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IRCT20260825070794N1 IRCT 2026-08-27 Iran University of Medical Sciences The effect of early versus late exercise initiation on the incidence of complex regional pain syndrome in patients with wrist fractures Investigating the effect of early versus late exercise initiation on the incidence of complex regional pain syndrome in patients with distal radius fractures 2026-10-12 anticipated 192 Pending https://irct.ir/trial/92814 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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 description: 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. 2-3 Distal radius fracture. Intervention 1: Intervention group: Patients in the intervention group receive educational content including 4 types of hand, wrist, and finger movements along with instructions on how to perform them and the number of repetitions (each 5 times during waking hours) through educational videos, booklets, or training sheets, and start exercise from the day after surgery or the day after cast removal, pin removal, or external fixator removal. These patients are taught to perform each of the movements 5 times daily while awake. Weekly telephone calls will be made to this group for follow-up and to remind them to perform the exercises. Intervention 2: Control group: Patients in the control group perform the same exercises (including 4 types of hand, wrist, and finger movements) later, at the time determined by the physician. These patients also receive educational content regarding how to perform the movements and the number of repetitions (each 5 times during waking hours), but the timing of exercise initiation is delayed and determined based on the physician's judgment. Weekly telephone calls will also be made to this group for follow-up and to remind them to perform the exercises. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Esmaeil Fathollahi Erami
Hazrat Rasoul Akram Hospital, Niyayesh St., Sattarkhan Ave., Tehran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 1000 e.fathollahierami@gmail.com Iran University of Medical Sciences scientific Esmaeil Fathollahi Erami
Hazrat Rasoul Akram Hospital, Niyayesh St., Sattarkhan Ave., Tehran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 1000 e.fathollahierami@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 70 years Both History of wrist fracture History of wrist fracture 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 S52.5 Fracture of lower end of radius Behavior Behavior Intervention group: Patients in the intervention group receive educational content including 4 types of hand, wrist, and finger movements along with instructions on how to perform them and the number of repetitions (each 5 times during waking hours) through educational videos, booklets, or training sheets, and start exercise from the day after surgery or the day after cast removal, pin removal, or external fixator removal. These patients are taught to perform each of the movements 5 times daily while awake. Weekly telephone calls will be made to this group for follow-up and to remind them to perform the exercises. Control group: Patients in the control group perform the same exercises (including 4 types of hand, wrist, and finger movements) later, at the time determined by the physician. These patients also receive educational content regarding how to perform the movements and the number of repetitions (each 5 times during waking hours), but the timing of exercise initiation is delayed and determined based on the physician's judgment. Weekly telephone calls will also be made to this group for follow-up and to remind them to perform the exercises. Incidence of complex regional pain syndrome. Timepoint: Weeks 1, 2, and 6 after treatment. Method of measurement: In-person examination by the outcome assessor physician based on Budapest criteria (including four categories: sensory, vasomotor, sudomotor/edema, and motor/trophism). Iran University of Medical Sciences Approved 2026-05-21 Ethics Committee of Iran University of Medical Sciences Shahid Hemmat Highway, Next to Milad Tower, Tehran, Tehran Tehran Iran (Islamic Republic of)