scholarly journals Motor Imagery to Facilitate Sensorimotor Re-Learning (MOTIFS) after traumatic knee injury: study protocol for an adaptive randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Niklas Cederström ◽  
Simon Granér ◽  
Gustav Nilsson ◽  
Rickard Dahan ◽  
Eva Ageberg
Keyword(s):  
Muscle Function ◽  
Psychological Factors ◽  
Patient Reported Outcomes ◽  
Knee Injury ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Psychological Training ◽  
Patient Reported ◽  
Return To Activity

Abstract Background Treatment following traumatic knee injury includes neuromuscular training, with or without surgical reconstruction. The aim of rehabilitation is to restore muscle function and address psychological factors to allow a return to activity. Attention is often on rehabilitation of knee function, but deficiencies often persist. Specific interventions addressing psychological factors are sparing with varying degrees of success. We have developed a novel training program, MOTor Imagery to Facilitate Sensorimotor Re-Learning (MOTIFS), which integrates simultaneous psychological training into physical rehabilitation exercises. The MOTIFS model individualizes rehabilitation to increase central nervous system involvement by creating realistic and relevant mental images based on past experiences. We hypothesize that a 12-week MOTIFS training intervention will improve psychological readiness to return to activity and muscle function to a greater extent than current neuromuscular training (Care-as-Usual). Methods This pragmatic 1:1 single assessor-blinded adaptive cumulative cluster-randomized controlled trial will include 106 knee-injured people with a goal of returning to physical activity. Participants are randomized to either the MOTIFS or Care-as-Usual condition. Primary outcomes are the ACL Return to Sport after Injury Scale and change in injured leg hop performance in a side hop task from baseline to 12 weeks. Secondary outcomes include patient-reported outcomes and assessment of muscle function using a hop test battery and Postural Orientation Errors at 12-week follow-up. At 12-month follow-up, patient-reported outcomes are assessed. A sub-group (7-10 in each group) will be interviewed to gain insight into experiences of rehabilitation. Discussion Strengths of this trial include that it is a randomized and pragmatic trial examining commonly under-studied aspects of rehabilitation following a knee injury. The model uses the patient as a reference, creating simultaneous psychological and physical training exercises with easily adopted principles for clinical practice. Limitations include that blinding is limited due to study design, and shifting the clinical paradigm to a more holistic model is a challenge. If successful, the MOTIFS model has implications for a clinically useful, individualized, and patient-relevant method of improving rehabilitation outcomes by integrating psychological training into physical training. Trial registration ClinicalTrials.gov NCT03473821. Registered March 22, 2018, with ethical approval that has been granted (Dnr 2016/413, Dnr 2018/927). Trial status Trial Status: Protocol Version is 2020, Dec 10 – Version 1

scholarly journals Non- or Minimally Displaced Distal Radial Fractures in Adult Patients: Three Weeks versus Five Weeks of Cast Immobilization—A Randomized Controlled Trial

2018 ◽  
Vol 08 (01) ◽  
pp. 043-048 ◽  
Author(s):  
A. Bentohami ◽  
J. Vermeulen ◽  
N. L. Sosef ◽  
N. de Korte ◽  
T. S. Bijlsma ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Reported Outcomes ◽  
Controlled Trial ◽  
Adult Patients ◽  
Cast Immobilization ◽  
Distal Radial Fractures ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Secondary Displacement

Background Patients with non- or minimally displaced distal radial fractures, that do not need repositioning, are mostly treated by a short-arm cast for a period of 4 to 6 weeks. A shorter period of immobilization may lead to a better functional outcome. Purpose We conducted a randomized controlled trial to evaluate whether the duration of cast immobilization for patients with non- or minimally displaced distal radial fractures can be safely shortened toward 3 weeks. Materials and Methods The primary outcomes were patient-reported outcomes measured by the Patient-Related Wrist Evaluation (PRWE) and Quick Disability of Arm, Shoulder and Hand (QuickDASH) score after 1-year follow-up. Secondary outcome measures were: PRWE and QuickDASH earlier in follow-up, pain (Visual Analog Scale), and complications like secondary displacement. Results Seventy-two patients (male/female, 23/49; median age, 55 years) were included and randomized. Sixty-five patients completed the 1-year follow-up. After 1-year follow up, patients in the 3 weeks immobilization group had significantly better PRWE (5.0 vs. 8.8 points, p = 0.045) and QuickDASH scores (0.0 vs. 12.5, p = 0.026). Secondary displacement occurred once in each group. Pain did not differ between groups (p = 0.46). Conclusion Shortening the period of immobilization in adult patients with a non- or minimally displaced distal radial fractures seems to lead to equal patient-reported outcomes for both the cast immobilization groups. Also, there are no negative side effects of a shorter period of cast immobilization. Therefore, we recommend a period of 3 weeks of immobilization in patients with distal radial fractures that do not need repositioning.

scholarly journals Two-year results of a multi-centre, randomized controlled trial comparing a second-generation uncemented trabecular metal-backed versus cemented polyethylene glenoid component in total shoulder arthroplasty

2021 ◽  
Vol 2 (9) ◽  
pp. 728-736
Author(s):  
Patrick Y. K. Chin ◽  
William D. Regan ◽  
Derek Plausinis ◽  
Zane D. Zarzour ◽  
Fay Leung ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Second Generation ◽  
Controlled Trial ◽  
Total Shoulder Arthroplasty ◽  
Glenoid Component ◽  
Trabecular Metal ◽  
Metal Debris ◽  
Randomized Controlled ◽  
Patient Reported

Aims To report early (two-year) postoperative findings from a randomized controlled trial (RCT) investigating disease-specific quality of life (QOL), clinical, patient-reported, and radiological outcomes in patients undergoing a total shoulder arthroplasty (TSA) with a second-generation uncemented trabecular metal (TM) glenoid versus a cemented polyethylene glenoid (POLY) component. Methods Five fellowship-trained surgeons from three centres participated. Patients aged between 18 and 79 years with a primary diagnosis of glenohumeral osteoarthritis were screened for eligibility. Patients were randomized intraoperatively to either a TM or POLY glenoid component. Study intervals were: baseline, six weeks, six-, 12-, and 24 months postoperatively. The primary outcome was the Western Ontario Osteoarthritis Shoulder QOL score. Radiological images were reviewed for metal debris. Mixed effects repeated measures analysis of variance for within and between group comparisons were performed. Results A total of 93 patients were randomized (46 TM; 47 POLY). No significant or clinically important differences were found with patient-reported outcomes at 24-month follow-up. Regarding the glenoid components, there were no complications or revision surgeries in either group. Grade 1 metal debris was observed in three (6.5%) patients with TM glenoids at 24 months but outcomes were not negatively impacted. Conclusion Early results from this RCT showed no differences in disease-specific QOL, radiographs, complication rates, or shoulder function between uncemented second-generation TM and cemented POLY glenoids at 24 months postoperatively. Revision surgeries and reoperations were reported in both groups, but none attributed to glenoid implant failure. At 24 months postoperatively, Grade 1 metal debris was found in 6.5% of patients with a TM glenoid but did not negatively influence patient-reported outcomes. Longer-term follow-up is needed and is underway. Cite this article: Bone Jt Open 2021;2(9):728–736.

No Difference in Outcomes Following Osteochondral Allograft with Fresh Precut Cores Compared to Hemi-Condylar Allografts

Cartilage ◽  
2021 ◽  
pp. 194760352110219
Author(s):  
Danielle H. Markus ◽  
Anna M. Blaeser ◽  
Eoghan T. Hurley ◽  
Brian J. Mannino ◽  
Kirk A. Campbell ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Knee Injury ◽  
Lesion Size ◽  
Osteochondral Allograft ◽  
Osteochondral Lesions ◽  
Radiographic Outcomes ◽  
Significant Difference ◽  
Patient Reported ◽  
The Mean

Objective The purpose of the current study is to evaluate the clinical and radiographic outcomes at early to midterm follow-up between fresh precut cores versus hemi-condylar osteochondral allograft (OCAs) in the treatment of symptomatic osteochondral lesions. Design A retrospective review of patients who underwent an OCA was performed. Patient matching between those with OCA harvested from an allograft condyle/patella or a fresh precut allograft core was performed to generate 2 comparable groups. The cartilage at the graft site was assessed with use of a modified Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system and patient-reported outcomes were collected. Results Overall, 52 total patients who underwent OCA with either fresh precut OCA cores ( n = 26) and hemi-condylar OCA ( n = 26) were pair matched at a mean follow-up of 34.0 months (range 12 months to 99 months). The mean ages were 31.5 ± 10.7 for fresh precut cores and 30.9 ± 9.8 for hemi-condylar ( P = 0.673). Males accounted for 36.4% of the overall cohort, and the mean lesion size for fresh precut OCA core was 19.6 mm2 compared to 21.2 mm2 for whole condyle ( P = 0.178). There was no significant difference in patient-reported outcomes including Visual Analogue Scale, Knee Injury and Osteoarthritis Outcome Score for Joint Replacement, and Tegner ( P > 0.5 for each), or in MOCART score (69.2 vs. 68.3, P = 0.93). Conclusions This study found that there was no difference in patient-reported clinical outcomes or MOCART scores following OCA implantation using fresh precut OCA cores or size matched condylar grafts at early to midterm follow-up.

scholarly journals Treatment of osteoarthritis with autologous, micro-fragmented adipose tissue: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rasmus Kramer Mikkelsen ◽  
Lars Blønd ◽  
Lisbeth Rosenkrantz Hölmich ◽  
Cecilie Mølgaard ◽  
Anders Troelsen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adipose Tissue ◽  
Knee Injury ◽  
Primary Outcome ◽  
Morphological Changes ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Outcome Score ◽  
Patient Reported

Abstract Background Osteoarthritis is a destructive joint disease that leads to degeneration of cartilage and other morphological changes in the joint. No medical treatment currently exists that can reverse these morphological changes. Intra-articular injection with autologous, micro-fragmented adipose tissue has been suggested to relieve symptoms. Methods/Design The study is a blinded randomized controlled trial with patients allocated in a 1:1 ratio to 2 parallel groups. Patients suffering from pain and functional impairment due to osteoarthritis Kellgren-Lawrence grades 2–3 in the tibiofemoral joint are eligible for inclusion. The intervention group is treated with an intra-articular injection with autologous, micro-fragmented adipose tissue prepared using the Lipogems® system. The control group receives an intra-articular injection with isotonic saline. In total, 120 patients are to be included. The primary outcome is The Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months. Secondary outcomes are KOOS at 3, 12 and 24 months; the Tegner activity score; treatment failure; and work status of the patient. The analysis will be conducted both as intention-to-treat and per-protocol analysis. Discussion This trial is the first to investigate the efficacy of autologous, micro-fragmented adipose tissue in a randomized controlled trial. The study uses the patient-reported outcome measure Knee Injury and Osteoarthritis Outcome Score (KOOS4) after 6 months as the primary outcome, as it is believed to be a valid measure to assess the patient’s opinion about their knee and associated problems when suffering from osteoarthritis.

scholarly journals The Effect of Physical Exercise Training on Neck and Shoulder Muscle Function Among Military Helicopter Pilots and Crew: A Secondary Analysis of a Randomized Controlled Trial

2020 ◽  
Vol 8 ◽  
Author(s):  
Mike Murray ◽  
Britt Lange ◽  
Karen Søgaard ◽  
Gisela Sjøgaard
Keyword(s):  
Exercise Training ◽  
Physical Exercise ◽  
Muscle Function ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Shoulder Muscle ◽  
Physical Exercise Training ◽  
Helicopter Pilots ◽  
Shoulder Elevation

Introduction: This study presents secondary outcome analyses, in terms of muscle function [i.e., maximal voluntary contraction (MVC) and rate of torque development (RTD)] from a parallel group, single blinded, randomized controlled trial introducing a physical exercise training intervention aiming to reduce neck pain among military helicopter pilots and crew-members.Methods: Participants (50 pilots, 58 crew-members) were recruited from the Royal Danish Air Force and randomized to either an exercise-training-group (ETG; n = 35) or a reference-group (REF; n = 34). Participants in ETG received 20 weeks of self-administered exercise training specifically tailored to target the neck and shoulder muscles. REF received no training. Outcome: (1) MVC was measured for cervical extension and flexion as well as shoulder elevation and abduction, (2) RTD was measured for cervical extension and flexion. Adherence to training was self-reported and categorized as regular if performed at least once a week.Results: MVC for cervical extension was significantly increased at follow-up in ETG (37.5 ± 11.2 Nm at baseline, change: 2.1 ± 8.3 Nm) compared to REF (38.1 ± 10.7 Nm at baseline, change: −2.4 ± 6.8 Nm) according to intension-to-treat analysis (p = 0.018). Likewise, RTD was significantly increased in ETG for cervical extension (149.6 ± 63.3 Nm/s at baseline, change: 14.7 ± 49.0 Nm/s) compared to REF (165.4 ± 84.7 Nm/s at baseline, change: −16.9±70.9 Nm/s) (p = 0.034). The cervical extension/flexion MVC-ratio was significantly different at follow-up (p = 0.039) between ETG (1.5 ± 0.5 at baseline, change: −0.0 ± 0.3) compared to REF (1.5 ± 0.5 at baseline, change: −0.2 ± 0.4). Per-protocol analysis of MVC, including only participants in ETG with regular training adherence (n = 10), showed a significant increase for cervical extension (33.2 ± 7.3 Nm at baseline, change: 6.0 ± 5.4 Nm) and shoulder elevation right side (143.0 ± 25.8 Nm at baseline, change: 15.8 ± 18.1 Nm).Conclusion: Physical exercise training significantly improved MVC and RTD in the upper neck extensors. Only approximately 1/3 of participants in ETG adhered to training regularly, which likely attenuated the effectiveness of the training intervention on neck and shoulder muscle function. Future studies should focus on the practical implementation of self-administered exercise training to improve adherence.

Sign in / Sign up

Export Citation Format

Share Document