Cao Yue (曹越), Chen Cheng (陈成), Zhou Wen-juan (周文涓), Zhong Feng (钟峰), Zhang Wei (章薇)

The First Hospital of Hunan University of Chinese Medicine, Changsha 410007, China

Abstract

Keywords: Acupuncture Therapy; Fire-needle Therapy; Motion Therapy, Continuous Passive; Frozen Shoulder; Shoulder Pain; Visual Analog Scale; Constant-Murley Score; Range of Motion, Articular

1 Clinical Materials

1.1 Diagnostic criteria

Referring to thePeriarthritis of Shoulder(ZYYXH/ T378-2012)[7]issued by China Association of Chinese Medicine, 2012 version: varied course of disease, induced by injury or cold invasion; pain, pressing pain, limitation of motion around the shoulder joint; usually a negative X-ray result in acute stage, while may show shoulder joint osteoporosis or calcification in supraspinatus tendon or subacromial bursa in chronic stage by X-ray examination.

1.2 Inclusion criteria

Conformed to the diagnostic criteria; aged between 35 and 65 years old; one side affected with obvious pain and shoulder joint motion dysfunction; without using anti-inflammation, analgesia drugs, acupuncture or rehabilitation therapy; informed consented.

1.3 Exclusion criteria

SP due to cervical problems, or shoulder pain caused by rotator cuff injury; bone fracture, dislocation, joint tuberculosis or other bone damage; having serious systematic disease or mental disorder; those feared fire-needle treatment or allergic to celecoxib; women during pregnancy or lactation.

1.4 Rejection and dropout criteria

Those were mistakenly included while didn’t conform to the inclusion criteria; poor compliance, initiatively quitting the experiment; having serious adverse events or complications, and inadequate to finish the experiment; insufficient clinical data that may influence clinical efficacy evaluation.

1.5 Statistical methods

The SPSS version 21.0 software was used for statistical analysis. Enumeration data were compared using Chi-square test. Measurement data conforming to normal distribution were described as mean ± standard deviation (±s). The paired samplet-test was for intra-group comparisons, and independent samplet-test for between-group comparisons. Non-parametric test was for comparing data with equal variance while not conforming to normal distribution, and also for ranked data. AP-value less than 0.05 indicated statistical significance.

1.6 General data

All cases were recruited between June 2017 and June 2018 in the First Hospital of Hunan University of Chinese Medicine. All 72 patients with FS were randomized into an observation group and a control group by the random number table method. The patients were aged between 37 and 62 years old in the observation group, and their disease duration ranged between 5 d and 1 year. The cases were aged between 39 and 65 years old in the control group, and their disease duration ranged between 7 d and 11 months. The between-group comparisons of gender, age, duration and the affected side showed no statistical significance (allP>0.05), indicating the comparability (Table 1).

Table 1. Comparison of the general data between the two groups

2 Treatment Methods

Patients in both groups received CPM treatment. Patients took a supine or prone position. Physician fixed the affected shoulder joint with one hand, and dragged the elbow with the other hand, then made passive movement including abduction, forward flexion and extension, and fixed it at the widest range where patients can endure for 5-10 s. Such motions were repeated 10 times in each direction and were done once a day.

2.1 Control group

The patients in the control group received additional oral administration of celecoxib capsule (Batch No.: 1700413, Pfizer Pharmaceuticals LLC, USA), 0.2 g every time, twice a day.

2.2 Observation group

Patients in the observation group received additional fire-needle therapy.

Points: Jianqian (Extra), Jianyu (LI 15), Jianliao (TE 14), Jianzhen (SI 9) and Ashi points on the affected side.

Method: Patients took a supine or prone position. After routine sterilization of the point areas, a filiform needle of 0.35 mm in diameter and 40 mm in length were burned to red or white color with an alcohol burner and swiftly inserted into skin for 3-10 mm. Then rotated the handle and withdrew the needle. At last, pressed the point with a dry cotton ball to prevent bleeding. The treatment was done every other day.

Patients in both groups were treated for 2 weeks.

3 Observation of Therapeutic Efficacy

3.1 Observation items

The pain severity, shoulder joint function and ROM were measured before and after treatment.

3.1.1 Visual analog scale (VAS)

The VAS was used for evaluating pain severity in the shoulder[8]. Zero point indicates no pain and 10 points indicate unbearable pain. The higher score indicates the more serious pain.

3.1.2 Constant-Murley score (CMS)

The modified CMS was used for evaluating shoulder joint function[9]. This scale includes pain severity, daily life capability and joint ROM. The total score ranges between 0 and 75 points, and the higher score indicates the better shoulder joint function.

3.1.3 ROM of shoulder joint

Measured the ROM in the direction of abduction, forward flexion and extension with the joint angle ruler. Repeated the measurement for three times and took the average.

3.2 Therapeutic efficacy criteria

Therapeutic evaluation criteria were based on theGuiding Principles for Clinical Study of New Chinese Medicines[10].

Cured: Disappearance of all symptoms, ROM of shoulder joint returned to normal.

Markedly effective: Obvious alleviation of symptoms, and ROM of shoulder joint improved significantly.

Effective: Substantial alleviation of symptoms, and ROM of shoulder joint improved partially.

Invalid: No improvement in symptoms and ROM of shoulder joint.

3.3 Results

There was no dropout case in the two groups during treatment.

3.3.1 Comparison of the clinical efficacy

The total effective rate was 91.7% in the observation group, higher than 72.2% in the control group, and the between-group comparison showed statistical significance (P<0.05), (Table 2).

3.3.2 Comparisons of the VAS score and CMS

After treatment, the VAS scores and CMSs in both groups dropped significantly (allP<0.05). After treatment, the VAS score in the observation group was significantly lower than that in the control group, the CMS in the observation group was significantly higher than that in the control group, and the between-group comparisons showed statistical significance (bothP<0.05), (Table 3).

Table 2. Comparison of the clinical efficacy (case)

Table 3. Comparisons of the VAS score and CMS between the two groups ( x±s, point)

3.3.3 Comparison of the ROM of shoulder joint

After treatment, the abduction, forward flexion and extension scores in both groups increased significantly, and the intra-group comparisons showed statistical significance (bothP<0.05); the abduction, forward flexion and extension scores in the observation group were higher than those in the control group, and the between-group comparisons showed statistical significance (allP<0.05), (Table 4).

Table 4. Comparison of the ROM of shoulder joint ( ±s, °)

Table 4. Comparison of the ROM of shoulder joint ( ±s, °)

Note: Intra-group comparison, 1) P<0.05; between-group comparison, 2) P<0.05

Group n Before treatment After treatment Abduction Forward flexion Extension Abduction Forward flexion Extension Observation 36 74.8±7.4 48.1±5.6 19.4±3.6 124.4±8.51)2) 122.9±9.31)2) 36.1±2.71)2) Control 36 73.2±8.1 47.5±4.9 20.2±4.3 109.7±9.11) 94.5±8.61) 27.7±3.81)

4 Discussion

FS is a common reason in causing shoulder pain, and can be frequently seen in orthopedic department. In 1934, Codman defined the shoulder pain without certain injury but with limited ROM of shoulder joint as FS[11]. FS usually occurs in middle aged people in their 40s-60s. Though its mechanism remains unclear, four theories including inflammation reaction, fibrosis, nerve root inflammation and endocrine factors have been put to explain the cause[12-13]. FS pertains to the Bi-impediment syndrome or shoulder Bi-impediment syndrome, or ‘fifty shoulder’ in traditional Chinese medicine (TCM) according to its clinical symptoms. TCM holds that the causes of FS including contraction of cold, injury, fatigue and laying on one side for a long time, which will lead to blockage of meridians and stagnation of qi and blood in the shoulder. In a long course, the stagnant qi and blood, the adhesion of local sinews and muscles will lead to the stiffness of joint and limited motion. Therefore, treatment for FS should be focused on relaxing sinews, dispersing wind-cold pathogens and activating blood flow to stop pain.

Fire-needle therapy is to insert a white-burned needle swiftly into certain point for clinical usage. It has the functions of warming meridians and dispersing cold, activating blood flow and unblocking meridians, and is usually applied for Bi-impediment syndrome. By stimulating the targeted area with fire-needle, pathological changes such as edema, congestion, exudation, adhesion and contracture can be mitigated or even eliminated. Moreover, local circulation and metabolism can be accelerated to facilitate the recovery of the impaired tissues and nerves[14-15]. Wu J,et al[16]and Lu WW,et al[17]observed chronic soft tissue damage treated with fire-needle and found that the scar node formed from chronic lesion shrank in size and softened. Under light microscope, the inflammation reaction in late stage was mild, the hyperproliferative connective tissues were centered with micro vessels and radiated to the surrounding muscle fibers, and the muscle fibers were in normal rank. By chemical elements test, fire-needle therapy can elevate the concentrations of zinc and calcium in chronic damaged soft tissues, thus facilitating recovery. However, traditional fire-needle has the defects of thick needle body, long burning time, high temperature and fierce pain. Moreover, the burning process may induce fear and resistance in patients, and thus limits its popularization.

Filiform fire-needle is reformed from traditional fire- needle. It inherits the function of traditional fire-needle, and also has the advantages of thin needle body, convenient manipulation, low stimulation, mild pain and easy for retaining, which largely promote the compliance. Filiform fire-needle boosts the merits of mild, mechanical and sterile burning stimulation, and has the functions of warming meridians and dispersing cold, activating blood flow and removing stasis, unblocking meridians and stopping pain, as well as softening the hard and lessening the node. By stimulating points, tenderness points and nodes, filiform fire-needle can burn and carbonize local tissues in the surrounding areas, hence softening the tissues in adhesion and improving circulation, facilitating metabolism, accelerating the absorption of the burned tissues, and thus reduce or eliminate the aseptic inflammation, cords or nodes[18]. We chose Jianqian (Extra), Jianyu (LI 15), Jianliao (TE 14), Jianzhen (SI 9) and Ashi points because they are all located around the shoulder, and can function directly at the affected area, producing a more rapid and effective effect with filiform fire-needle.

CPM has been widely used in orthopedics department for rehabilitation. By a mild and continuous contraction, it has the functions of improving circulation on the affected joint, and alleviating pain, restoring muscle contraction, improving joint ROM[19]. CPM plus needling or ultra-short wave was proven effective for the treatment of periarthritis of shoulder[20-21].

Our research showed that after 2 weeks of treatment, the total effective rate was 91.7% in the observation group, higher than 72.2% in the control group, indicating that filiform fire-needling plus CPM had more significant clinical efficacy than celecoxib capsule plus CPM. Moreover, the VAS scores in both groups dropped significantly, the CMS and ROM including abduction, forward flexion and extension increased significantly, indicating that both methods can rapidly alleviate pain, improve joint function and restore joint ROM. The between-group comparisons showed the improvement in each item in the observation group was more significant than that in the control group, indicating that filiform fire-needling plus CPM had advantages in treating FS, the two methods can work in coordination to alleviate inflammation and stop pain, remove adhesion and improve function, which sets a good example presenting the advantages of the combination of traditional and modern medicine.

Conflict of Interest

The authors declare that there is no conflict of interest.

Acknowledgments

This work was supported by Funding Project of National Administration of Traditional Chinese Medicine (国家中医药管理局资助项目, No. LP0118041).

Statement of Informed Consent

Informed consent was obtained from all individual participants.

Received: 24 October 2019/Accepted: 28 November 2019