Complex Regional Pain Syndrome Type INCT00625976
Graded Exposure (GEXP) in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I)
A study testing Graded exposure in vivo and Physiotherapy in people with Complex Regional Pain Syndrome Type I, run by Maastricht University Medical Center.
Trial summary
Background: Research on the treatment of CRPS-I, as described in the Dutch evidence based treatment guidelines (Richtlijn Complex Regional Pain Syndrome type I, 2006), mainly showed improvement at the level of pain and coping with pain. Only little improvement in functional restoration was found. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Complex Regional Pain Syndrome Type I
- What is being tested?
- Graded exposure in vivo and Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Sep 2014
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis CRPS-I according to IASP criteria.
- Pain related (PHODA-LE-score ≥ 35 and PHODA-UE-score ≥ 32)
- Age between 18 and 65.
- Rehabilitation treatment has been indicated.
Who cannot join
- Pregnancy.
- Insufficient fluency in Dutch.
- Generalized pain syndrome.
- Dystonia.
- Sympathectomy of the affected extremity.
- Psychopathology
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- Involvement in a claim regarding the disease.
- Substance abuse.
- Symptoms on both upper or both lower extremities.
About this study
Official title: The Effectivity of Graded Exposure in Vivo Versus Standardized Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I) Patients With Pain Related Fear: a Randomized Clinical Trial
Background:
Research on the treatment of CRPS-I, as described in the Dutch evidence based treatment guidelines (Richtlijn Complex Regional Pain Syndrome type I, 2006), mainly showed improvement at the level of pain and coping with pain. Only little improvement in functional restoration was found. Research in other pain populations such al neck- and back-pain patients has shown that pain related fear contributes to the development of functional disability. GEXP in vivo which aims on systematically reducing fear of movement, shows promising results in CRPS-I patients (de Jong et al., 2005).
Read more
Objective:
The objective of the proposed project is to compare the effectivity of GEXP in vivo with that of standardized physiotherapy in CRPS-I patients with pain related fear.
Design:
The study concerns a single blinded, single center, randomized clinical trial. The treatment will be preceded by two pre-measures. After treatment there will be one post-measurement and 3, 6 and 12 month follow-up measurements.
Population:
The study population will consist of chronic CRPS-I patients between 18 and 65, with pain related fear (PHODA-LE-score ≥ 35 and PHODA-UE-score ≥ 32).
Intervention:
The two interventions that will be compared are GEXP in vivo (de Jong et al., 2005) and standardized physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo en Goris (1999). The GEXP in vivo comprises 17 sessions of one hour, the physiotherapy treatment of 34 sessions of 30 minutes. Both treatments will be given over a period of 17 weeks.
- Conditions
- Complex Regional Pain Syndrome Type I
- Being tested
- Graded exposure in vivo, Physiotherapy
- Keywords
- Complex regional pain syndrome type I, Graded exposure in vivo, Physiotherapy, Pain-related fear
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded exposure in vivoBehavioural
Graded exposure in vivo according to the protocol of de Jong et al. (2005)
PhysiotherapyBehavioural
Physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo and Goris (1999)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Graded exposure in vivo |
| 2 | Experimental | Not described Receives: Behavioral: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional disability measured with: Radboud Skills Questionnaire (RASQ; Oerlemans, Cup et al., 2000), for upper limbs; Walking Ability Questionnaire (WAQ; Perez et al., 2002), for lower limbs
Measured: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Secondary outcomes (9)
Physical activity in daily life
Measured: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Body function and structure
Measured: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Fear of movement
Measured: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Fear of pain
Measured: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Catastrophizing Scale
Measured: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Coping with pain
Measured: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Emotional distress
Measured: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Participation
Measured: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Emotional involvement
Measured: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2012
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain Syndrome Type IStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marielle Goossens, Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625976
- Sponsor's protocol ID
- MEC 08-3-004
- Other IDs
- NL20067.068.08
- Status last verified
- Sep 2014
- First submitted
- 21 Feb 2008
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectivity of Graded Exposure in Vivo Versus Standardized Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I) Patients With Pain Related Fear: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00625976
- Acronym / sponsor ID
- MEC 08-3-004
- Conditions
- Complex Regional Pain Syndrome Type I
- Keywords
- Complex regional pain syndrome type I, Graded exposure in vivo, Physiotherapy, Pain-related fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 29 Feb 2008 (estimated)
- 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.
Background:
Research on the treatment of CRPS-I, as described in the Dutch evidence based treatment guidelines (Richtlijn Complex Regional Pain Syndrome type I, 2006), mainly showed improvement at the level of pain and coping with pain. Only little improvement in functional restoration was found. Research in other pain populations such al neck- and back-pain patients has shown that pain related fear contributes to the development of functional disability. GEXP in vivo which aims on systematically reducing fear of movement, shows promising results in CRPS-I patients (de Jong et al., 2005).
Objective:
The objective of the proposed project is to compare the effectivity of GEXP in vivo with that of standardized physiotherapy in CRPS-I patients with pain related fear.
Design:
The study concerns a single blinded, single center, randomized clinical trial. The treatment will be preceded by two pre-measures. After treatment there will be one post-measurement and 3, 6 and 12 month follow-up measurements.
Population:
The study population will consist of chronic CRPS-I patients between 18 and 65, with pain related fear (PHODA-LE-score ≥ 35 and PHODA-UE-score ≥ 32).
Intervention:
The two interventions that will be compared are GEXP in vivo (de Jong et al., 2005) and standardized physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo en Goris (1999). The GEXP in vivo comprises 17 sessions of one hour, the physiotherapy treatment of 34 sessions of 30 minutes. Both treatments will be given over a period of 17 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Graded exposure in vivo |
| 2 | Experimental | Behavioral: Physiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis CRPS-I according to IASP criteria.
- Pain related (PHODA-LE-score ≥ 35 and PHODA-UE-score ≥ 32)
- Age between 18 and 65.
- Rehabilitation treatment has been indicated.
Key exclusion criteria (9 listed)
- Pregnancy.
- Insufficient fluency in Dutch.
- Generalized pain syndrome.
- Dystonia.
- Sympathectomy of the affected extremity.
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 |
|---|---|---|
| Graded exposure in vivoGraded exposure in vivo according to the protocol of de Jong et al. (2005) | Behavioural | 1 |
| PhysiotherapyPhysiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo and Goris (1999) | Behavioural | 2 |
Primary outcome
Functional disability measured with: Radboud Skills Questionnaire (RASQ; Oerlemans, Cup et al., 2000), for upper limbs; Walking Ability Questionnaire (WAQ; Perez et al., 2002), for lower limbs
Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
9 secondary outcomes
Physical activity in daily life
Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Body function and structure
Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Fear of movement
Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Fear of pain
Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Catastrophizing Scale
Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Coping with pain
Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Emotional distress
Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Participation
Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
Emotional involvement
Time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up
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 19 Sep 2014.
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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.
Marielle Goossens, Dr. principal investigator
Maastricht University
Questions about this trial
What is this clinical trial studying?
A study testing Graded exposure in vivo and Physiotherapy in people with Complex Regional Pain Syndrome Type I, run by Maastricht University Medical Center.
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 4 inclusion and 9 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 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Functional disability measured with: Radboud Skills Questionnaire (RASQ; Oerlemans, Cup et al., 2000), for upper limbs; Walking Ability Questionnaire (WAQ; Perez et al., 2002), for lower limbs (time frame: 2 times pre treatment, one time post treatment and at 3, 6 and 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2014.