Abstract
BACKGROUND:
Frozen shoulder (FS), also known as shoulder adhesive capsulitis, is a musculoskeletal disorder associated with pain and functional disability. There is a lack of evidence on the optimal treatment strategy for FS.
OBJECTIVE:
The present study aimed to evaluate the effectiveness and safety of ultrasound-guided hydrodilatation of glenohumeral joint combined with acupotomy for treatment of FS.
METHODS:
In this prospective randomized, double-blind, controlled study, 63 FS patients were recruited, and equally allocated to treatment group and control group. The treatment group was treated with ultrasound-guided hydrodilatation of glenohumeral joint combined with acupotomy, while the control group was only treated with ultrasound-guided hydrodilatation of glenohumeral joint. The pain and mobility of shoulder, overall efficacy and adverse reactions were evaluated 3 months after treatment.
RESULTS:
At baseline, no significant difference in all characteristic value was found between the treatment group (
CONCLUSION:
The ultrasound-guided hydrodilatation of glenohumeral joint combined with acupotomy may benefit FS patients.
Introduction
Frozen shoulder (FS), also known as adhesive capsulitis, is a common shoulder disease, involving the musculoskeletal system, which can lead to continuous pain and limited range of motion (ROM) [1]. In FS patients, chronic shoulder strain produces aseptic inflammation, stimulating thickening of fibro cells and secreting a large number of type I and III collagen fibers to deposit around the joint capsule, tendons, and ligaments, leading to capsular contracture and reduction of joint volume [2, 3]. Histopathology included inflammation of glenoid and acromion synovial membrane, coracohumeral ligament (CHL) hypertrophy and joint capsule fibrosis [4]. The prevalence of FS in the general population is 2.5%, it is very rare before the age of 40, usually occurs around the age of 60 population [5]. It is reported that 40% of FS patients without proper treatment suffer from persistent pain and limited ROM, while 11% of these patients suffer from permanent shoulder dysfunction [6].
The treatment methods of FS include nonsteroidal anti-inflammatory drugs, physical therapy and intraarticular corticosteroid injection [7], in which, due to the physiological benefits of the contracture of the shoulder, hydrodilatation has been used for a long time as a treatment for FS [8]. Hydrodilatation is typically performed using ultrasound guidance via the posterior glenohumeral joint. Hydrodilatation of glenohumeral joint is to inject normal saline and sodium hyaluronate into the glenohumeral joint capsule to release the adhesion of the joint capsule, lubricate the joint cavity, increase the volume of the joint capsule, improve symptoms and promote rehabilitation [9, 10]. In FS patients, the degree of adhesion and contracture of the joint capsule is different, the volume of the joint capsule is also different, and thus the fluid volume required for hydrodilatation treatment is different [11]. Whether the amount of fluid required during the hydrodilatation of glenohumeral joint can predict the difference in the efficacy of FS treatment is rarely reported in previous study. Further, in FS patients, not only the glenohumeral joint capsule was involved, but also the CHL and rotator cuff space were involved to varying degrees [12]. Thus, simple hydrodilatation of glenohumeral joint capsule may be usually ineffective in treatment of FS.
Acupotomy is the essence of traditional Chinese medicine in China. Its principle is mainly to remove and release inflammatory and adhesive tissues, activate the body’s immune system to fight inflammation, reduce swelling and repair damaged tissues [13]. Acupotomy can treat a variety of diseases, including various pain conditions, such as leg pain, knee pain, back pain and nerve root cervical spondylosis [14]. In addition, one study also has reported that acupotomy under ultrasound-guidance may achieve more satisfactory effect for the treatment of FS [15]. Whether acupotomy for FS treatment will contribute to increasing the volume of joint capsule and further increase the efficacy has not been reported in previous study. In this study, we investigated the possible effectiveness of ultrasound-guided hydrodilatation combined with acupotomy treatment for patients with FS, to explore its clinical application value.
Material and methods
Design
This study was designed as a prospective randomized, double-blind, controlled study with 2 parallel groups. The eligible patients with FS were recruited from our hospital From January 2018 to September 2020. After screening, all included subjects were randomly allocated to treatment group or control group in a ratio of 1:1. The present study was approved by the ethics committee of Huzhou Central Hospital (20210404-01). All included patients were asked to provide the written informed consent before the study.
Patients
All patients had confirmed diagnosis of primary FS according to the physicians specializing in Orthopedics or Physical Medicine. To be eligible for this study, patient should also meet the following inclusion criteria: (1) Chronic onset, persistent dull pain in shoulder, with or without aggravation of pain at night; (2) Active and passive flexion, abduction, external rotation or internal rotation of shoulder joint, at least two of them limited range of motion
Sample size, randomization and blinding
To detect the difference between the treatment group and control group of at least 30% in pain intensity, measured by the VAS scale, with
Musculoskeletal ultrasound
A Yum Mylab90 color Doppler ultrasonic diagnostic device with a LA523 probe set to a frequency of 12–18 MHz was used. The conditions were set as follows: low-pass filtering, pulse repetition frequency 800–1000 Hz, and maximum gain was appropriate when no Doppler signal occurred behind the bone cortex. An associate chief physician examined the patients by combining transverse and longitudinal scanning: pay attention to the continuity of tendon, smooth of the humeral head bone surface, avulsion fracture of bone cortex; focus on the hypoechoic thickening in rotator cuff space, the thickening of coracohumeral ligament and axillary recess bursa; and inflammatory blood flow signals in abnormal areas were evaluated by energy Doppler ultrasound.
Treatment
Hydrodilatation of the glenohumeral joint
The patient was placed in the lateral decubitus position, and the probe was placed diagonally below the scapula from the outer top to the inner bottom, clearly showing the posterior recess bursa and posterior axillary lip of the glenohumeral joint. The intra-plane injection method was adopted. After the needle tip was confirmed to be located in the glenohumeral joint cavity by ultrasound and there was no obvious resistance to syringe injection, 10 mg of triamcinolone acetonide, 2.0 ml of 2% lidocaine and 2.0 ml of sodium hyaluronate were injected, followed by the gradual injection of normal saline for hydrodilatation. During the process of hydrodilatation, the patient’s reaction should be observed, such as acid swelling, unbearable pain or large resistance to push injection. If ultrasound showed that the fluid in the joint capsule overflows to the muscular layer, the needle was withdrawn to stop the hydrodilatation (Fig. 1).
The hydrodilatation of glenohumeral joint was performed, and a large number of fluid anechoic areas were observed in the posterior recess bursa of the glenohumeral joint.
The patient was in a lateral decubitus position with forearm flat on the lateral edge of the shoulder joint. If preoperative musculoskeletal ultrasound showed hypoechoic thickening in rotator cuff space (Fig. 2) or thickening of paracoracoid process CHL (Fig. 3)
Acupotomy was used to release the hypoechoic thickening in rotator cuff space and adhesion thickening area.
Acupotomy was used to release the thickening of paracoracoid process coracohumeral ligament.
The treatment group was treated with ultrasound-guided hydrodilatation of glenohumeral joint combined with acupotomy, while the control group was only treated with ultrasound-guided hydrodilatation of glenohumeral joint, all for once a week for 3 consecutive times. The musculoskeletal ultrasound interventional therapy was performed by an associate chief physician with more than 3 years of experience in musculoskeletal interventional surgery. After treatment, all patients underwent functional exercise within the maximum activity pain tolerance, such as climbing the wall, drawing circles, touching ears, once in the morning and evening, 30–60 mins.
After treatment, a 3-month follow-up was routinely performed to evaluate shoulder pain (Visual Analogue Scale, VAS [16]), mobility of shoulder joint (Active Range of Motion, AROM [17]), overall efficacy (Constant-Murley scale, CMS) and adverse reactions. CMS was classified into four subscales: pain,
Statistical analysis
SPSS 22.0 statistical software was used (IBM Corp., Armonk, NY, USA). The qualitative data were represented by rate, the quantitative data were represented by Mean
Results
A total of 63 FS patients (18 males and 45 females) were included in this study, divided into the treatment group (
Baseline characteristics of the patients
Baseline characteristics of the patients
BMI, Body mass index; VAS, Visual Analogue Scale; AROM, Active Range of Motion; CMS, Constant-Murley Scale; ARC, Axillary recess capsule; CHL, Coracohumeral ligament.
Three months after treatment, there was no significant difference between the two groups in pain VAS score and the thickness of the affected ARC (
Comparison of postoperative clinical and ultrasonic characteristics between the two groups
The volume increment of the glenohumeral joint of the two groups
There was no significant difference in injection volume at the first and second hydrodilatation between two groups (
After the first treatment, there was no significant difference in the volume increment of glenohumerus joint
The ultrasound-guided puncture of glenohumeral joint was successful in 63 patients, and the success rate was 100%. In the experimental group, there were 1 case of vagal reflex, 1 case of subcutaneous bruising, and 1 case of nausea and dizziness during treatment, with an adverse reaction rate of 9.09%. In the control group, there were 1 case of subcutaneous bruising, and 1 case of nausea and dizziness during treatment, with an adverse reaction rate of 6.67%. There was no significant difference in the incidence of adverse reactions between the two groups (
The etiology of primary FS is numerous and the pathological mechanism is complex, which has not yet been clarified. The normal glenohumeral joint lumen volume is about 15–20 mL, and
Ultrasound-guided hydrodilatation of glenohumeral joint is one of the effective methods in FS treatment [21]. We should make full use of the advantages of musculoskeletal ultrasound to comprehensively evaluate the involvement of FS structures. In this study, the effective rate of patients in the control group was 76.67% (23/30). Some patients had poor functional improvement, and ultrasound reexamination still showed thickening of CHL and rotator cuff space. In the experimental group, preoperative ultrasound examination was performed, and acupotomy treatment was performed on the areas with abnormal CHL thickness and rotator cuff space. The results showed that injection volume by hydrodilatation gradually increased with treatment times, and the joint volume continued to increase. Especially, after the second treatment, the increase value of glenohumeral joint volume
Ultrasound-guided acupotomy therapy can avoid tendon, ligament, nerve, blood vessel and other injuries caused by anatomical positioning and blind ligation of traditional small acupotomology [22, 23]. Ultrasonographic guidance greatly increased the safety of acupotomy treatment. Except the inflammation and contracture of the glenohumeral joint capsule, CHL, rotator cuff space and other anterior joint capsule involvement are also one of the important features of FS [2]. In this study, after acupotomy treatment was added in the experimental group, the CHL thickness and hypoechoic thickening in rotator cuff space were significantly lower than those in the control group 3 months after operation. The experimental group was performed acupotomy therapy on the abnormal areas that found under ultrasound examination, which could avoid the unnecessary damage to normal tissues caused by traditional needle knife and multi-point needle insertion.
Although there are several treatments for chronic pain in musculoskeletal disorders, such as continuous radiofrequency [24], extracorporeal shockwave therapy [25] and percutaneous electrical nerve stimulation [26], a certain number of patients may experience persistent or refractory pain. This study found that 3–5 days after the first treatment, the patient’s shoulder pain symptoms such as resting pain and nocturnal pain could be well controlled, which indicated ultrasound-guided hydrodilatation of glenohumeral joint combined with acupotomy might be benefit to multidimensional rehabilitation projects of FS patients. Triamcinolone acetonide 10 mg was injected into the two groups for anti-inflammatory treatment, which was about half of the dose of conventional local sealing treatment. With the help of ultrasound guidance, drugs can be accurately injected into the glenohumeral joint cavity, thus the dosage of steroid hormones is greatly reduced compared with the traditional palpation blind therapy. Further, after 3 months treatment, there was no significant difference in the pain VAS between two groups. The reason may be that the pain of FS patients was mainly related to inflammatory factors, and steroid hormones had a strong anti-inflammatory effect, which could quickly inhibit inflammation and improve symptoms [27].
Although the present study achieved satisfied results, it still suffered from several limitations. First, the sample size of this study was pretty small. Second, due to individual differences in pain sensitivity, there might be bias. Third, patients with different degree of fibrosis of joint capsule also have different elasticity of joint capsule, which might affect the elastic capacity of hydraulic fluid. In the future, we will include more cases who have the indication for acupotomy with both arms with and without acupotomy to further validate this study.
Conclusion
The ultrasound-guided hydrodilatation of glenohumeral joint combined acupotomy therapy is safe and effective, and can effectively improve the adhesion of the shoulder joint, increase the volume of the joint capsule and improve the efficacy of FS patients.
Footnotes
Conflict of interest
The authors declare that they have no competing interests.
Funding
This study was supported by the Public Welfare Application Research Project of Huzhou City, Zhejiang Province, China (No. 2017GYB25, No. 2018GYB68); and Medical and Health Science and Technology Project of Zhejiang Province, China (No. 2022RC263).
