Effect of a specific exercise programme during pregnancy on diastasis recti abdominis: study protocol for a randomised controlled trial

Introduction: Diastasis recti abdominis (DRA) is a common condition in pregnant and postpartum women. Evidence for the treatment of DRA is both sparse and weak. As this condition occurs during the last two trimesters of pregnancy and there is a paucity of high-quality studies on a pregnant population, we will conduct a randomised trial on the effect of a specific exercise programme during pregnancy on DRA. Methods and analysis: This is an exploratory, assessor-blinded, randomised parallel group trial carried out in a primary healthcare setting in a Norwegian city. 100 pregnant women, both primigravida and multigravida, in gestation week 24 presenting with DRA of ≥28 mm will be included. Participants will be allocated to either an intervention group or a control group by block randomisation. The intervention group will participate in a 12-week specific exercise programme. The control group will not participate in any exercise intervention. Data collection will take place prior to intervention, postintervention at gestation week 37, and 6 weeks, 6 and 12 months postpartum. The primary outcome measure will be change in the inter-recti distance, measured by two-dimensional ultrasonography. Data will be analysed and presented in accordance with international Consolidated Standards of Reporting Trials guidelines and analysed according to the intention-to-treat principle. Ethics and dissemination: Ethical approval has been obtained by the regional ethical committee (76296), and all procedures will be performed in adherence to the Helsinki declaration. The study has been registered with ClinicalTrials.gov. Results from this study will be presented at scientific conferences and in peer-reviewed scientific journals.publishedVersio

Effectiveness of Low-Level Laser Therapy Associated with Strength Training in Knee Osteoarthritis: Protocol for a Randomized Placebo-Controlled Trial

Physical activity and low-level laser therapy (LLLT) can reduce knee osteoarthritis (KOA) inflammation. We are conducting a randomized placebo-controlled trial to investigate the long-term effectiveness of LLLT combined with strength training (ST) in persons with KOA, since it, to our knowledge, has not been investigated before. Fifty participants were enrolled. LLLT and ST was performed 3 times per week over 3 and 8 weeks, respectively. In the LLLT group, 3 Joules of 904 nm wavelength laser was applied to 15 spots per knee (45 Joules/knee/session). The primary outcomes are pain during movement, at night and at rest (Visual Analogue Scale) and global pain (Knee injury and Osteoarthritis Outcome Score, KOOS) pain subscale. The secondary outcomes are KOOS disability and quality-of-life, analgesic usage, global health change, knee active range of motion, 30 s chair stand, maximum painless isometric knee extension strength, knee pain pressure threshold and real-time ultrasonography-assessed suprapatellar effusion, meniscal neovascularization and femur cartilage thickness. All the outcomes are assessed 0, 3, 8, 26 and 52 weeks post-randomization, except for global health change, which is only evaluated at completed ST. This study features the blinding of participants, assessors and therapists, and will improve our understanding of what occurs with the local pathophysiology, tissue morphology and clinical status of persons with KOA up to a year after the initiation of ST and a higher 904 nm LLLT dose than in any published trial on this topic.publishedVersio

Short-and Long-Term Effectiveness of Low-Level Laser Therapy Combined with Strength Training in Knee Osteoarthritis: A Randomized Placebo-Controlled Trial

Background: Both physical activity and low-level laser therapy (LLLT) can reduce knee osteoarthritis (KOA) inflammation. We conducted a randomized clinical trial to investigate the short- and long-term effectiveness of LLLT combined with strength training in persons with KOA. Methods: Fifty participants were randomly divided in two groups, one with LLLT plus strength training (n = 26) and one with placebo LLLT plus strength training (n = 24). LLLT and strength training were performed triweekly for 3 and 8 weeks, respectively. In the laser group, 3 joules 904 nm wavelength laser was applied to fifteen points (45 joules) per knee per session. Patient-reported outcomes, physical tests, and ultrasonography assessments were performed at baseline and 3, 8, 26, and 52 weeks after initial LLLT or placebo therapy. The primary outcomes were pain on movement, at rest, at night (Visual Analogue Scale), and globally (Knee injury and Osteoarthritis Outcome Score (KOOS) subscale). Parametric data were assessed with analysis of variance using Šidák’s correction. Results: There were no significant between-group differences in the primary outcomes. However, in the laser group there was a significantly reduced number of participants using analgesic and non-steroidal anti-inflammatory drugs and increased performance in the sit-to-stand test versus placebo-control at week 52. The joint line pain pressure threshold (PPT) improved more in the placebo group than in the laser group, but only significantly at week 8. No other significant treatment effects were present. However, pain on movement and joint line PPT were worse in the placebo group at baseline, and therefore, it had more room for improvement. The short-term percentage of improvement in the placebo group was much higher than in similar trials. Conclusions: Pain was reduced substantially in both groups. LLLT seemed to provide a positive add-on effect in the follow-up period in terms of reduced pain medication usage and increased performance in the sit-to-stand test.publishedVersio

Effect of a specific exercise programme during pregnancy on diastasis recti abdominis: study protocol for a randomised controlled trial

Introduction: Diastasis recti abdominis (DRA) is a common condition in pregnant and postpartum women. Evidence for the treatment of DRA is both sparse and weak. As this condition occurs during the last two trimesters of pregnancy and there is a paucity of high-quality studies on a pregnant population, we will conduct a randomised trial on the effect of a specific exercise programme during pregnancy on DRA. Methods and analysis: This is an exploratory, assessor-blinded, randomised parallel group trial carried out in a primary healthcare setting in a Norwegian city. 100 pregnant women, both primigravida and multigravida, in gestation week 24 presenting with DRA of ≥28 mm will be included. Participants will be allocated to either an intervention group or a control group by block randomisation. The intervention group will participate in a 12-week specific exercise programme. The control group will not participate in any exercise intervention. Data collection will take place prior to intervention, postintervention at gestation week 37, and 6 weeks, 6 and 12 months postpartum. The primary outcome measure will be change in the inter-recti distance, measured by two-dimensional ultrasonography. Data will be analysed and presented in accordance with international Consolidated Standards of Reporting Trials guidelines and analysed according to the intention-to-treat principle. Ethics and dissemination: Ethical approval has been obtained by the regional ethical committee (76296), and all procedures will be performed in adherence to the Helsinki declaration. The study has been registered with ClinicalTrials.gov. Results from this study will be presented at scientific conferences and in peer-reviewed scientific journals

Get Your Head in the Game:A Replicated Single-Case Experimental Design Evaluating the Effect of a Novel Virtual Reality Intervention in People With Chronic Low Back Pain

Chronic low back pain (CLBP) is a leading cause of disability worldwide. Contemporary treatment of CLBP is suboptimal, with small-moderate effect sizes and high relapse rates. Virtual reality (VR) is an increasingly accessible technology that can improve adherence to exercise programs through gamification. Using VR to facilitate exercise adherence and enjoyment may improve the clinical outcomes. This study aimed to evaluate the effects of a gamified VR graded activity intervention in people with CLBP, using commercially available and bespoke VR programs. A sequentially replicated, multiple-baseline, randomized AB single-case experimental design was undertaken in 10 people with CLBP. Outcomes were assessed daily and included pain intensity (primary) and pain catastrophizing, pain-related fear, and anxiety/worry (secondary). The effect of the intervention on the primary outcome was evaluated using a multilevel-model, nonparametric randomization test. The VR graded activity intervention resulted in a significant reduction in pain intensity (effect estimate = -1.0, standard error =.27, P <.0011) with 4 participants achieving =30% pain reduction (minimum important change). There was a significant effect of the intervention on pain catastrophizing but not pain-related fear or anxiety/worry measures. These findings provide preliminary support for a VR graded activity program to reduce pain in people with CLBP. Perspective: This novel, VR graded activity intervention reduced pain intensity and catastrophizing in people with CLBP. The intervention also had high adherence and enjoyment. Given that this intervention involved 2 freely available VR programs, it can be easily translated into clinical practice

Effectiveness of Low-Level Laser Therapy Associated with Strength Training in Knee Osteoarthritis: Protocol for a Randomized Placebo-Controlled Trial

Physical activity and low-level laser therapy (LLLT) can reduce knee osteoarthritis (KOA) inflammation. We are conducting a randomized placebo-controlled trial to investigate the long-term effectiveness of LLLT combined with strength training (ST) in persons with KOA, since it, to our knowledge, has not been investigated before. Fifty participants were enrolled. LLLT and ST was performed 3 times per week over 3 and 8 weeks, respectively. In the LLLT group, 3 Joules of 904 nm wavelength laser was applied to 15 spots per knee (45 Joules/knee/session). The primary outcomes are pain during movement, at night and at rest (Visual Analogue Scale) and global pain (Knee injury and Osteoarthritis Outcome Score, KOOS) pain subscale. The secondary outcomes are KOOS disability and quality-of-life, analgesic usage, global health change, knee active range of motion, 30 s chair stand, maximum painless isometric knee extension strength, knee pain pressure threshold and real-time ultrasonography-assessed suprapatellar effusion, meniscal neovascularization and femur cartilage thickness. All the outcomes are assessed 0, 3, 8, 26 and 52 weeks post-randomization, except for global health change, which is only evaluated at completed ST. This study features the blinding of participants, assessors and therapists, and will improve our understanding of what occurs with the local pathophysiology, tissue morphology and clinical status of persons with KOA up to a year after the initiation of ST and a higher 904 nm LLLT dose than in any published trial on this topic

Short-and Long-Term Effectiveness of Low-Level Laser Therapy Combined with Strength Training in Knee Osteoarthritis: A Randomized Placebo-Controlled Trial

Background: Both physical activity and low-level laser therapy (LLLT) can reduce knee osteoarthritis (KOA) inflammation. We conducted a randomized clinical trial to investigate the short- and long-term effectiveness of LLLT combined with strength training in persons with KOA. Methods: Fifty participants were randomly divided in two groups, one with LLLT plus strength training (n = 26) and one with placebo LLLT plus strength training (n = 24). LLLT and strength training were performed triweekly for 3 and 8 weeks, respectively. In the laser group, 3 joules 904 nm wavelength laser was applied to fifteen points (45 joules) per knee per session. Patient-reported outcomes, physical tests, and ultrasonography assessments were performed at baseline and 3, 8, 26, and 52 weeks after initial LLLT or placebo therapy. The primary outcomes were pain on movement, at rest, at night (Visual Analogue Scale), and globally (Knee injury and Osteoarthritis Outcome Score (KOOS) subscale). Parametric data were assessed with analysis of variance using Šidák’s correction. Results: There were no significant between-group differences in the primary outcomes. However, in the laser group there was a significantly reduced number of participants using analgesic and non-steroidal anti-inflammatory drugs and increased performance in the sit-to-stand test versus placebo-control at week 52. The joint line pain pressure threshold (PPT) improved more in the placebo group than in the laser group, but only significantly at week 8. No other significant treatment effects were present. However, pain on movement and joint line PPT were worse in the placebo group at baseline, and therefore, it had more room for improvement. The short-term percentage of improvement in the placebo group was much higher than in similar trials. Conclusions: Pain was reduced substantially in both groups. LLLT seemed to provide a positive add-on effect in the follow-up period in terms of reduced pain medication usage and increased performance in the sit-to-stand test