Abstract
Background
Some patients with postoperative adhesive capsulitis reach a plateau in their recovery with a standard protocol of physical therapy (PT), which puts them at risk for further surgical intervention.
Objectives
We aimed to evaluate therapy for postoperative adhesive capsulitis of the shoulder in 2 groups of patients: (1) those who used a high-intensity stretch (HIS) device after reaching a plateau in their recovery with a standard protocol of traditional PT (PT + HIS) and (2) those who showed no plateau in their recovery with a standard protocol of traditional PT alone (PT only).
Methods
We retrospectively reviewed the records for 60 patients (51 males; mean age 46.7 ± 12.6 years) with postoperative adhesive capsulitis who received treatment between March 2007 and May 2010. Forward elevation and combined internal/external rotation at the initial postoperative visit and final visit were measured. The measurements from group 2 patients were used as an observational benchmark.
Results
The PT + HIS ( n = 42) and PT-only ( n = 18) patients did not differ in total follow-up time. Initial elevation was worse for PT + HIS than PT-only patients (22.1° lower, P = 0.02), but the final elevation was equivalent. Initial rotation was worse for PT + HIS than PT-only patients (16.6° lower, P = 0.04), but the final rotation was higher for PT + HIS patients (10.6° higher, P = 0.04). Gains in elevation and rotation were greater for the PT + HIS than PT-only patients ( P = 0.04 and P = 0.01).
Conclusions
Patients with postoperative adhesive capsulitis of the shoulder who are unable to reach their PT treatment goals with a standard protocol of PT may benefit from the addition of HIS to their treatment regimen. HIS could be a valuable adjunct to PT for treating postoperative adhesive capsulitis in appropriate patients.
1
Introduction
Adhesive capsulitis of the shoulder occurs in up to 5% of the population . It can limit a patient’s ability to perform activities of daily living due to pain and to loss of both active and passive range of motion (ROM). Two general categories of adhesive capsulitis have been described:
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primary, or idiopathic;
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and secondary .
Primary adhesive capsulitis develops gradually over time without a specific known cause. Secondary adhesive capsulitis generally results from trauma or immobilization and can be separated into 3 types:
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endocrine disorder-related;
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post-traumatic;
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and postoperative .
Up to 40% of patients with adhesive capsulitis experience symptoms for longer than 3 years and up to 15% have a persistent disability . Recovery from primary adhesive capsulitis generally includes a return of motion and resolution of symptoms; however, secondary adhesive capsulitis can be more difficult to treat . Postoperative adhesive capsulitis can follow a more protracted course, often requiring a surgical release procedure . Postoperative adhesive capsulitis can occur in up to 13% of patients after rotator cuff repair . Other aetiologies of postoperative adhesive capsulitis include labral repair, capsulorrhaphy, shoulder arthroplasty and humerus fracture fixation . Adhesive capsulitis incurs significant costs: direct costs were reported to be $7 billion in the United States in 2000 (equivalent to more than $9 billion in 2016) .
The standard of care for postoperative adhesive capsulitis has included treatment with continuous passive motion (CPM) devices in the early postoperative period, followed by traditional physical therapy (PT). CPM devices are intended to prevent the formation of scar tissue and move the joint back and forth throughout the entire ROM of the joint. The use of CPM devices for treating frozen shoulder has had mixed results . Other non-surgical interventions used as adjunct therapy to PT include glucocorticoid injections and arthrographic joint distension . If motion loss persists after prolonged conservative treatment, surgical intervention including manipulation under anesthesia or lysis of adhesions is often the only recourse. An effective non-operative solution after surgery could provide significant savings in downstream healthcare costs by preventing a second surgical procedure along with the subsequent additional PT and doctor visits.
Mechanical therapy (performed at home) used as an adjunct to outpatient PT has been successful in treating adhesive capsulitis in the knee . Mechanical therapy devices can be classified as low- or high-intensity stretch (HIS) devices . HIS devices can apply torque to the joint similar to that applied by a physical therapist, whereas low-intensity devices apply lower torque to the joint and are usually used for longer treatment periods. Unlike CPM devices that are designed to prevent scar tissue formation, HIS devices are designed to stretch a joint at its end ROM to permanently elongate scar tissue that has already formed in the joint. In general, patients are given HIS devices when they are not meeting treatment milestones and have reached a plateau in their recovery with a standard protocol of PT. This plateau puts them at risk for further surgical intervention including manipulation under anesthesia or lysis of adhesions. A study of more than 60,000 patients with secondary adhesive capsulitis in the knee due to injury or surgery reported that patients receiving an HIS device were at significantly less risk of re-hospitalization or re-operation than those receiving a low-intensity device or PT alone . To our knowledge, only one study has evaluated the use of an HIS device for treating shoulder stiffness . That study dealt with frozen shoulder and is addressed in the discussion.
The purpose of this retrospective study of patients with postoperative adhesive capsulitis was to evaluate the efficacy of treatment for 2 groups of patients:
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patients who had reached a plateau in their recovery and failed to meet treatment goals with a standard protocol of traditional PT alone who were given an HIS device in addition to PT (PT + HIS);
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and patients with no evidence of reaching a plateau in their recovery and who met their treatment goals with PT alone (PT only).
We aimed to examine whether patients who had reached a plateau in their recovery with PT alone would benefit from the addition of HIS to their treatment protocol, so that they would recover to an equivalent level as compared to patients who reached all treatment goals with PT alone. The retrospective nature of this study and atypical study design precluded a direct comparison between group 1 and 2 patients. Results from group 2 patients were used as a benchmark to observe group 1 patients, for an observational study.
2
Materials and methods
2.1
Participants
This retrospective institutional research board-approved study was granted a waiver of informed consent. Clinical notes were examined for patients seen postoperatively between March 2007 and May 2010 after undergoing an arthroscopic shoulder procedure performed by one of the authors (PW). Within this time, 60 patients (51 males, mean age 46.7 ± 12.6 years, height 1.8 ± 0.1 m, weight 93.9 ± 18.1 kg) received treatment for postoperative adhesive capsulitis. Surgical procedures included rotator cuff repair, subacromial and nerve decompression, paracapsular release, biceps tenodesis, labral repair, repair of a superior labral tear from anterior to posterior, distal clavicle excision, capsulorrhaphy, and microfracture surgery ( see Supplementary Table ). Overall, 42/60 patients reached a plateau in their recovery after failing to achieve target treatment goals with a standard protocol of traditional PT. For these 42 patients, the addition of HIS mechanical therapy (High-Intensity Stretch Device, ERMI Shoulder Flexionater ® ) was considered the best treatment to avoid further surgical intervention (PT + HIS group). The other 18 patients showed no evidence of a plateau in their recovery and reached their treatment goals with a standard protocol of PT (PT-only group). For the 42 PT + HIS patients, the HIS device was introduced after a mean of 10.4 ± 4.0 weeks of treatment with a standard protocol of traditional PT. The 42 patients received the HIS device while continuing with PT for a mean of 15.8 ± 7.0 weeks, for a total mean of 26.2 ± 10.1 weeks treatment time (10.4 weeks of PT alone + 15.8 weeks of PT + HIS). The PT-only patients did not reach a plateau in their recovery and met all treatment goals with the standard protocol of traditional PT for a statistically equivalent duration (26.8 ± 10.3 weeks). Therefore, PT + HIS patients did not require more treatment time than PT-only patients. The groups did not differ in mean age (46.6 vs. 44.3; P = 0.41), height (1.8 m vs. 1.7 m; P = 0.14) or weight (96.2 kg vs. 78.0 kg; P = 0.16).
2.2
Intervention
The postoperative PT protocol for each patient was customized to the patient’s pathology and the surgical procedure performed. All patients started with formal PT within 3 days after surgery. All patients except those who underwent a subscapularis tendon repair began with passive flexion, elevation and internal and external rotation on the scapular plane, in addition to selected active-assisted ROM exercises.
Interval target goals for ROM progress during PT were specified for each patient and were based on the contralateral shoulder ROM. ROM goals varied among patients and depended on the age and sex of the patient, preoperative ROM in the injured shoulder, injury and surgery type, and ROM in the contralateral arm. The 42 patients in the PT + HIS group were consistently unable to reach their ROM goals and were prescribed an HIS device; they also continued PT. All of these patients showed failure after at least 5 weeks of PT (mean 10.4 ± 4.0 weeks) before the introduction of the HIS device, with the exception of one patient who had limited pre-surgery ROM, reached a plateau early in treatment and received the device after 2.6 weeks (18 days) of PT. Because this project is retrospective, we are not able, at this stage, to give specific numbers that define a plateau in recovery. However, patients with < 45° in external rotation and 120° in forward elevation after 5 or more weeks of PT are generally considered at risk of a poor outcome without additional intervention.
The PT + HIS patients were given an HIS device to be used at home ( Fig. 1 ). After the device was set up in the patient’s home, the patient received clear demonstrations on how to use it. Patients were asked to perform six 10-min sessions of end-range stretching per day with the device.
The HIS device could be set to stretch in external rotation, abduction or a combination of the 2 movements ( Fig. 1 ). The patient could increase the torque being applied to the shoulder by pumping the hydraulic actuator lever arm, which was controlled by the patient’s unaffected arm. By pumping the lever arm, the patient moved the affected shoulder to its end ROM, and that static position was maintained for periods of up to 10 min. The level of torque could be adjusted as needed throughout the stretch period by using the actuator lever arm to increase torque or the quick-release valve to reduce torque. A common treatment protocol was to stretch for 10 min, rest for 10 min, then stretch for 10 min. This protocol was repeated 2 additional times per day to achieve the desired goal of 60 min of end-range stretching per day.
Passive arc of elevation was measured according to the American Shoulder and Elbow Surgeons (ASES) recommendations for standardized shoulder assessment . This motion, also called “forward elevation,” consists of the maximum arm–trunk angle viewed from any direction. The arc of elevation was performed with the patient standing, and internal and external rotation was measured with the patient supine and with the scapula stabilized by the examiner and the shoulder at 90° of abduction. The same clinician used a goniometer for measurement at each office visit during the treatment. However, intermediate measurements are not presented in this paper, because this study focused on the baseline measurement at the initial postoperative follow-up visit and the final recorded measurements. Because this study is retrospective, the duration of PT and the timing of office visits differed for each subject.
2.3
Statistical analyses
Passive shoulder arc of elevation (ELEV), external rotation (ER), internal rotation (IR), and total range of rotation (ER + IR) measurements were obtained from each patient’s electronic medical records. Means (SD) and 95% confidence intervals were used to characterize measurements at each follow-up period. Two-sample equal variance t test was used to compare outcomes between groups. The F -test was used to ensure equal variances before applying t tests. P < 0.05 was considered statistically significant.
2
Materials and methods
2.1
Participants
This retrospective institutional research board-approved study was granted a waiver of informed consent. Clinical notes were examined for patients seen postoperatively between March 2007 and May 2010 after undergoing an arthroscopic shoulder procedure performed by one of the authors (PW). Within this time, 60 patients (51 males, mean age 46.7 ± 12.6 years, height 1.8 ± 0.1 m, weight 93.9 ± 18.1 kg) received treatment for postoperative adhesive capsulitis. Surgical procedures included rotator cuff repair, subacromial and nerve decompression, paracapsular release, biceps tenodesis, labral repair, repair of a superior labral tear from anterior to posterior, distal clavicle excision, capsulorrhaphy, and microfracture surgery ( see Supplementary Table ). Overall, 42/60 patients reached a plateau in their recovery after failing to achieve target treatment goals with a standard protocol of traditional PT. For these 42 patients, the addition of HIS mechanical therapy (High-Intensity Stretch Device, ERMI Shoulder Flexionater ® ) was considered the best treatment to avoid further surgical intervention (PT + HIS group). The other 18 patients showed no evidence of a plateau in their recovery and reached their treatment goals with a standard protocol of PT (PT-only group). For the 42 PT + HIS patients, the HIS device was introduced after a mean of 10.4 ± 4.0 weeks of treatment with a standard protocol of traditional PT. The 42 patients received the HIS device while continuing with PT for a mean of 15.8 ± 7.0 weeks, for a total mean of 26.2 ± 10.1 weeks treatment time (10.4 weeks of PT alone + 15.8 weeks of PT + HIS). The PT-only patients did not reach a plateau in their recovery and met all treatment goals with the standard protocol of traditional PT for a statistically equivalent duration (26.8 ± 10.3 weeks). Therefore, PT + HIS patients did not require more treatment time than PT-only patients. The groups did not differ in mean age (46.6 vs. 44.3; P = 0.41), height (1.8 m vs. 1.7 m; P = 0.14) or weight (96.2 kg vs. 78.0 kg; P = 0.16).
2.2
Intervention
The postoperative PT protocol for each patient was customized to the patient’s pathology and the surgical procedure performed. All patients started with formal PT within 3 days after surgery. All patients except those who underwent a subscapularis tendon repair began with passive flexion, elevation and internal and external rotation on the scapular plane, in addition to selected active-assisted ROM exercises.
Interval target goals for ROM progress during PT were specified for each patient and were based on the contralateral shoulder ROM. ROM goals varied among patients and depended on the age and sex of the patient, preoperative ROM in the injured shoulder, injury and surgery type, and ROM in the contralateral arm. The 42 patients in the PT + HIS group were consistently unable to reach their ROM goals and were prescribed an HIS device; they also continued PT. All of these patients showed failure after at least 5 weeks of PT (mean 10.4 ± 4.0 weeks) before the introduction of the HIS device, with the exception of one patient who had limited pre-surgery ROM, reached a plateau early in treatment and received the device after 2.6 weeks (18 days) of PT. Because this project is retrospective, we are not able, at this stage, to give specific numbers that define a plateau in recovery. However, patients with < 45° in external rotation and 120° in forward elevation after 5 or more weeks of PT are generally considered at risk of a poor outcome without additional intervention.
The PT + HIS patients were given an HIS device to be used at home ( Fig. 1 ). After the device was set up in the patient’s home, the patient received clear demonstrations on how to use it. Patients were asked to perform six 10-min sessions of end-range stretching per day with the device.
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