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Özet

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.

Representative 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
The differences in gender, age, affected side, course of disease, and stage of patients between the two groups were comparable (p > 0.05). There were 13 males and 24 females in the control group, 19 males and 17 females in the treatment group. Patients in the two groups ranged in age from 40 to 65 years, with 51.92 ± 7.17 years in the control group and 52.56 ± 7.10 years in the treatment group. There were 13 cases affected on the left side, 21 cases affected on the right side, and 3 cases affected on both sides in the control group, while 17 cases were affected on the left side, 17 cases on the right side, and 2 cases on both shoulders in the treatment group. The disease course of the two groups ranged from 1 to 9 months, the median was 3 months in the control group (interquartile range, 2 to 4.5) and 3 months in the treatment group (interquartile range, 2.0 to 5.0). There were 22 stages I and 15 stage II cases in the control group, while 19 stage I and 17 stage II patients were in the treatment group (Table 1).

VAS score and CMS score were improved with small needle knife therapy
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; Table 2).

CHL thickness was improved with small needle knife therapy
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; Table 2). Ultrasound images of CHL thickness from the representative patients are provided here (Figure 4 and Figure 5). The two representative female patients, with right shoulder pain and limited mobility for 3 months meeting the diagnostic criteria for frozen shoulder, voluntarily participated in the test. After excluding the contraindications, the patients were informed of the advantage and the disadvantage of small needle knife treatment and functional exercise. Through the random number table method, the No.1 patient, who was 53 years old, entered the control group to receive functional exercise treatment, and the No.2 patient, who was 57 years old, entered the treatment group to receive functional exercises with small needle knife therapy. The baseline VAS scores of both patients were 6 points, the CMS scores were 43 points, and the CHL thickness was 2.8 mm (Table 3 and Figure 4). After the treatment course, the VAS score was 3 points, CMS score was 67 points, and CHL thickness was 1.4 mm for the patient in the treatment group, while the VAS score was 5 points, CMS score was 55 points, and CHL thickness was 2.4 mm for the patient in the control group (Table 3 and Figure 5), indicating an improvement in pain, shoulder function and CHL thickness of the patient in the treatment group.

Adverse reaction
Two patients in the treatment group experienced swelling and pain around the pinhole after small needle knife treatment, which improved after 1 week of hot compress with saline and did not affect normal treatment and follow-up. No obvious adverse reactions were observed in the control group.

Figure 1: Materials for small needle knife treatment. The figure shows all the equipment, reagents and instruments used in this study. Please click here to view a larger version of this figure.

Figure 2: Operation diagram of small needle knife therapy. (A) Label and disinfection. coracoid process point – attachment point of the short head of the biceps; intertubercular sulcus – attachment point of the long head of the biceps muscle; subacromial bursae – attachment point of the supraspinatus muscle; lesser tuberosity of humerus – attachment point of the subscapular muscle; (B) Local anesthesia. (C) Small needle knife therapy operation. (D) Postoperative care. Please click here to view a larger version of this figure.

Figure 3: Assessment instruments used in this study. (A-B) A GJJDC01 high-precision joint motion electronic measuring instrument for shoulder joint motion measurement. (C-D) Ultrasound system. Please click here to view a larger version of this figure.

Figure 4: Ultrasound images of baseline CHL thickness. (A) Patient No. 1 in the control group. (B) Patient No. 2 in the treatment group. Abbreviations: CP = coracoid process; HOH = humeral head. Please click here to view a larger version of this figure.

Figure 5: Ultrasound images of post-intervention CHL thickness. (A) Patient No. 1 in the control group after a treatment course of functional exercises. (B) Patient No. 2 in the treatment group after a treatment course of functional exercises with small needle knife therapy. Please click here to view a larger version of this figure.

Baseline	Control group (n=37)	Treatment group (n=36)	Total	P
Gender (n/%)				0.129
Male	13 (35.1)	19 (52.8)	32 (43.8)
Female	24 (64.9)	17 (47.2)	41 (56.2)
Age-year (mean± SD)	51.92±7.17	52.56±7.10	52.23±7.09	0.704
Affected side (n/%)				0.613
Left	13 (35.1)	17 (47.2)	30 (41.1)
Right	21 (56.8)	17 (47.2)	38 (52.1)
Bilateral	3 (8.1)	2 (5.6)	5 (6.8)
Course of disease-month				0.436
Median	3.0	3.0	3.0
Interquartile range	2.0-4.5	2.0-5.0	2.0-5.0
Stage (n/%)				0.565
I	22 (59.5)	19 (52.8)	41 (56.2)
II	15 (40.5)	17 (47.2)	32 (43.8)

Table 1: Basic information of all included patients.

Observation index	Group	n	Baseline	After treatment
VAS score (mean ± SD, mm)	Treatment group	36	6.22±0.64	5.11±0.89*
	Control group	37	6.19±0.62	5.49±0.65
CMS score (mean ± SD, mm)	Treatment group	36	44.36±5.92	64.72±4.78*
	Control group	37	44.14±6.34	60.97±6.00
CHL thickness (mean ± SD, mm)	Treatment group	36	2.66±0.40	2.38±0.36*
	Control group	37	2.62±0.39	2.57±0.42
* Compared with control group, P < 0.05.

Table 2: Scores collected between the treatment and control group. VAS score, CMS score, CHL thickness were compared between the two groups. For significance calculation, t-test was used, and the data were expressed as the mean ± SEM. Compared with the control group, * p < 0.05).

Name	Group	Gender	Age (year)	Affected side	Course of disease	Stage	Baseline			After treatment
					(month)		VAS	CMS	CHL (mm)	VAS	CMS	CHL (mm)
No.1 patient	Control group	Female	53	Right	3	1	6	43	2.8	5	55	2.4
No.2 patient	Treatment group	Female	57	Right	3	1	6	43	2.8	3	67	1.4

Table 3: Information case study and the tests done. Basic information, VAS score, CMS score, and CHL thickness of the two representative cases.

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 points, acupuncture points, and specific anatomical parts. Because the principle of treatment is similar, no matter what operation sites are selected, a certain therapeutic effect can be achieved, but the therapeutic effect is slightly different due to the operation sites of different parts. Under the guidance of blocking leads to pain, most physicians choose tenderness points combined with anatomical knowledge as the operation sites. By observing the pathological changes of frozen shoulder under ultrasound, it was found that the main pain points of frozen shoulder were the coracoid process point (attachment point of the short head of the biceps), lesser tuberosity of humerus (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), and the 2 cm behind the greater tuberosity of humerus (attachment point of the teres minor muscle)²⁰. Therefore, these five tenderness points were applied as the fixed operation sites, and additional obvious tenderness points according to the specific conditions of patients were added.

The mechanism of small needle knife has been studied in great depth with its gradual popularization. It is currently believed that the frozen shoulder pain is mainly caused by inflammation, angiogenesis, and new innervation^25,26,27,28. Studies have shown that inflammatory factors such as interleukin-1α, interleukin-6 and tumor necrosis factor, the vascular endothelial growth factor, and the general nerve marker PGP9.5 and nerve growth marker GAP43 are all increased in patients with frozen shoulder^29,30. Studies have shown that the small needle knife therapy reduces serum inflammatory factor levels, and local tension, promotes active substance production in nerves and blood vessels and thus reduces the production of inflammatory transmitters and pain transmitters in nerve endings^31,32,33, which allows the microcirculation being built up again to reduce inflammation and relieve pain. The main cause of limited mobility in frozen shoulder patients is fibrosis, where fibroblasts from type I and type III collagen transform into myofibroblasts, resulting in fibrotic contracture and stiffness of the shoulder joint, which restricts movement^34,35. Studies have shown that small needle knife therapy alleviates the fibrosis process and improves shoulder joint function. The fibrosis-related factors mainly include transforming growth factor-β (TGF-β) and matrix metalloproteinases family (MMPs)^27,36,37. Through the incision and release of adhesion, the small needle knife therapy inhibits the TGF-β release, reduces the MMP-1 level, and prevents the fibrosis process, thereby improving contracture stiffness, promoting local blood circulation, and restoring the overall dynamic balance of the human body^37,38. A study on the mechanism of small needle knife not only provides more theoretical support but also further proves the effectiveness and safety of small needle knife therapy.

As for the test methods on treatment effects, evaluation of the treatment effect of frozen shoulder in the literature mainly includes five aspects: pain degree, joint range of motion, living ability, ligament thickness in ultrasound or MRI, and adverse reaction^39,40,41. In this study, VAS score was used to evaluate pain degree, CMS score was used to evaluate joint range of motion and living ability, and ultrasound was used to measure CHL thickness and ask patients about adverse reactions.

We have monitored the adverse reactions that may be caused by the application of small needle knife during the treatment and follow-up period and swelling and pain around the pinhole have been identified. However, these adverse reactions did not affect the planned treatment and follow-up. Since the entire treatment and follow-up period was only 4 weeks, sequelae and complications were not investigated in this current study. However, literature has reported that the sequelae of small needle knife treatment include adhesion, vascular and nerve injury. The adhesion may be caused by repeated (more than 6 times) small needle knife treatment²¹, and the vascular and nerve injury is due to the unfamiliarity with shoulder anatomy of the doctors who perform the small needle knife treatment⁴². In this study, only 4 small needle knife treatments were performed, which achieved therapeutic efficacy while avoiding adhesion. The experienced doctor who performed small needle knife treatments has been engaged in the medical industry for more than 30 years and is familiar with shoulder anatomy, which could ensure the safety of small needle knife treatment. The possible sequelae or complications have been asked by telephone follow-up.

There are some limitations of this study. Although more and more studies have proposed using CHL thickness as diagnostic and evaluation criteria for frozen shoulders, there is still no consensus and guidelines. The investigation time and sample size of this study were limited, therefore, a large sample size and multi-center trial with long-term follow-up focusing on the specific stage of frozen shoulder is needed.

In conclusion, this study demonstrated that the small needle knife therapy had a significant effect on the stage I-II frozen shoulder, which significantly relieved the pain symptoms, improved the shoulder function, reduced the thickness of CHL, and improved the quality of life in stage I-II frozen shoulder patients, with the advantages of safety, a short course of treatment and fewer side effects, which is worthy of promotion and application.

Materials

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