Efficacy of a high-intensity home stretching
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| Abstract Background Historically, in-person physical therapy serves as a foundational component of nonoperative treatment of adhesive capsulitis (AC). This study compares the efectiveness of an at-home high-intensity stretch (HIS) device to traditional physical therapy (PT) and to PT in combination with the HIS device. We hypothesize that the HIS device will be as efective as PT alone or as combination therapy in the frst-line treatment of AC and use of the HIS device will exhibit improvement at higher rate. Methods Thirty-four patients with idiopathic adhesive capsulitis and a minimum of 12 months follow-up were included in this study. Patients were randomized into one of the three groups: HIS device, PT alone, or HIS device+PT. Passive range of motion (ROM), American Shoulder and Elbow Surgeons (ASES), and Simple Shoulder Test (SST) scores were measured. Additionally, patient satisfaction, compliance and complications were recorded. Paired t-test, ANOVA and Chi-squared tests were used in analysis. Results Final ROM in all planes improved for all groups compared to baseline (p<0.001), with only HIS device group able to restore>95% of contralateral ROM in all planes at fnal follow-up. Patients with PT alone were on average slowest to improve ROM from baseline, at 3 months, 6 months, and 1 year in all planes except internal rotation. ASES and SST scores improved for all groups when compared to baseline (p<0.001). Use of HIS-device resulted in greater improvement in SST and ASES Total scores compared to PT alone (p=0.045, and p=0.048, respectively). Conclusions Use of an at-home high-intensity stretching device for conservative treatment of idiopathic adhesive capsulitis improves outcomes in ROM and in ASES and SST scores both when used as an adjunct to physical therapy and when used alone. Trial registration The study protocol was registered at www.clinicaltrials.gov (20/05/2022, NCT05384093). Keywords Adhesive capsulitis, Physical therapy, High-intensity stretching device | |
| *Correspondence: Christopher E. Baker chrisbaker78@gmail.com Full list of author information is available at the end of the article BMC LOGO | © The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecom- mons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
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| Background Idiopathic adhesive capsulitis (AC), commonly referred to as “frozen shoulder,” is a debilitating condition result- ing in painful and restricted range of motion (ROM) due to shoulder joint stiffness. Its incidence in the United States has been reported between 2–5% [1, 2]. Although the etiology is largely unknown, it has been associated with diabetes mellitus, thyroid dysfunction, and autoim- mune disease [3–7]. All planes of motion are commonly afected in AC, although passive external rotation is typi- cally more limited than abduction or internal rotation [8]. Treatment of AC is aimed at relieving pain and restoring motion and function of the shoulder. Con- servative therapy commonly includes oral nonsteroidal anti-infammatory drugs (NSAIDs), intra-articular ster- oid injections, and physical therapy (PT) [2, 3, 9]. Surgical treatment options include manipulation under anesthesia with or without capsular release, commonly performed arthroscopically [2, 3, 9]. Physical therapy is the most prescribed treatment for AC. Despite its widespread use, there is a lack of high-level evidence supporting the use of PT for the treatment of AC [10–12]. Griggs et al. evaluated 75 patients with AC treated with a stretching program and found 90% achieved a satisfactory outcome [13]. A meta-analysis by Jewell et al. found joint mobili- zation and exercises were the most efective modality for AC [14, 15]. Tere are signifcant costs regarding disability due to adhesive capsulitis and its management. Direct costs of managing AC were approximately $7 billion in the United States in 2000, and reached to greater than $9 billion in 2017 [16]. Absence from work, difculty with sleep, and inability to perform activities of daily living can be a sig- nifcant burden to patients. Visits to physician ofces and PT appointments can lead to signifcant fnancial and time costs for patients. Providing an efcient and cost- efective treatment plan continues to be a challenge in the treatment of AC [17]. Mechanical therapy performed at home has been a successful adjunct to outpatient PT for adhesive capsulitis because of its unique ability to apply torque, similar to a physical therapist, to stif joints [16, 18–21]. Patients typically are given high-intensity stretch (HIS) devices when they are not meeting treatment mile- stones and have reached a plateau in their recovery using standard physical therapy. Further, improvements in ROM can be achieved in patients regardless of pre-inter- ventional irritability level [22, 23]. However, HIS devices have not been studied as frst-line therapy in the treat- ment of AC. Tis study aimed to evaluate and compare the efficacy of AC treatment therapies. We further aimed to compare the rate of improvement within studied therapy options. And lastly, we reported on patient’s compliance and | overall satisfaction with HIS device. We hypothesize that the HIS device will be as efective as PT alone or as com- bination therapy in the frst-line treatment of AC and HIS device will exhibit improvement at higher rate. Methods Study settings Tis study is a prospective randomized control study beginning in September of 2019 until December 2022. All patients in the study were treated by one of two fel- lowship-trained orthopaedic surgeons at the Florida Orthopaedic Institute in Tampa, FL (CB, NK) prior to randomization into therapy. Participants Tirty-four patients (34 shoulders) between the ages of 38–74 diagnosed with AC were enrolled in the study (Fig. 1). Patients were randomized into one of three groups: HIS device only (n=13), PT only (n=10), and combined PT+HIS device (n=11). Adhesive capsulitis was defned as shoulder pain with limited ROM for more than one month with ≤130 degrees of passive forward fexion and ≤30 degrees of passive external rotation [16]. A minimum one-month criterion was selected to exclude all patients with short-term, temporary loss of motion which could have been attributed to causes unrelated to AC. Patients with prior treatment of the involved shoul- der, including previous injections or PT for AC, shoul- der surgery, ipsilateral shoulder infection, or rheumatoid arthritis were excluded. In addition, patients with any disorder that could result in pain or limited ROM such as infammatory joint disease, osteoarthritis evidenced on radiographs, full-thickness rotator cuf tears identifed on ultrasound or MRI imaging, history of trauma (fracture) involving the shoulder, or other shoulder deformity were also excluded. Patients with cognitive defcit, inability to comprehend PT/HIS-device instructions or non-english speakers were also excluded. Te surgeon confrmed the presence of AC as defned above before consenting the patients for enrollment. Ethical approval was obtained from the Institutional Review Board. Furthermore, a minimum of 12 months clinical follow-up was required for inclusion in this report. Lastly, patients enrolled in this study received no prior surgical intervention and conservative treatment was selected as the appropriate choice of treatment by the treating surgeon. Procedure A goniometer was used to measure and record passive ROM of both the non-afected and afected shoulder in forward fexion (FF), abduction (ABD), and external rota- tion (ER). Internal rotation was reported as a numerical value from 0 to 8 for the highest point the patient can |
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| reach behind the back: ipsilateral hip (0), ipsilateral back pocket (1), contralateral back pocket (2), S1 to L5 (3), T11 to L1 (4), T7 to T10 (5), T4 to T6 (6), T2 to T3 (7), and C8 to T1 (8) [24]. Each patient was given an intra-artic- ular injection via the Neviaser portal technique consist- ing of 2 cc 1% lidocaine, 2 cc 0.25% Marcaine, and 40 mg of Kenalog. Injections were given before initiating study treatment. Each patient was assigned to one of three groups by a research staf member using a random num- ber generator: group I used the HIS device alone, group II used physical therapy only, and group III used the HIS device and physical therapy in combination. Patient would start with PT typically within a week of injec- tion. Te treating surgeon was unaware of the patient’s treatment group assignment until follow-up. Treating surgeons and physical therapists have over 10+years of experience. | Te PT protocol consisted of shoulder range of motion exercises, including joint mobilization and scapular sta- bilization as deemed appropriate by the treating physical therapist according to a standardized protocol (Appen- dix A). Physical therapists instructed patients on proper techniques and specifc stretches and exercises. Te patients were scheduled for three 60-minute PT sessions per week. Patients continued physical therapy until the afected shoulder achieved external rotation and forward fexion ROM equal to or greater than 90% of the con- tralateral unafected side. Patients randomized to the HIS stretch device group (Flexionater Chair, Ermi, Atlanta, GA, Fig. 2) were instructed to stretch at a high intensity for 60 min per day divided into 3 time periods by the representative of the company. Patients were asked to use the HIS for 10 min, followed by 10 min of rest and another 10 min of |
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| stretch. Tis cycle was repeated two more times each day to achieve the goal of 60 min of stretching per day. Te chair was initially adjusted for ER. Once 90% of contralat- eral motion was completed, the HIS stretch device was then changed to perform abduction. Te patient contin- ued use until they reached ER and FF of at least 90% of the contralateral side. Patients in the combined therapy group were instructed to perform the daily HIS stretching exercises while attending PT for 2–3 sessions per week using the exact protocols followed by the other two groups. Outcome measures Primary outcome measures included shoulder range of motion (passive shoulder forward fexion, external rota- tion, abduction, internal rotation) measured by the treat- ing physician, American Shoulder and Elbow Surgeons standardized shoulder assessment form (ASES) scores for pain and function, and Simple shoulder test (SST) scores [24, 25]. Passive ROM was chosen to isolate gleno- humeral motion and reduce other potential confounding variables. Measurements in forward fexion and external rotation were included in this study as these are stand- ard measurements used by clinicians to assess patient recovery [26]. Furthermore, previous research has shown stretching external rotation and abduction improves the ROM in other planes [16, 22]. Achieving a minimal clini- cally important diference (MCID) for ASES Total (20 point improvement), and SST (2 point improvement) scores had been determined for each group [27, 28]. Patients in HIS device and combination therapy groups additionally reported on compliance, satisfaction, and convenience with the selected therapy option using | simplifed 5-point Likert scale. Furthermore, the same patients were asked to self-report their experience with the device (ease of use, comfort, satisfaction, and percep- tion of improvement in shoulder motion) using binary selection (yes/no). Statistical analysis Data analysis was performed using SPSS version 27 (IBM Corp, Armonk, NY). Mean shoulder range of motion, ASES, and SST scores were calculated at base- line, 6 weeks, 3 months, 6 months and the last available follow-up longer than 12 months for subjects in all three groups. A Shapiro Wilcox analysis was used to confrm normality of distribution. A paired t-test was utilized to evaluate improvement from baseline within each group and ANOVA was used to evaluate diferences between the groups. Chi-square test was used to evaluate associa- tions between categorical variables. Minimal sample size of 9 per group was determined with calculated efect size of 1.2 (average diference in ER 15±12.5 degrees [16]) power of 80%. Signifcance was considered at alpha 0.05. Results Demographics Te average age of the subjects in the study was 56 years (range, 38–74). Te average clinical follow up was 18 months (SD, 6.4). Eleven patients (32%) were male. Twenty-one patients had symptoms in the left shoul- der (62%), and thirteen patients had symptoms in the right shoulder (38%). Diabetes and thyroid dysfunction were present in 13 patients (38%) and 5 patients (15%), respectively. |
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| There were no statistical differences between study groups in terms of patient’ sex (p=0.497), age (p=0.305), laterality (p=0.4), diagnosis of diabetes (p=0.985) or thyroid dysfunction (p=0.657). Treatment efficacy There were significant improvements in all planes of motion and all recorded patient reported outcome measure (PROM) scores in each of the studied groups from baseline to final follow-up (Table 1, Appendix B). The HIS group achieved a minimum of 95% of con- tralateral shoulder ROM in all planes by final follow- up. Combination therapy achieved a minimum of 92% while PT alone achieved minimum of 82% of contralat- eral motion (Table 2). All patients in the HIS and PT+ HIS groups reached MCID for ASES, while 75% of patients in PT group achieved similar improvement. All patients in the HIS and PT+ HIS device groups reached MCID for SST compared to 88% of patients in the PT group. | Rate of improvement HIS device overperformed PT in abduction as early as in 3 months (p=0.04), 6 months (p=0.028), and fnal follow up (p=0.003 for HIS device alone, Fig. 3, Appen- dix C). Moreover, HIS device showed signifcantly larger improvement in SST score (p=0.045) and ASES Total score (p=0.048) at 6 months when compared to PT (Fig. 4, Appendix D). Compliance and satisfaction Compliance, satisfaction, and convenience with the HIS device was recorded via patient questionnaire. Compli- ance was self-reported, with 67% (HIS device group) and 85% (HIS device group+PT) of patients reported using HIS-device exactly as prescribed or more, respectively. Remaining 33% of HIS device group patients and 14% HIS device+PT group patients used HIS device less than prescribed. Patients reported greater satisfaction (100% very satisfed in HIS device, 57% very satisfed and 43% satisfed in HIS device+PT) and convenience (92% very convenient and 8% convenient with HIS device com- pared to 71% very convenient and 29% convenient with HIS device+PT) of treatment plan with HIS device alone |
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| versus in combination with in-person physical therapy. Te majority of patients reported comfort and ease of the HIS device (95% found HIS device easy to use, 84% found it comfortable, and 95% easy to perform repeti- tions) and 95% patients reported that HIS served as an efective means to restore ROM, and 100% was satisfed with improvement in shoulder motion. Tree patients (30%) in the PT group required addi- tional injection beyond 6 months follow-up compared to no patients in the HIS group and only 1 patient (9%) in the combination group. Discussion Adhesive capsulitis of the shoulder is a painful and disa- bling disease. Although physical therapy alone can be efective [3, 9, 10], it can be associated with substantial fnancial cost and time burden [16]. As patients using the HIS device had increased rate of recovery and decreased levels of pain, they are likely able to return to work faster, as well as require fewer follow-up clinician visits and pro- cedures. Terefore, efective treatment of patients with AC using an at-home HIS device could result in signif- cant savings for the healthcare system and for patients. Te HIS device evaluated in this study presents a viable | alternative to PT when PT is unavailable, which may facilitate greater patient compliance and better outcomes. Tis study showed that patients using a HIS device to treat AC may achieve better motion than patients enrolled in traditional PT (Fig. 3) to nearing motion seen in the unafected contralateral shoulder. Additionally, a higher percentage of patients using the HIS device met ASES and SST MCID thresholds than patients treated with PT alone. Furthermore, neither traditional PT nor combination therapy proved to be signifcantly better than the HIS device in any reported outcomes. Although not specifcally studied here, we suspect that compliance with HIS device use may be a factor explaining this fnd- ing. As the HIS device is set up in the patient’s home, patients may fnd it easier to use the device and complete their prescribed treatment time. During the course of this study, the COVID-19 epidemic was an additional factor that may have limited patient’s ability to maintain a con- sistent therapy regimen, as refected by large withdraw- als from the study by patients in both PT and HIS+PT groups. Te efectiveness of static stretching devices has been established in the literature for extremities other than the shoulder [29–31]. It has been theorized that prolonged, |
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| static stretching leads to permanent, progressive elon- gation of collagen fbers present in the infammatory reactive tissues that cause the contracture inherent to adhesive capsulitis [32, 33]. Very few studies have evalu- ated a HIS device for primary non-operative treatment of AC. Te results of the current paper are supported by Ibrahim et al., who evaluated the use of a static pro- gressive stretch device coupled with physical therapy in the treatment of AC [17]. Tis prospective, randomized controlled trial consisted of 60 patients with a mean fol- low-up of 1 year. Patients were randomized to traditional physical therapy or both traditional physical therapy and a static stretching device concurrently. At fnal follow- up, the authors found a signifcantly greater increase in all ROM scores in the combination group compared to the PT alone group. Additionally, VAS pain scores were signifcantly lower in the combination group. Te authors concluded that a static stretching device should be added to traditional PT in the treatment of AC. Te results of our study also found greater fnal ROM meas- urements in the combined group compared to the tradi- tional PT group. Te current study difers from Ibrahim et al.‘s in that we included a group who used the HIS | device without PT, which allowed the direct comparison between the HIS device and PT. We found greater aver- age improvements after 6 weeks in FF, abduction, ER, SST scores, and ASES Pain, Function and Total scores in the HIS device compared to the PT group. In addition to loss of motion, adhesive capsulitis is known to be a signifcantly painful condition. Corticos- teroid injection is a common means of pain control for AC and was provided to all patients at the initial visit. 30% of patients in the PT group required additional injection beyond 6 months follow-up compared to no patients in the HIS group and only 1 patient in the com- bination group. Patients in the HIS device and combina- tion groups showed better maintenance of pain control even at 6 months, in comparison to the PT only group. Tese results may in turn also explain the improved maintenance of range of motion in the HIS device and combination groups in comparison to the PT only group, however, larger cohort would be needed to fully evaluate all confounding efects. Tis study does have several limitations. First, some early participants in the study did not have complete follow-up due to COVID-19 related protocol deviations |
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| (particularly occurring for patients randomized to PT group (n=7) and combined HIS device and PT groups (n=7)) and were withdrawn from the study. Despite being blinded before randomization, the treating surgeon was aware of the randomized group at follow-up visits. Tis was done to ensure and record compliance with assigned treatments. Conclusion In this randomized controlled trial, it was found that the HIS stretch device studied was as good or better in every outcome recorded, including ROM (FF, ER, Abd, and IR), ASES, and SST when compared to PT alone or in combi- nation with PT. Te at-home HIS device studied may be an option for frst-line therapy in treating patients diag- nosed with adhesive capsulitis. Supplementary Information The online version contains supplementary material available at https://doi. org/10.1186/s12891-024-07448-4. Supplementary Material 1. Supplementary Material 2. Supplementary Material 3. Supplementary Material 4. Acknowledgements Authors would like to acknowledge the contributions and support of research staf Viktoria Sochor and Layanne Nayfeh. Authors’ contributions Protocol establishment: N.K., C.B., P.S., D.W.. Data collection entry, assessment, recoding, and analysis: D.E.T., D.W., N.K., C.B.. Preparation of manuscript and editing: ALL. Commentary and revisions of manuscript for pertinent content: C.D., S.N., P.S.. Final review of manuscript in preparation for submission: D.E.T., C.D., S.N., N.K. C.B.. Manuscript formatting and submission: C.D., S.N.. Figure preparation: C.D., S.N.. Funding Funding for this study was provided by Ermi, LLC. Availability of data and materials The datasets used and analyzed during the current study are not publicly available due to lack of participant consent to share their data but are avail- able from the corresponding author upon reasonable request and after ethical considerations are met. Declarations Ethics approval and consent to participate Informed written consent for patients was obtained for this study prior to enrollment. Ethical approval was obtained from the WCG Institutional Review Board (tracking number: 20191446, Report ID: 1970877). Consent for publication Not applicable. Competing interests The authors declare no competing interests. | Author details 1 Foundation for Orthopaedic Research and Education, Tampa, FL, USA. 2 Florida Orthopaedic Institute, 13020 Telecom Parkway North, Temple Ter- race, Tampa, FL 33637, USA. 3 Department of Medical Engineering, College of Engineering and Morsani College of Medicine, University of South Florida, Tampa, FL, USA. Received: 25 September 2023 Accepted: 16 April 2024 References 1. Bunker TD. Frozen shoulder: unravelling the enigma. Ann R Coll Surg Engl. 1997;79(3):210–3. 2. Hsu JE, Anakwenze OA, Warrender WJ, Abboud JA. Current review of adhesive capsulitis. J Shoulder Elb Surg. 2011;20(3):502–14. 3. 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