Prism Adaptation Therapy for CRPS Type 1

NCT07370012 | Completed

• 1 other identifier: AEŞH-EK1-2023-590
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Upper Extremity Rehabilitation; Budapest Criteria; Pain Management; Neuropathic Pain; Kinesiophobia; Quality of Life; Ultrasonography / Edema grading; Hand Function; Complex Regional Pain Syndrome I; Complex Regional Pain Syndrome; CRPS; Prism Adaptation Therapy; Prism Adaptation; Neglect; CRPS I; Reflex Sympathetic Dystrophy; Prism Goggles; Visuomotor Adaptation; Sensorimotor Training; Body Perception Disturbance; Neglect-like Symptoms; Distal Radius Fracture; Upper Limb; Wrist; RSD

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS)

  The visual analog scale (VAS) is an instrument used to quantify pain intensity. It can be presented in either a vertical or horizontal orientation. Patients are asked, "If 10 represents the worst pain imaginable and 0 represents no pain, how much pain are you experiencing at this moment?" The scale consists of a 100-mm straight line on which patients indicate the severity of their symptoms. The left endpoint is typically labeled "no pain," while the right endpoint is labeled "worst pain imaginable." Patients mark the point on the line that best corresponds to their perceived pain level. The distance from the left endpoint to the marked point is then measured and recorded as the pain score.

  Baseline, post-treatment (Week 4), and follow-up (Week 10)

• LANNS

  The LANSS is employed to evaluate neuropathic pain. It comprises five pain-related questions and two sensory assessments.In the sensory assessment section, allodynia and pin-prick sensation are examined. A score of 12 or above indicates that the pain is likely neuropathic in nature. The maximum total score is 24.

  Baseline, post-treatment (Week 4), and follow-up (Week 10)

Secondary Outcomes (11)

• Evaluation of Joint Range of Motion

  Baseline, post-treatment (Week 4), and follow-up (Week 10)

• Assessment of Light Touch Sensation

  Baseline, post-treatment (Week 4), and follow-up (Week 10)

• Assessment of Grip and Lateral Pinch Strength

  Baseline, post-treatment (Week 4), and follow-up (Week 10)

• Measurement of Wrist Circumference

  Baseline, post-treatment (Week 4), and follow-up (Week 10)

• Assessment of Hand and Wrist Volume

  Baseline, post-treatment (Week 4), and follow-up (Week 10)

Study Arms (2)

Prism Adaptation Therapy Group

ACTIVE COMPARATOR

The prism adaptation therapy intervention group

Device: The Prism Adaptation Therapy Group

Control Group

PLACEBO COMPARATOR

The control group that will undergo the protocol using sham goggles

Device: The Control Group

Interventions

The Prism Adaptation Therapy Group DEVICE

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.

Prism Adaptation Therapy Group

The Control Group DEVICE

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).

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged between 18 and 75 years
• Patients diagnosed with CRPS Type 1 according to the IASP 2003 CRPS Budapest diagnostic criteria
• Presence of traumatic etiologies, including surgical procedures, fractures, or immobilization
• Patients who consented to participate and provided written informed consent

You may not qualify if:

• History of inflammatory, autoimmune, hematologic, or neoplastic diseases
• Diabetes mellitus, thyroid disorders, hepatic or renal failure
• History of cranial trauma or cranial surgery within the preceding 6 months
• Use of diuretics, anti-inflammatory, antineoplastic, corticosteroid, immunosuppressive, antidepressant, or anxiolytic medications within the past 2 months
• Use of anticholinergic medications within the past 7 days
• Active ocular infection, inflammation, allergy, or recent use/exposure to ophthalmic drops
• History of lens or ocular surgery within the last 3 months
• Current or previous use of glasses or contact lenses, or diagnosis of refractive error ≥0.5 diopters
• Peripheral nerve injury in the affected hand consistent with CRPS Type 2 as per Budapest criteria
• Known progressive or non-progressive peripheral or central nervous system disorders
• CRPS Type 1 developing subsequent to central nervous system injury (e.g., stroke)
• Patients in the acute phase following primary or secondary tendon repair
• Presence of comorbid conditions likely to impair functionality and health-related quality of life, such as decompensated heart failure, chronic kidney failure, or malignancy
• Comorbid diseases affecting hand function, including rheumatoid arthritis, psoriatic arthritis, or other inflammatory disorders involving the hand
• Joint restriction and/or muscle weakness in the affected extremity that would impede movement

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Wrist Fractures; Neuralgia; Agnosia; Kinesiophobia; Reflex Sympathetic Dystrophy

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• ECE ÜNLÜ AKYÜZ, MD, Prof.

  Ankara Etlik City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants wore either prismatic-lens goggles or neutral-lens goggles during the pointing protocol. Both interventions were described as potentially beneficial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Specialist

Model Details: Participants were divided into two groups: one group received prism adaptation therapy, while the other underwent the identical protocol using sham goggles.

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 27, 2026
• Study Start: October 4, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)