Acupuncture for Treatment of Noncyclic Breast Pain: A Pilot Study

Noncyclic breast pain is a common breast disorder prompting women to seek medical evaluation. We aimed to perform a pilot study on the relief of noncyclic breast pain using acupuncture. Thirty-seven women seen at a diagnostic breast clinic between April 2003 and January 2009 were enrolled. Treatment consisted of four acupuncture sessions over two weeks, with three months of follow-up. Response to treatment was measured with use of a breast pain questionnaire, a quality of life (QOL) questionnaire, and the Cleeland Brief Pain Inventory (BPI) assessed at baseline, end of treatment, and three months after treatment. Data were analyzed using standard descriptive statistics. Twenty-two patients completed four acupuncture sessions. Pain described as throbbing and heavy decreased significantly after acupuncture (p = 0.04 and p = 0.03, respectively). After treatment, pain scores (on the 10-point BPI scale) decreased by an average of 3.5 points for the worst pain during the previous month (p = 0.001), by 2.7 points for average pain (p < 0.001), and by 2.3 points for pain interference (p = 0.002). The percentage of patients reporting a clinically meaningful decrease of 2 points from baseline to the end of treatment included 67% (12/18) for the worst pain, 65% (11/17) for average pain, and 56% (10/18) for pain interference. QOL data showed no improvement in QOL measures (mental, physical, emotional, social, or spiritual well-being). The results of this preliminary study suggest that a randomized controlled trial may be warranted to evaluate the effect of acupuncture on noncyclic breast pain, as well as the optimal frequency of acupuncture treatments.

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Transdiagnostic versus Diagnosis-Specific Group Cognitive Behavioral Therapy for Anxiety Disorders and Depression: A Randomized Controlled Trial

Psychotherapy and Psychosomatics ◽

10.1159/000516380 ◽

2021 ◽

pp. 1-14

Author(s):

Nina Reinholt ◽

Morten Hvenegaard ◽

Anne Bryde Christensen ◽

Anita Eskildsen ◽

Carsten Hjorthøj ◽

...

Keyword(s):

Mental Health ◽

Mental Health Services ◽

Health Services ◽

Behavioral Therapy ◽

Controlled Trial ◽

Well Being ◽

Major Depressive ◽

Outpatient Mental Health ◽

End Of Treatment

Introduction: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) delivered in a group format could facilitate the implementation of evidence-based psychological treatments. Objective: This study compared the efficacy of group UP and diagnosis-specific cognitive behavioral therapy (dCBT) for anxiety and depression in outpatient mental health services. Methods: In this pragmatic, multi-center, single-blinded, non-inferiority, randomized controlled trial (RCT), we assigned 291 patients with major depressive disorder, social anxiety disorder, panic disorder, or agoraphobia to 14 weekly sessions in mixed-diagnosis UP or single-diagnosis dCBT groups. The primary test was non-inferiority, using a priori criteria, on the World Health Organisation 5 Well-Being Index (WHO-5) at the end of the treatment. Secondary outcomes were functioning and symptoms. We assessed outcomes at baseline, end-of-treatment, and at a 6-month follow-up. A modified per-protocol analysis was performed. Results: At end-of-treatment, WHO-5 mean scores for patients in UP (n = 148) were non-inferior to those of patients in dCBT (n = 143; mean difference –2.94; 95% CI –8.10 to 2.21). Results were inconclusive for the WHO-5 at the 6-month follow-up. Results for secondary outcomes were non-inferior at end-of-treatment and the 6-month follow-up. Client satisfaction and rates of attrition, response, remission, and deterioration were similar across conditions. Conclusions: This RCT demonstrated non-inferior acute-phase outcomes of group-delivered UP compared with dCBT for major depressive disorder, social anxiety disorder, panic disorder, and agoraphobia in outpatient mental health services. The long-term effects of UP on well-being need further investigation. If study findings are replicated, UP should be considered a viable alternative to dCBT for common anxiety disorders and depression in outpatient mental health services.

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A Pilot Randomized Sham-Controlled Trial of MC5-A Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Journal of Palliative Care ◽

10.1177/0825859719827589 ◽

2019 ◽

Vol 35 (1) ◽

pp. 53-58 ◽

Cited By ~ 6

Author(s):

Thomas J. Smith ◽

A. Rab Razzak ◽

Amanda L. Blackford ◽

Jennifer Ensminger ◽

Catherine Saiki ◽

...

Keyword(s):

Peripheral Neuropathy ◽

Rating Scale ◽

Small Sample Size ◽

Controlled Trial ◽

Brief Pain Inventory ◽

Small Sample ◽

Sham Treatment ◽

The Real ◽

Average Pain ◽

Scrambler Therapy

Background: Chemotherapy-induced peripheral neuropathy (CIPN) affects 30% to 40% of patients with cancer with long-lasting disability. Scrambler therapy (ST) appeared to benefit patients in uncontrolled trials, so we performed a randomized sham-controlled Phase II trial of ST. Methods: The primary end point was “average pain” after 28 days on the Numeric Rating Scale. Each received ten 30-minute sessions of ST on the dermatomes above the painful areas, or sham treatment on the back, typically at L3-5 where the nerve roots would enter the spinal cord. Outcomes included the Brief Pain Inventory (BPI)-CIPN and the EORTC CIPN-20 scale. Patients were evaluated before treatment (day 0), day 10, and days 28, 60, and 90. Results: Data regarding pain as a primary outcome were collected for 33 of the 35 patients. There were no significant differences between the sham and the “real” ST group at day 10, 28, 60, or 90, for average pain, the BPI, or EORTC CIPN-20. Individual responses were noted during the ST treatment on the real arm, but most dissipated by day 30. There was improvement in the sensory subscale of the CIPN-20 at 2 months in the “real” group ( P = .14). All “real” patients wanted to continue treatment if available. Discussion: We observed no difference between sham and real ST CIPN treatment. Potential reasons include at least the following: ST does not work; the sham treatment had some effect; small sample size with heterogeneous patients; misplaced electrodes on an area of nonpainful but damaged nerves; or a combination of these factors.

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Flexible Dosed Duloxetine in the Treatment of Fibromyalgia: A Randomized, Double-blind, Placebo-controlled Trial

The Journal of Rheumatology ◽

10.3899/jrheum.100365 ◽

2010 ◽

Vol 37 (12) ◽

pp. 2578-2586 ◽

Cited By ~ 43

Author(s):

LESLEY M. ARNOLD ◽

DANIEL CLAUW ◽

FUJUN WANG ◽

JONNA AHL ◽

PAULA J. GAYNOR ◽

...

Keyword(s):

Short Form ◽

Controlled Trial ◽

Brief Pain Inventory ◽

Pain Severity ◽

Clinical Trial Registry ◽

Double Blind ◽

Global Improvement ◽

Sf 36 ◽

Average Pain ◽

Sleep Difficulties

Objective.To investigate the efficacy of flexible dose duloxetine 60–120 mg/day on changes in fibromyalgia (FM) symptoms assessed by the Patient Global Impression of Improvement (PGI-I) scale.Methods.Outpatients ≥ 18 years of age who met American College of Rheumatology criteria for FM, and had ≥ 4 score on the Brief Pain Inventory (BPI) average pain item, were randomized to duloxetine (n = 263) or placebo (n = 267) for 24 week double-blind treatment (primary endpoint at Week 12). Key secondary measures included BPI average pain severity, patient-rated scales assessing mood, anxiety, pain, sleep, and stiffness, Clinical Global Impression of Severity (CGI-S), Multidimensional Fatigue Inventory, Cognitive and Physical Functioning Questionnaire, Beck Depression Inventory (BDI), Beck Anxiety Inventory, and Medical Outcome Study Short-Form Health Survey (SF-36).Results.At Week 12, duloxetine-treated patients reported significantly greater global improvement with mean PGI-I scores of 2.8 compared to 3.4 in the placebo group (p < 0.001). Significantly more duloxetine- versus placebo-treated patients (57% vs 32%; p < 0.001) reported feeling “much” or “very much better” (PGI-I score ≤ 2). There was significantly greater improvement with duloxetine versus placebo treatment in BPI average pain severity, mood (including BDI total), anxiety (patient-rated only), stiffness, CGI-S, fatigue, all SF-36 domains (except role-physical and physical component summary), and being less bothered by pain or sleep difficulties. Treatment-emergent adverse events occurring significantly more frequently with duloxetine included: nausea, headache, constipation, dry mouth, dizziness, diarrhea, and hyperhidrosis.Conclusion.Treatment with duloxetine 60, 90, and 120 mg/day was associated with feeling much better, pain reduction, being less bothered by sleep difficulties, and improvement in mood, stiffness, fatigue and functioning. (Clinical trial registryNCT00673452).

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Frailty Modifies Effects of Chair Yoga on Chronic Pain in Older Adults With Osteoarthritis

Innovation in Aging ◽

10.1093/geroni/igaa057.865 ◽

2020 ◽

Vol 4 (Supplement_1) ◽

pp. 270-270

Author(s):

Juyoung Park ◽

Zuyun Liu

Keyword(s):

Older Adults ◽

Controlled Trial ◽

Frailty Index ◽

Social Activity ◽

Secondary Analysis ◽

Cohort Effect ◽

Well Being ◽

Pain Interference ◽

Intervention Effect ◽

Significant Interaction Effect

Abstract As a secondary analysis, this study used data from our previous 8-week chair yoga (CY) intervention trial with two-arm, access-blinded randomized controlled trial to examine modifying effect of baseline frailty on intervention effects of CY on pain and pain interference (i.e., consequences of pain on relevant aspects of life). Using the cumulative frailty index (FI) approach, we constructed the FI using 82 comprehensive deficits, including physical function, balance, fatigue, emotional well-being, and social activity. We calculated FI at baseline, 4 weeks, and 8 weeks. A linear mixed-effects model with random intercept was used, adjusting for research sites, cohort effect, and time. To test for potential modifying effects of baseline FI on the intervention effect by CY, we added a three-way interaction term: intervention (CY vs. Health Education Program), time, and baseline FI. A total of 112 participants (M = 75.3[7.5] years; 76% female, 40% White, 46% Hispanic) completed the study. Each 0.01 increment in baseline FI was associated with higher pain (β = 0.28, p < .001) and pain interference (β = 0.51, p < .001). There was a significant interaction effect among intervention, time, and baseline FI (p = .02 for pain, p = .01 for pain interference), indicating that participants with higher levels of baseline FI had greater declines in pain and pain interference. Frailty modified the intervention effect of CY on pain in older adults with lower extremity osteoarthritis, underscoring the importance of assessing frailty to improve management of pain in the population.

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Acupuncture for chronic pain in adults with sickle cell disease: a mixed-methods pilot study

Acupuncture in Medicine ◽

10.1177/09645284211017303 ◽

2021 ◽

pp. 096452842110173

Author(s):

Hongjin Li ◽

Crystal L Patil ◽

Robert E Molokie ◽

Franklin Njoku ◽

Alana D Steffen ◽

...

Keyword(s):

Chronic Pain ◽

Pilot Study ◽

Sickle Cell Disease ◽

Pain Intensity ◽

Sickle Cell ◽

Controlled Trial ◽

Structured Interview ◽

Pain Interference ◽

Common Symptom ◽

Cell Disease

Objective: Chronic pain is a common symptom experienced among patients with sickle cell disease (SCD). Our aims were to assess the feasibility and acceptability of performing acupuncture for the treatment of chronic pain in adults with SCD. Methods: This was a single-arm, prospective pilot study of six adults with SCD. Participants reported ⩾ 3 months of chronic pain and were > 18 years of age. Per protocol, acupuncture was to be administered twice per week for 5 weeks, for 30 min per session. All treatments were performed in the acupuncture treatment laboratory at the University of Illinois Chicago College of Nursing. Pain intensity, pain interference, and other symptoms were measured at baseline and after the intervention. Participants completed a semi-structured interview and a protocol acceptability questionnaire after the acupuncture intervention. Results: Six participants (mean age 52.5 years, six Black) were enrolled. Although the study was suspended due to COVID-19 and not all participants completed the 10-session protocol, completion rates were high with no missed appointments. One participant did not complete the study due to hospitalization unrelated to acupuncture. No adverse events were reported. At completion of the intervention at 4–5 weeks post-baseline, all participants had reduced pain intensity and pain interference. The mean acceptability score on the protocol acceptability questionnaire was 82%. Conclusion: It was feasible and acceptable to implement acupuncture in adults with SCD. This study can be used to guide a larger randomized controlled trial to evaluate the effect of acupuncture on reducing chronic pain in adults with SCD. Trial registration number: NCT04156399 (ClinicalTrials.gov)

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Early Treatment Improvements in Depression Are Associated With Overall Improvements in Fatigue Impact and Pain Interference in Adults With Multiple Sclerosis

Annals of Behavioral Medicine ◽

10.1093/abm/kaaa102 ◽

2020 ◽

Author(s):

Lindsey M Knowles ◽

Anne Arewasikporn ◽

Anna L Kratz ◽

Aaron P Turner ◽

Kevin N Alschuler ◽

...

Keyword(s):

Multiple Sclerosis ◽

Depressive Symptoms ◽

Controlled Trial ◽

Secondary Analysis ◽

Brief Pain Inventory ◽

Chronic Fatigue ◽

The Other ◽

Pain Interference ◽

Or Education ◽

Impact Scale

Abstract Background Depression, fatigue, and pain commonly co-occur in multiple sclerosis (MS) and are positively associated with one another. However, it is unclear whether treatment-related improvement in one of these symptoms is associated with improvements in the other two symptoms. Purpose This study examined whether early improvements in depressive symptoms, fatigue impact, and pain interference during a multisymptom intervention in persons with MS were associated with overall improvements in the other two symptoms. Methods Secondary analysis of a randomized controlled trial in which both treatments improved depressive symptoms, fatigue, and pain interference. Adults with MS experiencing chronic pain, chronic fatigue, and/or moderate depressive symptoms (N = 154, 86% women) participated in an 8-week, telephone-delivered intervention: self-management (n = 69) or education (n = 85); intervention groups were combined for the current study. Outcome measures were depressive symptoms (PHQ-9), fatigue impact (Modified Fatigue Impact Scale), and pain interference (Brief Pain Inventory). Path analysis examined associations between pre-to-mid intervention improvement in one symptom (i.e., depression, fatigue, pain interference) and pre-to-post (overall) improvement in the other two symptoms. Results Early reduction in depressive symptoms was associated with an overall reduction in pain interference and fatigue impact (p’s < .01). Early reduction in fatigue impact was associated with an overall reduction in depressive symptom severity (p = .04) but not pain interference. Early reduction in pain interference was not associated with reductions in fatigue impact or depressive symptoms. Conclusions These findings suggest the potential importance of reducing depressive symptoms to overall improvement in fatigue and pain interference in persons with MS. Clinical Trial Registrations NCT00944190.

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In dogs with osteoarthritis, how effective is treatment with tramadol in providing analgesia?

Veterinary Evidence ◽

10.18849/ve.v6i2.401 ◽

2021 ◽

Vol 6 (2) ◽

Author(s):

Adrian Wong ◽

Fernando Martinez-Taboada

Keyword(s):

Controlled Trial ◽

Research Question ◽

Clinical Signs ◽

Pain Severity ◽

Pain Interference ◽

Vertical Force ◽

Bottom Line ◽

End Of Treatment ◽

Significant Difference ◽

Interference Score

PICO question In dogs with osteoarthritis how effective is treatment with tramadol in reducing the severity of the clinical signs associated with pain when compared to no treatment? Clinical bottom line Category of research question Treatment The number and type of study designs reviewed Two papers were critically reviewed. There was one randomised crossover controlled trial and one non-randomised controlled trial Strength of evidence Strong Outcomes reported Budsberg et al. (2018) found no significant differences in the objective gait analyses (vertical ground reaction forces, and peak vertical force) between baseline and end of treatment, between tramadol and placebo. Similarly, there was no significant difference in the proportion of dogs with positive response based on the subjective Canine Brief Pain Inventory questionnaire (CBPI) between tramadol and placebo. The positive control of carprofen yielded significant differences to both placebo and tramadol in all outcomes measured. Malek et al. (2012) found no significant differences in the objective outcomes measured (gait analyses, and total daily activity) between tramadol and placebo. There were significant improvements in the subjective CBPI (total score, pain severity and pain interference score) between the baseline and end of treatment, within the tramadol group. However, there was no significant difference in the percentage change of the total score, pain severity or pain interference score between all treatment groups including tramadol and placebo Conclusion In dogs with osteoarthritis, the use of tramadol alone did not demonstrate any significant analgesic effects How to apply this evidence in practice The application of evidence into practice should take into account multiple factors, not limited to: individual clinical expertise, patient’s circumstances and owners’ values, country, location or clinic where you work, the individual case in front of you, the availability of therapies and resources. Knowledge Summaries are a resource to help reinforce or inform decision making. They do not override the responsibility or judgement of the practitioner to do what is best for the animal in their care.

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Clinical Effectiveness and Cost-effectiveness of Videoconference-Based Integrated Cognitive Behavioral Therapy for Chronic Pain: Randomized Controlled Trial (Preprint)

10.2196/preprints.30690 ◽

2021 ◽

Author(s):

Kayoko Taguchi ◽

Noriko Numata ◽

Rieko Takanashi ◽

Ryo Takemura ◽

Tokiko Yoshida ◽

...

Keyword(s):

Chronic Pain ◽

Cognitive Behavioral Therapy ◽

Pain Intensity ◽

Rating Scale ◽

Numerical Rating Scale ◽

Behavioral Therapy ◽

Controlled Trial ◽

Brief Pain Inventory ◽

Cognitive Behavioral ◽

Pain Interference

BACKGROUND Cognitive behavioral therapy is known to improve the management of chronic pain. However, the components of this therapy are still being investigated and debated. OBJECTIVE This study aimed to examine the effectiveness of an integrated cognitive behavioral therapy program with new components (attention-shift, memory work, video feedback, and image training) delivered via videoconferencing. METHODS This study was unblinded and participants were recruited and assessed face-to-face in the outpatient department. We conducted a randomized controlled trial for chronic pain to compare 16 weekly videoconference-based cognitive behavioral therapy (vCBT) sessions provided by a therapist with treatment as usual (TAU). Thirty patients (age range, 22-75 years) with chronic pain were randomly assigned to either vCBT (n=15) or TAU (n=15). Patients were evaluated at week 1 (baseline), week 8 (midintervention), and week 16 (postintervention). The primary outcome was the change in pain intensity, which was recorded using the numerical rating scale at 16 weeks from the baseline. Secondary outcomes were pain severity and pain interference, which were assessed using the Brief Pain Inventory. Additionally, we evaluated disability, pain catastrophizing cognition, depression, anxiety, quality of life, and cost utility. RESULTS In the eligibility assessment, 30 patients were eventually randomized and enrolled; finally, 15 patients in the vCBT and 14 patients in the TAU group were analyzed. Although no significant difference was found between the 2 groups in terms of changes in pain intensity by the numerical rating scale scores at week 16 from baseline (P=.36), there was a significant improvement in the comprehensive evaluation of pain by total score of Brief Pain Inventory (–1.43, 95% CI –2.49 to –0.37, df=24; P=.01). Further, significant improvement was seen in pain interference by using the Brief Pain Inventory (–9.42, 95% CI –14.47 to –4.36, df=25; P=.001) and in disability by using the Pain Disability Assessment Scale (–1.95, 95% CI –3.33 to –0.56, df=24; P=.008) compared with TAU. As for the Medical Economic Evaluation, the incremental cost-effectiveness ratio for 1 year was estimated at 2.9 million yen (about US $25,000) per quality-adjusted life year gained. CONCLUSIONS The findings of our study suggest that integrated cognitive behavioral therapy delivered by videoconferencing in regular medical care may reduce pain interference but not pain intensity. Further, this treatment method may be cost-effective, although this needs to be further verified using a larger sample size. CLINICALTRIAL University Hospital Medical Information Network UMIN000031124; https://tinyurl.com/2pr3xszb

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Does pain acceptance predict physical and psychological outcomes in cancer outpatients with pain?

Health Psychology Research ◽

10.4081/hpr.2013.1541 ◽

2013 ◽

Vol 1 (3) ◽

pp. 35 ◽

Cited By ~ 2

Author(s):

Evangelia Protopapa ◽

Victoria Senior

Keyword(s):

Depression Scale ◽

Brief Pain Inventory ◽

Patient Characteristics ◽

Well Being ◽

Functional Adaptation ◽

Pain Interference ◽

Anxiety And Depression ◽

Pain Acceptance ◽

Activity Engagement ◽

Management Interventions

Pain acceptance has been associated with improved physical and psychosocial well-being in chronic non-malignant pain patients. However, its effects are unclear in cancer outpatients with pain. Our aim was to determine whether pain acceptance predicts reduced pain, pain interference with function, anxiety, and depression in cancer outpatients. We recruited 116 outpatients from a tertiary oncology center, with various types of cancer and pain levels. Patients completed the Brief Pain Inventory, the Hospital Anxiety and Depression Scale and the Chronic Pain Acceptance Questionnaire, the latter of which comprises activity engagement and pain willingness. We carried out multiple regression analyses, adjusting for patient characteristics and outcomes. Activity engagement and pain willingness significantly predicted pain interference with function (P=0.033 and P=0.041 respectively). However, only activity engagement predicted anxiety (P=0.001) and depression (P<0.001). These findings support the benefi- cial role of pain acceptance in patients’ functional adaptation to cancer-related pain. Activity engagement in particular, shows promise in fostering psychological well-being. Further studies could confirm its role in reducing anxiety and depression in cancer patients with pain and whether it should be included in cancer pain management interventions.

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A Multi-Center Cohort Study on Characteristics of Pain, Its Impact and Pharmacotherapeutic Management in Patients with ALS

Journal of Clinical Medicine ◽

10.3390/jcm10194552 ◽

2021 ◽

Vol 10 (19) ◽

pp. 4552

Author(s):

Susanne Vogt ◽

Ina Schlichte ◽

Stefanie Schreiber ◽

Bernadette Wigand ◽

Grazyna Debska-Vielhaber ◽

...

Keyword(s):

Pain Relief ◽

Pain Therapy ◽

Rating Scale ◽

Numerical Rating Scale ◽

Brief Pain Inventory ◽

Pain Medication ◽

Pain Interference ◽

Moderate Intensity ◽

Average Pain ◽

Pain Descriptors

Background: Although pain is common in amyotrophic lateral sclerosis (ALS) and an effectively treatable symptom, it is widely under-recognized and undertreated. This study investigates epidemiological and clinical characteristics of pain, its impact and pharmacological treatment in ALS patients. In addition, opportunities for further optimization of pain therapy need to be identified. Methods: Patients from three German ALS outpatient clinics were asked to complete the Brief Pain Inventory and the ALS Functional Rating Scale—Extension and to participate in semi-structured telephone interviews. Results: Of the 150 study participants, 84 patients reported pain. Pain occurred across all disease stages, predominantly in the neck, back and lower extremities. It was described with a broad spectrum of pain descriptors and mostly interfered with activity-related functions. Of the 84 pain patients, 53.8% reported an average pain intensity ≥4 on the numerical rating scale (NRS), indicating pain of at least moderate intensity, and 64.3% used pain medication. Irrespective of the medication type, 20.4% of them had no sufficient pain relief. Thirteen out of 30 patients without pain medication reported an average NRS value ≥4. Eleven of them—mainly in the context of high pain interference with daily functions—were supposed to benefit from adequate pain therapy. However, many patients had relevant concerns and misconceptions about pain therapy. Conclusion: Given the frequency, extent and multi-faceted impact of pain, it is necessary to systematically assess pain throughout the disease course. Potentials to optimize pain therapy were seen in the subset of patients with insufficient pain relief despite medication and in those patients without pain medication but high pain interference. However, there is a need to respond to patients’ barriers to pain therapy.

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