scholarly journals Acupuncture for Comorbid Mild-Moderate Depression and Chronic Musculoskeletal Pain: Study Protocol for A Randomized Controlled Trial

2021 ◽  
Author(s):  
sheng Li ◽  
Jing Liu ◽  
Jianpeng Huang ◽  
Ding Luo ◽  
Qian Wu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Effective Treatment ◽  
Musculoskeletal Pain ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Sham Acupuncture ◽  
Chronic Musculoskeletal Pain ◽  
World Health ◽  
Secondary Outcome

Abstract Background: Depression and Chronic musculoskeletal pain (CMSP) are the leading causes of global years lived with disability diseases. Moreover, they often commonly coexist, which made a great difficult to diagnosis and treatment. A safe and effective treatment was urgently need. Previous studies showed that acupuncture was a cost-effective treatment for simple depression or CMSP. But limited evidence showed that acupuncture was effective for depression comorbid CMSP. Methods: This is a randomized, sham acupuncture-controlled trial with three arms: real acupuncture (RA), sham acupuncture (SA) and healthy control (HC). 48 depression combined CMSP participants and 12 healthy people will be recruited from GDTCM hospital and randomized 2:2:1 to RA, SA, HC group. The patients will receive RA or SA intervention for 8 weeks, and HC will not receive any intervention. Upon completion of the intervention, there is a 4 weeks follow-up. The primary outcome measures will be severity of depression and pain which assessed by Hamilton depression rating scale (HAMD-17) and brief pain inventory (BPI), respectively. The secondary outcome measures will be cognitive function, and quality of life which measured by Montreal cognitive assessment (MoCA), P300 and world health organization quality of life (WHOQOL-BREF). In addition, the correlation between brain derived neurotrophic factor (BDNF) and symptoms will also be determined. Discussion: The aim of this study is to evaluate the clinic efficacy and underlying mechanism of acupuncture on depression comorbid CMSP. This study will provide a convenient and cost-effectively means for future prevention and treatment of combined depression and CMSP.Trial registration: This study pre-registered at 2th Feb 2018, at Chinese Clinical Trail Registry (ChiCTR1800014754). The study is on the recruiting status.

scholarly journals Acupuncture for comorbid mild-moderate depression and chronic musculoskeletal pain: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sheng Li ◽  
Jing Liu ◽  
Jianpeng Huang ◽  
Ding Luo ◽  
Qian Wu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Effective Treatment ◽  
Musculoskeletal Pain ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Cost Effective ◽  
Sham Acupuncture ◽  
Chronic Musculoskeletal Pain ◽  
Secondary Outcome

Abstract Background Depression and chronic musculoskeletal pain (CMSP) are the leading causes of years lived with disabling diseases worldwide. Moreover, they often commonly coexist, which makes diagnosis and treatment difficult. A safe and effective treatment is urgently needed. Previous studies have shown that acupuncture is a cost-effective treatment for simple depression or CMSP. However, there is limited evidence that acupuncture is effective for depression comorbid with CMSP. Methods This is a randomized, sham acupuncture-controlled trial with three arms: real acupuncture (RA), sham acupuncture (SA), and healthy control (HC). Forty-eight depression combined CMSP participants and 12 healthy people will be recruited from GDTCM hospital and randomized 2:2:1 to the RA, SA, and HC groups. The patients will receive RA or SA intervention for 8 weeks, and HC will not receive any intervention. Upon completion of the intervention, there will be a 4-week follow-up. The primary outcome measures will be the severity of depression and pain, which will be assessed by the Hamilton Depression Rating Scale (HAMD-17) and Brief Pain Inventory (BPI), respectively. The secondary outcome measures will be cognitive function and quality of life, which will be measured by the Montreal Cognitive Assessment (MoCA), P300, and World Health Organization Quality of Life (WHOQOL-BREF). In addition, the correlation between brain-derived neurotrophic factor (BDNF) and symptoms will also be determined. Discussion The aim of this study is to evaluate the clinical efficacy and underlying mechanism of acupuncture in depression comorbid with CMSP. This study could provide evidence for a convenient and cost-effective means of future prevention and treatment of combined depression and CMSP. Trial registration Chinese Clinical Trial Registry ChiCTR1800014754. Preregistered on 2 February 2018. The study is currently recruiting.

scholarly journals Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042627
Author(s):  
María Reina-Bueno ◽  
María del Carmen Vázquez-Bautista ◽  
Inmaculada C Palomo-Toucedo ◽  
Gabriel Domínguez-Maldonado ◽  
José Manuel Castillo-López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Foot Orthoses ◽  
Systemic Lupus ◽  
Custom Made ◽  
Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

scholarly journals Effectiveness of a peer-mediated educational intervention in improving general practitioner diagnostic assessment and management of dementia: a cluster randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e021125 ◽  
Author(s):  
Dimity Pond ◽  
Karen Mate ◽  
Nigel Stocks ◽  
Jane Gunn ◽  
Peter Disler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Outcome Measures ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Mean Difference ◽  
Secondary Outcome ◽  
General Practices ◽  
Randomised Controlled

ObjectiveTest effectiveness of an educational intervention for general practitioners (GPs) on quality of life and depression outcomes for patients.DesignDouble-blind, cluster randomised controlled trial.SettingGeneral practices in Australia between 2007 and 2010.ParticipantsGeneral practices were randomly allocated to the waitlist (n=37) or intervention (n=66) group, in a ratio of 1:2. A total of 2030 (1478 intervention; 552 waitlist) community-dwelling participants aged 75 years or older were recruited via 168 GPs (113 intervention; 55 waitlist).InterventionsA practice-based academic detailing intervention led by a peer educator that included: (1) training in use of the GP assessment of cognition dementia screening instrument; (2) training in diagnosis and management based on Royal Australian College of General Practitioners Dementia Guidelines; (3) addressing GPs’ barriers to dementia diagnosis; and (4) a business case outlining a cost-effective dementia assessment approach.Outcome measuresPrimary outcome measures were patient quality of life and depression; secondary outcome measures were: (1) sensitivity and specificity of GP identification of dementia; (2) referral to medical specialists and/or support services; (3) patient satisfaction with care; and (4) carer quality of life, depression and satisfaction with care.ResultsThe educational intervention had no significant effect on patient quality of life or depression scores after 12 months. There were however improvements in secondary outcome measures including sensitivity of GP judgement of dementia (p=0.002; OR 6.0, 95% CI 1.92 to 18.73), satisfaction with GP communication for all patients (p=0.024; mean difference 2.1, 95% CI 0.27 to 3.93) and for patients with dementia (p=0.007; mean difference 7.44, 95% CI 2.02 to 12.86) and enablement of carers (p=0.0185; mean difference 24.77, 95% CI 4.15 to 45.40).ConclusionPractice-based academic detailing did not improve patient quality of life or depression scores but did improve detection of dementia in primary care and patient satisfaction with GP communication.Trial registration numberACTRN12607000117415; Pre-results.

scholarly journals Chronic Musculoskeletal Pain, Self-Reported Health and Quality of Life among Older Populations in South Africa and Uganda

2018 ◽  
Vol 15 (12) ◽  
pp. 2806 ◽  
Author(s):  
Chao Wang ◽  
Run Pu ◽  
Bishwajit Ghose ◽  
Shangfeng Tang
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
South Africa ◽  
Back Pain ◽  
Musculoskeletal Pain ◽  
Chronic Musculoskeletal Pain ◽  
Self Rated Health ◽  
Reported Health ◽  
Older Populations

Chronic musculoskeletal pain (CMP) is a serious health concern especially among the elderly population and has significant bearing on health and quality of life. Not much is known about the relationship between chronic pain with self-reported health and quality of life among older populations in low-resource settings. Based on sub-national data from South Africa and Uganda, the present study aimed to explore whether the older population living with CMP report health and quality of life differently compared to those with no CMP complaints. This study was based on cross-sectional data on 1495 South African and Ugandan men and women collected from the SAGE Well-Being of Older People Study. Outcome variables were self-reported physical and mental health and quality of life (QoL). Mental health was assessed by self-reported depressive symptoms during the last 12 months. CMP was assessed by self-reported generalised pain as well as back pain. Multivariable logistic regression models were used to measure the association between health and QoL with CMP by adjusting for potential demographic and environmental confounders. The prevalence of poor self-rated health (61.2%, 95% CI = 51.7, 70.0), depression (37.2%, 95% CI = 34.8, 39.6) and QoL (80.5%, 95% CI = 70.8, 87.5) was considerably high in the study population. Mild/moderate and Severe/extreme generalised pain were reported respectively by 34.5% (95% CI = 28.9, 40.5) and 15.7% (95% CI = 12.2, 19.9) of the respondents, while back pain was reported by 53.3% (95% CI = 45.8, 60.4). The prevalence of both types was significantly higher among women than in men (p < 0.001). In the multivariate analysis, both generalised pain and back pain significantly predicted poor health, depression and QoL, however, it varied between the two different populations. Back pain was associated with higher odds of poor self-rated health [OR = 1.813, 95% CI = 1.308, 2.512], depression [1.640, 95% CI = 1.425, 3.964] and poor QoL [1.505, 95% CI = 1.028, 2.202] in South Africa, but not in Uganda. Compared to having no generalised pain, having Mild/Moderate [OR = 2.309, 95% CI = 1.219, 7.438] and Severe/Extreme [OR = 2.271, 95% CI = 1.447, 4.143] generalised pain was associated with significantly higher odds of poor self-rated health in South Africa. An overwhelmingly high proportion of the sample population reported poor health, quality of life and depression. Among older individuals, health interventions that address CMP may help promote subjective health and quality and life and improve psychological health.

scholarly journals Effects of Long-term Growth Hormone Replacement in Adults With Growth Hormone Deficiency Following Cure of Acromegaly: A KIMS Analysis

2014 ◽  
Vol 99 (6) ◽  
pp. 2018-2029 ◽  
Author(s):  
Nicholas A. Tritos ◽  
Gudmundur Johannsson ◽  
Márta Korbonits ◽  
Karen K. Miller ◽  
Ulla Feldt-Rasmussen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Growth Hormone ◽  
General Population ◽  
Outcome Measures ◽  
Cardiovascular Mortality ◽  
Density Lipoprotein ◽  
Lipoprotein Cholesterol ◽  
World Health ◽  
Gh Replacement

Context: GH deficiency (GHD) may occur in adults with cured acromegaly (acroGHD). Objective: Our objective was to examine the effectiveness and safety of GH replacement in acroGHD. Design: This study was a retrospective analysis of data from KIMS (Pfizer International Metabolic Database). Setting: Data were extracted from a pharmaco-epidemiological survey of &gt;16 000 GHD adults from 31 countries. Patients: The effectiveness population included 115 adults with acroGHD and 142 age-, gender-, and body mass index-matched GHD adults with nonfunctioning pituitary adenoma (NFPA) followed up to 5 years on GH. The safety population included 164 adults with acroGHD and 2469 with NFPA, all GH-replaced. Both acroGHD and NFPA were compared with several cohorts from the general population (including the World Health Organization Global Burden of Disease). Outcome Measures: Outcome measures included quality of life (QoL-AGHDA), lipids, serious adverse events, and additional safety endpoints. Results: Median GH dose was 0.3 mg/d in acroGHD and NFPA at 5 years. There were comparable improvements in QoL-AGHDA and total and low-density lipoprotein cholesterol in acroGHD and NFPA. High-density lipoprotein cholesterol increased only in acroGHD. Cardiovascular mortality was increased in acroGHD vs NFPA (standardized mortality ratio = 3.03, P = .02). All-cause mortality was similar in acroGHD (ratio between observed/expected cases [95% confidence interval] = 1.32 [0.70–2.25]) and lower in NFPA [observed/expected = 0.58 [0.48–0.70]) in comparison with the general population. There was no difference in incidence of all cancers, benign or malignant brain tumors, or diabetes mellitus between acroGHD and NFPA. Conclusions: GH replacement has comparable effects on quality of life and lipids in acroGHD and NFPA. Further investigation is needed to examine whether the increased cardiovascular mortality may be attributed to the history of previous GH excess in acroGHD.

scholarly journals Efficacy of acupuncture in improving the symptoms and the quality of life of patients with moderate or severe acne vulgaris: a protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Ruimin Jiao ◽  
Man Huang ◽  
Weina Zhang ◽  
Zhishun Liu
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Acne Vulgaris ◽  
Sham Acupuncture ◽  
Lesion Count ◽  
Randomized Controlled ◽  
Scale Total Score

Abstract Background : Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the appearance and the quality of life (QoL) of patients. Although several trials have indicated the effectiveness of acupuncture for treatment of patients with AV, the results of these trials have been contested owing to potential bias in their design. Thus, there is a lack of robust data to evaluate the efficacy of acupuncture in patients with AV. In addition, none of the previous clinical trials of acupuncture therapy for AV used QoL as a primary outcome or employed a sham acupuncture control arm. The aim of the study is to evaluate the effect of acupuncture on the symptoms and the QoL of patients with moderate or severe AV. Methods/design: One hundred eligible participants with AV will be randomly assigned to acupuncture or sham acupuncture groups (1:1 allocation). All participants will receive 4-week treatment comprising of a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be: Skindex-16 subscale score; the Dermatology Life Quality Index scale total score; the total lesion count and inflammatory lesion count; visual analogue scale scores for assessment of itch and pain; patient expectations of acupuncture; and the blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population. Discussion: We expect to evaluate the effectiveness of acupuncture in ameliorating the symptoms and improving the QoL of patients with moderate or severe AV compared with sham acupuncture with more robust evidence. The limitations of the trial design are its single center scope, relatively small sample size, and lack of blinding of the acupuncturists. Trial Registration: Chinese Clinical Trial Registry, ChiCTR-1900023649 (Date of registration: Jan 2, 2019). Keywords: acupuncture, acne vulgaris, quality of life, randomized-controlled trial, protocol.

scholarly journals The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Tianye Hu ◽  
Hantong Hu ◽  
Feng Chen ◽  
Bin Jiang ◽  
Fengfei Shen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Outcome Measures ◽  
Vestibular Migraine ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Introduction: With a high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect the quality of life of patients, but it remains difficult to manage by current treatment options. Acupuncture may be a potential treatment option for VM prophylaxis, but the currently available evidence is still uncertain. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for VM prophylaxis.Methods: This is a 28-week parallel, randomized, controlled clinical trial including 4 weeks of baseline, 8 weeks of treatment, and 16 weeks of follow-up. A total of 72 participants will be randomly assigned to two groups. The participants will receive acupuncture in the experimental group, while the participants in the control group will be treated with venlafaxine. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in doses of rescue medication, anxiety level, depression level, and quality of life per 4 weeks from baseline. Adverse events will be recorded for safety evaluation.Discussion: This study will investigate the efficacy and safety of acupuncture for VM prophylaxis. The results will contribute to determining whether acupuncture can serve as an optional treatment strategy for treating VM.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT0464088.

scholarly journals Efficacy of acupuncture in improving the symptoms and the quality of life of patients with moderate or severe acne vulgaris: a protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Ruimin Jiao ◽  
Man Huang ◽  
Weina Zhang ◽  
Zhishun Liu
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Acne Vulgaris ◽  
Sham Acupuncture ◽  
Lesion Count ◽  
Randomized Controlled ◽  
Scale Total Score

Abstract Background : Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the appearance and the quality of life (QoL) of patients. Although several trials have indicated the effectiveness of acupuncture for treatment of patients with AV, the results of these trials have been contested owing to potential bias in their design. Thus, there is a lack of robust data to evaluate the efficacy of acupuncture in patients with AV. In addition, none of the previous clinical trials of acupuncture therapy for AV used QoL as a primary outcome or employed a sham acupuncture control arm. The aim of the study is to evaluate the effect of acupuncture on the symptoms and the QoL of patients with moderate or severe AV. Methods/design: One hundred eligible participants with AV will be randomly assigned to acupuncture or sham acupuncture groups (1:1 allocation). All participants will receive 4-week treatment comprising of a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be: Skindex-16 subscale score; the Dermatology Life Quality Index scale total score; the total lesion count and inflammatory lesion count; visual analogue scale scores for assessment of itch and pain; patient expectations of acupuncture; and the blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population. Discussion: We expect to evaluate the effectiveness of acupuncture in ameliorating the symptoms and improving the QoL of patients with moderate or severe AV compared with sham acupuncture with more robust evidence. The limitations of the trial design are its single center scope, relatively small sample size, and lack of blinding of the acupuncturists. Trial Registration: Chinese Clinical Trial Registry, ChiCTR-1900023649 (Date of registration: Jan 2, 2019). Keywords: acupuncture, acne vulgaris, quality of life, randomized-controlled trial, protocol.

Anxiety and depression are independent predictors of quality of life of patients with chronic musculoskeletal pain

2012 ◽  
Vol 18 (2) ◽  
pp. 167-175 ◽  
Author(s):  
Tage Orenius ◽  
Taru Koskela ◽  
Petteri Koho ◽  
Timo Pohjolainen ◽  
Hannu Kautiainen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Management ◽  
Musculoskeletal Pain ◽  
Management Programme ◽  
Chronic Musculoskeletal Pain ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

We examined the relative impact of baseline anxiety, depression and fear of movement on health related quality of life at 12-month follow-up after a multidisciplinary pain management programme. One hundred and eleven patients who had chronic musculoskeletal pain (mean age 45 years, 65% women) attended during 2003–2005 a multidisciplinary three-phase pain management programme with a total time frame of six to seven months, totalling 19 days. The Beck Anxiety Inventory was used to rate anxiety, the Beck Depression Inventory depression, the Tampa Scale of Kinesiophobia fear of movement. The generic 15D questionnaire was used to assess health related quality of life. Baseline data were collected at admission, follow-up data at 12 months. Mean health related quality of life increased significantly from baseline to 12-month follow-up. Anxiety at baseline predicted significant negative change in the health related quality of life, depression predicted significant positive change in the health related quality of life. Fear of movement did not predict any significant change in the health related quality of life. We concluded that patients with chronic musculoskeletal pain and mild to moderate depression benefit from a multidisciplinary pain management programme in contrast to anxious patients. The findings imply further research with bigger sample sizes, other than HRQoL outcome measures as well as with other groups of patients.

Sign in / Sign up

Export Citation Format

Share Document