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Cryotherapy is standard practice for treating patients with cervical precancer in see-and-treat programmes in low-income and middle-income countries (LMICs). Because of logistical difficulties with cryotherapy (eg, the necessity, costs, and supply chain difficulties of refrigerant gas; equipment failure; and treatment duration >10 min), a battery-operated thermal ablator that is lightweight and portable has been developed. We aimed to compare thermal ablation using the new device with cryotherapy. We report the pilot phase of a randomised controlled trial in routine screen-and-treat clinics providing cervical screening using visual inspection with acetic acid (VIA) in Lusaka, Zambia. We recruited non-pregnant women, aged 25 years or older, who were eligible for ablative therapy. We randomly assigned participants (1:1:1) to thermal ablation, cryotherapy, or large loop excision of the transformation zone (LLETZ), using computer-generated allocation. The randomisation was concealed but the nurses providing treatment and the participants were unmasked. Thermal ablation was achieved using the Liger thermal ablator (using 1–5 overlapping applications of the probe heated to 100°C, each application lasting for 40 s), cryotherapy was carried out using the double-freeze technique (freeze for 3 min, thaw for 5 min, and freeze again for 3 min), and LLETZ (using a large loop driven by an electro-surgical unit to excise the transformation zone) was done under local anaesthesia. The primary endpoint was treatment success, defined as either human papillomavirus (HPV) type-specific clearance among participants who were positive for the same HPV type at baseline, or a negative VIA test at 6-month follow-up, if the baseline HPV test was negative. Per protocol analyses were done. Enrolment for the full trial is ongoing. Here, we present findings from a prespecified pilot phase of the full trial. The final analysis of the full trial will assess non-inferiority of the groups for the primary efficacy endpoint. The study is registered with ClinicalTrials.gov, number NCT02956239. Between Aug 2, 2017, and Jan 15, 2019, 750 participants were randomly assigned (250 per group). 206 (84%) participants in the cryotherapy group, 197 (81%) in the thermal ablation group, and 204 (84%) in the LLETZ group attended the 6-month follow-up examination. Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31). Few participants complained of moderate to severe pain in any group immediately after the procedure (six [2%] of 250 in the cryotherapy group, four [2%] of 250 in the thermal ablation group, and five [2%] of 250 in the LLETZ group) and 2 weeks after the procedure (one [<1%] of 241 in the cryotherapy group, none of 242 in the thermal ablation group, and two [<1%] of 237 in the LLETZ group). None of the participants reported any complication requiring medical consultation or admission to hospital. Results from this pilot study preliminarily suggest that thermal ablation has similar treatment success to cryotherapy, without the practical disadvantages of providing cryotherapy in an LMIC. However, the study was not powered to establish the similarity between the techniques, and results from the ongoing randomised controlled trial are need to confirm these results. US National Institutes of Health.

Implementing standard-of-care cryotherapy or electrosurgical excision to treat cervical precancers is challenging in resource-limited settings. An affordable technological alternative that is as effective as standard-of-care techniques would greatly improve access to treatment. This randomized controlled trial aims to demonstrate the noninferiority efficacy of a portable, battery-driven thermal ablation (TA) device compared to cryotherapy and electrosurgical excision (large loop excision of transformation zone (LLETZ)) to treat cervical precancer in a screen-and-treat program in Zambia. A total of 3,124 women positive on visual inspection with acetic acid and eligible for ablative therapy were randomized to one of the treatment arms. Human papillomavirus (HPV) testing was performed at baseline and at the follow-up. The primary outcome was treatment success, defined as either type-specific HPV clearance at the follow-up in participants positive for HPV at baseline, or a negative visual inspection with acetic acid test for those who had a negative HPV test at baseline. After a median follow-up of 12 months, treatment success rates were 74.0%, 71.1% and 71.4% for the TA, cryotherapy and LLETZ arms, respectively, thus demonstrating noninferiority ( P  = 0.83). TA was a safe and well-accepted procedure. Only 3.6% of those randomized to TA reported moderate-to-severe pain, compared to 6.5% and 1.9% for the cryotherapy and LLETZ arms, respectively. Thus, our randomized controlled trial demonstrates the safety and efficacy of TA, which is not inferior to cryotherapy or surgical excision. ClinicalTrials.gov registration: NCT02956239 . A randomized controlled trial performed in a screen-and-treat program in Zambia found that a portable, battery-operated thermal ablation device was not inferior to cryotherapy and electrosurgical excision in cervical precancer treatment.

Background The prevalence of burning mouth syndrome (BMS) is approximately 8% in clinical patients; thus, BMS remains a therapeutic challenge. Photobiomodulation (PBM) and oral cryotherapy (OCT) have been evaluated for the treatment of burning pain, but no confirmatory trials have been performed. To evaluate the comparative effectiveness of PBM combined with OCT at reducing pain and psychological distress compared with PBM alone, OCT alone, or drug therapy (DT) alone in a cohort of patients with BMS. Methods This multi-institutional, single-blinded (assessor-blinded), randomized controlled trial with 4 treatment groups was conducted at Xinhua Hospital, Shanghai Jiao Tong University School of Medicine and Affiliated Stomatology Hospital of Guilin Medical University from December 12, 2022, to January 24, 2024. Among the 156 patients assessed for eligibility, 28 were excluded, and 128 patients with a BMS qualified for randomization to 1 of the 4 treatment groups. The participants received 7 treatment sessions of (1) PBM combined with OCT, (2) PBM, (3) OCT, or (4) DT during a 7-week period. The coprimary outcome measures were changes in visual analogue scale (VAS) scores and the overall response rate between baseline and 7 weeks of treatment. Results After 7 weeks of treatment, the PBM + OCT group achieved a high overall response rate for pain reduction (81.25%). This difference in pain reduction trends between the groups resulted in a nearly fivefold greater mean change in the VAS score at the 12-week assessment for the PBM + OCT group than for the DT group ( p  < 0.0083). Furthermore, anxiety symptoms were also significantly alleviated by PBM combined with OCT, resulting in a nearly tenfold greater mean change in the GAD-7 score at the 7-week assessment in the PBM + OCT group than in the DT group ( p  < 0.0083). No severe adverse events were reported during the study period. Conclusions PBM and OCT combination therapy reduces oral mucosa pain and alleviates anxiety symptoms in patients with BMS; thus, this combination therapy is expected to become a promising pain management option for patients with BMS. Trial registration Chinese Clinical Trial Registry Identifier: ChiCTR2300074518.

Purpose A predominance of parasympathetic drive is observed following cold exposure. Such modulation of the autonomic nervous system (ANS) is associated with faster post-exercise recovery. Within this context, whole-body cryotherapy (WBC) has been spreading in sport medicine, though the optimal temperature and frequency are unclear. The aim of this study was to examine the effects of different cryotherapy conditions on the sympathovagal balance. Methods Forty healthy males were randomly assigned into five different groups (− 110 °C, − 60 °C, − 10 °C, control temperature [≃ 24 °C]) and undertook 5 WBC sessions over 5 consecutive days. Cardiac autonomic activity was assessed through heart rate variability (HRV) using power density of high frequency (HF), root-mean square difference of successive R–R intervals (RMSSD) and sympathovagal balance (LF/HF). Systemic sympathetic activity was assessed via circulating blood catecholamines. Results Mean weekly RMSSD (pre: 48 ± 22 ms, post: 68 ± 29 ms) and HF (pre: 607 ± 692 ms 2 , post: 1271 ± 1180 ms 2 ) increased ( p  < 0.05) from pre to post WBC, only in the − 110 °C condition. A rise in plasma norepinephrine was found after the first − 110 °C WBC session only (pre: 173 ± 98, post: 352 ± 231 ng L −1 , p  < 0.01); whereas, it was not significant after the 5th session (pre: 161 ± 120, post: 293 ± 245 ng L −1 , p  = 0.15). Conclusion These results suggest that one − 110 °C WBC exposure is required to stimulate the ANS. After five daily exposures, a lower autonomic response was recorded compared to day one, therefore suggesting the development of physiological habituation to WBC.

To estimate the financial and economic costs and the cost-effectiveness of thermal ablation compared to cryotherapy and loop diathermy within a screen-and-treat approach to cervical cancer screening in Zambia. We analysed costs within a randomized controlled trial in which women eligible for ablative treatment after cervical cancer screening were assigned to one of three treatment arms: thermal ablation, cryotherapy or loop diathermy. We used a microcosting approach to calculate programme, personnel, equipment and consumable costs for two groups: women treated without follow-up (screened-and-treated) and women who completed follow-up (follow-up-completed). We also estimated trial costs and projected costs if the screen-and-treat approach were to be integrated into routine cervical cancer services. To assess how cost-effective the treatments were, we used a decision tree model. Out of the 3124 women who were screened-and-treated, 2386 (76.4%) completed follow-up. In the trial scenario, costs for thermal ablation were lower than cryotherapy and loop diathermy, both per screened-and-treated woman (39.6 United States dollars (US$) versus US$ 42.3 and US$ 50.6, respectively) and per follow-up-completed woman (US$ 55.1 versus US$ 57.9 and US$ 66.2, respectively). In the routine scenario, costs for thermal ablation were also lower than for other treatments (US$ 12.7 versus US$ 15.6 and US$ 34.9, respectively, for screen-and-treat) due to significantly lower personnel costs. Thermal ablation was cost-effective compared to cryotherapy and loop diathermy. Our study suggests that thermal ablation is a cost-effective option for the screen-and-treat approach to cervical cancer screening compared with cryotherapy and loop diathermy.

Background and objectivesNo previous study has assessed the outcomes of cooled radiofrequency ablation (C-RFA) of the medial branch nerves (MBN) for the treatment of lumbar facet joint pain nor compared its effectiveness with traditional RFA (T-RFA). This study evaluated 6-month outcomes for pain, function, psychometrics, and medication usage in patients who underwent MBN C-RFA versus T-RFA for lumbar Z-joint pain.MethodsIn this blinded, prospective trial, patients with positive diagnostic MBN blocks (>75% relief) were randomized to MBN C-RFA or T-RFA. The primary outcome was the proportion of ‘responders’ (≥50% Numeric Rating Scale (NRS) reduction) at 6 months. Secondary outcomes included NRS, Oswestry Disability Index (ODI), and Patient Global Impression of Change.ResultsForty-three participants were randomized to MBN C-RFA (n=21) or T-RFA (n=22). There were no significant differences in demographic variables (p>0.05). A ≥50% NRS reduction was observed in 52% (95% CI 31% to 74%) and 44% (95% CI 22% to 69%) of participants in the C-RFA and T-RFA groups, respectively (p=0.75). A ≥15-point or ≥30% reduction in ODI score was observed in 62% (95% CI 38% to 82%) and 44% (95% CI 22% to 69%) of participants in the C-RFA and T-RFA groups, respectively (p=0.21).ConclusionsWhen using a single diagnostic block paradigm with a threshold of >75% pain reduction, both treatment with both C-RFA and T-RFA resulted in a success rate of approximately 50% when defined by both improvement in pain and physical function at 6-month follow-up. While the success rate was higher in the C-RFA group, this difference was not statistically significant.Trial registration number NCT02478437.

Purpose Localized cooling is widely used in treating soft tissue injuries by modulating swelling, pain, and inflammation. One of the primary outcomes of localized cooling is vasoconstriction within the underlying skin. It is thought that in some instances, cryotherapy may be causative of tissue necrosis and neuropathy via cold-induced ischaemia leading to nonfreezing cold injury (NFCI). The purpose of this study is to quantify the magnitude and persistence of vasoconstriction associated with cryotherapy. Methods Data are presented from testing with four different FDA approved cryotherapy devices. Blood perfusion and skin temperature were measured at multiple anatomical sites during baseline, active cooling, and passive rewarming periods. Results Local cutaneous blood perfusion was depressed in response to cooling the skin surface with all devices, including the DonJoy (DJO, p  = 2.6 × 10 −8 ), Polar Care 300 (PC300, p  = 1.1 × 10 −3 ), Polar Care 500 Lite (PC500L, p  = 0.010), and DeRoyal T505 (DR505, p  = 0.016). During the rewarming period, parasitic heat gain from the underlying tissues and the environment resulted in increased temperatures of the skin and pad for all devices, but blood perfusion did not change significantly, DJO (n.s.), PC300 (n.s.), PC500L (n.s.), and DR505 (n.s.). Conclusions The results demonstrate that cryotherapy can create a deep state of vasoconstriction in the local area of treatment. In the absence of independent stimulation, the condition of reduced blood flow persists long after cooling is stopped and local temperatures have rewarmed towards the normal range, indicating that the maintenance of vasoconstriction is not directly dependent on the continuing existence of a cold state. The depressed blood flow may dispose tissue to NFCI.

Background After total knee arthroplasty (TKA), patients have limited knee range of motion (ROM), trophic changes and pain. Cryotherapy and compression are recommended in the literature, but no study has shown that cryotherapy and compression combined leads to better results than cryotherapy alone. The primary objective was to compare knee ROM after 21 days of rehabilitation post-TKA between patients who underwent rehabilitation with compressive cryotherapy with those who had cryotherapy alone. The secondary objectives were to compare other trophic, pain and functional outcomes. Methods Forty patients were randomized into two groups: Standard Cryotherapy (SC = 20, median age 77 years), which applied cold packs along with their rehabilitation; and Compressive Cryotherapy (CC = 20, median age 76 years), which received cold compression. Knee joint’s passive and active ROM (primary outcome) were measured with a goniometer. Knee’s circumference, fluctuation test, pain at rest and during activity, 6-minute walking test (6MWT) and KOOS questionnaire were secondary outcomes. The groups were compared on D1 (baseline) and D21 of rehabilitation. A survival analysis has compared the groups on D1, D8, D15, D21. Results All subjects had a significant improvement in all the parameters on D21 relative to D1 ( p  < .05), except for pain at rest ( p  = .065 for CC and p  = .052 for SC). On D21, the CC group had a significantly larger improvement in the joint effusion ( p  = .002), pain during activity ( p  = .005), 6MWT ( p  = .018) and KOOS ( p  = .004) than the SC group. Based on the survival analysis, the CC group had significantly faster improvement in the joint ROM ( p  = .011 for flexion and p  = .038 for extension) and knee circumference ( p  = .013) than the SC group. Conclusions Both cryotherapy methods improved joint ROM, trophic changes, pain and function. Adding dynamic compression to a cryotherapy protocol provided further benefits: a significantly faster improvement in passive knee flexion ROM, a greater reduction of swelling, and pain during activity. Similarly, walking distance and KOOS questionnaire were significantly better for CC. Trials registration The study was registered in the ClinicalTrials.gov database on 14/09/2023 (identifier: NCT06037824).

This study aimed to evaluate the efficacy of Pro-Yellow Laser (PYL) in treating plaque and patch lesions of classical Kaposi’s Sarcoma (KS) and compare its outcomes with cryotherapy (CT). A single-blind, randomized, comparative experimental study was conducted on nine HIV-negative classical KS patients at Kocaeli University Dermatology Outpatient Clinic between April 2022 and April 2023. Each patient received both CT and PYL treatments on separate lesions. Lesions were scored based on surface area and depth before and after treatment, and percentage change (PC) was calculated. A total of 41 lesions were treated (16 with CT and 25 with PYL). CT achieved 100% median PC, while PYL showed a median PC of 42.58% (p = 0.008). No significant difference was observed between CT and PYL in macule/patch lesions (DS-1, p = 0.192), but CT was significantly more effective for papule/plaque lesions (DS-2, p = 0.048). CT caused minor side effects such as blistering and delayed healing, while PYL was well-tolerated with no adverse events. PYL demonstrated comparable efficacy to CT for early-stage KS lesions with fewer complications, making it a promising alternative for patients unable to tolerate CT. However, CT remains more effective for advanced lesions. Further studies are needed to confirm these findings in larger cohorts.

Due to the specific loads that occur in combat sports athletes' forearm muscles, we decided to compare the immediate effect of monotherapy with the use of compressive heat (HT), cold (CT), and alternating therapy (HCT) in terms of eliminating muscle tension, improving muscle elasticity and tissue perfusion and forearm muscle strength. This is a single-blind, randomized, experimental clinical trial. Group allocation was performed using simple 1:1 sequence randomization using the website randomizer.org. The study involved 40 40 combat sports athletes divided into four groups and four therapeutic sessions lasting 20 min. (1) Heat compression therapy session (HT, n = 10) (2) (CT, n = 10), (3) alternating (HCT, n = 10), and sham, control (ShT, n = 10). All participants had measurements of tissue perfusion (PU, [non-reference units]), muscle tension (T—[Hz]), elasticity (E—[arb- relative arbitrary unit]), and maximum isometric force (Fmax [kgf]) of the dominant hand at rest (Rest) after the muscle fatigue protocol (PostFat.5 min), after therapy (PostTh.5 min) and 24 h after therapy (PostTh.24 h) . A two-way ANOVA with repeated measures: Group (ColdT, HeatT, ContrstT, ControlT) × Time (Rest, PostFat.5 min, PostTh.5 min, Post.24 h) was used to examine the changes in examined variables. Post-hoc tests with Bonferroni correction and ± 95% confidence intervals (CI) for absolute differences (△) were used to analyze the pairwise comparisons when a significant main effect or interaction was found. The ANOVA for PU, T, E, and Fmax revealed statistically significant interactions of Group by Time factors ( p  < 0.0001), as well as main effects for the Group factors ( p  < 0.0001; except for Fmax). In the PostTh.5 min. Period, significantly ( p  < 0.001) higher PU values were recorded in the HT (19.45 ± 0.91) and HCT (18.71 ± 0.67) groups compared to the ShT (9.79 ± 0.35) group (△ = 9.66 [8.75; 10.57 CI] > MDC (0.73) , and △ = 8.92 [8.01; 9.83 CI] > MDC (0.73) , respectively). Also, significantly ( p  < 0.001) lower values were recorded in the CT (3.69 ± 0.93) compared to the ShT (9.79 ± 0.35) group △ = 6.1 [5.19; 7.01 CI] > MDC (0.73) . For muscle tone in the PostTh.5 m period significantly ( p  < 0.001) higher values were observed in the CT (20.08 ± 0.19 Hz) group compared to the HT (18.61 ± 0.21 Hz), HCT (18.95 ± 0.41 Hz) and ShT (19.28 ± 0.33 Hz) groups (respectively: △ = 1.47 [1.11; 1.83 CI] > MDC (0.845) ; △ = 1.13 [0.77; 1.49 CI] > MDC (0.845) , and △ = 0.8 [0.44; 1.16 CI], < MDC (0.845) ). The highest elasticity value in the PostTh.5 m period were observed in the CT (1.14 ± 0.07) group, and it was significantly higher than the values observed in the HT (0.97 ± 0.03, △ = 0.18 [0.11; 0.24 CI] > MDC (0.094) , p  < 0.001), HCT (0.90 ± 0.04, △ = 0.24 [0.17; 0.31 CI] > MDC (0.094) , p  < 0.001) and ShT (1.05 ± 0.07, △ = 0.094 [0.03; 0.16 CI] = MDC (0.094) , p  = 0.003) groups. For Fmax, there were no statistically significant differences between groups at any level of measurement. The results of the influence of the forearm of all three therapy forms on the muscles' biomechanical parameters confirmed their effectiveness. However, the effect size of alternating contrast therapy cannot be confirmed, especially in the PostTh24h period. Statistically significant changes were observed in favor of this therapy in PU and E measurements immediately after therapy (PostTh.5 min). Further research on contrast therapy is necessary.