A self-managed exercise therapy program for wrist osteoarthritis: study protocol for a randomized controlled trial

The wrist joint performs complex movements in multiple directions and sustains high loads in many positions. Its involvement in most daily tasks, with great demands on mobility, stability, and load-bearing forces, puts the wrist at risk for problems after injuries and degenerative diseases, such as osteoarthritis (OA) [1]. The prevalence of wrist OA is low but increases with age [2]. In contrast to OA in other joints of the hand, wrist OA develops earlier in life and is more common in men (prevalence 1.7%) than in women (1.0%) [2, 3].

The cause of wrist OA is usually secondary due to a previous traumatic insult, such as a fracture or ligament injury. It selectively involves the joints surrounding the scaphoid bone [4]. Two common types of wrist OA patterns are the scaphoid non-union advanced collapse (SNAC), which is instigated by an unhealed fracture of the scaphoid [5], and the scapholunate advanced collapse (SLAC), which is caused by a traumatic or degenerative scapholunate ligament injury [6]. The SNAC and SLAC cause carpal instability, altered wrist kinematics, and joint loading with eventual arthritic degeneration of the radiocarpal and midcarpal joints [4]. A four-staged predictable and progressive pattern ranges from stage 1 that represents mild arthritic changes confined to the radial styloid to stage 4 that represents advanced arthritic changes affecting both the radiocarpal and midcarpal joints [6].

Post-traumatic wrist OA develops slowly, and the joint degeneration can lead to pain, muscular weakness, and stiffness of the wrist [7]. As a result, this can affect the function of the entire upper limb, which can interfere with activities of daily living (ADL) and the ability to work, thus leading to reduced quality of life [8]. In an OA affected joint, disturbed neuromuscular control can lead to a disproportionate load on the joint [9]. This unhealthy progress could aggravate the OA progression over time [10].

Currently, the treatment norm for wrist OA is initially directed at alleviating pain and decrease disability by splinting, non-steroidal anti-inflammatory medications, and intraarticular steroid injections. The surgical interventions for wrist OA include neurectomy, styloidectomy, proximal row carpectomy, fusions, or arthroplasty [11]. However, a self-managing approach, including therapeutic exercises, has traditionally not been a treatment strategy in wrist OA.

Exercise therapy is a regime of physical activities designed and prescribed for precise therapeutic goals, aiming at educating the performance of specific exercises to improve neuromuscular control, reduce pain, and achieve functional joint stability [12]. Self-management programs, including exercise therapy and joint protective strategies, are core treatments in knee and hip OA [13‐17]. Due to the complexity of the wrist joint, it cannot be fully compared to larger weight-bearing joints, such as the knee and hip. Therefore, there is a need to develop exercise therapy programs specially designed for the wrist. Such a program should be part of a comprehensive joint protective standard care and could be beneficial to decrease disability and postpone, or possibly even eliminate, the need for surgery in individuals with wrist OA.

The objective of the trial is to evaluate the effectiveness of an exercise therapy program with joint protective strategies to improve neuromuscular control (intervention group) compared to a training program with range of motion (ROM) exercises (control group). To evaluate these programs, we will use the Patient-Rated Wrist Evaluation (PRWE) as our primary outcome [18]. We hypothesize that 12 weeks of exercise therapy relieves pain and improves the ability to perform daily activities to a greater extent than the ROM training program.

While the trial is in progress, no other treatments will be allowed or prescribed. The information provided to participants will not specify any prohibitions. Participants will be able to take their usual pain medication, such as paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs), if needed. However, they will not be subscribed pain medication, such as opioids, or intraarticular wrist cortisone injection during their participation in the trial.

Outcome measures with good psychometric properties will be used covering both physical and patient-reported measures. Valid and reliable Swedish versions of the outcome measures will be used. Missing item responses for the patient-reported outcome measures will be handled in accordance with each scale’s specific recommendations. If the number of missing items makes calculating the score impossible, the lost score will not be replaced. Outcomes will be assessed at baseline and at 3, 6, and 12 months post-inclusion (Fig. 2).

An effective self-management treatment program, including structured education and therapeutic exercises, has not yet been introduced for individuals with wrist OA. Although there is no cure for OA, patients may benefit from self-management treatment options that enables them to manage symptoms and optimize quality of life [42]. There is strong evidence advocating that all patients with OA should be offered adequate education and exercises and that surgical interventions only should be considered when non-surgical treatments have failed [41]. In addition, worldwide, waiting times are long before consultation with a specialist or elective surgery is received, which emphasizes the need for physiotherapist-led interventions and new conservative treatment options [43]. Referral of patients with wrist OA to education and self-management programs is therefore an attractive first-line treatment option with the intention to inform patients about the disease and provide them with tools to facilitate everyday life and with the aim to postpone, or even eliminate, the need for surgical interventions [39]. Thus, evaluation of the present self-managed exercise therapy program may be beneficial for the individual who suffers from wrist OA as well as for the healthcare system.

Several international and national organizations recommend structured education and exercises as first-line treatment for OA. The European League Against Rheumatism (EULAR) recommends OA education and exercises for hand, knee, and hip OA [17, 44]. The Osteoarthritis Research Society International (OARSI) recommends education and exercise programs as core treatments for knee, hip, and polyarticular OA [13]. Furthermore, several evidence-based self-management programs have been developed for hip and knee OA and are implemented and used as first-line treatments with good results [16, 45]. Cochrane reviews have found high quality evidence that therapeutic exercises can reduce pain and improve function in knee and hip OA [14, 15]. For hand OA, however, the evidence is low owing to lack of blinding of participants, the small number of included studies, and inclusion of few individuals in the analyses [46]. In these studies, hand OA refers to the thumb carpometacarpal (CMC) joint and finger joint OA. For wrist OA, structured education, and exercise therapy as first-line treatment has not yet been studied.

A structured education and neuromuscular exercise therapy program is one type of conservative management for hip and knee OA [42]. Our exercise therapy program is designed based on the principles behind neuromuscular training that focus on improving the quality and effectiveness of movements [12, 22]. The rationale behind our choice of neuromuscular therapeutic exercises is that patients with OA may have impaired sensorimotor function in terms of sensory deficiency, altered muscle activation patterns, and reduced functional performance [9, 47]. Therefore, it seems evident that training programs should address several aspects of the sensorimotor system to improve function and alleviate symptoms.

The combination of structured education and neuromuscular exercise therapy has shown short- and long-term improvements in pain, physical function, function in ADL, and quality of life in individuals with knee and hip OA [48‐51]. Skou et al. evaluated the efficacy of a 12-week non-surgical treatment program for patients with knee OA not eligible for total knee replacement in a RCT. They found that participants in a structured education and neuromuscular exercise group experienced significant improvements regarding pain, function, and quality of life after 1 year compared to the control group receiving usual care consisting of two leaflets with information and advice on knee OA and recommended treatments [49]. In a large study, 418 patients with chronic knee pain/knee OA were randomized to either usual care or the Enabling Self-Management and Coping of Arthritic Knee Pain Through Exercise (ESCAPE) program. Significant improvements in pain and physical function were found in the ESCAPE group at 6 weeks post-intervention and the improvement sustained at a 30-month follow-up [48]. Da Silva et al. demonstrated, in an RCT, significant improvements in pain, physical function, ADL, and quality of life at the 8-week follow-up in the structured education and neuromuscular exercise group compared to patient education for patients with knee OA [50]. A 6-year follow-up RCT in patients with hip OA by Svege et al. found significant improvement in self-reported physical function for participants in the structured education and neuromuscular exercise group compared to the control group that only received patient education. The study also found that exercise therapy in addition to patient education can reduce the need for total hip replacement by 44% in patients with hip OA [51]. The wrist, with its complex anatomy and biomechanics, cannot be fully compared to weight-bearing joints such as the hip and knee, which emphasizes the need to evaluate if a self-management program, including patient education and neuromuscular exercises, can be beneficial also for individuals with wrist OA.

A review by Hagert from 2010 [24] highlighted the theoretical importance of sensorimotor control of the wrist and its function, thus setting a new standard for wrist rehabilitation. Clinical reviews by Valdes et al. [52], Karagiannopoulos and Michlovitz’s [26], and Lotters et al. [25] provided further support for including exercises of sensorimotor control in the rehabilitation of the wrist. In addition, there are a small number of single case reports [53, 54] and cohort studies [22, 55, 56], indicating clinical benefits of an exercise therapy program with a neuromuscular approach following various wrist injuries. The exercise therapy in our RCT is based on theoretical assumptions and outcomes from the above-mentioned cohort and case studies.

A potential limitation to our RCT is the fact that adherence may be more challenging for the participants in the intervention group due to the larger training intensity. To promote adherence, both treatment programs will be delivered and supervised by an experienced PT who will encourage, answer questions, and initiate individual adjustments when needed. Moreover, there may be a risk of self-selection bias; thus, individuals that accept to join the trial may differ in terms of motivation to training compared to those who chose not to participate.

Since the clinical importance of wrist rehabilitation remains in its infancy, we want to evaluate the concept of structured education and a self-management exercise therapy program as treatment for individuals with wrist OA.

We have designed a self-managed exercise therapy program for individuals with wrist OA that we will evaluate in a single-blinded RCT with two treatment arms. The knowledge gained will comprehend the effectiveness of this non-surgical treatment and, depending on the outcome, may redefine the current treatment strategies. If this self-management program proves to be effective, in terms of decreased pain and improved patient-reported function, it may be implemented in treatment protocols for individuals with wrist OA.

This protocol is version 3.0 (dated August 18, 2023). The recruitment of participants started 3 October 2019 and is estimated to be completed in June 2023. No trial amendments have been made since the enrollment of the first participants. Any substantive amendments that may impact the conduct of the trial or the ethical rigor will require a formal written modification to the protocol and an approval by the Swedish Ethical Review Authority.

The findings of this trial will be communicated to the participants and disseminated through peer-reviewed publications in scientific journals and conference presentations. It is also expected to, through presentations, generate a linkage with specialized hospitals and therapists working in this field.