Cryotherapy associated with tailored land-based exercises for knee osteoarthritis: a protocol for a double-blind sham-controlled randomised trial

IntroductionThere is an unmet need to develop tailored therapeutic exercise protocols applying different treatment parameters and modalities for individuals with knee osteoarthritis (KOA). Cryotherapy is widely used in rehabilitation as an adjunct treatment due to its effects on pain and the inflammatory process. However, disagreement between KOA guidelines remains with respect to its recommendation status. The aim of this study is to verify the complementary effects of cryotherapy when associated with a tailored therapeutic exercise protocol for patients with KOA.Methods and analysisThis study is a sham-controlled randomised trial with concealed allocation and intention-to-treat analysis. Assessments will be performed at baseline and immediately following the intervention period. To check for residual effects of the applied interventions, 3-month and 6-month follow-up assessments will be performed. Participants will be community members living with KOA divided into three groups: (1) the experimental group that will receive a tailored therapeutic exercise protocol followed by a cryotherapy session of 20 min; (2) the sham control group that will receive the same regimen as the first group, but with sham packs filled with dry sand and (3) the active treatment control group that will receive only the therapeutic exercise protocol. The primary outcome will be pain intensity according to a Visual Analogue Scale. Secondary outcomes will be the Western Ontario & McMaster Universities Osteoarthritis Index; the Short-Form Health Survey 36; the 30-s Chair Stand Test; the Stair Climb test; and the 40-m fast-paced walk test.Ethics and disseminationThe trial was approved by the Institutional Ethics Committee of Federal University of São Carlos, São Paulo, Brazil. Registration approval number: CAAE: 65966617.9.0000.5504. The results will be published in peer-reviewed journals.Trial registration numberNCT03360500

Download Full-text

The Effect of a Period of Kinesiotherapy and Reflexology on Pain Intensity and Range of Motion in Elderly Women With Knee Osteoarthritis

Journal of Sport Biomechanics ◽

10.32598/biomechanics.6.2.2 ◽

2020 ◽

Vol 6 (2) ◽

pp. 98-109

Author(s):

Fatemeh Kiani Dooghabadi ◽

◽

Nahid Khoshraftar Yazdi ◽

Hossein Farzaneh ◽

◽

...

Keyword(s):

Knee Osteoarthritis ◽

Pain Intensity ◽

Range Of Motion ◽

Elderly Women ◽

Pain Scale ◽

Control Group ◽

Osteoarthritis Of The Knee ◽

Therapeutic Exercise ◽

Exercise Protocol ◽

Rate Of Increase

Objective: The aim of this study was to compare the effect of a period of therapeutic exercise and reflexology on pain intensity and range of motion in elderly women with knee osteoarthritis. Methods: 45 elderly women with osteoarthritis of the knee were purposefully selected and randomly divided into three groups of 15: therapeutic exercise, reflexology and control. The therapeutic exercise and reflexology group practiced therapy and reflexology for 4 weeks and 5 sessions per week. The control group also performed their daily activities. To assess the intensity of pain and the range of motion of the subjectchr('39')s knee, the visual pain scale VAS and goniometer were used in pre-test and post-test, respectively. Data analysis was performed by one-way analysis of variance and Tukeychr('39')s Post Hoc test. Results: The results showed that both types of therapeutic exercise protocol and reflexology have positive and significant effects on reducing pain intensity and increasing range of motion of the knee joint of the subjects (P≤0.05), and the therapeutic exercise protocol compared to the protocol. Reflexology had more significant effects on the rate of increase in range of motion (P=0.001; P=0.001, respectively). Conclusion: Based on the results, the use of both protocols of therapeutic exercise and reflexology is recommended to reduce the severity of pain and increase the range of motion of elderly women with osteoarthritis of the knee. Simultaneous use of these two protocols for treatment and greater effectiveness in this group of patients is recommended

Download Full-text

Efficacy and safety of celecoxib combined with JOINS in the treatment of degenerative knee osteoarthritis: study protocol of a randomized controlled trial

Therapeutic Advances in Musculoskeletal Disease ◽

10.1177/1759720x211024025 ◽

2021 ◽

Vol 13 ◽

pp. 1759720X2110240

Author(s):

Man Soo Kim ◽

In Jun Koh ◽

Yong Gyu Sung ◽

Dong Chul Park ◽

Sung Cheol Yang ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Therapeutic Effect ◽

Combination Treatment ◽

Short Form ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Double Blind ◽

Knee Oa ◽

Anti Inflammatory

Background: The aim of this study will be to investigate the therapeutic effect and safety of non-steroidal anti-inflammatory drugs (NSAIDs) along with symptomatic slow-acting drugs for the treatment of osteoarthritis (SYSADOA), JOINS tablets, for degenerative knee osteoarthritis (OA) treatment and to determine the analgesic and anti-inflammatory effects of the combination therapy. In addition, we will investigate whether JOINS treatment alone after NSAID and JOINS combination treatment is effective in relieving and maintaining knee OA symptoms. Methods: This study will be a prospective, randomized, double-blind endpoint study design. All patients will be randomly assigned to either intervention (celecoxib+JOINS) or control (celecoxib+placebo) groups. In Part 1, the intervention group will be administered celecoxib once a day and JOINS three times a day for a total of 12 weeks. In the control group, celecoxib will be administered once a day and JOINS placebo three times a day for a total of 12 weeks. In Part 2, JOINS alone and JOINS placebo alone will be administered for an additional 24 weeks in both groups, respectively. The primary endpoint will be the amount of change during the 12 weeks as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index total score compared with baseline. The secondary endpoint will be the amount of change at 1, 4, 12, 24, and 36 weeks from the baseline for pain visual analog scale, Brief Pain Inventory, Short Form Health Survey-36 and biomarkers. Results: The trial was registered with Clinical-Trials.gov (NCT04718649). The clinical trial was also registered on Clinical Research Information Service (CRIS) with the trial registration number KCT0005742. Conclusions: The combination treatment of the most commonly used SYSADOA drug, JOINS, and selective COX-2 inhibitor celecoxib as the representative NSAID for knee OA treatment, can be compared with celecoxib alone treatment to determine the safety or therapeutic effect.

Download Full-text

Evaluation of the Use of Sterilized and Non-Sterilized Peruibe Black Mud in Patients with Knee Osteoarthritis

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18041666 ◽

2021 ◽

Vol 18 (4) ◽

pp. 1666 ◽

Cited By ~ 1

Author(s):

Paulo Fávio Macedo Gouvêa ◽

Zélia Maria Nogueira Britschka ◽

Cristina de Oliveira Massoco Salles Gomes ◽

Nicolle Gilda Teixeira de Queiroz ◽

Pablo Antonio Vásquez Salvador ◽

...

Keyword(s):

Quality Of Life ◽

Knee Osteoarthritis ◽

Short Form ◽

Serum Levels ◽

Double Blind ◽

Sf 36 ◽

Radiographic Grade ◽

Physical Functions ◽

Kellgren And Lawrence

This study aimed to evaluate the effects of treatment with Peruíbe Black Mud (PBM) on the clinical parameters and quality of life of patients with knee osteoarthritis and to compare the effects of PBM samples simply matured in seawater and PBM sterilized by gamma radiation. A controlled, double-blind trial was conducted with 41 patients divided into two treatment groups composed of 20 and 21 patients: one group was treated with matured PBM and the other with sterilized PBM. Evaluations were done using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) questionnaires, the Kellgren and Lawrence (KL) radiographic scale, and the quantification of the serum levels of inflammatory biomarkers. An improvement in pain, physical functions, and quality of life was observed in all of the patients who underwent treatment with both simply matured and sterilized PBM. Nine patients showed remission in the KL radiographic scale, but no statistically significant differences were observed in the serum levels of inflammatory mediators before or after treatment. Peruíbe Black Mud proves to be a useful tool as an adjuvant treatment for knee osteoarthritis (OA), as shown by the results of the WOMAC and SF-36 questionnaires and by the remission of the radiographic grade of some patients on the Kellgren and Lawrence scale.

Download Full-text

Intracavitary anaesthesia for medical thoracoscopy procedural pain: the CAMP randomised trial

Egyptian Journal of Bronchology ◽

10.1186/s43168-021-00091-w ◽

2021 ◽

Vol 15 (1) ◽

Author(s):

Ahmed Mohamed Abdelhady ◽

Mohamed Gadallah ◽

Moustafa Shaheen ◽

Sahar Mourad ◽

Maged Hassan

Keyword(s):

Pain Score ◽

Chest Tube ◽

Randomised Trial ◽

Study Groups ◽

Procedural Pain ◽

Control Group ◽

Clinical Trial Registry ◽

Double Blind ◽

Lidocaine Group ◽

Medical Thoracoscopy

Abstract Background Medical thoracoscopy (MT) under conscious sedation can be a painful procedure. A pilot study reported reduction in procedural pain with lidocaine application via chest tube before procedure. This study aimed at assessing the extent of effect of intrapleural lidocaine on pain during MT in a double-blind randomised trial. Results Thirty patients (mean age 48.3 years) were recruited, 14 randomised to the lidocaine group and 16 to the saline group. In four patients (two from each group), chest tube insertion prior to MT failed, and they were excluded from the final analysis. The mean (SD) visual analogue scale (VAS) pain score during procedure was 49 ± 33.2 for the lidocaine group and 57.4 ± 27.6 for the control group (mean difference − 8.4 points, p = 0.49). The VAS pain score as assessed by operator was 45.6 ± 19.8 for the lidocaine group and 46.6 ± 29.8 for the control group (p = 0.97). There was no difference in the VAS pain score at 120 min post MT or in the doses of sedatives used during procedure between the study groups. Conclusion ICA for MT does not seem to improve procedural pain as suggested by previous studies. Trial registration The study has been registered with the Pan African Clinical Trial Registry (PACTR202008762D159889).

Download Full-text

An epitope-based approach to use of HLA matched platelets for transfusion: a noninferiority, cross-over, randomised trial

Blood ◽

10.1182/blood.2020007199 ◽

2020 ◽

Author(s):

Judith C Marsh ◽

Simon Stanworth ◽

Laura Anne Pankhurst ◽

Delordson Kallon ◽

Adeline Gilbertson ◽

...

Keyword(s):

Randomised Trial ◽

Random Order ◽

Adverse Outcomes ◽

Bleeding Events ◽

Eligibility Criteria ◽

Donor Pool ◽

Double Blind ◽

Hla Antigen ◽

Intention To Treat ◽

Transfusion Requirements

Platelet transfusion refractoriness results in adverse outcomes and increased healthcare costs. Managing refractoriness due to HLA alloimmunization necessitates the use of HLA antigen matched platelets, but requires a large platelet donor pool, and does not guarantee full matching. We report the first ever randomized, double-blind, non-inferiority, cross-over trial comparing HLA epitope-matched (HEM) platelets with HLA standard antigen-matched (HSM) platelet transfusions. Eligibility criteria were alloimmunized, platelet refractory, thrombocytopenic patients with aplastic anemia, myelodysplastic syndrome or acute myeloid leukemia. HEM platelets were selected using HLAMatchMaker epitope (specifically eplet) matching. Patients received up to eight prophylactic HEM and HSM transfusions provided in random order. Primary outcome was one-hour post transfusion platelet count increment (PCI). 49 patients were randomized at 14 UK hospitals. For intention-to-treat, number of evaluable transfusions was 107 and 112 for HEM and HSM, respectively. Unadjusted mean (SD) PCI for HEM and HSM was 23.9 (15) and 23.5 (14.1) respectively (adjusted mean difference -0.1, 95% CI -2.9, 2.8). As the lower limit of 95% CI was not greater than pre-defined non-inferiority limit, HEM was declared non-inferior to HSM. There were no differences in secondary outcomes of platelet counts, transfusion requirements and bleeding events. Adequate one-hour PCI was more frequently observed with a mean number of 3.2 of epitope mismatches compared to 5.5 epitope mismatches for inadequate one-hour increments. For every additional one epitope mismatch, the likelihood of an adequate PCI decreased by 15%. Epitope matched platelets should be considered to support HLA alloimmunized patients. Funded by NHS Blood and Transplant, ISRCTN23996532.

Download Full-text

The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP) before External Cephalic Version (ECV): A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2012/626740 ◽

2012 ◽

Vol 2012 ◽

pp. 1-6 ◽

Cited By ~ 3

Author(s):

Joscha Reinhard ◽

Swati Peiffer ◽

Nicole Sänger ◽

Eva Herrmann ◽

Juping Yuan ◽

...

Keyword(s):

Medical Care ◽

Success Rate ◽

Controlled Trial ◽

Randomised Trial ◽

External Cephalic Version ◽

Control Group ◽

Amniotic Fluid Index ◽

Double Blind ◽

Standard Medical Care ◽

Clinical Hypnosis

Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group.Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 370/7(259 days) weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone ().Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (), successful ECV, whereas 38 women, who received NLP, had a 44.7% () successful ECV (). The control group had similar patient characteristics compared to the intervention groups (). In the control group () 27.3% () had a statistically significant lower successful ECV procedure than NLP () and hypnosis and NLP ().Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone.

Download Full-text

Antipsychotics withdrawal in adults with intellectual disability and challenging behaviour: study protocol for a multicentre double-blind placebo-controlled randomised trial

BMC Psychiatry ◽

10.1186/s12888-021-03437-2 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Sylvie Beumer ◽

Pauline Hamers ◽

Alyt Oppewal ◽

Dederieke Maes-Festen

Keyword(s):

Intellectual Disability ◽

Side Effects ◽

Psychiatric Disorders ◽

Randomised Trial ◽

Drop Out ◽

Withdrawal Symptoms ◽

Control Group ◽

Challenging Behaviour ◽

Double Blind ◽

Double Blind Placebo

Abstract Background In people with intellectual disability (ID) and challenging behaviour, antipsychotics (AP) are often used off-label and for a long period. Despite a lack of evidence for efficacy for challenging behaviour and concerns about common and clinically relevant side effects, complete withdrawal often fails. We postulate three possible hypotheses for withdrawal failure: 1. Influence of subjective interpretation of behavioural symptoms by caregivers and family; 2. Beneficial effects from AP treatment on undiagnosed psychiatric illness, through improvement in sleep or a direct effect on behaviour; and 3. Misinterpretation of withdrawal symptoms as a recurrence of challenging behaviour. Methods To investigate our hypotheses, we have designed a multicentre double-blind, placebo-controlled randomised trial in which AP (pipamperone or risperidone) are withdrawn. In the withdrawal group, the AP dose is reduced by 25% every 4 weeks and in the control group the dose remains unaltered. Behaviour, sleep, psychiatric disorders, withdrawal symptoms and side effects will be measured and compared between the two groups. If drop-out from the protocol is similar in both groups (non-inferiority), the first hypothesis will be supported. If drop-out is higher in the withdrawal group and an increase is seen in psychiatric disorders, sleep problems and/or behavioural problems compared to the control group, this suggests effectiveness of AP, and indications for AP use should be reconsidered. If drop-out is higher in the withdrawal group and withdrawal symptoms and side effects are more common in the withdrawal group compared to the control group, this supports the hypothesis that withdrawal symptoms contribute to withdrawal failure. Discussion In order to develop AP withdrawal guidelines for people with ID, we need to understand why withdrawal of AP is not successful in the majority of people with ID and challenging behaviour. With this study, we will bridge the gap between the lack of available evidence on AP use and withdrawal on the one hand and the international policy drive to reduce prescription of AP in people with ID and challenging behaviour on the other hand. Trial registration This trial is registered in the Netherlands Trial Register (NTR 7232) on October 6, 2018 (www.trialregister.nl).

Download Full-text

A Double-Blind, Randomized Controlled 12-Week Follow-Up Trial to Evaluate the Efficacy and Safety of Polycan in Combination with Glucosamine for the Treatment of Knee Osteoarthritis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2019/9750531 ◽

2019 ◽

Vol 2019 ◽

pp. 1-8 ◽

Cited By ~ 1

Author(s):

Thi Thanh Thuy Truong ◽

Jong Min Lim ◽

Hyung-Rae Cho ◽

Young Suk Kim ◽

Duc Giang Dao ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Rescue Medication ◽

Secondary Outcome ◽

Control Group ◽

Efficacy And Safety ◽

Double Blind ◽

Randomized Controlled ◽

Patient Reported ◽

Group A ◽

Group B

Aim. The aim of the present study was to examine the efficacy and safety of Polycan, a β-glucan produced from the black yeast Aureobasidium pullulans SM-2001, in combination with glucosamine in reducing knee osteoarthritis-associated symptoms. Methods. This was a double-blind, randomized controlled trial of a formulated product composed of 16.7 mg of Polycan and 250 mg of glucosamine (Group A), 16.7 mg of Polycan and 500 mg of glucosamine (Group B), or 500 mg of glucosamine (control group) per capsule, administered as three capsules once per day over a period of 12 weeks, conducted with 100 osteoarthritis patients, aged 35–80 years. The primary outcome measure was osteoarthritis symptoms assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. The secondary outcome measures included rescue medication use (according to data from a patient-reported diary) and other safety indices (body weight, blood pressure, hematological, and biochemistry markers). Results. Compared with the control group, Group B demonstrated a statistically significant reduction in the total WOMAC score after 12 weeks of treatment (p < 0.05). There was a significant reduction in the frequency of rescue medication used in Groups A and B compared with the control group (p < 0.05). There were no significant changes in hematology and biochemistry parameters or health indices between the active and the control group. Conclusion. Among patients with mild or moderate osteoarthritis, a daily oral dose of Polycan (50 mg) in combination with glucosamine (750 mg or 1500 mg; Group A or B, respectively) resulted in a better treatment outcome than treatment with glucosamine (1500 mg) alone.

Download Full-text

Effects of a therapeutic exercises program associated with pompage technique on pain, balance and strength in elderly women with knee osteoarthritis

Fisioterapia em Movimento ◽

10.1590/1980-5918.030.s01.ao01 ◽

2017 ◽

Vol 30 (suppl 1) ◽

pp. 11-21

Author(s):

Ihana Thaís Guerra de Oliveira Gondim ◽

Amanda Bruto da Costa Torres ◽

Amanda Telino Baudel de Lacerda ◽

Danielle Queiroz Kühni Fernandes ◽

Moisés Costa do Couto ◽

...

Keyword(s):

Muscle Strength ◽

Knee Osteoarthritis ◽

Postural Balance ◽

Elderly Women ◽

Intervention Group ◽

Knee Extensor ◽

Peak Torque ◽

Control Group ◽

Therapeutic Exercise ◽

Therapeutic Exercises

Abstract Introduction: Knee Osteoarthritis (OA) affects mainly elderly, being characterized by arthralgia, stiffness and strength and balance deficits. Scientific evidence suggests beneficial effects of exercise therapy on these changes, but lacks detailed protocols. In addition, there were published studies on effects of therapeutic exercise associated with pompage that were not located. Objective: To investigate the effects of a therapeutic exercise program associated with pompage on pain, balance and muscle strength in elderly women with knee osteoarthritis. Methods: A randomized pilot clinical trial that included 22 women (60 - 80 years) diagnosed with knee OA, randomized and allocated by simple raffle into two groups: intervention and control. Intervention group (strengthening and balance exercises and knee pompage) performed two sessions per week for 12 weeks. The control group received educational lectures, they were evaluated before and after 12 weeks: arthralgia- subscale pain of the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire (WOMAC); postural stability- postural balance protocol by Biodex Balance SD and muscle strength- concentric peak torque of the knee extensor by isokinetic dynamometer. The Independent Student t test was used for intergroup analysis. Results: The intervention group compared with the control showed better results for the outcomes pain, balance and muscle strength after 12 weeks. However, the difference was statistically significant (p < 0.05) for levels of antero-posterior oscillation (DM -0.28, 95% CI -0.54 a -0.02; p = 0.035) and global oscillation (DM -0.36, 95% CI -0.68 a -0.04; p = 0.028). Conclusion: The intervention had a positive effect on postural balance in elderly women with knee osteoarthritis.

Download Full-text

The effectiveness of Kinesio Taping® for pain management in knee osteoarthritis: a randomized, double-blind, controlled clinical trial

Therapeutic Advances in Musculoskeletal Disease ◽

10.1177/1759720x19869135 ◽

2019 ◽

Vol 11 ◽

pp. 1759720X1986913 ◽

Cited By ~ 3

Author(s):

Venta Donec ◽

Raimondas Kubilius

Keyword(s):

Pain Management ◽

Knee Osteoarthritis ◽

Knee Pain ◽

Rating Scale ◽

Pain Tolerance ◽

Control Group ◽

Double Blind ◽

Kinesio Taping ◽

Pain Subscale

Background: Kinesio Taping® method is a nonpharmacological alternative for pain management in musculoskeletal disorders. However, the existing evidence is insufficient to assess its full effectiveness for pain management in knee osteoarthritis (KO). Our aim was to evaluate the effectiveness of the Kinesio Taping method in reducing knee pain for KO patients. Methods: In this randomized, double blind, controlled trial, we recruited 187 patients with grade I-III KO who were allocated to either the Kinesio Taping or control group. The study was carried out in outpatient facility. Either Kinesio Taping or nonspecific taping was applied on the affected knee area for 4 weeks. Pain evaluation was performed at baseline, after 1 month of taping and after 1 further month without taping. The data on usage of painkillers were collected; Numeric Pain Rating Scale; an algometer, and Knee injury and Osteoarthritis Outcome Scores (KOOS) pain subscale were used to assess pain. Tolerance and subjective opinions toward the effectiveness of taping were evaluated. The chosen level of significance was p < 0.05, ß ⩽ 0.2. Results: The majority (>70%) of both groups’ patients indicated that tapes reduced the knee pain. The reported use of painkillers decreased, in addition to self-reported increase in the KOOS subscale, thereby indicating pain alleviation. All self-reported improvement remained at the 1-month follow up ( p < 0.05). Significantly higher and clinically meaningful reduction of pain intensity was found in the Kinesio Taping group after the treatment month, in comparison with the control group ( p < 0.05). More pain reduction was reported in the daytime for participants in the Kinesio Taping group at the follow up ( p = 0.022). No changes in algometry results were observed. Conclusions: Elastic taping can safely relieve knee pain and reduce the need for pharmacological management in KO. A specific Kinesio Taping technique is clinically more beneficial for knee-pain alleviation in comparison with nonspecific taping. [ ClinicalTrials.gov identifier: NCT03076177.]

Download Full-text