Fire Needling Therapy versus Usual Care for Parkinson's Disease-Related Chronic Pain: A Pilot Randomized Controlled Trial.

Introduction: Parkinson's disease (PD)-related chronic pain is a prevalent non-motor symptom, this study aimed to detect the effect and safety of fire needling therapy (FNT) for PD-related chronic pain relief. Methods: Patients with PD-related chronic pain were randomly allocated to FNT group and control group with a treatment phase of 8 weeks and a follow-up phase of 4 weeks. Primary outcome was the King's Parkinson's Pain Scale (KPPS), Secondary outcomes included Visual Analogue Scale (VAS), Unified Parkinson's Disease Rating Scale-III (UPDRS-III), and the Parkinson's Disease Questionnaire-39 (PDQ-39). Study was registered on Chinese Clinical Trial Registry (Registered number: ChiCTR2400084951). Results: 60 participants were randomized, with 30 in the FNT group and 30 in the control group. KPPS was significantly influenced by the interaction of treatment and time, with a significant reduction in pain observed in the FNT group compared to the control group at Week 4 (difference [95% CI]: -20.693[-27.619,-13.767], P<0.001), Week 8 (difference [95% CI]: 44.680[-52.359,-37.000], P<0.001), and Week 12 (difference [95% CI]: -44.982[-52.771,-37.193], P<0.001). For VAS, UPDRS-III, and PDQ-39, there were significant differences between groups at Week 4, Week 8, and Week 12. Conclusion: FNT could be an effective and safe method for managing PD-related chronic pain. However, large-sample studies conducted in multiple centers are necessary to further verify the findings in the future.

Fire Needling Therapy of Different Frequencies versus External Diclofenac Diethylamine Emulgel for Knee Osteoarthritis: Study Protocol for a Pilot Randomized Controlled Trial.

Purpose: Knee osteoarthritis (KOA) is regarded as one of the leading musculoskeletal diseases. Although the efficacy is under exploration, fire needling therapy is considered an effective alternative for KOA. This trial aims to investigate the effectiveness of different frequencies of fire needling therapy in attenuating pain and promoting function in KOA patients. Methods: This is a study protocol for a pilot, three-arm, single-center, randomized controlled trial. A total of 90 participants with KOA will be recruited and randomly assigned to the high-frequency fire needling group (3 sessions per week, for 6 weeks), the low-frequency fire needling group (1 session per week, for 6 weeks) or the positive control group (Diclofenac Diethylamine Emulgel, 3 times per day, for 6 weeks) in a 1:1:1 ratio. Participants will accomplish the trial at Week 14 after a follow-up evaluation. The response rate will be set as the primary outcome that the proportion of participants obtaining a minimal clinically important difference, which is identified as ≥2 units on the numerical rating scale (NRS) and ≥6 units on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score at Week 6 compared with Week 0. Secondary outcomes are NRS, WOMAC, Brief Pain Inventory, Short-Form Health Survey-12, Timed Up and Go Test, and pain threshold. Discussion: This is the first standardized protocol comparing fire needling therapy and positive control drugs. This trial may provide reliable evidence for the effectiveness of fire needling therapy and dose-effect property of it in KOA. Trial registration: The trial has been registered on Chinese Clinical Trial Registry (Registered number: ChiCTR2100043041), registered on 4 February 2021.

Fire Needling Therapy versus Manual Acupuncture in Post-Stroke Complex Regional Pain Syndrome of the Upper Limb: Study Protocol for a Pilot Randomised Controlled Trial.

Introduction: Post-stroke complex regional pain syndrome (CRPS) is a devastating disease that causes severe physical and emotional consequences. Conventional therapies are limited due to the insufficient benefits and side effects, and fire needling therapy is considered an alternative for post-stroke CRPS of the upper limb. Methods and Analysis: This is a study protocol for a pilot randomised, two-arm, single-centre, clinical trial at Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University. The trial started in March 2023 and is expected to end in December 2024. A total of 60 patients (aged 40-75 years, male or female) with post-stroke CRPS of the upper limb will be randomly assigned to treatment group (fire needling therapy, 5 sessions per week for 2 weeks) or control group (manual acupuncture, 5 sessions per week for 2 weeks) in a 1:1 ratio using block randomisation and opaque envelopes. Fire needling therapy or manual acupuncture will be performed in ten acupoints. Participants will complete the trial by visiting the research centre at Week 14 for a follow-up assessment. The primary outcome is the response rate. Secondary outcomes include FMA, Barthel Scale/Index (BI), pain threshold (PPT), and muscle elasticity modulus (using shear wave elastography [SWE]). A chi-squared test will be used for response rate. A mixed-effects linear model and a mixed-effects model will be used for FMA, BI, PPT, and SWE, respectively. Discussion: This is the first standardised protocol to compare the effectiveness of fire needling therapy and manual acupuncture. We will use a rigorous methodology to minimise bias and set up supervising committees to ensure the quality of our study, thus providing trustworthy evidence for better understanding of fire needling therapy in treating post-stroke CRPS of the upper limb.

[Innovation, development and application of contemporary fire needling].

Physicians in the past dynasties have improved the theory of fire needling from the aspects of fire needling instruments, clinical efficacy, application scope, operation, precautions, etc., which promoted the clinical application of fire needling. Modern fire needling breaks through the traditional clinical taboos such as heat syndrome, face, forbidden acupoints, and no needle retention. By using modern fire needling with various types, characteristics and functions, multiple needles and multiple methods are used to treat various diseases, which can further exert the therapeutic effect of fire needling and promote the popularization and application of fire needle therapy.

[Diarrhea-predominant irritable bowel syndrome of spleen deficiency and damp excess treated with fire needling therapy with filiform needle and acupoint application therapy: a randomized controlled trial].

OBJECTIVE: To compare the clinical therapeutic effect on diarrhea-predominant irritable bowel syndrome (IBS-D) of spleen deficiency and damp excess among fire needling therapy with filiform needle combined with acupoint application therapy, simple acupoint application therapy and pinaverium bromide tablets, and explore the mechanism on the improvements in IBS-D. METHODS: A total of 150 patients with IBS-D of spleen deficiency and damp excess were randomized into a combined treatment group (50 cases, 14 cases dropped off), an acupoint application group (50 cases, 16 cases dropped off ) and a western medication group (50 cases, 13 cases dropped off ). In the western medication group, pinaverium bromide tablets were prescribed for oral administration, 50 mg per time, three times a day. In the acupoint application group, the herbal plaster of shenling baizhu powder mixed with fresh ginger juice was placed on Shenque (CV 8), once every two days. In the combined treatment group, on the base of the treatment as the acupoint application group, the fire needling therapy with filiform needle was exerted at Tianshu (ST 25), Shangjuxu (ST 37), Yinlingquan (SP 9) and Dachangshu (BL 25), once every two days. The duration of treatment in each group was 4 weeks. Separately, before treatment and after 7 and 28 days of treatment, the score of clinical symptoms and the score of quality of life scale for IBS (IBS-QOL) were observed in each group. Before treatment and after 28 days of treatment, the levels of , and T lymphocytes, and the ratio of / in peripheral blood of patients were detected successively; as well as the expressions of 5-HT3R mRNA and 5-HT4R mRNA in colon mucosal tissues in each group separately. RESULTS: Except the score for abdominal pain in the acupoint application group and the scores for abdominal pain and abdominal distention in the western medication group after 7 days of treatment, the scores for abdominal pain, abdominal distention, defecation frequency, stool form and incomplete bowel movement after 7 and 28 days of treatment were all reduced as compared with those before treatment in each group separately (P<0.05). After 7 days of treatment, the scores for abdominal distention, defecation frequency and stool form in the combined treatment group were all lower than those in the western medication group (P<0.05). After 28 days of treatment, the score of each clinical symptom in the combined treatment group was lower than either of the rest two groups respectively (P<0.05); and the scores for abdominal pain, abdominal distention and incomplete bowel movement in the acupoint application group were lower than those in the western medication group separately (P<0.05). After 7 and 28 days of treatment, the score of each item in IBS-QOL was increased as compared with that before treatment in each group (P<0.05). After 7 days of treatment, except the scores for heterosexual relationship and human relations, scores of the other items, other scores of IBS-QOL in the combined treatment group were higher than those in the western medication group separately (P<0.05); while the scores of anxiety and behavior disorder in the acupoint application group were higher than those in the western medication group (P<0.05). After 28 days of treatment, the each score of IBS-QOL in the combined treatment group was higher than the other two groups respectively (P<0.05), while the scores of anxiety, behavior disorder, dietary control, social reaction and human relations in the acupoint application group were all higher than the western medication group (P<0.05). After treatment, the levels of and T lymphocytes and the ratio of /in peripheral blood, as well as the expressions of 5-HT4R mRNA in colon tissue were all increased in each group (P<0.05), but the levels of T lymphocyte and 5-HT3R mRNA expressions in colon tissue were reduced in each group (P<0.05). After treatment, regarding the levels of and T lymphocytes and the ratio of /in peripheral blood, as well as the expressions of 5-HT4R mRNA in colon tissue, the values in the combined treatment group were all higher than either of the rest two groups respectively (P<0.05), while the values in the acupoint application group were higher than the western medication group (P<0.05). Concerning to the level of T lymphocytes and 5-HT3R mRNA expression, the values in the combined treatment group were lower than the rest two groups respectively (P<0.05), and the values in the acupoint application group were lower than the western medication group (P<0.05). CONCLUSION: The combined treatment with the fire needling therapy with filiform needle and the acupoint application therapy effectively relieves the clinical symptoms, improves the quality of life and strengthens the immunity in the patients with IBS-D. The therapeutic effect of this combined regimen is better than either simple acupoint application therapy or the oral medication of pinaverium bromide. The mechanism may be related to the regulation of the levels of T lymphocyte subsets and the modulation of the expressions of 5-HT3R and 5-HT4R mRNA in colon tissue.

[Exploration of fire needling therapy on coronavirus disease 2019].

Combined with previous clinical experience in anti-epidemic and acupuncture, the prevention program of fire needling therapy for coronavirus disease 2019 (COVID-19) was drawn out. Fire needling therapy has the effects of clearing heat, removing dampness, replenishing for the deficiency, removing stasis and detoxifying, which is mainly aimed at preventing populations, light and common types cases, and cases in the recovery period. Acupoints of governor vessel, lung meridian, bladder meridian and stomach meridian are mainly used in this program. For the special groups, such as children, elderly and weak, and pregnant women, Shenzhu (GV 12), Danshu (BL 19), Geshu (BL 17), Zhigou (TE 6), etc. are added. It is hoped that fire needling therapy will be applied in the community and square cabin hospitals as an effective supplement to anti-epidemic of traditional Chinese medicine (TCM).

[Therapeutic effects of "kidney three-needle" therapy plus fire needling therapy in treatment of post-stroke urinary incontinence].

OBJECTIVE: To observe the efficacy of "kidney three-needle" therapy［Qugu（CV2） and 1 cun to the left and right of CV2］ and the pricking technique of fire needing therapy on urinary frequency and maximal bladder volume in potients with post-stroke urinary incontinence. METHODS: A total of 60 patients with post-stroke urinary incontinence were collected according to the inclusion and exclusion criteria and were randomized into an observation group (30 cases) and a control group (30 cases). On the base of the routine medication and rehabilitation treatment, acupuncture was applied to the general acupoints for motor impairment and speech disorder in the two groups. Additionally, the combination of "kidney three-needle" therapy and the pricking technique of fire needling therapy was used for urinary incontinence in the observation group and the common acupuncture was applied in the control group. Needles were retained for 30 min and acupuncture was provided once daily, 5 days a weeks, 2 weeks of treatment as one course. Both groups were treated for 3 courses. Before and after treatment, the rank of daytime urinary frequency was compared in the patients of the two groups. Ultrasound B was adopted to determine the maximal bladder volume. The total effective rate was compared between the two groups. RESULTS: After treatment, the rank of daytime urinary frequency all reduced significantly as compared with that before treatment in the patients of the two groups (P<0.01)， and the observation group was lower than the control group (P<0.05). After the treatment, the maximal bladder volume increased significantly as compared with that before treatment in the self-comparison of each group (P<0.01) and the volume in the observation group was significantly higher than that in the control group (P<0.01). The total effective rate was 93.3% (28/30) in the observation group and was 66.7% (20/30) in the control group. The total effective rate in the observation group was higher obviously than that in the control group (P<0.05). CONCLUSION: The combination of "kidney three-needle" therapy and the pricking technique of fire needling therapy significantly reduces the rank of daytime urinary frequency and increases maximal bladder volume in the patients with post-stroke urinary incontinence. The therapeutic effect of such combined acupuncture treatment is better than the common acupuncture therapy.

[Application time-point and effect observation of fire needling therapy in IVF-ET].

OBJECTIVE: To observe the effects of the intervention with fire needling therapy on the uterine microenvironment at the specific time points of menstrual cycle and evaluate the effects on the assisted reproduction. METHODS: Sixty-eight patients of in vitro fertilization and embryo transplantation (IVF-ET) were randomized into an observation group (35 cases) and a control group (33 cases). The patients in the two groups all received post-IVF-ET corpus luteum support of the microstimulation scheme in the Clinical Reproduction Center of Jiangsu People's Hospital. In the control group, the regular sequential therapy of acupuncture was used. In the observation group, on the basis of the treatment as the control group, the intervention of fire needling therapy was applied after ovulation (the 1st time point, on the 1st day after ovulation) and at the end of premenstrual stage (the 2nd time point, 3 days before the menstruation). At the 1st time point, Shenshu (BL 23), Mingmen (GV 4) and Yaoyangguan (GV 3) were selected and at the 2nd time point, Shenshu (BL 23) and Ciliao (BL 32) were selected. The acupoints were stimulated from up to down and from the left to the right. The changes in TCM syndrome during the preparation, the endometrial thickness and types on the day of transplantation, the biochemical pregnant rate after transplantation and clinical pregnant rate were observed and compared in the patients of the two groups. RESULTS: After treatment, TCM syndrome scores were all reduced in the two groups (both P<0.05). In the observation group, the biochemical pregnant rate and clinical pregnant rate were slightly higher than those in the control group, without significant difference in comparison (both P>0.05). In the observation group, the endo-metrial thickness on the day of transplantation was higher than that in the control group (P<0.05). After treatment, the differences in TCM syndrome score and endometrial type were not significant statistically between the two groups (all P>0.05). CONCLUSIONS: The intervention of fire needling therapy at the specific time points of menstrual cycle relieves menstrual symptoms and increases endometrial thickness so as to assist embryo implantation in the patients of infertility.

[Professor WU Zhongchao's experience in the treatment of bi syndrome with fire needling therapy at lower he-sea points].

Bi syndrome is classified into five categories. Based on the syndrome differentiation of meridians and collaterals and zangfu theories, Professor WU Zhongchao proposed the fire needling therapy at the lower he-sea points for five types of bi syndromes. Professor WU stresses on the flexible application of fire needling therapy for bi syndrome at the lower he-sea points and innovated the unique five techniques of fire needling therapy, named lifting and threating needle of small amplitude at the lower he-sea points, the stimulation along the relevant meri-dians before fire needling, detecting the sensitive sites by gentle pressing the relevant lower he-sea points, combining the movement of affected upper limb or joint during fire needling, or combining with contralateral needling technique, and controlling the depth of fire needling based on the duration of sickness and depth of affected site. He pointed out that Shangjuxu (ST 37) is for skin bi syndrome, Zusanli (ST 36) for muscle bi syndrome, Yanglingquan (GB 34) for tendon bi syndrome, Weizhong (BL 40) for bone bi syndrome and Xiajuxu (ST 39) for vessel bi syndrome.

Diarrhea-predominant irritable bowel syndrome of spleen deficiency and damp excess treated with fire needling therapy with filiform needle and acupoint application therapy: a randomized controlled trial / 中国针灸

OBJECTIVE@#To compare the clinical therapeutic effect on diarrhea-predominant irritable bowel syndrome (IBS-D) of spleen deficiency and damp excess among fire needling therapy with filiform needle combined with acupoint application therapy, simple acupoint application therapy and pinaverium bromide tablets, and explore the mechanism on the improvements in IBS-D.@*METHODS@#A total of 150 patients with IBS-D of spleen deficiency and damp excess were randomized into a combined treatment group (50 cases, 14 cases dropped off), an acupoint application group (50 cases, 16 cases dropped off ) and a western medication group (50 cases, 13 cases dropped off ). In the western medication group, pinaverium bromide tablets were prescribed for oral administration, 50 mg per time, three times a day. In the acupoint application group, the herbal plaster of @*RESULTS@#Except the score for abdominal pain in the acupoint application group and the scores for abdominal pain and abdominal distention in the western medication group after 7 days of treatment, the scores for abdominal pain, abdominal distention, defecation frequency, stool form and incomplete bowel movement after 7 and 28 days of treatment were all reduced as compared with those before treatment in each group separately (@*CONCLUSION@#The combined treatment with the fire needling therapy with filiform needle and the acupoint application therapy effectively relieves the clinical symptoms, improves the quality of life and strengthens the immunity in the patients with IBS-D. The therapeutic effect of this combined regimen is better than either simple acupoint application therapy or the oral medication of pinaverium bromide. The mechanism may be related to the regulation of the levels of T lymphocyte subsets and the modulation of the expressions of 5-HT3R and 5-HT4R mRNA in colon tissue.