An interventional study of The Prism Adaptation Therapy Group and The Control Group in Complex Regional Pain Syndrome I (CRPS I), Distal Radius Fracture and CRPS (Complex Regional Pain Syndromes), sponsored by Ankara Etlik City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Ankara Etlik City Hospital · Not applicable, Interventional, and Treatment
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.
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.
205 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.
This study's enrollment of 54 is above the median of 40 across 152 interventional studies indexed under Complex Regional Pain Syndromes.
Browse Complex Regional Pain Syndromes studies →Ankara Etlik City Hospital is the lead sponsor of 176 studies on the registry; 77 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The prism adaptation therapy intervention group
Device: The Prism Adaptation Therapy Group
The control group that will undergo the protocol using sham 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 prismatic-lens goggles.
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).
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.
Time frame: 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.
Time frame: Baseline, post-treatment (Week 4), and follow-up (Week 10)
Evaluation of Joint Range of Motion
Range of motion was assessed using a goniometer for the wrist (flexion/extension, radial/ulnar deviation) and the forearm (supination/pronation). Each measurement was performed three times, and the mean value was calculated and recorded.
Time frame: Baseline, post-treatment (Week 4), and follow-up (Week 10)
Assessment of Light Touch Sensation
Light touch sensation was evaluated using Semmes-Weinstein monofilaments (SWM). The assessment was conducted at seven sites corresponding to the dermatomal distribution of the median, radial, and ulnar nerves. During the procedure, patients were instructed to avert their gaze from the tested area. Each filament was applied perpendicularly for 1.5 seconds until it bent. Patients were asked to indicate when they perceived the stimulus. Filaments within the 1.65-4.08 range were applied three times, whereas those within the 4.17-6.65 range were applied once, and the patient's response was recorded. Values between 1.65 and 2.83 (green) were classified as normal; 3.22-3.61 (blue) indicated diminished light touch; 3.84-4.31 (purple) signified diminished protective sensation; and 4.56-6.65 (red) represented loss of protective sensation. In cases where there was no response to the 6.65 filament, this was documented as no response, and deep pressure sensation was subsequently assessed.
Time frame: Baseline, post-treatment (Week 4), and follow-up (Week 10)
Assessment of Grip and Lateral Pinch Strength
Grip strength and lateral pinch strength were assessed using a Lafayette digital hand dynamometer. Grip strength measurements were conducted in the seated position as recommended by the American Society of Hand Therapists (ASHT), with the wrist maintained in a neutral position, the forearm supported in mid-rotation, the elbow flexed at 90°, and the shoulder positioned neutrally with adduction. Each measurement was performed three times per patient, and the mean value was calculated. For lateral pinch strength, the dynamometer was pressed using the distal phalanx of the thumb, supported against the lateral aspect of the second phalanx of the index finger. Patients were instructed to exert maximal force during the measurement. Each measurement was repeated three times per patient, and the average value was recorded.
Time frame: Baseline, post-treatment (Week 4), and follow-up (Week 10)
Measurement of Wrist Circumference
Wrist circumference was measured in all patients using a measuring tape, carefully positioned to fit precisely over the styloid processes of the radius and ulna. To ensure measurement reliability, each assessment was conducted three times, and the mean value was recorded. Measurements were reported in centimeters.
Time frame: Baseline, post-treatment (Week 4), and follow-up (Week 10)
Assessment of Hand and Wrist Volume
The assessment of extremity volume is considered the gold standard for volumetric measurements. For each patient, the volumeter was filled with water until it overflowed, and the extremity to be measured was immersed such that the thumb faced the opening of the volumeter and the web space between the second and third fingers aligned with the marked midpoint of the volumeter. The volume of the displaced water was measured using a graduated container for both the healthy and affected extremities of each patient. Measurements were repeated three times separately, recorded individually, and the average value was determined in milliliters (ml).
Time frame: Baseline, post-treatment (Week 4), and follow-up (Week 10)
Evaluation of Manual Dexterity
Upper-extremity function was evaluated using the Nine-Hole Peg Test. Participants were instructed to sequentially pick up nine pegs from the side compartment, insert them one by one into the nine holes on the board, and then remove them as quickly as possible. The time taken to complete the task was recorded using a stopwatch. Completion times were standardized based on participants' age, sex, and dominant hand. The test was administered three times per participant, and the mean completion time was calculated.
Time frame: Baseline, post-treatment (Week 4), and follow-up (Week 10)
Assessment of Functional Status in Activities of Daily Living (ADL)
The hand function of the patients included in the study was assessed using the Duruöz Hand Index (DHI), an 18-item questionnaire that does not require prior training or specialized equipment. The questionnaire evaluates activities of daily living categorized into domains such as kitchen tasks, dressing, hygiene and cleaning, work-related activities, and other routine daily functions. Each item is scored on a Likert scale, resulting in a total score ranging from 0 to 90, where lower scores correspond to better functional ability.
Time frame: Baseline, post-treatment (Week 4), and follow-up (Week 10)
Assessment of Disability
Disability in all participants was evaluated using the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire to assess limitations in activity and participation.
Time frame: Baseline, post-treatment (Week 4), and follow-up (Week 10)
Assessment of Quality of Life
To evaluate quality of life, all participants completed the Short Form-36 Health Survey (SF-36). Initially comprising 149 items in 1999, the instrument was subsequently refined to the SF-20. To expand the assessment's scope and improve its psychometric robustness, the 36-item version was developed. The SF-36 consists of 36 items categorized into eight subscales. Respondents are instructed to consider their experiences over the preceding four weeks. An alternative version assessing the prior one week is also available to capture acute changes. Items 4 and 5 are answered with binary (yes/no) responses, while the remaining items utilize Likert-type scales with three to six response options. Each subscale is scored independently on a scale from 0 to 100, where higher scores denote better health status.
Time frame: Baseline, post-treatment (Week 4), and follow-up (Week 10)
Assessment of Kinesiophobia
Patients were evaluated using the Tampa Scale for Kinesiophobia (TSK), a 17-item questionnaire designed to assess fear of movement and/or re-injury. The total score ranges from 17 (lowest) to 68 (highest), with elevated scores indicating greater kinesiophobia, which corresponds to an increased fear of movement and falling.
Time frame: Baseline, post-treatment (Week 4), and follow-up (Week 10)
Ultrasonographic Assessment
Ultrasonographic measurements of all patients included in the study were conducted using a G.E. LOGIQ P5 ultrasound system. The device frequency was set between 7 and 12 MHz, and measurements were obtained by positioning a linear transducer over the third metacarpophalangeal joint of the affected limb. Echogenicity, subcutaneous tissue structure, and edema characteristics were assessed, and the findings were classified according to the Ultrasonographic Subcutaneous Edema Grading (USEG) scale.
Time frame: Baseline, post-treatment (Week 4), and follow-up (Week 10)
Plan to share: No — Individual participant data (IPD) will not be shared publicly due to institutional policies and ethical considerations. De-identified, aggregate results will be reported in publications.
No publications or documents are linked to this record.
Ran from Oct 2023 to primary completion in May 2024, 7 months.
Of 64 non-industry interventional studies with no phase under Complex Regional Pain Syndromes, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's 7 months is below that.
Counting every sponsor, half of 65 studies reached it within 24 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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