria rhizome, 15g psoralea fruit, 15g cistanche, 12g achyranthes root, 15g epimedium, 15g eucommia bark, 12g astragalus root, 12g yam, 12g prepared rehmannia root, 12g angelica root, 12g salvia root, 20g calcined dragon bone, 20g calcined oyster shell, 6g prepared licorice root, 20g codonopsis root, and 30g atractylodes rhizome.

[0047] How to use:

[0048] (1) For internal use: Take the above-mentioned medicinal materials, wash them and place them in a clay pot. Add 400ml of water, bring to a boil over high heat at 100-100℃, then reduce to low heat at 80℃ and simmer for 22 minutes until concentrated to 200ml. Take 100ml twice a day, morning and evening.

[0049] (2) External use: Put the remaining dregs after internal decoction into a clay pot again, add 25g of Atractylodes macrocephala and 18g of Clematis chinensis, add 300ml of water, decoct again for 15 minutes, filter, add 40℃ warm water, stir well, and make the water level cover the ankle. Starting from the day after internal use, soak the affected foot for 20 minutes before bedtime every day.

[0050] Example 2:

[0051] A traditional Chinese medicine composition for treating heel pain, by weight, consists of the following ingredients: 14g tortoise shell, 14g wolfberry, 14g drynaria rhizome, 14g psoralea fruit, 14g cistanche, 11g achyranthes root, 14g epimedium, 14g eucommia bark, 11g astragalus root, 11g yam, 11g prepared rehmannia root, 11g angelica root, 11g salvia root, 19g calcined dragon bone, 19g calcined oyster shell, 5g prepared licorice root, 19g codonopsis root, and 28g atractylodes rhizome.

[0052] How to use:

[0053] (1) For internal use: Take the above-mentioned medicinal materials, wash them and place them in a clay pot. Add 450ml of water, bring to a boil over high heat, then simmer over low heat at 90℃ for 18 minutes to concentrate to 300ml. Take 150ml twice a day, morning and evening.

[0054] (2) External use: Put the remaining dregs after internal decoction into a clay pot again, add 35g of Atractylodes macrocephala and 22g of Clematis chinensis, add 350ml of water, decoct again for 20 minutes, filter, add 45℃ warm water, stir well, and make the water level cover the ankle. Starting from the day after internal use, soak the affected foot for 25 minutes before bedtime every day.

[0055] The present invention will be further illustrated by specific implementation examples below, but the present invention is not limited to these specific examples.

[0056] Fifty-eight elderly patients diagnosed with heel pain who visited the Hand, Foot and Ankle Clinic of Wujin Affiliated Hospital of Nanjing University of Chinese Medicine were selected and divided into a study group (28 cases) and a control group (30 cases) according to different treatment plans. There were no statistically significant differences between the two groups in terms of gender, age, affected side, bone mineral density, and duration of disease (P>0.05), making them comparable. See Table 1 for details.

[0057] Table 1 compares the basic information of the two groups of patients:

[0058] Grouping Number of examples Gender (Male / Female) Age (years) Affected side (left / right) Bone mineral density (T-score) Duration of illness (months) research group 28 15 / 13 66.78±4.49 14 / 14 -1.79±0.52 3.06±1.41 control group 30 19 / 11 68.40±5.37 17 / 13 -1.87±0.55 2.90±1.30 t / X² value - 0.849 1.002 0.383 0.459 0.364 p-value - 0.558 0.161 0.770 0.324 0.359

[0059] Treatment plan:

[0060] The research group used the traditional Chinese medicine composition and its usage method described in Example 1 of this invention for combined internal and external treatment for one month.

[0061] Control group: The plantar fascia tenderness was treated with local injection of triamcinolone acetonide injection (5ml; 50mg, Zhejiang Xianju Pharmaceutical) 1ml + lidocaine hydrochloride injection (5ml; 0.1g, Chengdu Beite Pharmaceutical) 4ml at the medial red and white skin junction. Oral and topical Chinese medicine were not given. Warm water foot baths covering the ankle were used within 1 month after the operation.

[0062] Therapeutic efficacy evaluation indicators:

[0063] (1) Pain rating: The visual analog scale (VAS) was used, with a rating range of 0-10 points. The higher the score, the more severe the pain.

[0064] (2) Foot function score: The American Academy of Foot and Ankle Surgery (AOFAS) ankle-hindfoot score and the Maryland foot score were used. The higher the score, the better the foot function.

[0065] (3) Safety evaluation: Observe the adverse reactions of the two groups of patients during treatment and follow-up, including local swelling and tenderness at the injection site, rebound pain, gastrointestinal reactions, etc.

[0066] Experimental results:

[0067] Pain score comparison: There was no significant difference in VAS scores between the two groups before treatment (P>0.05); on the second day of treatment, 1 month after treatment, and 3 months after treatment, the VAS scores of the study group were significantly lower than those of the control group, and the differences were statistically significant (P<0.05), indicating that the composition of the present invention can effectively relieve the pain symptoms of patients with heel pain, and the long-term relief effect is better, as shown in Table 2.

[0068] Table 2 Comparison of VAS scores before and after treatment in the two groups of patients:

[0069] Grouping Number of examples Before treatment The day after treatment Treatment for 1 month 3 months of treatment research group 28 5.57±1.02 3.65±0.94 2.05±0.74 0.65±0.28 control group 30 5.67±0.87 4.17±0.61 2.45±0.46 0.85±0.37 t-value - 0.326 2.043 2.023 1.862 p-value - 0.373 0.024 0.025 0.035

[0070] Comparison of foot function scores: Before treatment, there was no significant difference in AOFAS ankle-hindfoot scores and Maryland foot scores between the two groups (P>0.05); on the second day of treatment, and 1 month and 3 months after treatment, both scores in the study group were significantly higher than those in the control group, and the differences were statistically significant (P<0.05), indicating that the composition of the present invention can effectively improve foot function in patients with heel pain, as detailed in Tables 3 and 4.

[0071] Table 3 Comparison of AOFAS ankle-hindfoot scores before and after treatment in the two groups of patients:

[0072] Grouping Number of examples Before treatment The day after treatment Treatment for 1 month 3 months of treatment research group 28 52.28±2.78 62.89±4.35 72.94±4.69 87.44±4.48 control group 30 52.35±2.35 63.25±4.34 73.20±4.65 82.45±5.22 t-value - 0.084 0.255 0.171 3.144 p-value - 0.467 0.400 0.432 0.002

[0073] Table 4 Comparison of Maryland foot scores between the two groups of patients:

[0074] Grouping Number of examples Before treatment The day after treatment Treatment for 1 month 3 months of treatment research group 28 47.5±5.06 60.78±6.10 77.72±5.23 87.17±3.93 control group 30 46.85±5.58 55.9±4.42 73.55±5.73 82.15±3.44 t-value - 0.375 2.845 2.334 4.199 p-value - 0.355 0.004 0.013 ＜0.001

[0075] Safety evaluation: During the follow-up period, 2 cases of injection site swelling and tenderness occurred in the control group, and 2 cases of pain rebound occurred at the last follow-up, with an adverse reaction rate of 13.33%; no persistent injection site swelling and tenderness, pain rebound at the last follow-up, or gastrointestinal reactions occurred in the study group, with an adverse reaction rate of 0%, indicating that the traditional Chinese medicine composition of the present invention has high safety and no obvious side effects, as detailed in Table 5.

[0076] Table 5 Comparison of adverse reactions between the two groups of patients:

[0077] Grouping Number of examples Persistent swelling and tenderness at the injection site Rebound pain at last follow-up Gastrointestinal reactions research group 28 0 0 0 control group 30 2 2 0

[0078] Experimental conclusion: The traditional Chinese medicine composition for treating heel pain and its method of use provided by this invention can effectively relieve the pain symptoms of patients with heel pain, improve foot function, and has high safety and no side effects. Its efficacy is significantly better than traditional hormone injection therapy, and it has good clinical application value.

[0079] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating heel pain, characterized in that, By weight, it consists of the following ingredients: 14-16g tortoise shell, 14-16g wolfberry, 14-16g drynaria rhizome, 14-16g psoralea fruit, 14-16g cistanche, 11-13g achyranthes root, 14-16g epimedium, 14-16g eucommia bark, 11-13g astragalus root, 11-13g yam, 11-13g prepared rehmannia root, 11-13g angelica root, 11-13g salvia root, 19-21g calcined dragon bone, 19-21g calcined oyster shell, 5-7g prepared licorice root, 19-21g codonopsis root, and 28-32g atractylodes rhizome.

2. The traditional Chinese medicine composition for treating heel pain as described in claim 1, characterized in that, The ingredients are composed of the following ingredients by weight: 15g tortoise shell, 15g wolfberry, 15g drynaria rhizome, 15g psoralea fruit, 15g cistanche, 12g achyranthes root, 15g epimedium, 15g eucommia bark, 12g astragalus root, 12g yam, 12g prepared rehmannia root, 12g angelica root, 12g salvia root, 20g calcined dragon bone, 20g calcined oyster shell, 6g prepared licorice root, 20g codonopsis root, and 30g atractylodes rhizome.

3. The method of using the traditional Chinese medicine composition for treating heel pain as described in claim 1 or 2, characterized in that, Includes the following steps: Step 1, Preparation for oral administration: Take the Chinese herbal composition, add 400-450ml of water, bring to a boil over high heat, then simmer over low heat for 18-22 minutes until concentrated to 200-300ml, to obtain the decoction for oral administration; Step 2, Oral administration: 1 dose per day, once in the morning and once in the evening, 100-150ml each time; Step 3, preparation for external use: Take the dregs after decoction in step 1, add 25-35g of Atractylodes macrocephala and 18-22g of Clematis chinensis, add 300-350ml of water, decoct again for 15-20 minutes, filter and take the liquid to prepare the external foot bath liquid. Step 4: Add warm water and 50ml of vinegar to the foot bath solution from step 3, and soak the affected foot in the foot bath solution for 20-25 minutes daily.

4. The method of using the traditional Chinese medicine composition for treating heel pain as described in claim 3, characterized in that: In the first step, the boiling temperature is 100℃, and the simmering temperature is 80-90℃.

5. As described in claim 1, characterized in that: In the fourth step, the water temperature for the foot bath is 40-45℃.