A Trial of a Brief Group-Based Form of Acceptance and Commitment Therapy (ACT) for Chronic Pain in General Practice: Pilot Outcome and Process Results

Acceptance and commitment therapy (ACT) is a developing approach for chronic pain. The current study was designed to pilot test a brief, widely inclusive, local access format of ACT in a UK primary care setting. Seventy-three participants (68.5% women) were randomized to either ACT or treatment as usual (TAU). Many of the participants were aged 65 years or older (27.6%), were diagnosed with fibromyalgia (30.2%) and depression (40.3%), and had longstanding pain (median = 10 years). Standard clinical outcome measures included disability, depression, physical functioning, emotional functioning, and rated improvement. Process measures included pain-related and general psychological acceptance. The recruitment target was met within 6 months, and 72.9% of those allocated to ACT completed treatment. Immediately post treatment, relative to TAU, participants in ACT demonstrated lower depression and higher ratings of overall improvement. At a 3-month follow-up, again relative to TAU, those in ACT demonstrated lower disability, less depression, and significantly higher pain acceptance; d = .58, .59, and .64, respectively. Analyses based on intention-to-treat and on treatment “completers,” perhaps predictably, revealed more sobering and more encouraging results, respectively. A larger trial of ACT delivered in primary care, in the format employed here, appears feasible with some recommended adjustments in the methods used here (Trial registration: ISRCTN49827391).     

Web-Based Symptom Management for Women With Recurrent Ovarian Cancer: A Pilot Randomized Controlled Trial of the WRITE Symptoms Intervention

ContextLittle research has focused on symptom management among women with ovarian cancer. Written Representational Intervention To Ease Symptoms (WRITE Symptoms) is an educational intervention delivered through asynchronous web-based message boards between a study participant and a nurse.ObjectivesWe evaluated WRITE Symptoms for 1) feasibility of conducting the study via message boards, 2) system usability, 3) participant satisfaction, and 4) initial efficacy.MethodsParticipants were 65 women (mean age, 56.5; SD = 9.23) with recurrent ovarian cancer randomized using minimization with race/ethnicity (non-Hispanic white vs. minority) as the stratification factor. Measures were obtained at baseline and two and six weeks after intervention. Outcomes were feasibility of conducting the study, system usability, participant satisfaction, and efficacy (symptom severity, distress, consequences, and controllability).ResultsFifty-six (87.5%) participants were retained, and the mean usability score (range 1–7) was 6.18 (SD = 1.29). All satisfaction items were scored at 5 (of 7) or higher. There were significant between-group effects at T2 for symptom distress, with those in the WRITE Symptoms group reporting lower distress than those in the control group [t(88.4) = −2.57; P = 0.012], with a similar trend for symptom severity [t(40.4) = −1.95; P = 0.058]. Repeated measures analysis also supported a group effect, with those in the WRITE Symptoms group reporting lower symptom distress than those in the control condition [F(1, 56.7) = 4.59; P = 0.037].ConclusionParticipants found the intervention and assessment system easy to use and had high levels of satisfaction. Initial efficacy was supported by decreases in symptom severity and distress.     

Self-Management Support Needs of Patients with Chronic Diseases in a South African Township: A Qualitative Study

Despite the need for chronic disease self-management strategies in developing countries, few studies have aimed to contextually adapt programs; yet culture has a direct impact on the way people view themselves and their environment. This study aimed to explore the knowledge, attitudes, and self-management needs and practices of patients with chronic diseases. Four patient focus groups (n = 32), 2 patient interviews, group observations, and key informant interviews (n = 12) were conducted. Five themes emerged: health-system and service-provision challenges, healthcare provider attitudes and behavior, adherence challenges related to medication and lifestyle changes, patients’ personal and clinic experiences and self-management tool preferences. The findings provide a window of opportunity for the development of contextually adapted self-management programs for community health nursing in developing countries.     

Effects of a Patient-Centered Graded Exposure Intervention Added to Manual Therapy for Women With Chronic Pelvic Pain: A Randomized Controlled Trial

Objective

To explore the effects of a 6-week patient-centered graded exposure intervention added to manual therapy in women with chronic pelvic pain (CPP) and fear of movement/(re)injury.

The Pain Course: 12- and 24-Month Outcomes From a Randomized Controlled Trial of an Internet-Delivered Pain Management Program Provided With Different Levels of Clinician Support

Little is known about the long-term outcomes of emerging Internet-delivered pain management programs. The current study reports the 12- and 24-month follow-up data from a randomized controlled trial (n?=?490) of an Internet-delivered pain management program, the Pain Course. The initial results of the trial to the 3-month follow-up have been reported elsewhere. There were significant improvements in disability, depression, anxiety, and pain levels across 3 treatment groups receiving different levels of clinician support compared with a treatment as the usual control. No marked or significant differences were found between the treatment groups either after treatment or at the 3-month follow-up. The current study obtained long-term follow-up data from 78% and 79% of participants (n?=?397) at the 12-month and 24-month follow-up marks, respectively. Clinically significant decreases (average percent reduction; Cohen's d effect sizes) were maintained at the 12- and 24-month follow-ups for disability (average reduction ≥27%; d ≥ .67), depression (average reduction ≥36%; d ≥ .80), anxiety (average reduction ≥38%; d ≥ .66), and average pain levels (average reduction ≥21%; d ≥ .67). No marked or consistent differences were found among the 3 treatment groups. These findings suggest that the outcomes of Internet-delivered programs may be maintained over the long term.

Acceptance and Commitment Therapy for Prevention of Chronic Postsurgical Pain and Opioid Use in At-Risk Veterans: A Pilot Randomized Controlled Study

High levels of pain, significant anxiety, or depressive symptoms before surgery put patients at elevated risk for chronic pain and prolonged opioid use following surgery. The purpose of this preliminary study was to assess the efficacy of a 1-day Acceptance and Commitment Therapy (ACT) workshop in “at-risk” veterans for the prevention of chronic pain and opioid use following orthopedic surgery. In a randomized controlled trial, 88 at-risk veterans undergoing orthopedic surgery were assigned to treatment as usual (TAU; n?=?44) or TAU plus a 1-day ACT workshop (n?=?44). Pain levels and opioid use were assessed up to 3 months following surgery. Pain acceptance and values-based behavior were assessed at baseline and 3-month follow-up. Participants who completed the ACT workshop reached pain and opioid cessation sooner than those in TAU. Postoperative complications exhibited a moderating effect on these outcomes, such that the effects of ACT were greater in patients without complications. Increases in pain acceptance and values-based behavior, processes targeted in ACT, were related to better outcomes. These promising results merit further investigation in a larger clinical trial. Providing an intervention before surgery for at-risk veterans has the potential to change clinical practice from a focus on management of postoperative pain to prevention of chronic pain in at-risk individuals.

Extracorporeal Shock Wave Therapy Combined With Oral Medication and Exercise for Chronic Low Back Pain: A Randomized Controlled Trial

ObjectiveTo compare extracorporeal shock wave therapy combined with oral medication and an exercise program vs sham treatment with medication and exercise for the treatment of chronic low back pain (CLBP).DesignRandomized controlled trial.SettingOutpatient clinic at a university hospital.ParticipantsEligibility criteria were age older than 18 years and duration of CLBP exceeding 3 months. Exclusion criteria were concurrent treatment or history of surgery for CLBP, cancer, fractures, infections, and disk degeneration.InterventionThe intervention group received extracorporeal shock wave therapy once a week for 4 weeks along with oral medications and an exercise program. The control group received sham extracorporeal shock wave therapy along with oral medications and an exercise program.Main Outcome MeasuresVisual analog scale and Oswestry Disability Index (ODI) were used to assess pain and disability at baseline and after 3 months.ResultsThe pain score in the intervention group (N=16) was 6.6 at baseline and 3.0 after 1 month (P<.0001) and 1.8 after 3 months (P<.0001). In the control group (N=16), the pain score was 6.8 at baseline, 4.6 after 1 month (P<.0001), and 1.1 after 3 months (P<.0001). ODI scores decreased significantly in both groups compared with baseline values (first month: P<.001, third month: P<.05). The mean ODI score did not differ significantly between the groups (P=.942).ConclusionExtracorporeal shock wave therapy combined with oral medication and exercise was safe and effective in the short-term treatment of chronic low back pain.     

Physiotherapy for Sleep Disturbance in People With Chronic Low Back Pain: Results of a Feasibility Randomized Controlled Trial

Objective

To determine the feasibility of a randomized controlled trial investigating the effectiveness of physiotherapy for sleep disturbance in chronic low back pain (CLBP) (≥12wks).

Design

Randomized controlled trial with evaluations at baseline, 3 months, and 6 months.

Setting

Outpatient physiotherapy department in an academic teaching hospital.

Participants

Participants with CLBP were randomly assigned to a walking program (n=20; mean age ± SD, 46.4±13.8y), supervised exercise class (n=20; mean age ± SD, 41.3±11.9y), or usual physiotherapy (n=20; mean age ± SD, 47.1±14.3y). The 3-month evaluation was completed by 44 participants (73%), and 42 (70%) participants completed the 6-month evaluation.

Interventions

Participants received a physiotherapy-delivered 8-week walking program, an 8-week group supervised exercise class (1 class/wk), or 1-to-1 usual physiotherapy (advice, manual therapy, and exercise).

Main Outcome Measures

Sleep was assessed by the self-reported Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Pittsburgh Sleep Diary, and objective actigraphy.

Results

Groups were comparable at baseline. Most (95%, n=57) of the participants had sleep disturbance. The acceptability of actigraphy was excellent at baseline (58 of 60 participants), but dropped at 3 months (26 of 44 participants). There were improvements on the PSQI and ISI in all groups at 3 and 6 months, with predominantly medium effect sizes (Cohen d=0.2–0.5).

Conclusions

The high prevalence of sleep disturbance indicated the feasibility of good recruitment in future trials. The PSQI would be a suitable screening tool and outcome measure alongside an objective nonobtrusive sleep outcome measure. The effectiveness of physiotherapy for sleep disturbance in CLBP warrants investigation in a fully powered randomized controlled trial.     

Measures of Functioning in Patients With Episodic Migraine: Findings From a Double‐Blind,Randomized, Placebo‐Controlled Phase 2b Trial With Galcanezumab

Objective – To evaluate 12‐week changes from baseline of 2 disease‐specific patient‐reported outcome (PRO) measures in adults with migraine treated with galcanezumab, an investigational humanized antibody binding calcitonin gene‐related peptide (CGRP), or placebo. Background – Preventing headache‐related functional impairment is an important goal of migraine preventive treatment and a measurement target for PROs. Understanding which drugs have the potential to improve patient functioning in addition to preventing migraine headaches is vital to lessening patient burden. Design/Methods – This Phase 2b double‐blind, randomized, placebo‐controlled study enrolled adults with episodic migraine. Galcanezumab (120 mg subcutaneous injection; n = 60) or placebo (n = 127) was administered every 28 days for 12 weeks. Post hoc secondary analyses were conducted for those who completed 12 weeks of treatment on 2 PROs: The Migraine‐Specific Quality of Life Questionnaire (MSQ) v2.1 and the Headache Impact Test? (HIT‐6). Results – Analysis of covariance revealed significant differences in least square mean changes from baseline between galcanezumab and placebo for all MSQ domains including total mean change placebo of 18.63, galcanezumab of 27.36 (95% CI 2.449, 15.008; P‐value of .0067); Role Function‐Restrictive mean change placebo of 22.40, galcanezumab of 31.92 (95% CI 2.636, 16.518; P‐value of .0071); Role Function‐Preventive mean change placebo of 13.43, galcanezumab of 19.76 (95% CI 0.476, 12.185; P‐value of .0342); and Emotional Function mean change placebo of 16.88, galcanezumab of 26.61 (95% CI 2.789, 16.674; P‐value of .0063). At baseline, mean number of migraine headache days (MHDs) did not correlate with MSQ total scores or HIT‐6. At 12 weeks post‐treatment, MHD correlated with MSQ and HIT‐6 scores (all P < .0001). Change in MHD was associated with change in MSQ domains and change in HIT‐6 scores (all P < .0001). Conclusions – In comparison with placebo, treatment with galcanezumab was associated with significant functional improvements as reflected by changes in MSQ scores. Change in MHD was associated with improvements in MSQ and reductions in HIT‐6 scores, indicating the clinical importance of these changes in relation to PROs that measure function.     

Efficacy of Periosteal Stimulation for Chronic Pain Associated With Advanced Knee Osteoarthritis: A Randomized,Controlled Clinical Trial

Background

Because of morbidity associated with painful knee osteoarthritis (OA) and commonly prescribed analgesics, patients often pursue complementary and alternative modalities (eg, acupuncture). Clinical trials have demonstrated modest therapeutic efficacy of traditional Chinese acupuncture for knee OA pain, and patients with advanced disease have largely been excluded. We have previously demonstrated preliminary short-term tolerability and efficacy of periosteal stimulation therapy (PST) (ie, electrical stimulation of the periosteum facilitated by acupuncture needles) for older adults with advanced knee OA.

Objective

This study evaluated the sustained efficacy of PST and boosters for treating chronic pain with advanced knee OA.

Methods

One hundred ninety participants age >50 years with Kellgren-Lawrence grade 3 or 4 knee OA and chronic pain were randomized to (1) PST (once a week for 10 weeks) followed by PST boosters for 6 months (once every 2 weeks 2 times, then once a month), (2) control PST (ie, periosteal needles and brief electrical stimulation of control points) once a week for 10 weeks, or (3) PST for 10 weeks followed by control PST boosters for 6 months. Change in the Western Ontario and McMaster Universities Osteoarthritis Index pain score immediately after the 10-week intervention and at 6-month follow-up (9 months after baseline) was the primary outcome. OMERACT-OARSI (Outcome Measures in Rheumatology Clinical Trials–Osteoarthritis Research Society International) criteria also were evaluated. Secondary measures of outcome included (1) physical performance (Short Physical Performance Battery, gait speed, Timed Up and Go, and timed stair climb); (2) psychological factors (depressive symptoms measured with the Center for Epidemiologic Studies–Depression scale, coping measured with the catastrophizing subscale of the Coping Strategies Questionnaire, and self-efficacy measured with the Arthritis Self-Efficacy Scale); (3) health-related quality of life measured with the Medical Outcomes Study 36-Item Short-Form Health Survey; (4) rescue pain medication use tracked with diaries; and (5) health care utilization and interim physical activity were monitored via monthly telephone calls.

Results

After adjustment for pain at baseline, the PST and control booster did not differ from controls at 10 weeks (difference, 1.3; 95% CI, −0.10 to 2.8; P = 0.0683) or 9 months (difference, 1.1; 95% CI, −0.32 to 2.6; P = 0.13). The PST and PST booster group had similar improvement compared with controls at 10 weeks (baseline adjusted difference, 1.1; 95% CI, −0.34 to 2.5; P = 0.1369) but significantly more improvement at 9 months (baseline adjusted difference, 1.5; 95% CI, 0.069 to 3.0; P = 0.0401). Baseline depressive symptoms, low self-efficacy, higher difficulty performing daily activities, and greater knee stiffness predicted a lower likelihood of response.

Conclusion

PST plus PST boosters in patients age >50 with advanced knee OA were well-tolerated and modestly reduced pain. ClinicalTrials.gov identifier: NCT00865046.     

Efficacy of Videoconference Group Acceptance and Commitment Therapy (ACT) and Behavioral Activation Therapy for Depression (BATD) for Chronic Low Back Pain (CLBP) Plus Comorbid Depressive Symptoms: A Randomized Controlled Trial (IMPACT Study)

This study examined the efficacy of adding a remote, synchronous, group, videoconference-based form of acceptance and commitment therapy (ACT) or behavioral activation therapy for depression (BATD) to treatment-as-usual (TAU) in 234 patients with chronic low back pain (CLBP) plus comorbid depressive symptoms. Participants were randomly assigned to ACT, BATD, or TAU. Compared to TAU, ACT produced a significant reduction in pain interference at posttreatment (d = .64) and at follow-up (d = .73). BATD was only superior to TAU at follow-up (d = .66). A significant reduction in pain catastrophizing was reported by patients assigned to ACT and BATD at posttreatment (d = .45 and d = .59, respectively) and at follow-up (d = .59, in both) compared to TAU. Stress was significantly reduced at posttreatment by ACT in comparison to TAU (d = .69). No significant between-group differences were found in depressive or anxiety symptoms. Clinically relevant number needed to treat (NNT) values for reduction in pain interference were obtained at posttreatment (ACT vs TAU = 4) and at follow-up (ACT vs TAU = 3; BATD vs TAU = 5). In both active therapies, improvements in pain interference at follow-up were significantly related to improvements at posttreatment in psychological flexibility. These findings suggest that new forms of cognitive-behavioral therapy are clinically useful in improving pain interference and pain catastrophizing. Further research on evidence-based change processes is required to understand the therapeutic needs of patients with chronic pain and comorbid conditions.Trial numberNCT04140838.PerspectiveGroup videoconference-based ACT and BATD showed greater efficacy than TAU for reducing pain interference and pain catastrophizing in patients with CLBP plus clinically relevant depression. Psychological flexibility appeared to be the main contributor to treatment effects for both ACT and BATD.     

Effect of a Novel Perturbation-Based Pinch Task Training on Sensorimotor Performance of Upper Extremity for Patients With Chronic Stroke: A Pilot Randomized Controlled Trial

ObjectiveTo investigate the effects of perturbation-based pinch task training on the sensorimotor performance of the upper extremities of patients with chronic stroke via a novel vibrotactile therapy system.DesignA single-blinded randomized controlled trial.SettingA university hospital.ParticipantsPatients with chronic stroke (N=19) randomly assigned into either an experimental group or a control group completed the study.InterventionsIn addition to 10 minutes of traditional sensorimotor facilitation, each participant in the experimental group received 20 minutes of perturbation-based pinch task training in each treatment session, and the controls received 20 minutes of task-specific motor training twice a week for 6 weeks.Main Outcome MeasuresThe scores for the primary outcome, Semmes-Weinstein monofilament (SWM), and those for the secondary outcomes, Fugl-Meyer Assessment (FMA), amount of use, quality of movement (QOM) on the Motor Activity Log (MAL) scale, and box and block test (BBT), were recorded. All outcome measures were recorded at pretreatment, post treatment, and 12-week follow-up.ResultsThere were statistically significant between-group differences in the training-induced improvements revealed in the SWM results (P=.04) immediately after training and in the BBT results (P=.05) at the 12-week follow-up. The changes in muscle tone and in the QOM, SWM, and BBT scores indicated statistically significant improvements after 12 sessions of treatment for the experimental group. For the control group, a significant statistical improvement was found in the wrist (P<.001) and coordination (P=.01) component of the FMA score.ConclusionsThis study indicated that the perturbation-based pinch task training has beneficial effects on sensory restoration of the affected thumb in patients with chronic stroke.     

Effect of Elastic Therapeutic Taping on Abdominal Muscle Endurance in Patients With Chronic Nonspecific Low Back Pain: A Randomized,Controlled, Single-Blind,Crossover Trial

Objective

The purpose of this study was to determine the immediate effect of elastic therapeutic taping and sham taping of the abdominal musculature on maximum hold time of endurance tests in patients with chronic nonspecific low back pain (CNLBP).

Patient safety on psychiatric wards: A cross‐sectional,multilevel study of factors influencing nurses' willingness to share power and responsibility with patients

The World Health Organization highlights the need for more patient participation in patient safety. In mental health care, psychiatric nurses are in a frontline position to support this evolution. The aim of the present study was to investigate the demographic and contextual factors that influence the willingness of psychiatric nurses to share power and responsibility with patients concerning patient safety. The patient participation culture tool for inpatient psychiatric wards was completed by 705 nurses employed in 173 psychiatric wards within 37 hospitals. Multilevel modelling was used to analyse the self‐reported data. The acceptance of a role wherein nurses share power and responsibility with patients concerning patient safety is influenced by the nurses' sex, age, perceived competence, perceived support, and type of ward. To support nurses in fulfilling their role in patient participation, patient participation‐specific basic and continuing education should be provided. Managers and supervisors should recognize and fulfil their facilitating role in patient participation by offering support to nurses. Special attention is needed for young nurses and nurses on closed psychiatric wards, because these particular groups report being less willing to accept a new role. Ward characteristics that restrict patient participation should be challenged so that these become more patient participation stimulating. More research is needed to explore the willingness and ability of psychiatric nurses to engage in collaborative safety management with patients who have specific conditions, such as suicidal ideation and emotional harm.     

Efficacy of Internet-Delivered Mindfulness for Improving Depression in Caregivers of People With Spinal Cord Injuries and Chronic Neuropathic Pain: A Randomized Controlled Feasibility Trial

Objectives

To explore the feasibility and efficacy of web-based mindfulness training for carers of people with spinal cord injury (SCI).

Effects of Anteroposterior Talus Mobilization on Range of Motion,Pain, and Functional Capacity in Participants With Subacute and Chronic Ankle Injuries: A Controlled Trial

Objective

The purpose of this study was to measure the acute (1 session) and chronic effects (6 sessions) and the follow-up (2 weeks) of anteroposterior articular mobilization of the talus, grade III of Maitland, on the dorsiflexion range of motion (ROM), pain, and functional capacity of individuals with subacute and chronic traumatic injuries of the ankle.