Clinical Efficacy of Small Needle Knife Therapy on Stage I-II Frozen Shoulder

Summary

The protocol presented here describes the detailed operation method and proves the effectiveness of a small needle knife in the treatment of frozen shoulders.

Abstract

Frozen shoulder is a kind of aseptic inflammatory disease of the shoulder caused by strain, trauma, and other reasons, resulting in shoulder joint pain and limited function. The protocol presented here demonstrates the operation of a small needle knife in treating frozen shoulders, including patient management, material preparation, positioning, operation, and postoperative care. The purpose of this protocol is to relieve the pain and functional limitations and improve the living ability of patients with frozen shoulders. In our study, 76 stage I-II frozen shoulder patients who met the inclusion criteria were randomly divided into a control group and a treatment group (n=38). Patients in the control group received functional exercise, while the treatment group received small needle knife therapy with functional exercise. The visual analogue scores (VAS), the Constant and Murley scores (CMS), and the thickness of the coracohumeral ligament (CHL) under ultrasound were evaluated. After small needle knife therapy, the VAS score was significantly lower in the treatment group (5.11 ± 0.89) than in the control group (5.49 ± 0.65; t=-2.065, p<0.05); the CMS score was significantly higher in the treatment group (64.72 ± 4.78) than in the control group (60.97 ± 6.00; t=2.947, p<0.05); the CHL thickness was significantly decreased in the treatment group (2.38 ± 0.36) than in the control group (2.57 ± 0.42; t=-2.117, p<0.05). These results indicate that the small needle knife significantly relieved the pain symptoms, improved the shoulder function, reduced the CHL thickness, and improved the quality of life and, therefore, had significant therapeutic efficacy in stage I-II frozen shoulder patients.

Introduction

Frozen shoulder is a disease characterized by pain and limitation of active and passive shoulder movement, which causes great inconvenience to the work and life of patients¹. The global incidence of frozen shoulder is 2%-5%^2,3 and higher in females than in males, showing a certain genetic tendency⁴. The majority of frozen shoulder patients are 40-60 years old⁵. Moreover, the frozen shoulder brings about a heavy social burden due to the longer recovery cycle and the absence of established treatment consensus in the clinic practice.

The main treatment methods for frozen shoulders include oral or external use of herbal medicine, acupuncture, massage, functional exercise, and so on⁶; however, the compliance of the patients is poor due to the multiple treatment frequency and longer time-consuming, and cannot meet the urgent necessities of patients to improve pain and functional limitations. Therefore, it is urgently needed to identify more effective therapeutics in the clinical management of frozen shoulder patients.

Small needle knife therapy is a special and effective external treatment of traditional Chinese medicine, which has arisen rapidly in the field of traditional Chinese medicine in recent decades⁷. It has the advantages of quick effect, definite curative effect, and high repeatability. Moreover, the operation instrument is cheap and easy to obtain, the operation process is simple, and the method is not limited by the environment and condition. The normal work and life of patients are not affected after the small needle knife therapy since the micro-incision will be recovered quickly without damage to the body, causing infection, or other side effects^8,9,10,11. Systematic reviews showed that the efficacy of small needle knife on frozen shoulder was significantly superior to acupuncture, massage, and oral Chinese medicine^12,13. Modern studies show that the mechanism of small needle knife treatment of frozen shoulder is to dredge the meridians and collaterals, promote the circulation of qi and blood, cut and strip the lesion tissue, remove adhesion, promote tissue repair, and restore the dynamic balance of the human body^14,15.

The protocol presented here demonstrates the operation of small needle knife in treating frozen shoulders including patient management, material preparation, positioning, operation, and postoperative care. The purpose of this protocol is to relieve the pain and functional limitations and improve the living ability of patients with frozen shoulders.

With the development of small needle knife therapy, its application has been extended from the treatment of neck, shoulder, waist, leg pain, and other muscle and bone diseases to internal medicine, surgery, gynecology, pediatrics, and other diseases, playing an increasingly important role in the field of rehabilitation medicine¹⁶. In recent years, the small needle knife shows a more accurate, scientific, and safe therapeutic efficacy due to the application of ultrasound-guided small needle knife visualization therapy, whose development has entered a new stage^17,18.

Protocol

The protocol of this study has been approved by the Human Research Ethics Committee of Longhua Hospital Affiliated with Shanghai University of Traditional Chinese Medicine (Approval Number: 2023-LHXS-030). Before the trial, written informed consent was provided by each patient included in the study. A total of 76 patients with stage I-II frozen shoulder in the rehabilitation department of Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine from December 2022 to May 2023, who met the inclusion criteria, were randomly divided into a control group and a treatment group, with 38 cases in each group. The operator must be familiar with the anatomy of the shoulder joint and the specific surgical method.

1. Recruitment of patients

1. Use the following inclusion criteria to enroll patients in this study: Conform to the diagnostic criteria of frozen shoulder; stage I or II frozen shoulder; regardless of gender, 40-65 years old; VAS score ≤ 7; without other treatment at the same time.
2. Use the following exclusion criteria to not include patients in this study: Patients with blood coagulation dysfunction; diabetic patients with unstable blood sugar control; pregnant pand lactating women; patients with damaged treatment sites or serious infection; Patients with allergies to anesthesia.

2. Exercises regime for control group

1. Subject patients in the control group to a treatment course of functional exercises as described below¹⁹.
   1. Hand wall climbing: Ask the patient to stand facing the wall with both feet open and raising both hands to climb up along the wall. Ask the patient to take the hands to the highest scales with the maximum tolerance and record this for each patient.
   2. Assisted hand: In a standing position, ask the patient to keep the affected upper limb in the state of backward extension and perform internal rotation to the opposite side by pulling the wrist of the affected upper limb with the healthy upper limb, and then maintain the upward pulling state to the maximum tolerance for the patient.
   3. Pendulum swings: In standing and bending down position, ask the patient to support the healthy arm of each patient and drop to the affected side and perform the back and forth, left and right, as well as circle movements. Increase the range of motion when the symptoms are improved and draw circles by holding an object which is 1-2 kg (such as water bottles, dumbbells) to increase the intensity of stretching exercises.
2. Course of functional exercise: Ensure the patients in the control group perform functional exercises every day including wall climbing, assisted hand and the pendulum swings, 30 times/day for 4 weeks.
   NOTE: The functional exercise must be carried out within the tolerance range; otherwise, it may cause soft tissue strain in the shoulder and lead to deterioration of the condition.
3. Follow the principle of - from light to heavy, from small to large, step by step and continuously - during the functional exercise. Ask the patient to avoid long-term shoulder work, heavy lifting, or strenuous activities, though the patient can perform all day-to-day activities during treatment.

3. Exercise regime for treatment group

1. Subject patients in the treatment group to small needle knife therapy with functional exercises.
2. Preoperative preparation
   1. Material preparation (Figure 1): Sterilize disposable medical plastic cup, medical tweezers, absorbent cotton ball, dressing block, a 40 mm x 40 mm disposable sterile small needle knife, marker pen, type II skin disinfectant, 2% lidocaine hydrochloride, sterile water for injection, 10 mL disposable sterile syringe, disposable sterile injection needle, rubber surgical gloves, self-adhesive dressing.
   2. Patient information check: Check the basic information of each patient (name, age, affected shoulder). Explain the process and advantages of the small needle knife therapy. Make sure that the patients fully understand and relax during the operational procedure.
   3. Patient preparation: Fully expose the affected shoulder in a sitting position.
   4. Positioning (Figure 2): Mark the obvious tenderness points of the affected shoulder, such as the coracoid process point (attachment point of the short head of the biceps), lesser tuberosity of greater (attachment point of the subscapular muscle), intertubercular sulcus (attachment point of the long head of the biceps muscle), subacromial bursae (attachment point of the supraspinatus muscle), 2 cm behind the greater tuberosity of humerus (attachment point of the teres minor muscle)²⁰.
   5. Disinfection: Prepare cotton balls in type II skin disinfectant. Routinely disinfect the skin 3x with gradually reduced diameter starting from 15 cm around the marking point.
3. Operational procedure (Figure 2)
   1. Load 5 mL 2% lidocaine plus 5 mL of sterile water into a 10 mL syringe to prepare a 10 mL 1% lidocaine working solution. 
   2. Replace the 22G needle with a 25G needle (use thinner needles to ease the pain). Wear the sterile gloves on the left hand and hold the syringe in the right hand.
   3. Insert the needle into the mark and make sure no blood returns upon aspiration. Perpendicularly inject 1-2 mL of 1% lidocaine working solution at each marked point.
   4. Small needle knife insertion (Figure 2): Wear sterile gloves in the right hand to hold the small needle knife. Rapidly insert the small needle knife into the lidocaine injection site perpendicularly with a depth of about 1-3 cm. Make sure that the blade of the small needle knife is parallel to the muscle fibers to avoid damage to important blood vessels and nerves.
   5. Perform the 3-step manipulation of longitudinal incision, stripping and releasing the adhesion^7,15. The patient will feel local soreness and pain, and the operator will feel resistance under the knife.
   6. Withdraw the needle when the operator feels a sense of looseness under the knife.
4. Postoperative care (Figure 2)
   1. Press the injection site for 1 min with a dry sterile cotton ball. Cover the operating area with a sterile self-adhesive dressing.
   2. Assist the patients to dress well.
      NOTE: Put the medical waste into the medical waste trash can.
   3. Ask the patient to sit still for about 15 min before leaving the operating room to avoid postoperative discomfort. Advice the patient to keep the self-adhesive dressing dry until it is removed 48 h later to avoid bleeding and infection.
5. Course of small needle knife therapy²¹: Subject the patients in the treatment group to small needle knife therapy, once a week with a total of 4 sessions. Carry out the same functional exercises for patients in the treatment group as done for the control group.

4. Post-intervention outcome assessments

1. Evaluation index^22,23,24
   1. Use the visual analogue scores (VAS), the Constant and Murley scores (CMS), and the thickness of CHL under ultrasound to assess the outcome.
      NOTE: The baseline measurements were performed before and one week after the treatment.
2. Assessment instruments
   1. Use the GJJDC01 high-precision joint motion electronic measuring instrument for shoulder joint motion measurement and a portable color ultrasound system (Figure 3).
3. Assessment instruments operation method (Figure 3)
   1. Measurement of shoulder range of motion.
      1. Press ON to turn on the power. Ask the subject to uplift the shoulder to the maximum angle possible. Rotate the measuring ruler and obtain the measured value.
      2. Set the measuring instrument scale back to 0 and repeat the measurement 2x. Press and hold OFF to turn the power off.
   2. Measurement of the thickness of CHL using an ultrasound.
      1. Turn ON the ultrasound machine by pressing the Power button. Press the Patient button, click New Patient, and enter the name of the subject.
      2. Ask the patient to fully expose the affected shoulder in a seated position. Move the shoulder joint of the patient passively to locate the CHL. Align the ultrasound probe with the CHL.
      3. Press the Freeze button to save the ultrasound image. Press the Caliper button to test CHL thickness. Record the measurement and turn it OFF.

5. Statistical analysis

1. Present the continuous variables as mean ± standard deviation (SD). Use the independent sample t-test to compare the differences between the two groups. All statistical tests were two-sided, and P<0.05 was considered statistically significant. All analyses were performed using statistical software.

Results

In the control group, 1 patient received other treatment (intra-articular steroid injection) due to aggravation of pain, so the trial was terminated, and the remaining 37 patients in the control group were included in the final statistical analysis. For 2 patients in the treatment group CHL could not be detected under ultrasound, so the test was eliminated, and the remaining 36 patients in the treatment group entered the final statistical analysis.

Baseline characteristics

Discussion

In this study, we found that the small needle knife therapy significantly relieved the pain symptoms, improved the shoulder joint function, reduced the thickness of CHL, and improved the quality of life in stage I-II frozen shoulder patients. The small needle knife therapy had exact effect on frozen shoulder. However, the operation site is controversial. Due to the different knowledge backgrounds, many operation sites can be selected to treat frozen shoulders with small needle knife. The main operation sites are tender p...

Materials

Name	Company	Catalog Number	Comments
Disposable sterile injection needle	Shanghai Mishava Medical Industry Co., Ltd	601900973	Type specification:0.5 x 38 RWLB
Disposable sterile small needle-knife	Wujiang Yunlong Medical equipment Co., Ltd	PR-4040	Type specification:40 mm x 40 mm
Disposable sterile syringe	Shandong Weigo Group Medical polymer Products Co., Ltd	601909174	Type specification:10 mL
Lidocaine hydrochloride	Shanghai Hefeng Pharmaceutical Co., Ltd	6904996104121	Type specification:5 mL
Marker pen	Zebra Trading (Shenzhen) Co., Ltd	4901681518111	Type specification:1.0 mm/0.5 mm
Sterile absorbent cotton ball	Shanghai Honglong Medical Supplies Equipment Co., Ltd	601905637	Type specification:0.3  25 g
Sterile disposable medical plastic cup	Shanghai Honglong Medical Supplies Equipment Co., Ltd	709008633	Type specification:Waist-shaped disc
Sterile dressing block	Ningbo Haishu Shenyuan Medical Materials Co.,  Ltd	601909470	Type specification:7.5 cm x 7.5 cm x 8 floors
Sterile medical tweezers	Shanghai Honglong Medical Supplies Equipment Co.,Ltd	603917444	Type specification:Small size
Sterile rubber surgical gloves	Guilin Hengbao health protection Co.,  Ltd	6971787071320	Type specification:6.5
Sterile self-adhesive dressing	Shanghai ISO Medical Products Co., Ltd	601909414	Type specification:10 cm x 15 cm
Sterile water for injection	Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd	6938493300953	Type specification:5 mL
Type II skin disinfectant	Shanghai Likang Disinfection high-tech Co., Ltd	6909157000359	Type specification:500 mL/ bottle
Ultrasound	Suzhou Daer Medical Equipment Co., Ltd	100018857	uSmart3300 portable color ultrasound system