F.P. Klomp

Safety of "pain exposure" physical therapy in patients with complex regional pain syndrome type 1.

&NA; “Pain exposure” physical therapy (PEPT) is a new treatment for patients with complex regional pain syndrome type 1 (CRPS‐1) that consists of a progressive‐loading exercise program and management of pain‐avoidance behavior without the use of specific CRPS‐1 medication or analgesics. The aim of this study was to investigate primarily whether PEPT could be applied safely in patients with CRPS‐1. Twenty patients with CRPS‐1 were consecutively enrolled in the study after giving informed consent. The diagnosis of CRPS‐1 was defined using the Bruehl and Harden/IASP diagnostic criteria. CRPS‐1 was diagnosed between 3 and 18 months after the inciting event (trauma). According to a multiple single‐case design (baseline [A1], treatment [B], follow‐up [A2]), multiple baseline and follow‐up measurements were performed to evaluate changes in CRPS signs and symptoms and to assess functional parameters. When comparing the baseline with the follow‐up phase, patients improved significantly with respect to pain on the visual analogue scale (57%), pain intensity (48%), muscle strength (52%), arm/shoulder/hand disability (36%), 10‐meter walking speed (29%), pain disability index (60%), kinesiophobia (18%), and the domains of perceived health change in the SF‐36 survey (269%). Three patients initially showed increased vegetative signs but improved in all other CRPS parameters and showed good functional recovery at follow‐up. We conclude that PEPT is a safe and effective treatment for patients with CRPS‐1. A progressive‐loading exercise program and management of pain‐avoidance behavior without the use of specific medication (“pain exposure” physical therapy) is safe and effective for patients with complex regional pain syndrome.

Pain exposure physical therapy may be a safe and effective treatment for longstanding complex regional pain syndrome type 1: a case series:

Objective: To determine if treatment of longstanding complex regional pain syndrome type 1, focusing on functional improvement only while neglecting pain, results in clinical improvement of this syndrome. Design: Prospective description of a case series of 106 patients. Setting: Outpatient clinic for rehabilitation. Interventions: Physical therapy of the affected limb directed at a functional improvement only while neglecting the pain, was performed following an extensive explanation. Normal use of the limb between the treatments was encouraged despite pain. A maximum of five of these sessions were performed in three months. Measures: Radboud Skills Test was used to monitor functional improvement of the arms. Speed and walking distance was used as the measure of outcome for the legs. Results: The function of the affected arm or leg improved in 95 patients. Full functional recovery was experienced in 49 (46%) of them. A reduction in pain presented in 75 patients. In 23 patients functional recovery was reached despite an increase in pain. Four patients stopped early due to pain increase. Conclusions: Our results suggest that ‘pain exposure physical therapy’ is effective and safe for patients who are unresponsive to accepted standard therapies. Avoiding the use of a limb due to pain will result in loss of function. Forced usage of limbs restores the function, reverses these adaptive processes and leads to regain of control by practice with a reduction of pain in most cases.

Pain exposure physical therapy (PEPT) compared to conventional treatment in complex regional pain syndrome type 1: a randomised controlled trial

Objective To compare the effectiveness of pain exposure physical therapy (PEPT) with conventional treatment in patients with complex regional pain syndrome type 1 (CRPS-1) in a randomised controlled trial with a blinded assessor. Setting The study was conducted at a level 1 trauma centre in the Netherlands. Participants 56 adult patients with CRPS-1 participated. Three patients were lost to follow-up. Interventions Patients received either PEPT in a maximum of five treatment sessions, or conventional treatment following the Dutch multidisciplinary guideline. Measurements Outcomes were assessed at baseline and at 3, 6 and 9 months after randomisation. The primary outcome measure was the Impairment level Sum Score—Restricted Version (ISS-RV), consisting of visual analogue scale for pain (VAS-pain), McGill Pain Questionnaire, active range of motion (AROM) and skin temperature. Secondary outcome measures included Pain Disability Index (PDI); muscle strength; Short Form 36 (SF-36); disability of arm, shoulder and hand; Lower Limb Tasks Questionnaire (LLTQ); 10 m walk test; timed up-and-go test (TUG) and EuroQol-5D. Results The intention-to-treat analysis showed a clinically relevant decrease in ISS-RV (6.7 points for PEPT and 6.2 points for conventional treatment), but the between-group difference was not significant (0.96, 95% CI −1.56 to 3.48). Participants allocated to PEPT experienced a greater improvement in AROM (between-group difference 0.51, 95% CI 0.07 to 0.94; p=0.02). The per protocol analysis showed larger and significant between-group effects on ISS-RV, VAS-pain, AROM, PDI, SF-36, LLTQ and TUG. Conclusions We cannot conclude that PEPT is superior to conventional treatment for patients with CRPS-1. Further high-quality research on the effects of PEPT is warranted given the potential effects as indicated by the per protocol analysis. Trial registration numbers NCT00817128 and NTR 2090.

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.

BackgroundPain Exposure Physical Therapy is a new treatment option for patients with Complex Regional Pain Syndrome type 1. It has been evaluated in retrospective as well as in prospective studies and proven to be safe and possibly effective. This indicates that Pain Exposure Physical Therapy is now ready for clinical evaluation. The results of an earlier performed pilot study with an n = 1 design, in which 20 patients with Complex Regional Pain Syndrome type 1 were treated with Pain Exposure Physical Therapy, were used for the design and power calculation of the present study.After completion and evaluation of this phase III study, a multi-centre implementation study will be conducted.The aim of this study is to determine whether Pain Exposure Physical Therapy can improve functional outcomes in patients with Complex Regional Pain Syndrome type 1.Methods/designThis study is designed as a single-blinded, randomized clinical trial. 62 patients will be randomized with a follow-up of 9 months to demonstrate the expected treatment effect. Complex Regional Pain Syndrome type 1 is diagnosed in accordance with the Bruehl/International Association for the Study of Pain criteria. Conventional therapy in accordance with the Dutch guideline will be compared with Pain Exposure Physical Therapy. Primary outcome measure is the Impairment level SumScore, restricted version.DiscussionThis is the first randomized controlled study with single blinding that has ever been planned in patients with Complex Regional Pain Syndrome type 1 and does not focus on a single aspect of the pain syndrome but compares treatment strategies based on completely different pathophysiological and cognitive theories.Trial registrationClinical trials NCT00817128; National Trial Register NTR2090

Brugada syndrome during physical therapy: a case report.

This case report describes about a young, male patient with persisting syncope during physical therapy for complex regional pain syndrome type 1 after metatarsal fractures.The patient was referred to the Emergency Department, where Brugada syndrome was diagnosed. A cardioverter defibrillator was prophylactically implanted successfully. After this procedure, there were no contraindications for resuming further physical therapy for his painful foot. No clear causal inference with Brugada could be drawn from the complex regional pain syndrome type 1 or physical therapy described in this case report. Hyperthermia may, however, occur during such therapy, which is associated with dysrhythmia in general.

Pain Exposure Physical Therapy versus conventional treatment in complex regional pain syndrome type 1—a cost-effectiveness analysis alongside a randomized controlled trial:

Objective: To analyze cost-effectiveness of Pain Exposure Physical Therapy compared to conventional treatment alongside a randomized controlled trial (NCT00817128) in patients with complex regional pain syndrome type 1, where no clinical difference was shown between the two groups in an intention-to-treat analysis. Design: Randomized controlled trial with 9 months follow-up. Setting: Patients were recruited from hospitals and general practitioners in the region around a university hospital. Subjects: A total of 56 patients, 45 (80.4%) female, were randomized. About 4 patients in the intervention and 11 patients in the conventional group switched groups. The mean (SD) age was 44.3 (16.6) years, and in 37 (66.1%) patients, the upper extremity was affected. Interventions: Patients received either Pain Exposure Physical Therapy (maximum of five sessions), or conventional treatment conforming with the Dutch multidisciplinary guideline. Main measures: For the economic evaluation difference between the groups in health-related quality of life (quality-adjusted life years (QALYs)), and the clinical outcomes Impairment level Sum Score—Restricted Version and Pain Disability was determined based on the intention-to-treat analysis as well as differences in both healthcare-related costs and travel expenses. Cost-effectiveness planes were constructed using bootstrapping to compare effects and costs. Results: No significant effects were found for QALYs (mean difference = −0.02; 95% confidence interval (CI) −0.10 to 0.04) and clinical outcomes. A cost minimization analysis showed a significant difference in costs between groups. The conventional treatment was 64% more expensive than the Pain Exposure Physical Therapy. Conclusion: This economic analysis shows that Pain Exposure Physical Therapy compared to conventional treatment is cost-effective.

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

Objective To investigate whether pain-related fears are mediators for reducing disability and pain in patients with Complex Regional Pain Syndrome type 1 when treating with Pain Exposure Physical Therapy. Design An explorative secondary analysis of a randomised controlled trial. Participants Fifty-six patients with Complex Regional Pain Syndrome type 1. Interventions The experimental group received Pain Exposure Physical Therapy in a maximum of five treatment sessions; the control group received conventional treatment following the Dutch multidisciplinary guideline. Outcome measures Levels of disability, pain, and pain-related fears (fear-avoidance beliefs, pain catastrophizing, and kinesiophobia) were measured at baseline and after 3, 6, and 9 months follow-up. Results The experimental group had a significantly larger decrease in disability of 7.77 points (95% CI 1.09 to 14.45) and in pain of 1.83 points (95% CI 0.44 to 3.23) over nine months than the control group. The potential mediators pain-related fears decreased significantly in both groups, but there were no significant differences between groups, which indicated that there was no mediation. Conclusion The reduction of pain-related fears was comparable in both groups. We found no indication that pain-related fears mediate the larger reduction of disability and pain in patients with Complex Regional Pain Syndrome type 1 treated with Pain Exposure Physical Therapy compared to conventional treatment. Trial registration International Clinical Trials Registry NCT00817128

Pain exposure physical therapy in complex regional pain syndrome: promising enough to warrant further investigation

To the Editor, We wish to comment on the recent review article by Duong et al. discussing the evidence surrounding various treatments for patients with complex regional pain syndrome. Besides addressing different pharmaceutical agents and other non-pharmaceutical therapies, they also discuss the merits of various forms of physical therapy for this often disabling and treatment-resistant disorder. In their discussion of our own trial (n = 56) on the effects of pain exposure physical therapy (PEPT) vs conventional treatment, the authors conclude there is no evidence favoring PEPT based on the results of our published intention-to-treatment analysis. While this may seem a justified conclusion based on a quick review of our data, we believe a more nuanced interpretation of the study’s results is warranted. Unfortunately, that trial suffered from an important weakness—i.e., shortly after randomization, a substantial number of participants (27%) switched groups thereby diluting the potential treatment effect. Nevertheless, the per-protocol analysis showed a significant (and positive) between-group effect of PEPT on impairment, pain, self-reported (and objectively measured) disability, and quality of life. In a more recent paper using an intention-to-treat analysis, we further showed that PEPT is less expensive and thereby more costeffective than conventional treatment. In that study, patients who received PEPT had fewer visits to physical therapists and other healthcare providers. In another trial in patients with complex regional pain syndrome, the effects of a similar exposure-based intervention versus conventional treatment were studied with positive results found for disability, pain, pain catastrophizing, perceived harmfulness of activities, and quality of life. This study was different from our study since the intervention was targeted to patients with moderate pain-related fears, was supervised by a psychologist, and followed a more strict hierarchical exposure-in vivo protocol aimed at movements perceived as threatening. The PEPT intervention that we used consisted of five physical therapy sessions provided by two physical therapists. Patients were directly exposed to painful stimuli (i.e., activities) and told to ignore the pain. Despite these differences, both interventions have much in common as well. They share the theory of exposure to pain and stimulated use of the affected limb being beneficial in complex regional pain syndrome. Although a firmer evidence base is definitely required, the results of exposure-based treatments so far hold promise and suggest that activity and function-centred strategies deserve a place in the treatment of complex regional pain syndrome like what they have in other musculoskeletal pain conditions. This letter is accompanied by a reply. Please see Can J Anesth 2019; 66: this issue.