Complex Regional Pain SyndromesNCT05696587

Physical and Psychological Changes in CRPS Patients Undergoing Multimodal Rehabilitation

A study testing Multimodal rehabilitation in people with Complex Regional Pain Syndromes, run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to learn about cognitive changes during rehabilitation in CRPS patients. The main questions it aims to answer are: What are the cognitive changes in CRPS? Do cognitive functions change during multimodal rehabilitation in CRPS? What is the effect of multimodal rehabilitation on pain… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Complex Regional Pain Syndromes
What is being tested?: Multimodal rehabilitation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 sitePoland
Study dates: 10 Oct 2021to 1 Feb 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Clinical diagnosis of CRPS (or equivalent);
MMSE >24 points;
Has signed an informed consent to the study.

Who cannot join

MMSE ≤24 points;
Inability to perform scheduled tasks (multimodal rehabilitation program).

Trial locations and contacts

1 site in 1 country.

Poland1 site

National Institute of Geriatrics, Rheumatology and Rehabilitation
Warsaw, 02-637

Other trials in Poland

About this study

Official title: Physical and Psychological Changes in Complex Regional Pain Syndrome (CRPS) Patients Undergoing Multimodal Rehabilitation

The goal of this clinical trial is to learn about cognitive changes during rehabilitation in CRPS patients. The main questions it aims to answer are:

What are the cognitive changes in CRPS?
Do cognitive functions change during multimodal rehabilitation in CRPS?
What is the effect of multimodal rehabilitation on pain, functioning, mood, active range of motion, cognitive functions.

Participants will undergo a 4-week program of multimodal rehabilitation of physical therapy, education and Graded Motor Imagery. Assessment will be made at baseline and after 4 weeks.

Researchers will compare the interventional arm with healthy control to see if the observed psychological results are exclusive to CRPS group.

There is no expanded access scheduled for this study.

Conditions: Complex Regional Pain Syndromes
Being tested: Multimodal rehabilitation
Keywords: CRPS, cognitive functions, physical therapy, pain, Graded Motor Imagery, mirror therapy, rehabilitation
Medical subject headings: Complex Regional Pain Syndromes, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multimodal rehabilitationOther
The multimodal rehabilitation program included comprehensive therapy 5 times a week during the 4 weeks between assessments. The therapy consists of:
- Individual physical therapy focused on improving range of motion and alleviating pain in the affected limb;
- Mechanical desensitization;
- Transcutaneous electric nerve stimulation (TENS) electrotherapy;
- Aquatherapy (arm or leg whirlpool bath of the affected extremity);
- Graded Motor Imagery, including the Recognise™ app and mirror therapy;
- Psychoeducation on relaxation and coping with chronic pain.

Study groups in NCT05696587
Study group	Role	What they receive
CRPS	Experimental	Participants meeting inclusion and exclusion criteria undergoing 4-week multimodal rehabilitation, undergoing assessment at baseline and at 4 weeks. Receives: Other: Multimodal rehabilitation
Healthy Control	No intervention	Participants matched according to sex, age and education to experimental arm, undergoing psychological assessment at baseline and at 4 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean change from baseline in Reproduction score on the Rey's Complex Figure Test (RCFT) score at 4 weeks.
The RCFT is a task-based test assessing visual-spatial abilities. Reproduction score measures learning and planning on visual material. Possible scores range from 0 (significant deficit) to 36 (highest possible score). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks

Secondary outcomes (28)

Mean change from baseline in Copy score on the Rey's Complex Figure Test (RCFT) score at 4 weeks.
The RCFT is a task-based test assessing visual-spatial abilities. Copy score measures planning on visual material. Possible scores range from 0 (significant deficit) to 36 (highest possible score). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in pain score on the Numeric Rating Scale (NRS) at 4 weeks
The NRS is a self-reported instrument assessing average pain intensity over the past 24 hour period. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) at 4 weeks in Participants with upper extremity CRPS
The DASH is a self-reported instrument assessing ability to perform certain upper extremity activities. Possible scores range from 0 (no disability) to 100 (complete disability). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Lower Extremity Functional Scale (LEFS) at 4 weeks in Participants with lower extremity CRPS
The LEFS is a self-reported instrument assessing ability to perform certain lower extremity activities. Possible scores range from 0 (complete disability) to 80 (no disability). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Number of Participants meeting the Budapest Criteria for CRPS at baseline as percent of Participants in the CRPS arm
The Budapest Criteria are a set of clinical criteria used to diagnose CRPS. Possible outcomes include: CRPS-I, CRPS-II, CRPS-RSF, not meeting Budapest Criteria. Number = ((number of CRPS-I + number of CRPS-II + number of CRPS-RSF) / total Participants in CRPS arm) * 100%.
Measured: Baseline
Mean change from baseline in active range of motion (aROM) of affected joint at 4 weeks
The aROM is a clinical measure calculated as an angle between extreme positions of a joint. Possible scores range from 0° (no motion) to 360° (full rotation). Change = ((week 4 score / baseline score) * 100%).
Measured: At baseline and in 4 weeks
Mean change from baseline in Central Sensitization Inventory (CSI) part A at 4 weeks
The CSI is a self-reported instrument assessing overlapping health-related symptom dimensions of central sensitization. Possible scores range from 0 (subclinical) to 100 (extreme). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) part A score at 4 weeks
The SF-MPQ is a self-reported instrument assessing different types of pain. Possible scores range from 0 (no pain) to 45 (severe pain). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in PainDetect Questionnaire (PDQ) score at 4 weeks
The PDQ is a self-reported instrument assessing neuropathic pain. Possible scores range from -1 (neuropathic component <15%) to 38 (neuropathic component >90%). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Diverting Attention score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
The CSQ is a self-reported instrument assessing different pain coping strategies. The Diverting Attention score measures the use of attention diversion as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 36 (strategy significantly engaged). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Reinterpreting Pain Sensations score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
The CSQ is a self-reported instrument assessing different pain coping strategies. The Reinterpreting Pain Sensations score measures the use of pain sensation reinterpretation as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 36 (strategy significantly engaged). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Catastrophizing score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
The CSQ is a self-reported instrument assessing different pain coping strategies. The Catastrophizing score measures the use of catastrophising as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 36 (strategy significantly engaged). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Ignoring Sensation score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
The CSQ is a self-reported instrument assessing different pain coping strategies. The Ignoring Sensation score measures the use of ignoring pain sensation as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 36 (strategy significantly engaged). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Praying or Hoping score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
The CSQ is a self-reported instrument assessing different pain coping strategies. The Praying or Hoping score measures the use of prayer and wishful thinking as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 36 (strategy significantly engaged). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Coping Self Statements score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
The CSQ is a self-reported instrument assessing different pain coping strategies. The Coping Self Statements score measures positive self-affirmations as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 36 (strategy significantly engaged). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Increased Behavioral Activity score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
The CSQ is a self-reported instrument assessing different pain coping strategies. The Increased Behavioral Activity score measures the use of behavioral activity increase as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 36 (strategy significantly engaged). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Control Over Pain score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
The CSQ is a self-reported instrument assessing different pain coping strategies. The Control Over Pain score measures the notion of control over pain as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 6 (strategy significantly engaged). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Ability to Decrease Pain score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
The CSQ is a self-reported instrument assessing different pain coping strategies. The Ability to Decrease Pain score measures the notion of being able to decrease pain as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 6 (strategy significantly engaged). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean score on the Mini-Mental State Examination (MMSE) at baseline.
The MMSE is a clinician-reported screening test assessing general cognitive functioning. Possible scores range from 0 (severe cognitive deficit) to 30 (no cognitive deficit).
Measured: Baseline
Mean change from baseline in Total Number Correct score in Benton Visual Retention Test (BVRT) at 4 weeks.
The BVRT is a task-based test assessing visual-spatial working memory and visual-spatial abilities. Total Number Correct score counts correct answers. Possible scores range from 0 (significant deficit) to 10 (highest possible score). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Number of Errors score in the Benton Visual Retention Test (BVRT) at 4 weeks.
The BVRT is a task-based test assessing visual-spatial working memory and visual-spatial abilities. Number of Errors score counts wrong answers. Possible scores range from 0 (best possible score) to infinite number of errors (worst possible score). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Digit Span (DS) score in Wechsler's Adult Intelligence Scale Revised (WAIS-R) at 4 weeks.
WAIS-R is a task-based test assessing intelligence. The DS score measures attention and working memory. Possible scores range from 0 (significant deficit) to 28 (highest possible score). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Beck Depression Inventory - II (BDI-II) score at 4 weeks.
The BDI-II is a self-reported questionnaire assessing depression severity. Possible scores range from 0 (no depression) to 66 (severe depression). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Speed of Work score in the Attention and Perceptiveness Test (TUS) - at 4 weeks.
The TUS is a task-based test assessing attention. Speed of Work measures number of tasks completed in a fixed amount of time. Possible scores range from 0 (lowest possible speed) to 972 (highest possible speed). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Number of Mistakes score in the Attention and Perceptiveness Test (TUS) at 4 weeks.
The TUS is a task-based test assessing attention. Number of Mistakes score measures resistance to distraction. Possible scores range from 0 (perfect score) to 972 (worst possible score). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in Number of Omissions in the Attention and Perceptiveness Test (TUS) at 4 weeks.
The TUS is a task-based test assessing attention. Number of Omissions score measures resistance to distraction. Possible scores range from 0 (perfect score) to 349 (worst possible score). Change = (week 4 score - baseline score).
Measured: At baseline and in 4 weeks
Mean change from baseline in execution time in the Color-Trials Test part 1 (CTT-1) at 4 weeks.
The CTT-1 is a task-based test assessing psychomotor speed in time (seconds). Possible scores range from 0s (impossibly fast) to infinite time (unable to complete). Change = (week 4 time in seconds - baseline time in seconds).
Measured: At baseline and in 4 weeks
Mean change from baseline in shifting attention score on the Color-Trials Test part 2 (CTT-2) at 4 weeks.
The CTT-2 is a task-based test assessing shifting attention in time (seconds). Possible scores range from 0s (impossibly fast) to infinite time (unable to complete task). Change = (week 4 time in seconds - baseline time in seconds).
Measured: At baseline and in 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 20211 Feb 2023

First posted25 Jan 2023
Study start10 Oct 2021
Primary completion20 Jan 2023
Study completion1 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Complex Regional Pain SyndromesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Treatment arm will undergo a 4-week multimodal rehabilitation program with outcome measures recorded at baseline and at 4 weeks. Healthy control will be assessed for psychological outcome measures at baseline and at 4 weeks, with no intervention applied.
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05696587
Sponsor's protocol ID: STATUT 2020
Status last verified: Nov 2023
First submitted: 13 Jan 2023
Last updated: 15 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All of the individual participant data collected during the trial, after deidentification will be made published on Open Science Framework.

Publications

Fallico N, Padmanabhan R, Rahman S, Somma F, Spagnoli AM. A randomised placebo-controlled clinical trial on the efficacy of local lidocaine injections and oral citalopram for the treatment of complex regional pain syndrome. J Plast Reconstr Aesthet Surg. 2022 Mar;75(3):970-979. doi: 10.1016/j.bjps.2021.11.022. Epub 2021 Nov 14.
PubMed 34903493
Yoo Y, Lee CS, Kim J, Jo D, Moon JY. Botulinum Toxin Type A for Lumbar Sympathetic Ganglion Block in Complex Regional Pain Syndrome: A Randomized Trial. Anesthesiology. 2022 Feb 1;136(2):314-325. doi: 10.1097/ALN.0000000000004084.
PubMed 34890455
Defina S, Niedernhuber M, Shenker N, Brown CA, Bekinschtein TA. Attentional modulation of neural dynamics in tactile perception of complex regional pain syndrome patients. Eur J Neurosci. 2021 Aug;54(4):5601-5619. doi: 10.1111/ejn.15387. Epub 2021 Jul 22.
PubMed 34250660
Lunden LK, Jorum E. The challenge of recognizing severe pain and autonomic abnormalities for early diagnosis of CRPS. Scand J Pain. 2021 Apr 12;21(3):548-559. doi: 10.1515/sjpain-2021-0036. Print 2021 Jul 27.
PubMed 33838088
Beales D, Carolan D, Chuah-Choong J, Hammond S, O'Brien E, Boyle E, Ranelli S, Holthouse D, Mitchell T, Slater H. Exploring peoples' lived experience of complex regional pain syndrome in Australia: a qualitative study. Scand J Pain. 2021 Jan 6;21(2):393-405. doi: 10.1515/sjpain-2020-0142. Print 2021 Apr 27.
PubMed 34387965
Canos-Verdecho A, Abejon D, Robledo R, Izquierdo R, Bermejo A, Gallach E, Argente P, Peraita-Costa I, Morales-Suarez-Varela M. Randomized Prospective Study in Patients With Complex Regional Pain Syndrome of the Upper Limb With High-Frequency Spinal Cord Stimulation (10-kHz) and Low-Frequency Spinal Cord Stimulation. Neuromodulation. 2021 Apr;24(3):448-458. doi: 10.1111/ner.13358. Epub 2021 Jan 18.
PubMed 33462918
Halicka M, Vitterso AD, McCullough H, Goebel A, Heelas L, Proulx MJ, Bultitude JH. Prism adaptation treatment for upper-limb complex regional pain syndrome: a double-blind randomized controlled trial. Pain. 2021 Feb 1;162(2):471-489. doi: 10.1097/j.pain.0000000000002053.
PubMed 32833791
Yavuz Keles B, Onder B, Kesiktas FN, Ones K, Paker N. Acute effects of contrast bath on sympathetic skin response in patients with poststroke complex regional pain syndrome. Somatosens Mot Res. 2020 Dec;37(4):320-325. doi: 10.1080/08990220.2020.1830756. Epub 2020 Oct 14.
PubMed 33135537
Frederico TN, da Silva Freitas T. Peripheral Nerve Stimulation of the Brachial Plexus for Chronic Refractory CRPS Pain of the Upper Limb: Description of a New Technique and Case Series. Pain Med. 2020 Aug 1;21(Suppl 1):S18-S26. doi: 10.1093/pm/pnaa201.
PubMed 32804227
Halicka M, Vitterso AD, McCullough H, Goebel A, Heelas L, Proulx MJ, Bultitude JH. Disputing space-based biases in unilateral complex regional pain syndrome. Cortex. 2020 Jun;127:248-268. doi: 10.1016/j.cortex.2020.02.018. Epub 2020 Mar 13.
PubMed 32251901
Benedetti MG, Cavazzuti L, Mosca M, Fusaro I, Zati A. Bio-Electro-Magnetic-Energy-Regulation (BEMER) for the treatment of type I complex regional pain syndrome: A pilot study. Physiother Theory Pract. 2020 Apr;36(4):498-506. doi: 10.1080/09593985.2018.1491661. Epub 2018 Jul 9.
PubMed 29985719
Levy RM, Mekhail N, Kramer J, Poree L, Amirdelfan K, Grigsby E, Staats P, Burton AW, Burgher AH, Scowcroft J, Golovac S, Kapural L, Paicius R, Pope J, Samuel S, McRoberts WP, Schaufele M, Kent AR, Raza A, Deer TR. Therapy Habituation at 12 Months: Spinal Cord Stimulation Versus Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome Type I and II. J Pain. 2020 Mar-Apr;21(3-4):399-408. doi: 10.1016/j.jpain.2019.08.005. Epub 2019 Sep 5.
PubMed 31494275
Mancini F, Wang AP, Schira MM, Isherwood ZJ, McAuley JH, Iannetti GD, Sereno MI, Moseley GL, Rae CD. Fine-Grained Mapping of Cortical Somatotopies in Chronic Complex Regional Pain Syndrome. J Neurosci. 2019 Nov 13;39(46):9185-9196. doi: 10.1523/JNEUROSCI.2005-18.2019. Epub 2019 Sep 30.
PubMed 31570533
Lewis JS, Kellett S, McCullough R, Tapper A, Tyler C, Viner M, Palmer S. Body Perception Disturbance and Pain Reduction in Longstanding Complex Regional Pain Syndrome Following a Multidisciplinary Rehabilitation Program. Pain Med. 2019 Nov 1;20(11):2213-2219. doi: 10.1093/pm/pnz176.
PubMed 31373373
Kim YH, Kim SY, Lee YJ, Kim ED. A Prospective, Randomized Cross-Over Trial of T2 Paravertebral Block as a Sympathetic Block in Complex Regional Pain Syndrome. Pain Physician. 2019 Sep;22(5):E417-E424.
PubMed 31561653

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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CRPS (Complex Regional Pain Syndromes)
RecruitingPhase 3
Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
Complex Regional Pain Syndrome Type I
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain

All Complex Regional Pain Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physical and Psychological Changes in Complex Regional Pain Syndrome (CRPS) Patients Undergoing Multimodal Rehabilitation
ClinicalTrials.gov ID: NCT05696587
Acronym / sponsor ID: STATUT 2020
Conditions: Complex Regional Pain Syndromes
Keywords: CRPS, cognitive functions, physical therapy, pain, Graded Motor Imagery, mirror therapy, rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, PolandResearch network
Study start: 10 Oct 2021 (actual)
Primary completion: 20 Jan 2023 (actual)
Study completion: 1 Feb 2023 (actual)
First posted: 25 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of this clinical trial is to learn about cognitive changes during rehabilitation in CRPS patients. The main questions it aims to answer are:

What are the cognitive changes in CRPS?
Do cognitive functions change during multimodal rehabilitation in CRPS?
What is the effect of multimodal rehabilitation on pain, functioning, mood, active range of motion, cognitive functions.

Participants will undergo a 4-week program of multimodal rehabilitation of physical therapy, education and Graded Motor Imagery. Assessment will be made at baseline and after 4 weeks.

Researchers will compare the interventional arm with healthy control to see if the observed psychological results are exclusive to CRPS group.

There is no expanded access scheduled for this study.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Treatment arm will undergo a 4-week multimodal rehabilitation program with outcome measures recorded at baseline and at 4 weeks. Healthy control will be assessed for psychological outcome measures at baseline and at 4 weeks, with no intervention applied.

Arm	Type	Receives
CRPS	Experimental	Other: Multimodal rehabilitationParticipants meeting inclusion and exclusion criteria undergoing 4-week multimodal rehabilitation, undergoing assessment at baseline and at 4 weeks.
Healthy Control	No intervention	–Participants matched according to sex, age and education to experimental arm, undergoing psychological assessment at baseline and at 4 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Clinical diagnosis of CRPS (or equivalent);
MMSE >24 points;
Has signed an informed consent to the study.

Key exclusion criteria (2 listed)

MMSE ≤24 points;
Inability to perform scheduled tasks (multimodal rehabilitation program).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Multimodal rehabilitationThe multimodal rehabilitation program included comprehensive therapy 5 times a week during the 4 weeks between assessments. The therapy consists of: * Individual physical therapy focused on improving range of motion and alleviating pain in the affected limb; * Mechanical desensitization; * Transcutaneous electric nerve stimulation (TENS) electrotherapy; * Aquatherapy (arm or leg whirlpool bath of the affected extremity); * Graded Motor Imagery, including the Recognise™ app and mirror therapy; * Psychoeducation on relaxation and coping with chronic pain.	Other	CRPS

Primary outcome

Mean change from baseline in Reproduction score on the Rey's Complex Figure Test (RCFT) score at 4 weeks.
Time frame: At baseline and in 4 weeks
The RCFT is a task-based test assessing visual-spatial abilities. Reproduction score measures learning and planning on visual material. Possible scores range from 0 (significant deficit) to 36 (highest possible score). Change = (week 4 score - baseline score).

28 secondary outcomes

Mean change from baseline in Copy score on the Rey's Complex Figure Test (RCFT) score at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in pain score on the Numeric Rating Scale (NRS) at 4 weeks
Time frame: At baseline and in 4 weeks
Mean change from baseline in Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) at 4 weeks in Participants with upper extremity CRPS
Time frame: At baseline and in 4 weeks
Mean change from baseline in Lower Extremity Functional Scale (LEFS) at 4 weeks in Participants with lower extremity CRPS
Time frame: At baseline and in 4 weeks
Number of Participants meeting the Budapest Criteria for CRPS at baseline as percent of Participants in the CRPS arm
Time frame: Baseline
Mean change from baseline in active range of motion (aROM) of affected joint at 4 weeks
Time frame: At baseline and in 4 weeks
Mean change from baseline in Central Sensitization Inventory (CSI) part A at 4 weeks
Time frame: At baseline and in 4 weeks
Mean change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) part A score at 4 weeks
Time frame: At baseline and in 4 weeks
Mean change from baseline in PainDetect Questionnaire (PDQ) score at 4 weeks
Time frame: At baseline and in 4 weeks
Mean change from baseline in Diverting Attention score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in Reinterpreting Pain Sensations score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in Catastrophizing score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in Ignoring Sensation score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in Praying or Hoping score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in Coping Self Statements score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in Increased Behavioral Activity score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in Control Over Pain score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in Ability to Decrease Pain score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean score on the Mini-Mental State Examination (MMSE) at baseline.
Time frame: Baseline
Mean change from baseline in Total Number Correct score in Benton Visual Retention Test (BVRT) at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in Number of Errors score in the Benton Visual Retention Test (BVRT) at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in Digit Span (DS) score in Wechsler's Adult Intelligence Scale Revised (WAIS-R) at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in Beck Depression Inventory - II (BDI-II) score at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in Speed of Work score in the Attention and Perceptiveness Test (TUS) - at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in Number of Mistakes score in the Attention and Perceptiveness Test (TUS) at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in Number of Omissions in the Attention and Perceptiveness Test (TUS) at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in execution time in the Color-Trials Test part 1 (CTT-1) at 4 weeks.
Time frame: At baseline and in 4 weeks
Mean change from baseline in shifting attention score on the Color-Trials Test part 2 (CTT-2) at 4 weeks.
Time frame: At baseline and in 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
Background: PubMed 34903493Fallico N, Padmanabhan R, Rahman S, Somma F, Spagnoli AM. A randomised placebo-controlled clinical trial on the efficacy of local lidocaine injections and oral citalopram for the treatment of complex regional pain syndrome. J Plast Reconstr Aesthet Surg. 2022 Mar;75(3):970-979. doi: 10.1016/j.bjps.2021.11.022. Epub 2021 Nov 14.
Background: PubMed 34890455Yoo Y, Lee CS, Kim J, Jo D, Moon JY. Botulinum Toxin Type A for Lumbar Sympathetic Ganglion Block in Complex Regional Pain Syndrome: A Randomized Trial. Anesthesiology. 2022 Feb 1;136(2):314-325. doi: 10.1097/ALN.0000000000004084.
Background: PubMed 34250660Defina S, Niedernhuber M, Shenker N, Brown CA, Bekinschtein TA. Attentional modulation of neural dynamics in tactile perception of complex regional pain syndrome patients. Eur J Neurosci. 2021 Aug;54(4):5601-5619. doi: 10.1111/ejn.15387. Epub 2021 Jul 22.
Background: PubMed 33838088Lunden LK, Jorum E. The challenge of recognizing severe pain and autonomic abnormalities for early diagnosis of CRPS. Scand J Pain. 2021 Apr 12;21(3):548-559. doi: 10.1515/sjpain-2021-0036. Print 2021 Jul 27.
Background: PubMed 34387965Beales D, Carolan D, Chuah-Choong J, Hammond S, O'Brien E, Boyle E, Ranelli S, Holthouse D, Mitchell T, Slater H. Exploring peoples' lived experience of complex regional pain syndrome in Australia: a qualitative study. Scand J Pain. 2021 Jan 6;21(2):393-405. doi: 10.1515/sjpain-2020-0142. Print 2021 Apr 27.
Background: PubMed 33462918Canos-Verdecho A, Abejon D, Robledo R, Izquierdo R, Bermejo A, Gallach E, Argente P, Peraita-Costa I, Morales-Suarez-Varela M. Randomized Prospective Study in Patients With Complex Regional Pain Syndrome of the Upper Limb With High-Frequency Spinal Cord Stimulation (10-kHz) and Low-Frequency Spinal Cord Stimulation. Neuromodulation. 2021 Apr;24(3):448-458. doi: 10.1111/ner.13358. Epub 2021 Jan 18.
Background: PubMed 32833791Halicka M, Vitterso AD, McCullough H, Goebel A, Heelas L, Proulx MJ, Bultitude JH. Prism adaptation treatment for upper-limb complex regional pain syndrome: a double-blind randomized controlled trial. Pain. 2021 Feb 1;162(2):471-489. doi: 10.1097/j.pain.0000000000002053.
Background: PubMed 33135537Yavuz Keles B, Onder B, Kesiktas FN, Ones K, Paker N. Acute effects of contrast bath on sympathetic skin response in patients with poststroke complex regional pain syndrome. Somatosens Mot Res. 2020 Dec;37(4):320-325. doi: 10.1080/08990220.2020.1830756. Epub 2020 Oct 14.
Background: PubMed 32804227Frederico TN, da Silva Freitas T. Peripheral Nerve Stimulation of the Brachial Plexus for Chronic Refractory CRPS Pain of the Upper Limb: Description of a New Technique and Case Series. Pain Med. 2020 Aug 1;21(Suppl 1):S18-S26. doi: 10.1093/pm/pnaa201.
Background: PubMed 32251901Halicka M, Vitterso AD, McCullough H, Goebel A, Heelas L, Proulx MJ, Bultitude JH. Disputing space-based biases in unilateral complex regional pain syndrome. Cortex. 2020 Jun;127:248-268. doi: 10.1016/j.cortex.2020.02.018. Epub 2020 Mar 13.
Background: PubMed 29985719Benedetti MG, Cavazzuti L, Mosca M, Fusaro I, Zati A. Bio-Electro-Magnetic-Energy-Regulation (BEMER) for the treatment of type I complex regional pain syndrome: A pilot study. Physiother Theory Pract. 2020 Apr;36(4):498-506. doi: 10.1080/09593985.2018.1491661. Epub 2018 Jul 9.
Background: PubMed 31494275Levy RM, Mekhail N, Kramer J, Poree L, Amirdelfan K, Grigsby E, Staats P, Burton AW, Burgher AH, Scowcroft J, Golovac S, Kapural L, Paicius R, Pope J, Samuel S, McRoberts WP, Schaufele M, Kent AR, Raza A, Deer TR. Therapy Habituation at 12 Months: Spinal Cord Stimulation Versus Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome Type I and II. J Pain. 2020 Mar-Apr;21(3-4):399-408. doi: 10.1016/j.jpain.2019.08.005. Epub 2019 Sep 5.
Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification will be made published on Open Science Framework.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Beata Tarnacka, ASSC PROF study director

National Institute of Geriatrics, Rheumatology and Rehabilitation

Adam Zalewski, MD principal investigator

National Institute of Geriatrics, Rheumatology and Rehabilitation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal rehabilitation in people with Complex Regional Pain Syndromes, run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline in Reproduction score on the Rey's Complex Figure Test (RCFT) score at 4 weeks. (time frame: At baseline and in 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05696587, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.