Ethical support
This was a prospective clinical trial study with 47 patients who underwent shoulder arthroscopic capsule and IGHL release performed by a senior doctor between January 2018 and June 2019. The study was approved by the Medical Ethics Committee of the Northern Jiangsu People's Hospital (number 2019029), and all 47 patients signed informed consent forms to participate in this study. The coordinating investigator will report any adverse events to the ethical committee in accordance with the ethical committee adverse events reporting procedures.
Data collection and follow-up
The data were collected at the Northern Jiangsu People's Hospital. A shoulder arthroscopic specialist team evaluated and informed all patients. Postoperative follow-up examinations were scheduled at 4, 8, 12 and 28 weeks at the orthopedics outpatient clinic of the study hospital. Three patients did not go to orthopedic outpatient clinics for review, and they were excluded at 12 weeks. Four patients did not go to orthopedic outpatient clinics for review, and they were excluded at 24 weeks. In total, 40 patients completed the 28-week follow-up, and the data of these patients were applied for statistical analyses and compared with the preoperative data. The experimental process is shown in Fig 1.
Among the 40 patients, there were 15 male patients and 25 female patients. There were 23 patients with left shoulder and 17 patients with right shoulder. There were 9 patients with diabetes and 31 patients without diabetes. The ages ranged from 41 to 77 years, and the mean age was 54.95±8.88 years. The course of the disease ranged from 3 to 26 months, and the average disease duration was 7.18±5.98 months.
Inclusion and exclusion criteria
Primary FS is not a definitive diagnostic criterion, and the diagnosis based on a physical examination17. All our studies are primary FS. A clinical diagnosis of FS can be made if the patient has painful, limited active and passive motion in at least two motion planes18. The inclusion criteria for this study were as follows: (1) restricted passive glenohumeral motion of 100° or less during forward flexion (FF) and 20°or less during external rotation (ER); (2) a history of at least 3 month of pain and stiffness; and (3) a normal radiologic appearance19. The exclusion criteria for this study were as follows: (1) acute shoulder injury; (2) combined with cervical spondylosis; (3) history of previous shoulder dislocation; (4) complicated cardiovascular and cerebrovascular diseases, nervous system diseases or blood system diseases; (5) combined with shoulder infections and tumors; (6) large and irreparable rotator cuff tears; and (7) combined with upper limb neuropathy.
Functional assessments
All of the patients were evaluated before and after surgery by the two professional orthopedists together completed a questionnaire with each patient about his or her subjective and objective symptoms. The primary outcome was the American Shoulder and Elbow Surgeons Score (ASES) score (scale 0-100, with higher scores indicating better outcomes and fewer symptoms). The secondary outcome was the Constant score criteria, which mainly accounts for subjective symptoms and the objective performance of the patients (scale 0-100, with higher scores indicating better outcomes and fewer symptoms). The third outcome was the visual analog scale (VAS) score for pain (range 0-10, 0 means no pain, and 10 means terrible pain). The fourth outcome was the active range of motion (ROM)20; the ROM includes FF and abduction (ABD), which were measured with a universal goniometer. The hand-behind-the-back method was used to measure internal rotation (IR). The hand-over-the-head method was used to measure ER.
At 12 and 24 weeks, the apprehension test of the shoulder primarily checks for a possible torn labrum or anterior instability problems and was mainly applied to detect the stability of the arthroscopic capsule and IGHL release in the shoulder joint.
Surgical procedures
The patients who participated in this study all underwent the same surgical treatment. The affected shoulder was marked while the patient was under general anesthesia, and the patient was placed in the lateral position (Fig. 2A). Then, the affected shoulder joint was sterilized, and the area was draped (Fig. 2B). The surgeon first closed the manipulate to release the shoulder joint on the affected side. The affected shoulder was passively flexed and abducted to the maximum possible extent. Next, passive ER and IR were performed at 0° of ABD or 90° of ABD.
A 30° arthroscope (Smith & Nephew, America) traversed a standard posterior portal between the head of the humerus and the biceps tendon. An anterior-superior portal was made just below the long head of the biceps tendon and positioned with a puncture needle under direct vision with the arthroscope (Fig. 3A). A radiofrequency probe was used to first release the rotator interval, then the superior capsule. At the same time, the superior glenohumeral ligament was dissected (Fig. 3B). The anterior capsular and middle glenohumeral ligaments of the affected shoulder were dissected through a rotator interval with a radiofrequency probe (Fig. 3C). Then, the inferior capsular and anterior IGHL were dissected with the radiofrequency probe along the margin of the glenoid as far inferiorly as possible (Fig. 3D). To avoid surgically damaging the axillary nerve, a radiofrequency probe was inserted in the anterior-superior portal to dissect the inferior aspect of the capsule away from the axillary nerve. Finally, the residual posterior IGHL was dissected through the posterior portal.
Postoperative rehabilitation
All patients followed the same rehabilitation program at least once a day starting on postoperative day one; the program comprised shoulder ROM exercises, and exercises to strengthen the shoulder muscles were started as soon as the postoperative pain and active shoulder motion allowed. The patients were informed to perform each rehabilitation exercise twice a day. In weeks 1 to 4, the rehabilitation exercises included passive FF and ABD with the patient in a supine position and passive ER and IR with the support of the unaffected side at 0° of ABD. The patients were also encouraged to use the affected arm in activities of daily living. In weeks 5 to 8, the affected shoulder joint gradually recovered the active ROM, and the patients actively increased the ROM of the affected shoulder joint. In weeks 9 to 12, exercises to strengthen the shoulder muscles of the affected side were performed. In weeks 13 to 28, the patients independently performed these exercises at home.
Statistics
SPSS 20 software for Windows (SPSS Inc., Chicago, IL, USA) was used to record the data and for the statistical analyses. The data of the various measurements are presented as the means±standard deviations (SDs). Student's t-test was used to compare the 28-week follow-up data with the preoperative data. A p value <0.05 was considered statistically significant.