Complex Regional Pain Syndrome, Type IPhase 2/3PEPTOCNCT00817128
Pain Exposure Physical Therapy (PEPT) Versus CBO in Patients With Complex Regional Pain Syndrome Type I (CRPS-1)
A Phase 2/3 study testing PEPT and CBO standard in people with Complex Regional Pain Syndrome, Type I, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The current Dutch CBO guideline treatment of Complex Regional Pain Syndrome Type I (CRPS-1) is very disappointing with chronification, disability and subsequent high medical costs and personal suffering. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complex Regional Pain Syndrome, Type I
- What is being tested?
- PEPT and CBO standard
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2009to Jul 2012
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 80 years of age with Complex Regional pain Syndrome (CRPS-1) of either upper or lower extremity according to Bruehl's/IASP criteria between 3 and 24 months after initial injury will be selected for the study.
Who cannot join
- Patients who do not comply with the inclusion criteria especially those who have other causes that may explain a pain syndrome will be excluded (IASP criterium)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Exposure Physical Therapy Or Conservative Therapy for Patients With Complex Regional Pain Syndrome Type I
The current Dutch CBO guideline treatment of Complex Regional Pain Syndrome Type I (CRPS-1) is very disappointing with chronification, disability and subsequent high medical costs and personal suffering. A possible better treatment is intensive function-oriented physical therapy or Pain Exposure in Physical Therapy (PEPT). However, there are no adequate studies performed that demonstrate the efficacy of PEPT and therefore PEPT is lacking in the Dutch CBO CRPS-1 guidelines. Despite a lacking scientific argumentation, the PEPT approach or Macedonian therapy, is now being adopted on a large scale among physical therapists in The Netherlands. There are two level C retrospective cohort studies demonstrating a promising and clinical relevant beneficial effect on pain and function after PEPT. In response to the growing demand for scientific argumentation among doctors and physical therapists with respect to the efficacy of PEPT, we conducted a pilot study at the UMC St Radboud Nijmegen. The results of this pilot study were very promising and therefore, we decided to design a large RCT to investigate the treatment effects and costs in CRPS patients treated with PEPT compared to CRPS patients treated with usual therapy according to the Dutch CBO guidelines.
Read the detailed description
Hypothesis:
PEPT is expected to be 30% more effective and around three-folds cheaper than usual therapy (CBO)
Objective:
The current Dutch CBO guideline treatment of Complex Regional Pain Syndrome Type I (CRPS-1) is very disappointing with chronification, disability and subsequent high medical costs and personal suffering. A possible better treatment is intensive function-oriented physical therapy or Pain Exposure in Physical Therapy (PEPT). However, there are no adequate studies performed that demonstrate the efficacy of PEPT and therefore PEPT is lacking in the Dutch CBO CRPS-1 guidelines. Despite a lacking scientific argumentation, the PEPT approach or Macedonian therapy, is now being adopted on a large scale among physical therapists in The Netherlands. There are two level C retrospective cohort studies demonstrating a promising and clinical relevant beneficial effect on pain and function after PEPT. In response to the growing demand for scientific argumentation among doctors and physical therapists with respect to the efficacy of PEPT, we conducted a pilot study at the UMC St Radboud Nijmegen. The results of this pilot study were very promising and therefore, we decided to design a large RCT to investigate the treatment effects and costs in CRPS patients treated with PEPT compared to CRPS patients treated with usual therapy according to the Dutch CBO guidelines.
Study design:
Prospective, single-blinded, randomized clinical trial. After base-line measurements (T0), measurements are performed at three (T1) and six months (T2) after inclusion. Follow-up is at nine months (T3).
Study population:
Patients with Complex Regional pain Syndrome (CRPS-1) of either upper or lower extremity according to Bruehl's/IASP criteria (see attachment) between 3 and 24 months after initial injury will be selected for the study. After information about standard and experimental treatments for CRPS and after informed consent, patients will enter the study and randomization for usual (CBO) or experimental (PEPT) treatment will be performed.
Intervention:
Treatment group: In the treatment group medication prescribed for CRPS is tapered to zero. No invasive treatments like sympathetic blocks, and/or operations will be performed. After information about the mechanism of action of PEPT in relation to CRPS, patients receive five sessions of PEPT including homework exercises. The basic of PEPT is a function-oriented exercise therapy. The PEPT physical therapist manipulates restricted joints and intensively trains functional skills irrespective of pain experience during or after the therapy. Patients are stimulated to use an active coping style to achieve a clear functional goal in 5 sessions.
Control group: Usual treatment of CRPS according to the Dutch CBO CRPS guideline 2006 including, analgesics (WHO pain ladder), neuropathic drugs, N-acetylcysteine, calcium channel blocker, ketanserin and DMSO (dimethylsulphoxide). On indication, percutaneous sympathetic blocks or spinal cord stimulation will be performed. In addition, patients receive physical therapy with exercises within pain limits (pain contingent), splints and if necessary, aids for ADL activities.
Outcome measures:
Primary outcome measure is the Impairment level SumScore (ISS), which consists of three measurement parameters (pain, active range of motion and temperature) and four measurement instruments (VAS, McGill Pain Questionnaire, goniometry of mobility of joints and skin thermometer). A cost-effectiveness analysis from a societal perspective comparing PEPT to usual care in patients with CRPS will be performed. This will be done along-side the clinical trial.
Sample size calculation/data analysis:
The sample size calculation is based on the following finding and expectation. The improvement in ISS (primary outcome) over one year for the standard physical therapy group was 50% [Oerlemans, APMR 2000], for the PEPT group it is estimated at minimal 70-80%. Given an alpha of 0,05 and a power of 80% for a one sided Chi-square test 31 patients are needed per group. The Student T- test is used to calculate differences between both groups in mean ISS.
- Conditions
- Complex Regional Pain Syndrome, Type I
- Being tested
- PEPT, CBO standard
- Keywords
- Complex Regional Pain Syndrome Type I, Sympathetic Reflex Dystrophy, Pain Exposure Physical Therapy, Pharmacological treatment, Functional recovery
- Medical subject headings
- Reflex Sympathetic Dystrophy, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEPTProcedure or surgery
Pain Exposure Physical Therapy
CBO standardProcedure or surgery
Standard therapy as defined in CBO guideline 2006
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PEPT after randomization Receives: Procedure: PEPT |
| 2 | Experimental | CBO after randomization Receives: Procedure: CBO standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure is the Impairment level SumScore (ISS): pain, active range of motion and temperature, measured with VAS, McGill Pain Questionnaire, goniometry of mobility of joints and skin thermometer
Measured: t=0; t= 3 months; t= 6 months; t= 9 months
Secondary outcomes (1)
DASH; FABQ; SF36; mycrofet dynamometer; RSQ; 10 meter walking test and the timed up-and-go-test; Adherence behavior; Seven Days PAR; IPAQ; PCS; PDI; PAM; Economic evaluation with diary; EuroQol 5D; adverse reactions SAE forms
Measured: t=0; t=3 months; t= 6 months; t= 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain Syndrome, Type IStudies of the same condition, open and under way.
- More trials run by Radboud 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Jan Paul Frolke, Radboud University Medical Center
- Investigators
- Jan Paul Frölke, MD; PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817128
- Sponsor's protocol ID
- 170991004
- Other IDs
- ZonMw 1709901004
- Acronym
- PEPTOC
- Status last verified
- Jul 2013
- First submitted
- 5 Jan 2009
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Oerlemans HM, Oostendorp RA, de Boo T, van der Laan L, Severens JL, Goris JA. Adjuvant physical therapy versus occupational therapy in patients with reflex sympathetic dystrophy/complex regional pain syndrome type I. Arch Phys Med Rehabil. 2000 Jan;81(1):49-56.
PubMed 10638876Sherry DD, Wallace CA, Kelley C, Kidder M, Sapp L. Short- and long-term outcomes of children with complex regional pain syndrome type I treated with exercise therapy. Clin J Pain. 1999 Sep;15(3):218-23. doi: 10.1097/00002508-199909000-00009.
PubMed 10524475Perez RS, Oerlemans HM, Zuurmond WW, De Lange JJ. Impairment level SumScore for lower extremity Complex Regional Pain Syndrome type I. Disabil Rehabil. 2003 Sep 2;25(17):984-91. doi: 10.1080/0963828031000122302.
PubMed 12851087Vaneker M, Wilder-Smith OH, Schrombges P, Oerlemans HM. Impairments as measured by ISS do not greatly change between one and eight years after CRPS 1 diagnosis. Eur J Pain. 2006 Oct;10(7):639-44. doi: 10.1016/j.ejpain.2005.10.003. Epub 2005 Nov 21.
PubMed 16300975Frolke JP, Bruggeman AW, Klomp FP, Smeets JL. Brugada syndrome during physical therapy: a case report. Cases J. 2008 Aug 18;1(1):107. doi: 10.1186/1757-1626-1-107.
PubMed 18710557Barnhoorn KJ, van de Meent H, van Dongen RT, Klomp FP, Groenewoud H, Samwel H, Nijhuis-van der Sanden MW, Frolke JP, Staal JB. Pain exposure physical therapy (PEPT) compared to conventional treatment in complex regional pain syndrome type 1: a randomised controlled trial. BMJ Open. 2015 Dec 1;5(12):e008283. doi: 10.1136/bmjopen-2015-008283.
PubMed 26628523Barnhoorn KJ, Staal JB, van Dongen RT, Frolke JP, Klomp FP, van de Meent H, Samwel H, Nijhuis-van der Sanden MW. Are pain-related fears mediators for reducing disability and pain in patients with complex regional pain syndrome type 1? An explorative analysis on pain exposure physical therapy. PLoS One. 2015 Apr 28;10(4):e0123008. doi: 10.1371/journal.pone.0123008. eCollection 2014.
PubMed 25919011Barnhoorn KJ, Oostendorp RA, van Dongen RT, Klomp FP, Samwel H, van der Wilt GJ, Adang E, Groenewoud H, van de Meent H, Frolke JP. The effectiveness and cost evaluation of pain exposure physical therapy and conventional therapy in patients with complex regional pain syndrome type 1. Rationale and design of a randomized controlled trial. BMC Musculoskelet Disord. 2012 Apr 19;13:58. doi: 10.1186/1471-2474-13-58.
PubMed 22515496
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Exposure Physical Therapy Or Conservative Therapy for Patients With Complex Regional Pain Syndrome Type I
- ClinicalTrials.gov ID
- NCT00817128
- Acronym / sponsor ID
- PEPTOC / 170991004
- Conditions
- Complex Regional Pain Syndrome, Type I
- Keywords
- Complex Regional Pain Syndrome Type I, Sympathetic Reflex Dystrophy, Pain Exposure Physical Therapy, Pharmacological treatment, Functional recovery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jan 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 6 Jan 2009 (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.
The current Dutch CBO guideline treatment of Complex Regional Pain Syndrome Type I (CRPS-1) is very disappointing with chronification, disability and subsequent high medical costs and personal suffering. A possible better treatment is intensive function-oriented physical therapy or Pain Exposure in Physical Therapy (PEPT). However, there are no adequate studies performed that demonstrate the efficacy of PEPT and therefore PEPT is lacking in the Dutch CBO CRPS-1 guidelines. Despite a lacking scientific argumentation, the PEPT approach or Macedonian therapy, is now being adopted on a large scale among physical therapists in The Netherlands. There are two level C retrospective cohort studies demonstrating a promising and clinical relevant beneficial effect on pain and function after PEPT. In response to the growing demand for scientific argumentation among doctors and physical therapists with respect to the efficacy of PEPT, we conducted a pilot study at the UMC St Radboud Nijmegen. The results of this pilot study were very promising and therefore, we decided to design a large RCT to investigate the treatment effects and costs in CRPS patients treated with PEPT compared to CRPS patients treated with usual therapy according to the Dutch CBO guidelines.
Detailed description
Hypothesis:
PEPT is expected to be 30% more effective and around three-folds cheaper than usual therapy (CBO)
Objective:
The current Dutch CBO guideline treatment of Complex Regional Pain Syndrome Type I (CRPS-1) is very disappointing with chronification, disability and subsequent high medical costs and personal suffering. A possible better treatment is intensive function-oriented physical therapy or Pain Exposure in Physical Therapy (PEPT). However, there are no adequate studies performed that demonstrate the efficacy of PEPT and therefore PEPT is lacking in the Dutch CBO CRPS-1 guidelines. Despite a lacking scientific argumentation, the PEPT approach or Macedonian therapy, is now being adopted on a large scale among physical therapists in The Netherlands. There are two level C retrospective cohort studies demonstrating a promising and clinical relevant beneficial effect on pain and function after PEPT. In response to the growing demand for scientific argumentation among doctors and physical therapists with respect to the efficacy of PEPT, we conducted a pilot study at the UMC St Radboud Nijmegen. The results of this pilot study were very promising and therefore, we decided to design a large RCT to investigate the treatment effects and costs in CRPS patients treated with PEPT compared to CRPS patients treated with usual therapy according to the Dutch CBO guidelines.
Study design:
Prospective, single-blinded, randomized clinical trial. After base-line measurements (T0), measurements are performed at three (T1) and six months (T2) after inclusion. Follow-up is at nine months (T3).
Study population:
Patients with Complex Regional pain Syndrome (CRPS-1) of either upper or lower extremity according to Bruehl's/IASP criteria (see attachment) between 3 and 24 months after initial injury will be selected for the study. After information about standard and experimental treatments for CRPS and after informed consent, patients will enter the study and randomization for usual (CBO) or experimental (PEPT) treatment will be performed.
Intervention:
Treatment group: In the treatment group medication prescribed for CRPS is tapered to zero. No invasive treatments like sympathetic blocks, and/or operations will be performed. After information about the mechanism of action of PEPT in relation to CRPS, patients receive five sessions of PEPT including homework exercises. The basic of PEPT is a function-oriented exercise therapy. The PEPT physical therapist manipulates restricted joints and intensively trains functional skills irrespective of pain experience during or after the therapy. Patients are stimulated to use an active coping style to achieve a clear functional goal in 5 sessions.
Control group: Usual treatment of CRPS according to the Dutch CBO CRPS guideline 2006 including, analgesics (WHO pain ladder), neuropathic drugs, N-acetylcysteine, calcium channel blocker, ketanserin and DMSO (dimethylsulphoxide). On indication, percutaneous sympathetic blocks or spinal cord stimulation will be performed. In addition, patients receive physical therapy with exercises within pain limits (pain contingent), splints and if necessary, aids for ADL activities.
Outcome measures:
Primary outcome measure is the Impairment level SumScore (ISS), which consists of three measurement parameters (pain, active range of motion and temperature) and four measurement instruments (VAS, McGill Pain Questionnaire, goniometry of mobility of joints and skin thermometer). A cost-effectiveness analysis from a societal perspective comparing PEPT to usual care in patients with CRPS will be performed. This will be done along-side the clinical trial.
Sample size calculation/data analysis:
The sample size calculation is based on the following finding and expectation. The improvement in ISS (primary outcome) over one year for the standard physical therapy group was 50% [Oerlemans, APMR 2000], for the PEPT group it is estimated at minimal 70-80%. Given an alpha of 0,05 and a power of 80% for a one sided Chi-square test 31 patients are needed per group. The Student T- test is used to calculate differences between both groups in mean ISS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: PEPTPEPT after randomization |
| 2 | Experimental | Procedure: CBO standardCBO after randomization |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between 18 and 80 years of age with Complex Regional pain Syndrome (CRPS-1) of either upper or lower extremity according to Bruehl's/IASP criteria between 3 and 24 months after initial injury will be selected for the study.
Key exclusion criteria (1 listed)
- Patients who do not comply with the inclusion criteria especially those who have other causes that may explain a pain syndrome will be excluded (IASP criterium)
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 |
|---|---|---|
| PEPTPain Exposure Physical Therapy | Procedure or surgery | 1 |
| CBO standardStandard therapy as defined in CBO guideline 2006 | Procedure or surgery | 2 |
Primary outcome
Primary outcome measure is the Impairment level SumScore (ISS): pain, active range of motion and temperature, measured with VAS, McGill Pain Questionnaire, goniometry of mobility of joints and skin thermometer
Time frame: t=0; t= 3 months; t= 6 months; t= 9 months
1 secondary outcome
DASH; FABQ; SF36; mycrofet dynamometer; RSQ; 10 meter walking test and the timed up-and-go-test; Adherence behavior; Seven Days PAR; IPAQ; PCS; PDI; PAM; Economic evaluation with diary; EuroQol 5D; adverse reactions SAE forms
Time frame: t=0; t=3 months; t= 6 months; t= 9 months
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 24 Jul 2013.
- Background: PubMed 10638876Oerlemans HM, Oostendorp RA, de Boo T, van der Laan L, Severens JL, Goris JA. Adjuvant physical therapy versus occupational therapy in patients with reflex sympathetic dystrophy/complex regional pain syndrome type I. Arch Phys Med Rehabil. 2000 Jan;81(1):49-56.
- Background: PubMed 10524475Sherry DD, Wallace CA, Kelley C, Kidder M, Sapp L. Short- and long-term outcomes of children with complex regional pain syndrome type I treated with exercise therapy. Clin J Pain. 1999 Sep;15(3):218-23. doi: 10.1097/00002508-199909000-00009.
- Background: PubMed 12851087Perez RS, Oerlemans HM, Zuurmond WW, De Lange JJ. Impairment level SumScore for lower extremity Complex Regional Pain Syndrome type I. Disabil Rehabil. 2003 Sep 2;25(17):984-91. doi: 10.1080/0963828031000122302.
- Background: PubMed 16300975Vaneker M, Wilder-Smith OH, Schrombges P, Oerlemans HM. Impairments as measured by ISS do not greatly change between one and eight years after CRPS 1 diagnosis. Eur J Pain. 2006 Oct;10(7):639-44. doi: 10.1016/j.ejpain.2005.10.003. Epub 2005 Nov 21.
- Background: PubMed 18710557Frolke JP, Bruggeman AW, Klomp FP, Smeets JL. Brugada syndrome during physical therapy: a case report. Cases J. 2008 Aug 18;1(1):107. doi: 10.1186/1757-1626-1-107.
- Derived from this study: PubMed 26628523Barnhoorn KJ, van de Meent H, van Dongen RT, Klomp FP, Groenewoud H, Samwel H, Nijhuis-van der Sanden MW, Frolke JP, Staal JB. Pain exposure physical therapy (PEPT) compared to conventional treatment in complex regional pain syndrome type 1: a randomised controlled trial. BMJ Open. 2015 Dec 1;5(12):e008283. doi: 10.1136/bmjopen-2015-008283.
- Derived from this study: PubMed 25919011Barnhoorn KJ, Staal JB, van Dongen RT, Frolke JP, Klomp FP, van de Meent H, Samwel H, Nijhuis-van der Sanden MW. Are pain-related fears mediators for reducing disability and pain in patients with complex regional pain syndrome type 1? An explorative analysis on pain exposure physical therapy. PLoS One. 2015 Apr 28;10(4):e0123008. doi: 10.1371/journal.pone.0123008. eCollection 2014.
- Derived from this study: PubMed 22515496Barnhoorn KJ, Oostendorp RA, van Dongen RT, Klomp FP, Samwel H, van der Wilt GJ, Adang E, Groenewoud H, van de Meent H, Frolke JP. The effectiveness and cost evaluation of pain exposure physical therapy and conventional therapy in patients with complex regional pain syndrome type 1. Rationale and design of a randomized controlled trial. BMC Musculoskelet Disord. 2012 Apr 19;13:58. doi: 10.1186/1471-2474-13-58.
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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.
Jan Paul Frölke, MD; PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PEPT and CBO standard in people with Complex Regional Pain Syndrome, Type I, run by Radboud University Medical Center at 1 site in Netherlands.
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 1 inclusion and 1 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 24 Jul 2013. 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 Netherlands. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary outcome measure is the Impairment level SumScore (ISS): pain, active range of motion and temperature, measured with VAS, McGill Pain Questionnaire, goniometry of mobility of joints and skin thermometer (time frame: t=0; t= 3 months; t= 6 months; t= 9 months). 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 NCT00817128, which also lists 8 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 24 Jul 2013.