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Progressive early passive and active exercise therapy after surgical rotator cuff repair - study protocol for a randomized controlled trial (the CUT-N-MOVE trial).

ABSTRACT: BACKGROUND:Rotator cuff tear is a common cause of shoulder disability and results in patients predominantly complaining of pain and loss of motion and strength. Traumatic rotator cuff tears are typically managed surgically followed by ~?20 weeks of rehabilitation. However, the timing and intensity of the postoperative rehabilitation strategy required to reach an optimal clinical outcome is unknown. Early controlled and gradually increased tendon loading has been suggested to positively influence tendon healing and recovery. The aim of this trial is therefore to examine the effect of a progressive rehabilitation strategy on pain, physical function and quality of life compared to usual care (that limits tendon loading in the early postoperative phase) in patients who have a rotator cuff repair of a traumatic tear. METHODS:The current study is a randomized, controlled, outcome-assessor blinded, multicenter, superiority trial with a two-group paralleled design. A total of 100 patients with surgically repaired traumatic rotator cuff tears will be recruited from up to three orthopedic departments in Denmark, and randomized to either a progressive early passive and active movement program or a limited early passive movement program (usual care). The primary outcome measure will be the change from pre-surgery to 12 weeks post-surgery in the Western Ontario Rotator Cuff Index questionnaire. Secondary outcomes include the Disabilities Arm, Shoulder and Hand questionnaire (DASH), range of motion, strength and tendon healing characteristics from ultrasound measurements at 12 months follow up. DISCUSSION:We hypothesized that patients who receive the progressive rehabilitation strategy will benefit more with respect to pain reduction, physical function and quality of life than those who receive care as usual. If this is confirmed our study can be used clinically to enhance the recovery of patients with traumatic rotator cuff tear. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02969135 . Registered on 15 November 2016.

SUBMITTER: Kjær BH

PROVIDER: S-EPMC6122575 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Progressive early passive and active exercise therapy after surgical rotator cuff repair - study protocol for a randomized controlled trial (the CUT-N-MOVE trial).

Kjær Birgitte Hougs BH Magnusson S Peter SP Warming Susan S Henriksen Marius M Krogsgaard Michael Rindom MR Juul-Kristensen Birgit B

Trials 20180903 1

<h4>Background</h4>Rotator cuff tear is a common cause of shoulder disability and results in patients predominantly complaining of pain and loss of motion and strength. Traumatic rotator cuff tears are typically managed surgically followed by ~ 20 weeks of rehabilitation. However, the timing and intensity of the postoperative rehabilitation strategy required to reach an optimal clinical outcome is unknown. Early controlled and gradually increased tendon loading has been suggested to positively i ...[more]

PMID: 30176943

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Project description:Purpose To compare patient-reported and surgical outcome measures in patients with and without secondary shoulder stiffness (SSS) undergoing rotator cuff repair (RCR). Methods Patients 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. Results A 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. Conclusions Operative 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 Evidence Level III retrospective comparative study.

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.

Dataset Information

Progressive early passive and active exercise therapy after surgical rotator cuff repair - study protocol for a randomized controlled trial (the CUT-N-MOVE trial).

Publications

Progressive early passive and active exercise therapy after surgical rotator cuff repair - study protocol for a randomized controlled trial (the CUT-N-MOVE trial).

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