Dataset Information

Post-operative rehabilitation using a digital healthcare system in patients who had undergone rotator cuff repair: protocol for a single-center randomized controlled trial.

ABSTRACT:

Background

Operative repair of a rotator cuff tear requires up to 12 weeks of post-operative (post-op) home-based rehabilitation. Maintaining patients' compliance in the post-op rehabilitation program is a pivotal component for generating successful outcomes. By developing a post-op rehabilitation-oriented digital healthcare system and applying it in patients who had undergone rotator cuff repair, we aim to increase the efficacy of the rehabilitation program and raise patients' compliance levels. Here, we present a protocol developed for comparing the efficacy of rehabilitation using a newly developed augmented reality (AR)-based digital healthcare system with that of conventional rehabilitation for post-op rehabilitation of rotator cuff repair.

Methods

This study will recruit a total of 115 patients who had undergone rotator cuff repair within 3 days after surgery. Patients will be randomly allocated to rehabilitation using an AR-based digital healthcare system (digital group) or conventional rehabilitation (conventional group). Patients in both groups will perform brochure-based exercises from the immediate post-op period to post-op 6 weeks. From post-op 6 weeks to 12 weeks, patients in the digital group will use the AR-based system for post-op exercises, whereas patients in the conventional group will continue brochure-based rehabilitation exercises. The primary outcome will be scores on the Simple Shoulder Test at post-op 12 weeks. Secondary outcomes include numeric rating scale scores for pain, measures of range of motion and muscle strength of the affected shoulder, grip strength of the affected arm, scores on the Disabilities of the Arm, Shoulder and Hand test, the Shoulder Pain and Disability Index, and the EuroQoL-5D-5L quality-of-life measure. Analyses will be conducted using an intention-to-treat approach.

Discussion

This study will examine the effectiveness of an AR-based digital healthcare system for post-op rehabilitation in the patients after rotator cuff repair. The study will add evidence for the application of digital healthcare systems in post-op rehabilitation.

Trial registration

ClinicalTrials.gov NCT04511377. Registered on 10 August 2020.

SUBMITTER: Chang WK

PROVIDER: S-EPMC9386934 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Post-operative rehabilitation using a digital healthcare system in patients who had undergone rotator cuff repair: protocol for a single-center randomized controlled trial.

Chang Won Kee WK Lee Jong In JI Hwang Ji Hye JH Lim Jae-Young JY

Trials 20220817 1

<h4>Background</h4>Operative repair of a rotator cuff tear requires up to 12 weeks of post-operative (post-op) home-based rehabilitation. Maintaining patients' compliance in the post-op rehabilitation program is a pivotal component for generating successful outcomes. By developing a post-op rehabilitation-oriented digital healthcare system and applying it in patients who had undergone rotator cuff repair, we aim to increase the efficacy of the rehabilitation program and raise patients' complianc ...[more]

PMID: 35978437

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Project description:BackgroundThe use of opioid analgesia is common in both the acute and extended post-operative periods after rotator cuff repair. The current opioid crisis has prompted surgeons to seek alternatives that minimize or even eliminate the need for oral opioids after surgery.Questions/purposesWe sought to investigate the effects on post-operative opioid use of a surgeon-administered block of the suprascapular and axillary nerves in arthroscopic rotator cuff repair (ARCR), in particular to quantify outpatient opioid consumption and duration.MethodsIn this prospective observational study, all patients undergoing primary ARCR performed under general anesthesia by a single surgeon were studied over a 15-month period. Of 91 ARCRs performed, 87 patients were enrolled and followed prospectively. At the conclusion of the procedure, the surgeon performed "local-regional" nerve blockade with injections to the sensory branches of the suprascapular nerve and the axillary nerve, as well as local infiltration about the shoulder. Use of medications in the post-anesthesia care unit was left up to the anesthesiologist. Patients were prescribed oral opioids (hydrocodone/acetaminophen 5/325 mg) for analgesia after discharge. The quantity and duration of opioid use and pain scores were recorded for 4 months. Statistical analysis was performed to evaluate factors that could account for greater opioid use.ResultsTotal opioid consumption ranged from 0 to 30 opioid tablets (average, 4.2 tablets) over the 4-month period. Post-operatively, 91% of patients took between ten or fewer tablets, and 39% took no opioids. The average duration of opioid use was 2.4 days. No patients were taking opioids at the 4- to 6-week or 4-month follow-up visits, none required refills, and none received prescriptions from outside prescribers. No statistically significant differences were seen in opioids taken or duration of use in regard to tear size, sex, body mass index, surgery location, or procedure time. There was a significant inverse correlation between opioid use and age. In addition, the cost of the surgeon-performed procedure was substantially lower than that associated with pre-operative nerve blockade performed by an anesthesiologist. All patients were satisfied with the post-operative pain management protocol. Average reported post-operative pain scores were low and decreased at each visit.ConclusionWith this local-regional nerve-blocking protocol, opioid use after ARCR was unexpectedly low, and a large proportion of patients recovered without any post-surgical opioids. The correlation seen between opioid use and age may not be clinically significant, given the low use of post-operative opioids overall. These results may be useful in guiding post-operative opioid prescribing after ARCR, as well as in lowering costs associated with ARCR.

Project description:Introduction: Post-operative rehabilitation following rotator cuff tear repair (RCR) is important to promote tendon healing, restore strength, and recover normal function. Aquatic therapy in hot water allows body relaxation, which promotes patient conditioning for efficient rehabilitation. The aim of this study was to assess whether aquatic therapy is more efficient than standard (land-based) rehabilitation in terms of range of motion (ROM), function, and pain after arthroscopic RCR. Methods: We prospectively randomized 86 patients scheduled for arthroscopic RCR to either aquatic therapy (n = 44) or standard rehabilitation (n = 42) using block sizes of four or six. Patients were evaluated clinically at 1.5, 3, 6, and 24 months and using ultrasound (US) at 6 months. Two-way mixed ANOVA tests were performed to evaluate the effects of rehabilitation type (between-subjects factor) on ROM and patient reported outcome measures (PROMs) over time (within-subjects factor). Post-hoc inter-group comparisons at each time point were also conducted using Wilcoxon rank sum tests or unpaired Student t-tests and adjusted for multiple comparisons using the Bonferroni correction. Results: The two groups did not differ significantly in terms of demographic data or pre-operative characteristics, except for the Single Assessment Numeric Evaluation (SANE) score, which was lower in the aquatic therapy group (37.9 ± 23.6 vs. 55.6 ± 24.9, p = 0.019). The mixed model revealed the absence of interaction effect between the type of rehabilitation and time on PROMs and ROM except on the SANE score (p < 0.001), which was biased by the existing pre-operative difference mentioned above. Furthermore, none of the post-operative outcomes were statistically different between the two groups at 1.5, 3, 6, and 24 months. In addition, no significant difference could be noted regarding tendon healing rate (p = 0.443), complication (p = 0.349), workstop duration (0.585), or patient satisfaction (p = 0.663). Conclusion: Compared to the standard rehabilitation, the aquatic therapy did not yield superior clinical and functional outcomes after arthroscopic RCR when started immediately after the surgery.

Project description:PurposeTo compare patient-reported and surgical outcome measures in patients with and without secondary shoulder stiffness (SSS) undergoing rotator cuff repair (RCR).MethodsPatients undergoing rotator cuff repair from 2014 to 2020 with complete patient-reported outcome measures (PROMs) by the short-form 12 survey (SF-12) were retrospectively reviewed to identify if operative intervention for SSS was performed alongside the RCR. Those patients with operative intervention for SSS were propensity matched to a group without prior intervention for stiffness by age, sex, laterality, body mass index, diabetes mellitus status, and the presence of a thyroid disorder. The groups were compared by rotator cuff tear (RCT) size, surgical outcomes, further surgical intervention, rotator cuff retear rate, postoperative range of motion (ROM), and SF-12 results at 1 year after surgery. Delta values were calculated for component scores of the SF-12 and ROM values by subtracting the preoperative result from the postoperative result.ResultsA total of 89 patients with SSS were compared to 156 patients in the control group at final analysis. The patients in the SSS group experienced a significant improvement in the delta mental health component score (MCS-12) of the SF-12 survey that was not seen in the control group (P = .005 to P = .539). Both groups experienced significant improvement by the delta physical health component score (PCS-12) of the SF-12 survey (SSS: 7.68; P < .001; control: 6.95; P < .001). The SSS group also experienced greater improvement of their forward flexion (25.8° vs 12.9°; P = .005) and external rotation (7.13° vs 1.65°; P = .031) ROM than the control group.ConclusionsOperative intervention of SSS at the time of RCR has equivalent postoperative SF-12 survey outcome scores when compared to patients undergoing RCR without preoperative stiffness despite those patients having lower preoperative scores.Level of evidenceLevel III retrospective comparative study.

Dataset Information

Post-operative rehabilitation using a digital healthcare system in patients who had undergone rotator cuff repair: protocol for a single-center randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Post-operative rehabilitation using a digital healthcare system in patients who had undergone rotator cuff repair: protocol for a single-center randomized controlled trial.

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