Acupoint Application for Constipation in Thoracolumbar Compression Fracture

Summary

This protocol describes the use of acupoint application as an effective and safe adjuvant, non-pharmacological intervention for managing constipation in patients with thoracolumbar compression fractures.

Abstract

Thoracolumbar compression fractures (TLFs) are common spinal injuries. Due to prolonged bed rest, pain-induced stress, and other factors, the incidence of constipation in affected patients exceeds 70%, which hinders rehabilitation. This study describes the operational procedures of acupoint application for the treatment of such constipation. To do this, acupoints were selected, including Tianshu (ST25), Daheng (SP15), Zusanli (ST36), Shangjuxu (ST37), and Zhigou (TE6), Chinese medicinal herbs such as Rheum officinale were ground into a paste for application, with a frequency of 1x a day, 6 h per session, and 2 weeks as one treatment course. Efficacy and safety were evaluated using the time interval to the first defecation after treatment, Patient Assessment of Constipation Symptom, Patient Assessment of Constipation Quality of Life, Visual Analog Scale scores, and adverse reactions. Forty-two patients with TLFs complicated by constipation were enrolled and randomly divided into an experimental group and a control group. After 2 weeks, constipation was improved in both groups, with all efficacy indicators of the experimental group being superior to those of the control group (p <0.05). No severe adverse reactions were observed in either group. The study indicates that acupoint application can effectively improve constipation in patients with high safety, providing a non-invasive intervention protocol. In the future, it is planned to expand the sample size to conduct multi-center studies, optimize the medicinal formula and treatment course, and explore the mechanism of action to support clinical promotion.

Introduction

Thoracolumbar Compression Fractures (TLFs) are common traumatic conditions in the fields of spinal surgery and geriatrics. Their pathogenesis is closely associated with factors such as osteoporosis, trauma, and tumors, and they have a particularly high incidence in the elderly population^1,2,3,4. Postmenopausal women have a significantly increased risk of developing TLFs^3,5. In young adults, TLFs are mostly caused by trauma, with males accounting for as high as 80% of such cases⁶. TLFs not only cause symptoms like severe low back pain and kyphosis deformity of the spine in patients but also induce a series of complications due to factors including prolonged bed rest and immobilization, pain-induced stress, and impaired neurological function. Among these complications, constipation is one of the most prevalent and has the most significant impact on patients' quality of life⁷. A retrospective study involving 117 patients showed that 70.9% of patients developed constipation after TLFs⁸. Another cross-sectional study on trauma patients also reported a similarly high constipation rate of 76%, indicating that this problem is widespread among fracture patients⁹. Constipation following TLFs greatly increases patients' suffering and significantly impairs their quality of life. Moreover, it may lead to severe secondary issues, prolong the rehabilitation process, and increase the demand for additional treatment and healthcare expenditure, thus constituting a socioeconomic burden that cannot be ignored^4,10.

Currently, Western medical treatment for constipation secondary to TLFs primarily involves health education and the use of oral or topical medications to promote defecation. When medical treatment fails, surgical intervention is adopted. Laxatives and microecological preparations are commonly used oral medications. Laxatives include botanical, lubricating, and stimulant types, which exert their effects by promoting intestinal absorption and increasing osmotic pressure. However, they are prone to causing electrolyte imbalances, and their efficacy is limited in elderly patients with concurrent colonic hypotonia^11,12. Although microecological preparations can maintain intestinal physiological functions by constructing an intestinal biological barrier and inhibiting endotoxin production, they have the limitation of suboptimal efficacy when used alone¹³. While surgical treatment can achieve certain effects targeting different etiologies, due to its high invasiveness, it is hardly suitable for the population of osteoporotic TLF patients, who are mostly elderly¹⁴. Therefore, it is particularly crucial to explore simple, safe, and effective treatment methods.

Traditional Chinese Medicine (TCM) demonstrates unique advantages in the treatment of constipation after TLFs, with the holistic concept and syndrome differentiation and treatment as its core^8,15. TCM focuses closely on the core pathogenesis of qi stagnation and disordered qi movement of the fu organs caused by bed rest and immobilization in patients after fractures. It emphasizes the compatibility of external therapy with the patient's physiological state, avoids the direct stimulation of the gastrointestinal tract by oral medications and the invasiveness of surgical intervention, and is particularly suitable for elderly osteoporotic patients who have low tolerance. A study has shown that TCM external therapy can improve intestinal peristalsis and alleviate constipation symptoms by regulating the composition of intestinal flora¹⁶. Acupoint application, as a non-invasive external therapy, offers a distinct advantage by avoiding systemic electrolyte disturbances and direct gastrointestinal stimulation. Unlike oral laxatives that may cause unpredictable responses in elderly patients with colonic hypotonia, and unlike surgical interventions that pose significant risks in frail populations, acupoint application provides a safer, well-tolerated alternative that can be easily implemented during bed rest¹⁷. Previous clinical findings have indicated that acupoint application has favorable effects in improving constipation symptoms after fractures and reducing the incidence of adverse reactions^15,18. From a practical applicability perspective, this therapy requires only simple herbal preparation and basic anatomical knowledge for acupoint selection, making it feasible for bedside application by nurses or trained caregivers without specialized equipment. This low-threshold, high-safety profile positions acupoint application as a particularly suitable intervention for geriatric TLF patients in both inpatient and home-care settings¹⁹.

Given that acupoint application has shown initial potential in the treatment of constipation after TLFs, currently, some studies still have issues, such as non-uniform operational procedures and single-dimensional efficacy evaluation²⁰. No standardized protocol that can be widely promoted has been developed yet, and this study aims to fill this gap. This study not only provides a basis for standardized operations for TCM intervention in constipation after TLFs, but also further consolidates the application foundation of acupoint application in this field through objective data. It is conducted with the expectation of providing a reference for optimizing the clinical constipation management protocol for elderly patients with osteoporotic TLFs.

Protocol

The protocol was approved by the ethics committee of the Hospital of Chengdu University of Traditional Chinese Medicine (ethics No. 2023SL-006). The subjects were fully informed and signed the informed consent form.​

1. Patient selection

1. Inclusion criteria
   1. Meet the diagnostic criteria for TLFs²¹; meet the diagnostic criteria for functional constipation²²; have not received any other constipation intervention treatments after fracture; able to maintain clear consciousness, be able to cooperate with treatment and efficacy evaluation, and sign the informed consent form; aged between 18 and 80 years old.
2. Exclusion criteria
   1. Have allergies to the drugs in acupoint application (Rheum officinale, sodium sulfate decahydrate, Citrus aurantium, Magnolia officinalis, honey) or application materials; have comorbid severe gastrointestinal diseases or functional failure of major organs such as the heart, liver, and kidneys; have local skin lesions such as erosion, infection, or eczema at the acupoints (Zhigou [TE6], Zusanli [ST36], Shangjuxu [ST37], Tianshu [ST25], Daheng [SP15]); have comorbid mental illnesses, cognitive impairment, or inability to independently report symptoms.
3. Dropout criteria
   1. Use of other constipation treatment regimens without authorization during the treatment period; experience severe adverse reactions and be unable to continue the treatment; voluntarily withdraw from the study due to personal reasons or be lost to follow-up.

2. Research design

1. Trial type
   1. Define the trial as a prospective randomized controlled clinical trial.
2. Grouping method
   1. Use a random number table method to divide patients who meet the inclusion criteria into an experimental group and a control group; allocate the sample size of the two groups at a 1:1 ratio.
3. Intervention measures
   1. For the control group: Provide routine care for thoracolumbar compression fractures (TLFs), including posture guidance, dietary guidance, abdominal massage, and administer lactulose oral solution at 15–30 mL/day (concentration: 10 g/15 mL, equivalent to 667 mg/mL), taken orally after breakfast.
   2. For the experimental group: Along with routine care provided to the control group, administer acupoint application treatment at Zhigou (TE6), Zusanli (ST36), Shangjuxu (ST37), Tianshu (ST25), and Daheng (SP15)²³(Table 1).
4. Observation period
   1. Set the observation period as 2 weeks (1 treatment course). Conduct efficacy and safety evaluations before treatment, at 1 week of treatment, and at 2 weeks of treatment.
5. Evaluation indicators
   1. General indicators: Record general indicators, including gender, age, BMI, and fractured vertebral segments.
   2. Efficacy indicators: Record efficacy indicators, including the time interval to the first defecation after treatment, Patient Assessment of Constipation Symptom (PAC-SYM), Patient Assessment of Constipation Quality of Life (PAC-QOL), and Visual Analog Scale (VAS) scores for pain at the fractured vertebral body before and after treatment.
   3. Safety indicators: Monitor safety indicators, including general vital signs such as body temperature, respiration, pulse, and blood pressure.
   4. Record the incidence of adverse events (e.g., local skin allergic reactions at acupoints, gastrointestinal discomfort, etc.). Classify adverse reactions with reference to the Guiding Principles for Clinical Research of New Chinese Medicines²⁴ (Grade 1: mild reaction, no treatment required; Grade 2: moderate reaction, symptomatic treatment required; Grade 3: severe reaction, treatment termination required).

3. Preparations before procedure

1. Staff preparation
   1. Wear disposable medical masks. Check the patient’s name, medical record number, fractured site, and course of constipation. Confirm that there are no contraindications for the local skin at the acupoints by visual inspection and palpation to exclude erythema, swelling, abrasion, rash, or any skin lesion.
2. Item preparation
   1. Medication preparation
      1. Weigh the Chinese herbal pieces in the ratio of Rheum officinale: sodium sulfate decahydrate: Citrus aurantium: Magnolia officinalis = 3:2:1:1.
      2. Grind the herbal pieces into fine powder using an ultra-fine grinder operated at 25,000 rpm for 10 min, with intermittent pauses to avoid overheating, until the powder passes through a 200‑mesh sieve and store them in a sealed container.
      3. Take 30 g of the herbal powder, add an appropriate amount of honey (mass ratio of herbal powder to honey is 1:1.5), and mix it into a uniform thick paste (it should be non-flowing and easy to shape). Stability verification shows that the retention rate of active ingredients of the prepared herbal paste is more than 95% with 24 h of refrigeration and use²⁵.
   2. Consumable preparation
      1. Prepare the following consumables: 4 cm x 4 cm sterile medical application patches, 75% alcohol, sterile cotton swabs, forceps, disposable medical gloves, alcohol-based no-rinse hand sanitizer, and disposable medical masks (Figure 1).
3. Patient preparation
   1. Explain to the patient and their family members the purpose of acupoint application, the basis for acupoint selection, the operation process, the expected effects, and possible adverse reactions, and relieve their tension.
   2. Assist the patient to take a supine position, maintain a neutral spinal position, and avoid spinal twisting.
   3. Fully expose the acupoint areas on the abdomen, wrists, and lower limbs.
   4. Disinfect the skin at the acupoints with 75% ethanol cotton balls and wait for the ethanol to air-dry completely.

4. Treatment procedure

1. Disinfect hands with alcohol-based no-rinse hand sanitizer and put on disposable medical gloves.
2. Accurately locate acupoints using the anatomical landmark method, which uses palpable or visible body landmarks—such as bone prominences, muscle margins, tendons, and joint spaces—as fixed reference points to determine acupoint positions according to standardized meridian mapping. For each acupoint, the corresponding landmark was first identified, and the point location was marked based on proportional measurements (cun) relative to that landmark, following the Acupuncture and Moxibustion textbook²³(Figure 2).
3. Use forceps to take 3 g of the mixed Chinese herbal paste and place it in the center of a sterile medical application patch.
4. Align the medicinal patches with the 5 marked groups of acupoints, stick them flat on the skin surface, gently press the edges of the patches with fingers for 1 min, and ensure the patches adhere closely without wrinkles or loosening (Figure 3).
5. Inform the patient that the application time is 6 h and advise them not to remove the patches in advance or extend the application time without authorization.
6. Set the treatment frequency: Conduct the treatment 1x a day, fix the treatment time, and take 2 consecutive weeks of treatment as one course.

5. Post-treatment care

1. Inquire about the changes in the patient’s constipation symptoms every 4 h after treatment, focus on observing whether the local skin at acupoints has redness, pruritus, or rashes, and record the findings.
2. After removing the patches, gently wipe the skin at acupoints with warm water and avoid vigorous rubbing. If there are residual medicinal stains on the skin, clean the area with a sterile cotton swab dipped in a small amount of normal saline.
3. Provide dietary guidance: Strengthen the patient’s dietary fiber intake and advise them to avoid spicy, greasy, and gas-producing foods.
4. Guide the patient to develop a regular defecation habit, instruct them to maintain a neutral spinal position during defecation, and advise them to avoid holding breath and straining.
5. Dispose of used patches, cotton swabs, and other items according to medical waste classification.
6. Seal the remaining herbal paste and refrigerate it (at 2-8 °C) with a storage time not exceeding 24 h and rewarm it to room temperature before use next time.

6. Adverse incident handling methods

1. Handling of local skin adverse reactions
   1. For Grade 1 reactions (mild redness and pruritus of local skin at acupoints), stop the application immediately. Clean the skin with warm water, then apply calamine lotion (2x-3x a day) and observe for 24 h. If symptoms are relieved, continue treatment (adjust the application time to 4-6 h).
   2. For Grade 2 reactions (obvious redness, papules, and aggravated pruritus of local skin at acupoints), terminate the current application; administer oral loratadine tablets (10 mg per dose, 1x a day) and apply desonide cream locally (2x a day). Report to the attending physician and assess whether to continue treatment.
   3. For Grade 3 reactions (blisters, erosion, and exudation on local skin at acupoints), terminate treatment immediately. Irrigate the wound with sterile normal saline, apply mupirocin ointment, and cover with sterile gauze. Change the dressing 1x a day until the wound heals. Simultaneously report to the research ethics committee and record the details of the adverse event.

Results

A total of 42 patients were included in this study, 21 cases in the experimental group and 21 cases in the control group, and no patient dropped out of the study. Table 2 and Table 3 compare the changes in four evaluation indices between the control group and the experimental group before and after treatment. The results showed that after treatment, the time interval to the first defecation, PAC-SYM, PAC-QOL, and VAS scores all improved, but the improvement in the experimental group was ...

Discussion

This study verified the efficacy and safety of acupoint application as an adjuvant therapy for constipation in patients with TLFs through a randomized controlled trial. The core results showed that, after 2 weeks of treatment, the experimental group had a shorter time interval to the first defecation after treatment, PAC-SYM, PAC-QOL, and VAS scores. The results after treatment were better than the results before treatment for both groups, and there were no serious adverse reactions. This result not only provides new evi...

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Chinese herbal medicine	Hospitalof Chengdu University ofTraditional Chinese Medicine	/
75% Alcohol	Sichuan Province Yijieshi Medical Technology Co., Ltd.	250706
Disposable Medical Gloves	Guangdong Huitong Latex Products Group Co., Ltd.	20122206
Forceps	Jiangxi Province Yuyuan Medical Devices Co., Ltd.	20180132
Hand Sanitizer	Shandong Lilkang Medical Technology Co., Ltd.	25070401B
Medical Disposable Mask	Xuchang Zhende Medical Dressings Co., Ltd.	20160002
Sterile Cotton Swab	Chengdu Zhongxin Hygienic Materials Co., Ltd.	20250613
sterile medical application patches	Jiangsu Guangyi Medical Dressings Co., Ltd.	20160028