| Authors: Amanda L. Dempsey, MD Timothy Mills, RN Robert M. Karsch, MD Thomas P. Branch, MD Affiliations: From the Department of Orthopaedic Surgery and Sports Medicine, University of Kentucky College of Medicine, Lexington, KY (ALD); and University Orthopaedics & Sports Medicine, Decatur, Georgia (TM, RMK, TPB). Correspondence: All correspondence and requests for reprints should be addressed to: Amanda L. Dempsey, MD, University of Kentucky, Department of Orthopaedic Surgery and Sports Medicine, Kentucky Clinic, 740 South Limestone St, Suite K-401, Lexington, KY 40536. Disclosures: Funded by ERMI, Inc, Atlanta, GA. One author (T.P.B.) is a stockholder for ERMI, Inc. Financial disclosure statements have been obtained, and no conflicts of interest have been reported by the authors or by any individuals in control of the content of this article. 0894-9115/11/9009-0738/0 American Journal of Physical Medicine & Rehabilitation Copyright * 2011 by Lippincott Williams & Wilkins DOI: 10.1097/PHM.0b013e318214ed0d |
MusculoskeletalMaximizing Total End Range Time is Safe and Effective for the Conservative Treatment of Frozen Shoulder PatientsAbstractDempsey AL, Mills T, Karsch RM, Branch TP: Maximizing total end range time is safe and effective for the conservative treatment of frozen shoulder patients. Am J Phys Med Rehabil 2011;90:738Y745.Objective: The purpose of this retrospective cohort study was to compare range of motion, subjective outcomes, and the prevalence of reoperation in groups of frozen shoulder patients with either low or moderate/high irritability treated with the same total end range time maximizing protocol. Design: A total of 36 patients were treated with the total end range time- maximizing protocol (12 patients with low irritability and 24 patients with moderate/ high irritability). American Shoulder and Elbow Society Standardized Shoulder Assessment Form (ASES) scores and external rotation and abduction were recorded before and after the rehabilitation protocol and were compared between the two groups. Results: For both groups, external rotation and abduction of the involved shoulder significantly increased from pretreatment to posttreatment, and the posttreatment external rotation and abduction of the involved shoulder did not differ from those of the uninvolved shoulder. There were no differences between the groups in either external rotation (P = 0.71) or abduction (P = 0.46). ASES scores were significantly lower and pain scores were significantly higher for the moderate/high irritability group both before and after treatment than for the low irritability group; however, the moderate/high irritability group demonstrated sig- nificantly greater gains in both ASES and pain scores. One patient in the low irritability group underwent a lysis of adhesions. Conclusions: We conclude that a total end range time maximizing rehabili- tation protocol is a safe, effective treatment option for patients with frozen shoulder. Key Words: Shoulder, Range of Motion, Adhesive Capsulitis, Rehabilitation Outcome |
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| Frozen shoulder, whether the result of primary adhesive capsulitis or secondary factors, is asso- ciated with a painful, restricted range of motion. Fibrosis and contracture of the capsuloligamentous complex and rotator cuff interval occur, resulting in restricted range of glenohumeral external rota- tion.1Y3 Because of the role of these contractures in limiting range of motion, previous authors have suggested that treatment protocols attempting to increase external rotation target the capsuloliga- mentous complex and rotator cuff intervals. Kelley et al.4 recently proposed that rehabili- tation protocols for frozen shoulder patients should be based on the patient’s irritability classification. The authors suggested that patients be classified with low, moderate, or high irritability based on patient-reported level of pain and disability, the presence of night pain, the degree of active and passive motion restriction, and where pain is noted in the available arc of motion.4 One basic premise of the proposed rehabilitation guidelines was that the amount of total stress being applied to the joint be varied according to the patient’s level of irritability. Patients classified with high irritability would be treated with low-intensity, short-duration stretches lasting no more than 5 secs and would be asked to repeat these exercises two to three times per day. As a patient’s irritability decreased, patients would then perform higher-intensity stretching exercises and would be asked to increase both the duration and the frequency of the stretches to maximize the total end range time (TERT). TERT is a function of the intensity, duration, and frequency that stretch- ing exercises are performed,5,6 and Kelley et al.4 further stated that TERT can be maximized through the use of home mechanical therapy devices. How- ever, it was also stated that low-load, prolonged stretch devices are typically not tolerated by patients with moderate or high irritability.4 Although this was suggested to be true of low- load, prolonged stretch devices, it is unclear whether high-intensity stretch (HIS) mechanical therapy devices may be more easily tolerated by frozen shoulder patients. High-intensity mechani- cal therapy devices apply forces to the joint that more closely replicate the forces applied by physical therapists.7 By applying a higher intensity, the duration and frequency use may be reduced while still maximizing TERT. Furthermore, by allowing patients to increase the intensity of stretch as tolerated, it is also unclear whether a TERT- maximizing treatment protocol including both outpatient physical therapy (PT) and adjunctive HIS | home mechanical therapy may be effective not only with low irritability (LI) patients but also with moderate and high irritability patients. The purpose of this retrospective study was to compare range of motion, subjective outcomes, and the prevalence of reoperation in groups of frozen shoulder patients with either LI or moderate/high irritability (MHI) treated with the same TERT-maximizing protocol. MATERIALS AND METHODS As part of this institutional review boardY approved retrospective protocol, we reviewed the medical records of a single, board-certified orthope- dic surgeon, reviewing all frozen shoulder patients who were treated with the TERT-maximizing proto- col. All patients were initially treated with a cus- tomized PT program specific to his/her pathology and/or surgical procedure. Patients who had under- gone either distal clavicle resection, open reduction with internal fixation, or a rotator cuff repair for a tear less than 1 cm immediately began postoperative PT three times weekly, focusing on passive and active range of motion exercises. Patients who required repair of a tear bigger than 1 cm used a sling and focused solely on passive motion during the first four postoperative weeks. Patients with massive cuff tears used a sling for 6 wks, followed by slow pro- gressive range of motion and outpatient PT. Capsu- lar reconstruction patients were allowed to begin motion between 2 and 4 wks after the procedure. Patients with idiopathic primary frozen shoulder immediately began outpatient PT three times per week, focusing on both active and passive range of motion exercises. Patients who failed at least 6 wks of supervised PT with three sessions per week were then treated with the TERT-maximizing protocol. Patients were considered to have failed supervised PT if they did not achieve glenohumeral abduction and gleno- humeral external rotation equal to those of the opposite, uninvolved limb. The TERT-maximizing protocol did not include a corticosteroid injection and consisted of continued outpatient PT, nonste- roidal anti-inflammatory drugs, and home use of a HIS home mechanical therapy device (ERMI Shoul- der Flexionater; ERMI, Inc, Atlanta, GA; Fig. 1). The HIS device was used in the patients’ homes as an adjunct to outpatient PT, and patients were instruc- ted to perform six 10-min bouts of end-range stretching per day with the HIS device per the man- ufacturer’s instructions. Patients used the hydraulic pump to move the joint to the end range of motion, and the device’s quick-release mechanism gave |
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| compare the efficacy of this TERT-maximizing pro- tocol among patients having either LI or MHI, we compiled range of motion and ASES scores from the date when the TERT-maximizing protocol was initi- ated and when the patient completed the protocol. Passive external rotation and abduction range of motion were compared between groups using sepa- rate 2 3 mixed-model analyses of variance. Range of motion was compared between the LI and MHI groups and between the pretreatment measurements of the involved shoulder, posttreatment measure- ments of the involved shoulder, and the measure- ments of the unaffected contralateral shoulder. Pretreatment and posttreatment ASES scores, pain ratings, and the activity of daily living subcompo- nent of the ASES score were compared using a 2 2 analysis of variance. Two-tailed independent t tests were used to compare patient age, height, weight, number of weeks of PT, number of weeks of HIS | mechanical therapy, and duration of follow-up be- tween groups. Between-group differences in sex and the prevalence of reoperation were evaluated with Fisher’s exact tests. An > level of P e 0.05 was con- sidered significant for all t tests and Fisher’s exact tests. For the 2 3 range of motionYrelated analyses of variance, a Bonferroni correction was made for multiple comparisons and determined that an > level of P e 0.006 was considered significant. For the 2 2 ASES-related analyses of variance, a Bonferroni cor- rection was made for multiple comparisons and determined that an > level of P e 0.0125 was con- sidered significant. All analyses were performed using Statistics v 17.0 (SPSS, Inc, Chicago, IL). RESULTS Over a 15-mo period, 36 patients with com- plete medical records were treated with this TERT- maximizing protocol. Of these 36 patients, 10 (28%) |
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| were treated as part of a worker’s compensation claim. Twelve patients were classified with LI and 24 were classified with MHI. The two groups did not differ in age, sex, height, weight, number of weeks of PT, number of weeks of HIS mechanical therapy, or duration of follow-up (Table 1). For both groups, passive external rotation and abduction of the involved shoulder significantly increased from pretreatment to posttreatment, and the posttreatment external rotation and abduction of the involved shoulder did not differ from those of the uninvolved shoulder (Figs. 2 and 3). There were no differences noted between the groups in either external rotation (P = 0.71) or abduction (P = 0.46). | claim. Twelve patients were classified with LI and 24 were classified with MHI. The two groups did not differ in age, sex, height, weight, number of weeks of PT, number of weeks of HIS mechanical therapy, or duration of follow-up (Table 1). For both groups, passive external rotation and abduction of the involved shoulder significantly increased from pretreatment to posttreatment, and the posttreatment external rotation and abduction of the involved shoulder did not differ from those of the uninvolved shoulder (Figs. 2 and 3). There were no differences noted between the groups in either external rotation (P = 0.71) or abduction (P = 0.46). ASES, pain, and activity of daily living scores all significantly improved from pretreatment to post- treatment (Table 2). ASES scores were significantly lower and pain scores were significantly higher for the MHI group both before and after treatment than for the LI group; however, the MHI group demon- strated significantly greater gains in both ASES and pain scores than the LI group did. There were no group differences in activity of daily living scores (P = 0.46). No patients in this series underwent manipu- lation under anesthesia (MUA). One 46-yr-old male patient in the LI group required reoperation, result- ing in an overall reoperation rate of 2.8% (1/36) for |
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| patients treated with this TERT-maximizing pro- tocol. He had initially undergone anterior capsule reconstruction, distal clavicle resection, and sub- acromial decompression as part of a worker’s com- pensation claim. After failing 12 wks of PT, he was subsequently treated with the TERT-maximizing protocol. After 10 wks of the TERT-maximizing protocol, his ranges of external rotation and abduc- tion improved to 60- and 90-, respectively. At that time, there was radiographic evidence of acromio- clavicular osteoarthritis. The patient was given a corticosteroid injection and scheduled to undergo revision distal clavicle resection. During the proce- dure, a significant amount of scar tissue was noted in the area of the coracohumeral ligament, and a lysis of adhesions was performed. DISCUSSION The purpose of this retrospective study was to compare range of motion, subjective outcomes, and the prevalence of reoperation in groups of LI or MHI frozen shoulder patients treated with the same TERT-maximizing treatment protocol. Both the LI and MHI groups demonstrated significant gains in glenohumeral external rotation and abductions and significantly improved ASES, pain, and activity of daily living scores. In addition to being equally effective in both groups of frozen shoulder patients, the two groups did not differ in either the number of weeks of PT or HIS mechanical therapy. One key aspect of this TERT-maximizing treatment protocol was that patients were asked to stretch multiple times per day at an intensity that was near, but not above, the pain threshold. Inferior clinical results have been reported by Diercks and Stevens9 when treating frozen shoulder patients with aggressive end range of motion stretching performed above the pain threshold. In addition, the authors stated that aggressive stretching be- yond the pain threshold was especially detrimental in the early phases of frozen shoulder syndrome,9 when patients were most likely to have increased levels of irritability. Patients in the current study, regardless of irritability classification, were asked to stretch multiple times per day near, but not above, the pain threshold. Maximizing TERT within each patient’s tolerance level while avoiding po- tential exacerbation of symptoms and/or inflam- mation seemed to result in safe, effective, and timely return of range of motion. Proper patient selection is another factor that seems to be vital to the clinical success of this regi- men. All patients in the current study had previously | failed a minimum of 6 wks of outpatient PT before initiating the TERT-maximizing protocol. Overpres- sure stretching applied by a physical therapist at the patient’s end range of motion often results in im- proved range of motion; however, these gains have been reported to be temporary.5,6,10Y12 These tran- sient gains in motion may be related to the findings of Griggs et al.,13 who reported that frozen shoulder patients who were previously treated with PT were at greater risk of requiring MUA to address their motion restrictions. With this in mind, it is note- worthy that only 1 (2.8%) of the 36 patients treated with the TERT-maximizing protocol required motion-restoring surgery. Multiple nonoperative treatment options have been reported for the treatment of frozen shoulder patients. Other successful protocols have included PT and nonsteroidal anti-inflammatory drugs14 and corticosteroid injections in conjunction with either outpatient PT and/or a home exercise pro- gram,15 MUA,16 and arthroscopic capsular release.17 All protocols have reported improved range of mo- tion or a decrease in pain and/or functional limita- tion; however, all of these protocols have significant drawbacks that limited their use in our clinical practices. Intra-articular corticosteroid injections have been reported not only to be a successful treatment option15,18 but also to be associated with a high rate of adverse reactions.18 van der Windt et al.18 reported that 53% of patients treated with an intra-articular injection of 40 mg triamcinolone acetonide had an adverse reaction, which included pain, facial flushing, fever, skin irritation, sweating, fatigue, dry mouth, dizziness, and headache. Fur- thermore, a recent systematic review by Blanchard et al.19 demonstrated that corticosteroid injections may provide a short-term benefit over other non- operative treatment options, but that there is no clear long-term benefit. To minimize the risk of adverse reactions while still promoting both short- and long-term gains in range of motion and reduction of pain and disability, we opt not to treat our frozen shoulder patients with corticosteroid injections. Surgical treatment options are available for frozen shoulder patients who fail to respond to conservative measures. Both MUA and arthroscopic capsular release have documented histories of suc- cess17,20 but have been reported to be more suc- cessful in patients who have failed 6 mos or more of previous treatment.17,21 MUA allows for noninvasive release of capsuloligamentous adhesions; however, it does so in an uncontrolled manner. Loew et al.22 arthroscopically evaluated patients who had |
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| undergone closed MUA and reported that 80% demonstrated tearing the anterior joint capsule, resulting in significant bleeding into the joint. Neither the short- nor long-term effects of this tearing and inflammatory response are well un- derstood. In theory, the inflammatory response and increased intra-articular bleeding result in the proliferation of fibroblasts and an increased risk of arthrofibrosis.23 This uncontrolled capsular tear- ing and associated inflammatory response may then be related to why 20% of frozen shoulder patients who have undergone a MUA report persistent pain and limited motion 2 yrs after the procedure.24 Furthermore, the long-term effects of potential gle- nohumeral instability resulting from the tearing of the anterior capsule have not been established. It is for these reasons that we prefer not to manipu- late frozen shoulder patients within the first six symptomatic months but instead prefer to treat patients with persistent frozen shoulder symptoms with the TERT-maximizing conservative protocol. For the very small percentage of patients (2.8% of patients in the current study) who fail the TERT- maximizing protocol, we feel that arthroscopic capsular release is the safest and most effective surgical treatment option. This study was not without limitation. The 36 patients were treated at 19 different outpatient PT clinics; thus, the individual PT programs un- doubtedly differed among patients. Despite the risk of inconsistent treatment among therapists, this retrospective case series demonstrated that daily adjunctive use of the HIS mechanical therapy device in combination with routine outpatient PT resulted in improved motion and outcome scores with a minimal risk of reoperation. Although the results of this study are promising, future prospective, ran- domized controlled trials are necessary to evaluate the TERT-maximizing protocol. In conclusion, we used a TERT-maximizing re- habilitation protocol consisting of outpatient PT, HIS home mechanical therapy, and nonsteroidal anti- inflammatory drugs to treat frozen shoulder patients. Regardless of the patient’s irritability classification, the protocol resulted in significant gains in gleno- humeral external rotation and abduction and signif- icant improvements in ASES scores, with a very low rate of reoperation (2.8%). REFERENCES 1. Neviaser J: Adhesive capsulitis of the shoulder, a study of the pathological findings in periarthritis of the shoulder. J Bone Joint Surg Am 1945;27: 211Y22 | 2. Pouliart N, Somers K, Eid S, et al: Variations in the superior capsuloligamentous complex and de- scription of a new ligament. J Shoulder Elbow Surg 2007;16:821Y36 3. 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| 18. van der Windt D, Koes B, Deville W, et al: Effective- ness of corticosteroid injections versus physiotherapy for treatment of painful stiff shoulder in primary care: a randomized trial. BMJ 1998;317:1292Y6 19. Blanchard V, Barr S, Cerisola F: The effectiveness of corticosteroid injections compared with physiother- apeutic interventions for adhesive capsulitis: a sys- tematic review. Physiotherapy 2010;96:95Y107 20. Dodenhoff R, Levy D, Wilson A, et al: Manipulation under anesthesia for primary frozen shoulder. Effect on early recovery and return to activity. J Shoulder Elbow Surg 2000;9:23Y6 | 21. Kessel L, Bayley I, Young A: The upper limb: the frozen shoulder. Br J Hosp Med 1981;25:334Y9 22. Loew M, Heichel T, Lehner B: Intraarticular le- sions in primary frozen shoulder after manipulation under anesthesia. J Shoulder Elbow Surg 2005;14: 16Y21 23. Murakami S, Muneta T, Furuya K, et al: Immuno- histologic analysis of synovium in infrapatellar fat pad after anterior cruciate ligament injury. Am J Sports Med 1995;23:763Y8 24. Hill J, Bogumill H: Manipulation in the treatment of frozen shoulder. Orthopedics 1988;9:1255Y60 |