NCT07370012

Prism Adaptation Therapy for CRPS Type 1

Evaluation Of The Effectiveness Of Prism Adaptation Therapy In Patients With Complex Regional Pain Syndrome (CRPS) Type I

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Ankara Etlik City Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Complex Regional Pain Syndrome (CRPS) is a clinical condition characterized by pain that arises either without an identifiable triggering factor or with a severity disproportionate to the initiating event. Its progression is typically unpredictable, and most therapeutic interventions yield only partial efficacy. Prism Adaptation Therapy (PAT) is a sensorimotor training method traditionally employed to mitigate attentional deficits in post-stroke hemispatial neglect and has recently been explored as a treatment modality for CRPS. Preliminary non-blinded studies with small patient cohorts have demonstrated its potential to reduce pain and related symptoms. The present study aims to assess the effects of prism adaptation therapy administered during the acute phase on pain intensity and other clinical outcomes in CRPS, addressing the considerable challenges associated with managing chronic pain in this disorder.

Detailed description

A total of 54 patients diagnosed with Complex Regional Pain Syndrome (CRPS) type 1, in accordance with the Budapest diagnostic criteria and fulfilling the inclusion and exclusion criteria, were enrolled in this study. Utilizing the sealed-envelope method, participants were randomized into two equal groups: 27 patients assigned to the prism adaptation therapy group and 27 to the control group. The control group received standard physical therapy and rehabilitation interventions supplemented by a pointing protocol administered once daily over 20 sessions under the supervision of the same physician/physiotherapist, with the use of neutral-lens goggles. Conversely, the prism adaptation therapy group underwent the identical pointing protocol employing prismatic-lens goggles in conjunction with standard physical therapy and rehabilitation interventions. Baseline data collection prior to randomization included demographic characteristics such as age (years), sex (female/male), marital status (married/single), occupation, educational level, living arrangement, and alcohol and tobacco consumption. Clinical and disease-related baseline variables were also recorded, comprising height (cm), body weight (kg), body mass index (kg/m²), comorbidities, and current medication regimens. The etiology or inciting event(s) were documented, including fracture, surgery, immobilization, and casting. For fracture-related cases, detailed information on fracture pattern, intra-articular involvement, casting, surgical intervention, type and duration of immobilization, and the interval from the inciting event(s) to presentation at the physical medicine and rehabilitation outpatient clinic was noted. Furthermore, CRPS-associated signs and symptoms-including pain, edema, color changes, temperature alterations or asymmetry, sweating changes, nail and hair abnormalities, involuntary movements, tremor, weakness, and limitations in hand and wrist range of motion-were assessed at baseline. Sensory evaluations encompassed hyperalgesia testing with cotton wool and allodynia assessment using a 22-gauge black-tipped needle. All patients were evaluated at three time points: baseline prior to treatment initiation (T0), immediately following treatment completion (T1), and six weeks post-treatment (T2). Assessments included clinical parameters, standardized evaluation tests, and ultrasonographic examinations.

Conditions

• Complex Regional Pain Syndrome I (CRPS I)
• Distal Radius Fracture
• CRPS (Complex Regional Pain Syndromes)
• Neuropathic Pain

Interventions

Type	Name	Description
DEVICE	The Prism Adaptation Therapy Group	Once daily for a total of 20 sessions, in addition to the standard physical therapy and rehabilitation program, a pointing protocol was conducted under the supervision of the same physician/physiotherapist using prismatic-lens goggles.
DEVICE	The Control Group	Once daily for a total of 20 sessions, in addition to the standard physical therapy and rehabilitation program, a pointing protocol was conducted under the supervision of the same physician/physiotherapist using neutral-lens goggles (sham goggles).

Timeline

• Start date: 2023-10-04
• Primary completion: 2024-05-30
• Completion: 2024-05-30
• First posted: 2026-01-27
• Last updated: 2026-01-28

Locations

1 site across 1 country: Turkey (Türkiye)