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The Cochrane Database of Systematic... Feb 2019Chronic pain, considered to be pain lasting more than three months, is a common and often difficult to treat condition that can significantly impact upon function and...
BACKGROUND
Chronic pain, considered to be pain lasting more than three months, is a common and often difficult to treat condition that can significantly impact upon function and quality of life. Treatment typically includes pharmacological and non-pharmacological approaches. Transcutaneous electrical nerve stimulation (TENS) is an adjunct non-pharmacological treatment commonly recommended by clinicians and often used by people with pain.
OBJECTIVES
To provide an overview of evidence from Cochrane Reviews of the effectiveness of TENS to reduce pain in adults with chronic pain (excluding headache or migraine).To provide an overview of evidence from Cochrane Reviews of the safety of TENS when used to reduce pain in adults with chronic pain (excluding headache or migraine).To identify possible sources of inconsistency in the approaches taken to evaluating the evidence related to TENS for chronic pain (excluding headache or migraine) in the Cochrane Library with a view to recommending strategies to improve consistency in methodology and reporting.To highlight areas of remaining uncertainty regarding the effectiveness of TENS for chronic pain (excluding headache or migraine) with a view to recommending strategies to reduce any uncertainty.
METHODS
Search methodsWe searched the Cochrane Database of Systematic Reviews (CDSR), in the Cochrane Library, across all years up to Issue 11 of 12, 2018.Selection of reviewsTwo authors independently screened the results of the electronic search by title and abstract against inclusion/exclusion criteria. We included all Cochrane Reviews of randomised controlled trials (RCTs) assessing the effectiveness of TENS in people with chronic pain. We included reviews if they investigated the following: TENS versus sham; TENS versus usual care or no treatment/waiting list control; TENS plus active intervention versus active intervention alone; comparisons between different types of TENS; or TENS delivered using different stimulation parameters.Data extraction and analysisTwo authors independently extracted relevant data, assessed review quality using the AMSTAR checklist and applied GRADE judgements where required to individual reviews. Our primary outcomes included pain intensity and nature/incidence of adverse effects; our secondary outcomes included disability, health-related quality of life, analgesic medication use and participant global impression of change.
MAIN RESULTS
We included nine reviews investigating TENS use in people with defined chronic pain or in people with chronic conditions associated with ongoing pain. One review investigating TENS for phantom or stump-associated pain in people following amputation did not have any included studies. We therefore extracted data from eight reviews which represented 51 TENS-related RCTs representing 2895 TENS-comparison participants entered into the studies.The included reviews followed consistent methods and achieved overall high scores on the AMSTAR checklist. The evidence reported within each review was consistently rated as very low quality. Using review authors' assessment of risk of bias, there were significant methodological limitations in included studies; and for all reviews, sample sizes were consistently small (the majority of studies included fewer than 50 participants per group).Six of the eight reviews presented a narrative synthesis of included studies. Two reviews reported a pooled analysis.Primary and secondary outcomes One review reported a beneficial effect of TENS versus sham therapy at reducing pain intensity on a 0 to 10 scale (MD -1.58, 95% CI -2.08 to -1.09, P < 0.001, I² = 29%, P = 0.22, 5 studies, 207 participants). However the quality of the evidence was very low due to significant methodological limitations and imprecision. A second review investigating pain intensity performed a pooled analysis by combining studies that compared TENS to sham with studies that compared TENS to no intervention (SMD -0.85, 95% CI -1.36 to -0.34, P = 0.001, I² = 83%, P < 0.001). This pooled analysis was judged as offering very low quality evidence due to significant methodological limitations, large between-trial heterogeneity and imprecision. We considered the approach of combining sham and no intervention data to be problematic since we would predict these different comparisons may be estimating different true effects. All remaining reviews also reported pain intensity as an outcome measure; however the data were presented in narrative review form only.Due to methodological limitation and lack of useable data, we were unable to offer any meaningful report on the remaining primary outcome regarding nature/incidence of adverse effects, nor for the remaining secondary outcomes: disability, health-related quality of life, analgesic medication use and participant global impression of change for any comparisons.We found the included reviews had a number of inconsistencies when evaluating the evidence from TENS studies. Approaches to assessing risk of bias around the participant, personnel and outcome-assessor blinding were perhaps the most obvious area of difference across included reviews. We also found wide variability in terms of primary and secondary outcome measures, and inclusion/exclusion criteria for studies varied with respect to including studies which assessed immediate effects of single interventions.
AUTHORS' CONCLUSIONS
We found the methodological quality of the reviews was good, but quality of the evidence within them was very low. We were therefore unable to conclude with any confidence that, in people with chronic pain, TENS is harmful, or beneficial for pain control, disability, health-related quality of life, use of pain relieving medicines, or global impression of change. We make recommendations with respect to future TENS study designs which may meaningfully reduce the uncertainty relating to the effectiveness of this treatment in people with chronic pain.
Topics: Adult; Chronic Pain; Humans; Randomized Controlled Trials as Topic; Systematic Reviews as Topic; Transcutaneous Electric Nerve Stimulation
PubMed: 30776855
DOI: 10.1002/14651858.CD011890.pub2 -
Scandinavian Journal of Pain Jan 2018Treatment of pain following major limb amputations is often a clinical challenge in a patient population consisting mainly of elderly with underlying diseases....
BACKGROUND AND AIMS
Treatment of pain following major limb amputations is often a clinical challenge in a patient population consisting mainly of elderly with underlying diseases. Literature on management of acute post-amputation pain is scarce. We performed a systematic review on this topic to evaluate the efficacy and safety of analgesic interventions for acute pain following major limb amputation.
METHODS
A literature search was performed in PubMed, Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews using the following key words: [(amputation) AND (pain OR analgesi* OR pain relief)] AND (acute OR postoperative). Randomized controlled studies (RCTs) and observational studies investigating treatment of acute pain following major amputations for any indication (peripheral vascular disease, malignant disease, trauma) were included. The review was performed according to the standards described in the PRISMA statement. The Cochrane quality assessment tool was used to evaluate the risk of bias in the RCTs.
RESULTS
Nineteen studies with total of 949 patients were included. The studies were generally small and heterogeneous on outcomes, study designs and quality. There were 16 studies on epidural or continuous perineural analgesia (CPI). Based on five RCTs (n=268) and two observational studies (n=49), epidural analgesia decreased the intensity of acute stump pain as compared to systemic analgesics, during the first 24 h after the operation. Based on one study epidural analgesia caused more adverse effects like sedation, nausea and motor block than continuous perineural local anesthetic infusion. Based on one RCT (n=21) and eight observational studies (n=501) CPI seemed to decrease opioid consumption as compared to systemic analgesics only, on the first three postoperative days, and was well tolerated. Only three trials investigated systemic analgesics (oral memantine, oral gabapentine, iv ketamine). Ketamine did not decrease acute pain or opioid consumption after amputation as compared to other systemic analgesics. Gabapentin did not decrease acute pain when combined to epidural analgesia as compared to epidural analgesia and opioid treatment, and caused adverse effects.
CONCLUSIONS
The main finding of this systematic review is that evidence regarding pain management after major limb amputation is very limited. Epidural analgesia may be effective, but firm evidence is lacking. Epidural causes more adverse effects than CPI. The results on efficacy of CPI are indecisive. The data on adjuvant medications combined to epidural analgesia or CPI is limited. Studies on efficacy and adverse effects of systemic analgesics for amputation pain, especially concentrating on elderly patients, are needed.
Topics: Acute Pain; Amputation, Surgical; Analgesia, Epidural; Analgesics; Chemotherapy, Adjuvant; Humans; Pain Management; Pain, Postoperative
PubMed: 29794290
DOI: 10.1515/sjpain-2017-0170 -
Technology and Innovation Sep 2016Patients with lower extremity amputation (LEA) experience 65% more dermatologic issues than non-amputees, and skin problems are experienced by ≈75% of LEA patients who...
Patients with lower extremity amputation (LEA) experience 65% more dermatologic issues than non-amputees, and skin problems are experienced by ≈75% of LEA patients who use prostheses. Continuously referring LEA patients to a dermatologist for every stump related skin condition may be impractical. Thus, physical rehabilitation professionals should be prepared to recognize and manage common non-emergent skin conditions in this population. The purpose of this study was to determine the quantity, quality, and strength of available evidence supporting treatment methods for prosthesis-related residual limb (RL) ulcers. Systematic literature review with evidence grading and synthesis of empirical evidence statements (EES) was employed. Three EESs were formulated describing ulcer etiology, conditions in which prosthetic continuance is practical, circumstances likely requiring prosthetic discontinuance, and the consideration of additional medical or surgical interventions. Continued prosthetic use is a viable option to manage minor or early-stage ulcerated residual limbs in compliant patients lacking multiple comorbidities. Prosthetic discontinuance is also a viable method of residual limb ulcer healing and may be favored in the presence of severe acute ulcerations, chronic heavy smoking, intractable pain, rapid volume and weight change, history of chronic ulceration, systemic infections, or advanced dysvascular etiology. Surgery or other interventions may also be necessary in such cases to achieve restored prosthetic ambulation. A short bout of prosthetic discontinuance with a staged re-introduction plan is another viable option that may be warranted in patients with ulceration due to poor RL volume management. High-quality prospective research with larger samples is needed to determine the most appropriate course of treatment when a person with LEA develops an RL ulcer that is associated with prosthetic use.
PubMed: 28066521
DOI: 10.21300/18.2-3.2016.115 -
Journal of Rehabilitation Research and... 2015This review is an attempt to untangle the complexity of transtibial prosthetic socket fit, determine the most important characteristic for a successful fitting, and... (Meta-Analysis)
Meta-Analysis Review
This review is an attempt to untangle the complexity of transtibial prosthetic socket fit, determine the most important characteristic for a successful fitting, and perhaps find some indication of whether a particular prosthetic socket type might be best for a given situation. Further, it is intended to provide directions for future research. We followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and used medical subject headings and standard key words to search for articles in relevant databases. No restrictions were made on study design or type of outcome measure. From the obtained search results (n = 1,863), 35 articles were included. The relevant data were entered into a predefined data form that incorporated the Downs and Black risk of bias assessment checklist. Results for the qualitative outcomes (n = 19 articles) are synthesized. Total surface bearing sockets lead to greater activity levels and satisfaction in active persons with amputation, those with a traumatic cause of amputation, and younger persons with amputation than patellar tendon bearing sockets. Evidence on vacuum-assisted suction and hydrostatic sockets is inadequate, and further studies are much needed. To improve the scientific basis for prescription, comparison of and correlation between mechanical properties of interface material, socket designs, user characteristics, and outcome measures should be conducted and reported in future studies.
Topics: Amputation, Surgical; Amputation Stumps; Artificial Limbs; Humans; Pressure; Prosthesis Design; Stress, Mechanical; Surface Properties; Tibia; Weight-Bearing
PubMed: 26436666
DOI: 10.1682/JRRD.2014.08.0183 -
PloS One 2015Traumatic arm amputations can be treated with replantation or surgical formalization of the stump with or without subsequent prosthetic fitting. In the literature, many... (Review)
Review
BACKGROUND
Traumatic arm amputations can be treated with replantation or surgical formalization of the stump with or without subsequent prosthetic fitting. In the literature, many authors suggest the superiority of replantation. This systematic review compared available literature to analyze whether replantation is functionally and psychologically more profitable than formalization and prosthetic fitting in patients with traumatic arm amputation.
METHODS
Functional outcome and satisfaction levels were recorded of patients with amputation levels below elbow, through elbow, and above elbow.
RESULTS
Functional outcomes of 301 replantation patients and 172 prosthesis patients were obtained. In the replantation group, good or excellent functional scores were reported in 39% of above elbow, 55% of through elbow, and 50% of below elbow amputation cases. Nearly 100% of patients were satisfied with the replanted limb. In the prosthesis group, full use of the prosthesis was attained in 48% of above elbow and in 89% of below elbow amputation patients. Here, 29% of patients elected not to use the prosthesis for reasons including pain and functional superfluity. In both replantation patients and prosthesis wearers, a below elbow amputation yielded better functional results than higher amputation levels.
CONCLUSIONS
Replantation of a traumatically amputated arm leads to good function and higher satisfaction rates than a prosthesis, regardless of the objective functional outcome. Sensation and psychological well-being seem the two major advantages of replantation over a prosthesis. The current review of the available literature shows that in carefully selected cases replantation could be the preferred option of treatment.
Topics: Adolescent; Adult; Aged; Amputation, Traumatic; Arm; Arm Injuries; Artificial Limbs; Child; Child, Preschool; Elbow Joint; Female; Humans; Infant; Male; Middle Aged; Patient Satisfaction; Quality of Life; Treatment Outcome; Elbow Injuries
PubMed: 26340003
DOI: 10.1371/journal.pone.0137729 -
The Cochrane Database of Systematic... Aug 2015This is the first update of a Cochrane review published in Issue 5, 2010 on transcutaneous electrical nerve stimulation (TENS) for phantom pain and stump pain following... (Review)
Review
BACKGROUND
This is the first update of a Cochrane review published in Issue 5, 2010 on transcutaneous electrical nerve stimulation (TENS) for phantom pain and stump pain following amputation in adults. Pain may present in a body part that has been amputated (phantom pain) or at the site of amputation (stump pain), or both. Phantom pain and stump pain are complex and multidimensional and the underlying pathophysiology remains unclear. The condition remains a severe burden for those who are affected by it. The mainstay treatments are predominately pharmacological, with increasing acknowledgement of the need for non-drug interventions. TENS has been recommended as a treatment option but there has been no systematic review of available evidence. Hence, the effectiveness of TENS for phantom pain and stump pain is currently unknown.
OBJECTIVES
To assess the analgesic effectiveness of TENS for the treatment of phantom pain and stump pain following amputation in adults.
SEARCH METHODS
For the original version of the review we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, AMED, CINAHL, PEDRO and SPORTDiscus (February 2010). For this update, we searched the same databases for relevant randomised controlled trials (RCTs) from 2010 to 25 March 2015.
SELECTION CRITERIA
We only included RCTs investigating the use of TENS for the management of phantom pain and stump pain following an amputation in adults.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and extracted data. We planned that where available and appropriate, data from outcome measures were to be pooled and presented as an overall estimate of the effectiveness of TENS.
MAIN RESULTS
In the original review there were no RCTs that examined the effectiveness of TENS for the treatment of phantom pain and stump pain in adults. For this update, we did not identify any additional RCTs for inclusion.
AUTHORS' CONCLUSIONS
There were no RCTs to judge the effectiveness of TENS for the management of phantom pain and stump pain. The published literature on TENS for phantom pain and stump pain lacks the methodological rigour and robust reporting needed to confidently assess its effectiveness. Further RCT evidence is required before an assessment can be made. Since publication of the original version of this review, we have found no new studies and our conclusions remain unchanged.
Topics: Adult; Amputation Stumps; Humans; Pain Management; Phantom Limb; Transcutaneous Electric Nerve Stimulation
PubMed: 26284511
DOI: 10.1002/14651858.CD007264.pub3 -
European Journal of Vascular and... Aug 2015The aim of this systematic review and meta-analysis was to evaluate the effects of using an intraoperatively placed perineural catheter (PNC) with a postoperative local... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The aim of this systematic review and meta-analysis was to evaluate the effects of using an intraoperatively placed perineural catheter (PNC) with a postoperative local anaesthetic infusion on immediate and long-term outcomes after lower limb amputation.
METHODS
A systematic review of key electronic journal databases was undertaken from inception to January 2015. Studies comparing PNC use with either a control, or no PNC, were included. Meta-analysis was performed for postoperative opioid use, pain scores, mortality, and long-term incidence of stump and phantom limb pain. Sensitivity analysis was performed for opioid use. Quality of evidence was assessed using the GRADE system.
RESULTS
Seven studies reporting on 416 patients undergoing lower limb amputation with PNC usage (n = 199) or not (n = 217) were included. Approximately 60% were transtibial amputations PNC use reduced postoperative opioid consumption (standardised mean difference: -0.59, 95% CI -1.10 to -0.07, p = .03), maintained on sensitivity analysis for large (p = .03) and high-quality (p = .003) studies, but was marginally lost (p = .06) on studies enrolling patients with peripheral arterial disease only. PNC treatment did not affect postoperative pain scores (p = .48), in-hospital mortality (p = .77), phantom limb pain (p = .28) or stump pain (p = .37). GRADE quality of evidence for all outcomes was very low.
CONCLUSION
There is poor-quality evidence that PNC usage significantly reduces opioid consumption following lower limb amputation, without affecting other short- or long-term outcomes. Well-performed randomised studies are required.
Topics: Amputation, Surgical; Analgesics, Opioid; Anesthetics, Local; Catheterization; Catheters, Indwelling; Chi-Square Distribution; Humans; Infusions, Parenteral; Lower Extremity; Odds Ratio; Pain Measurement; Pain, Postoperative; Phantom Limb; Time Factors; Treatment Outcome
PubMed: 26067167
DOI: 10.1016/j.ejvs.2015.04.030 -
The Cochrane Database of Systematic... Apr 2014Below knee amputation (BKA) may be necessary in patients with advanced critical limb ischaemia or diabetic foot sepsis in whom no other treatment option is available.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Below knee amputation (BKA) may be necessary in patients with advanced critical limb ischaemia or diabetic foot sepsis in whom no other treatment option is available. There is no consensus as to which surgical technique achieves the maximum rehabilitation potential. This is the third update of the review first published in 2004.
OBJECTIVES
To assess the effects of different types of incision on the outcome of BKA in people with lower limb ischaemia or diabetic foot sepsis, or both. The main focus of the review was to assess the relative merits of skew flap amputation versus the long posterior flap technique.
SEARCH METHODS
For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched 28 March 2013) and CENTRAL (2013, Issue 2).
SELECTION CRITERIA
Randomised controlled trials comparing two or more types of skin incision for BKA were identified. People with lower limb ischaemia (acute or chronic) or diabetic foot sepsis, or both, were considered for inclusion. People undergoing below knee amputation for other conditions were excluded.
DATA COLLECTION AND ANALYSIS
One review author identified potential trials. Two review authors independently assessed trial quality and extracted the data. Additional information, if required, was sought from study authors.
MAIN RESULTS
Three studies with a combined total of 309 participants were included in the review. One study compared two-stage versus one-stage BKA; one study compared skew flaps BKA versus long posterior flap BKA; and one study compared sagittal flaps BKA versus long posterior flap BKA. Overall the quality of the evidence from these studies was moderate. BKA using skew flaps or sagittal flaps conferred no advantage over the well established long posterior flap technique (primary stump healing was 60% for both skew flaps and long posterior flap (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.71 to 1.42) and primary stump healing was 58% for sagittal flaps and 55% for long posterior flap (Peto odds ratio (OR) 1.04, 95% CI 0.45 to 2.43). For participants with wet gangrene, a two-stage procedure with a guillotine amputation at the ankle followed by a definitive long posterior flap amputation led to better primary stump healing than a one-stage procedure (Peto OR 0.08, 95% CI 0.01 to 0.89). Post-operative infection rate or wound necrosis, reamputation, and mobility with a prosthetic limb were similar in the different comparisons.
AUTHORS' CONCLUSIONS
There is no evidence to show a benefit of one type of incision over another. However, in the presence of wet gangrene a two-stage procedure leads to better primary stump healing compared to a one-stage procedure. The choice of amputation technique can, therefore, be a matter of surgeon preference taking into account factors such as previous experience of a particular technique, the extent of non-viable tissue, and the location of pre-existing surgical scars.
Topics: Amputation, Surgical; Diabetic Foot; Gangrene; Humans; Ischemia; Leg; Randomized Controlled Trials as Topic; Reoperation; Surgical Flaps; Treatment Outcome; Wound Healing
PubMed: 24715679
DOI: 10.1002/14651858.CD003749.pub3 -
Gait & Posture Feb 2014Postural control has been widely evaluated for the normal population and different groups over the past 20 years. Numerous studies have investigated postural control in... (Review)
Review
Postural control has been widely evaluated for the normal population and different groups over the past 20 years. Numerous studies have investigated postural control in quiet standing posture among amputees. However, a comprehensive analysis is lacking on the possible contributing factors to balance. The present systematic review highlights the current findings on variables that contribute to balance instability for lower extremity amputees. The search strategy was performed on PubMed, Web of Science, Medline, Scopus, and CINAHL and then followed by additional manual searching via reference lists in the reviewed articles. The quality of the articles was evaluated using a methodological quality assessment tool. This review included and evaluated a total of 23 full-text articles. Despite the inconsistencies in the methodological design of the studies, all articles scored above the acceptable level in terms of quality. A majority of the studies revealed that lower extremity amputees have increased postural sway in the standing posture. Asymmetry in body weight, which is mainly distributed in the non-amputated leg, was described. Aside from the centre of pressure in postural control, sensory inputs may be a related topic for investigation in view of evidence on their contribution, particularly visual input. Other balance-related factors, such as stump length and patients' confidence level, were also neglected. Further research requires examination on the potential factors that affect postural control as the information of standing postural is still limited.
Topics: Amputation Stumps; Amputees; Humans; Lower Extremity; Postural Balance; Posture
PubMed: 24331296
DOI: 10.1016/j.gaitpost.2013.07.006 -
Journal of Rehabilitation Research and... 2011Management of residual limb volume affects decisions regarding timing of fit of the first prosthesis, when a new prosthetic socket is needed, design of a prosthetic... (Review)
Review
Management of residual limb volume affects decisions regarding timing of fit of the first prosthesis, when a new prosthetic socket is needed, design of a prosthetic socket, and prescription of accommodation strategies for daily volume fluctuations. This systematic review assesses what is known about measurement and management of residual limb volume change in persons with lower-limb amputation. Publications that met inclusion criteria were grouped into three categories: group I: descriptions of residual limb volume measurement techniques; group II: studies investigating the effect of residual limb volume change on clinical care in people with lower-limb amputation; and group III: studies of residual limb volume management techniques or descriptions of techniques for accommodating or controlling residual limb volume. We found that many techniques for the measurement of residual limb volume have been described but clinical use is limited largely because current techniques lack adequate resolution and in-socket measurement capability. Overall, limited evidence exists regarding the management of residual limb volume, and the evidence available focuses primarily on adults with transtibial amputation in the early postoperative phase. While we can draw some insights from the available research about residual limb volume measurement and management, further research is required.
Topics: Amputation Stumps; Anthropometry; Artificial Limbs; Humans; Lower Extremity; Organ Size; Prosthesis Design; Prosthesis Fitting
PubMed: 22068373
DOI: 10.1682/jrrd.2010.09.0189