Clinical trials

This randomized pilot feasibility trial will evaluate the feasibility of conducting a full-scale randomized controlled trial comparing custom-made, prefabricated, and sham foot orthoses in people with painful hallux valgus. All participants will also receive a standardized program of foot exercises and education. Thirty-six participants will be randomized to one of the three intervention groups and assessed at baseline, 6 weeks, and 12 weeks. The primary outcomes will assess the feasibility of recruitment, retention, treatment adherence, intervention credibility and expectancy, and use of cointerventions. Secondary outcomes will assess foot pain and function, perceived clinical improvement, and health-related quality of life. The findings will inform the design and conduct of a future full-scale randomized controlled trial.

Background Progressive collapsing foot deformity (PCFD) is a painful musculoskeletal disorder leading to a progressively developing flat foot, which affects mobility and function and negatively impairs quality of life. Foot orthoses (FOs) are often prescribed to attenuate pain and improve function in patients with PCFD. However, no study has yet investigated the impact of adding FOs, whether custom (CFOs) or prefabricated (PFOs), to the usual treatment for PCFD. Thus, the primary objective of this trial will be to compare three different non-surgical interventions combining foot exercises and education with either CFOs, PFOs or sham FOs (SFOs). Methods/Design This participant-blinded multicentric superiority randomized controlled trial with three parallel groups will be conducted at the Université du Québec à Trois Rivières (UQTR) and the Center for Interdisciplinary Research in Rehabilitation and Social Integration (Cirris) in Canada. One hundred and ninety-eight participants with PCFD will be recruited via referral from physiotherapy and podiatry clinics and targeted advertising on social media. Participants will be randomized to receive CFOs, PFOs or SFOs. All groups will also receive a foot and ankle exercises program and education about their condition. They will be evaluated at four time points: baseline, 12 weeks, 24 weeks and 52 weeks. The primary outcome will be the subcategories of pain from the Foot Function Index (FFI) questionnaire. The secondary outcomes will be: foot pain and limitations (other categories of FFI, mean and maximal pain during walking for the most painful foot during the past week), self-assessed clinical progress (Global Rating Of Change), health-related quality of life (5-Level EQ-5D), gait biomechanics, fear avoidance (Fear avoidance Scale), supination resistance and ankle and hip endurance and force. Discussion This trial first aims to determine whether FOs treatment is effective, and second, whether one of the three FO interventions is more effective than the others. This trial will help guide FOs prescription recommendations for managing foot pain, function, and biomechanical outcomes in individuals with PCFD in the future.

Thumb osteoarthritis or trapeziometacarpal osteoarthritis (TMO) is a common and painful form of hand arthritis that limits thumb mobility and hand function, affecting patients' quality of life. Although corticosteroids injections are a typical treatment, their effectiveness has been challenged, and side effects have been reported. Recent studies suggest that saline injections, usually considered inactive, might be a viable treatment option. The primary goal of this study is to compare the effectiveness of saline injections versus corticosteroids injections in reducing TMO-related pain and improving hand function. In this study, 40 people with TMO will be randomly assigned to receive either a corticosteroids or a saline injection, without them or the doctors performing the injection knowing which one was administered (double blind). If saline injections prove more effective, they could provide a less harmful and cheaper therapeutic alternative for TMO patients.

Olfactory dysfunction is a defining symptom of COVID-19 infection. Studies have demonstrated improved olfaction in patients with post infectious olfactory dysfunction after an olfactory training (OT). The aim of this study is to assess the clinical outcomes of olfactory training (12 weeks) therapy in the treatment of persistent olfactory dysfunctions after COVID-19. Specially, we aim to compare the effectiveness of two different olfactory training (different odors). A group will train themselves with 4 scents (rose, orange, clove and eucalyptus) and another group with 4 different scents (cheese, coffee, strawberries and lemon). Olfaction sensory evaluation will be performed by using different olfaction tests (Sniffin' Sticks and UPSIT) and complete questionnaires to assess olfactory perception and particularly parosmia and phantosmia.

The goal of this observational study is to determine whether the Count Me In Program (Participe-Présent in French), which focuses on the strengths and power to act of older adults, can improve social participation and psychosocial factors among older adults with loss of autonomy, as assessed by the following outcome measures: (1) loneliness; (2) depressive symptoms; (3) cognition; (4) frequency of participation in leisure activities; and (5) type of social participation. Participants will attend seven weekly workshops in the Count Me In Program.

Background Chronic metatarsalgia (CM) causes significant pain and disability, affecting quality of life. Foot orthoses (FOs) including medially wedged designs with a metatarsal pad decrease excessive plantar pressure under the metatarsal heads, which is a suggested risk factor for developing CM. This FOs model may be effective in diminishing pain and improving function in these individuals. Thus, the objective of this trial will be to compare the effects of medially wedged FOs with a metatarsal pad and sham FOs on pain and foot function in individuals with CM. Methods/design This participant- and assessor-blinded superiority randomized controlled trial (RCT) with two parallel groups will be conducted in Trois-Rivières, Canada. Sixty-four participants with CM will be recruited from the Université du Québec à Trois-Rivières outpatient podiatry clinic and via social media invitations. They will be randomized into intervention (customized FOs) or control (sham FOs) groups and will be evaluated at baseline and after 6 and 12 weeks. The primary outcome will be: (1) mean pain during walking for the most painful foot during the past week. The secondary outcomes will be: (1) Foot Function Index, (2) Global rating of change and (3) the 5-level EQ-5D. Discussion Medially wedged FOs with a metatarsal pad are expected to provide a greater reduction in pain and improvement in foot function compared to sham FOs. This trial will help guide FOs prescription recommendations for managing foot pain in individuals with CM in the future.

The goal of this clinical trial is to test the effects of spinal manipulative therapy in individuals with chronic primary low back pain and determine the neurophysiological mechanisms underlying pain relief. The main questions it aims to answer are: • Is pain relief produced by spinal manipulative therapy in patients with chronic primary low back pain caused by a reduction of C-fiber-related nociceptive processing? • Are these effects greater when spinal manipulative therapy is applied to the whole spine where it is clinically indicated compared with lumbar spine only? • Are these effects greater after 36 treatments over 3 months compared with 12 treatments over 1 month. Participants will receive spinal manipulative therapy (all clinically indicated spine segments or back only) or a control intervention. A group of healthy volunteers will be recruited to assess secondary outcome measures over the same time period, as reference data for comparisons. Researchers will compare the two groups receiving spinal manipulative therapy to the group receiving the control intervention to see if clinical pain relief and the reduction of temporal summation of second pain (produced experimentally) is significantly greater with spinal manipulative therapy.