Investigating the effect of early versus late exercise initiation on the incidence of complex regional pain syndrome in patients with distal radius fractures

Comparison of the effect of early versus late exercise initiation on the incidence of complex regional pain syndrome in patients with distal radius fractures

A randomized, single-blind, parallel-group, controlled phase 2–3 clinical trial will be conducted on 192 patients. Randomization will be performed using the RAND function in Microsoft Excel.

This randomized clinical trial is conducted at Rasoul Akram Hospital in Tehran. Patients aged 18–70 years with distal radius fractures are included. Patients are allocated to intervention and control groups using block randomization via Excel. The intervention group starts exercise the day after surgery or cast removal, and the control group starts at the time determined by the physician. Blinding is assessor‑blind (single‑blind). Outcomes are assessed at weeks 1, 2, and 6 using the Budapest criteria.

Inclusion criteria: Diagnosis of distal radius fracture based on clinical and radiographic evidence, age range 18-70 years, patients with multiple trauma accompanied by distal radius fracture. Exclusion criteria: History of wrist fracture, central nervous system injury, spinal cord lesion, known neuropathy, burn, muscle atrophy, pathological wrist fracture, wrist injury with fracture other than distal radius, unwillingness to participate in the study.

Intervention group (early exercise initiation): Patients in this group will perform exercises including 4 types of hand, wrist, and finger movements, each 5 times during waking hours, starting from the day after surgery or the day after cast removal, pin removal, or external fixator removal. Control group (late exercise initiation): Patients in this group will perform the same exercises later, at the time determined by the physician

complex regional pain syndrome

Randomization in this study will be performed using block randomization with quadruple blocks, and the unit of randomization is individual. The randomization sequence will be generated using Microsoft Excel and the RAND function, and after determining the patient's treatment type, the software generates a block randomization sequence and assigns the patient to either the intervention or control group. To conceal the allocation sequence, sealed, opaque, and sequentially numbered envelopes will be used, each containing a group code, and until the envelope is opened, neither the research team nor the patient will be aware of the group assignment. The envelopes will be prepared and numbered by an individual independent of the research team, and patients, in order of referral, will open their respective envelope and be assigned to one of the two groups based on the code inside.

Blinding in this study is performed as assessor-blind, meaning that only the outcome assessor remains blinded to the study group allocation. For blinding of the outcome assessor, the examining physician who evaluates the primary outcome is unaware of the patients' group allocation and records clinical information without knowledge of the intervention type. Patients' records are provided to them without any indication of group allocation. The exercise training researcher, although aware of the group allocation, has no role in outcome assessment and does not share the group allocation information with the outcome assessor.