Group and home-based tai chi in elderly subjects with knee osteoarthritis: a randomized controlled trial

OBJECTIVE: To evaluate the effects of tai chi consisting of group and home-based sessions in elderly subjects with knee osteoarthritis. DESIGN: A randomized, controlled, single-blinded 12-week trial with stratification by age and sex, and six weeks of follow-up. SETTING: General community. PARTICIPANTS: Forty-one adults (70 +/- 9.2 years) with knee osteoarthritis. INTERVENTIONS: The tai chi programme featured six weeks of group tai chi sessions, 40 min/session, three times a week, followed by another six weeks (weeks 7 -12) of home-based tai chi training. Subjects were requested to discontinue tai chi training during a six-week follow-up detraining period (weeks 13-18). Subjects in the attention control group attended six weeks of health lectures following the same schedule as the group-based tai chi intervention (weeks 0 -6), followed by 12 weeks of no activity (weeks 7-18). MAIN OUTCOME MEASURES: Knee pain measured by visual analogue scale, knee range of motion and physical function measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) were recorded at baseline and every three weeks throughout the 18-week study period. Data were analysed using a mixed model ANOVA. RESULTS: The six weeks of group tai chi followed by another six weeks of home tai chi training showed significant improvements in mean overall knee pain (P = 0.0078), maximum knee pain (P = 0.0035) and the WOMAC subscales of physical function (P = 0.0075) and stiffness (P = 0.0206) compared to the baseline. No significant change of any outcome measure was noted in the attention control group throughout the study. The tai chi group reported lower overall pain and better WOMAC physical function than the attention control group at weeks 9 and 12. All improvements disappeared after detraining.     

Effects of Functional Fascial Taping on pain and function in patients with non-specific low back pain: a pilot randomized controlled trial

Objectives: To compare the short-term and medium-term effect of Functional Fascial Taping to placebo taping on pain and function in people with non-specific low back pain. Design: A pilot randomized controlled trial with a 2-week intervention, and 2-, 6- and 12-week follow-up. Setting: Individuals with non-specific low back pain recruited from local communities. Participants: Forty-three participants with non-specific low back pain for more than 6 weeks were randomized into either Functional Fascial Taping group (n = 21) or placebo group (n = 22). Interventions: The intervention group was treated with Functional Fascial Taping while the control group was treated with placebo taping. Both groups received four treatments over 2 weeks. Main outcome measures: Worst and average pain and function were assessed at baseline, after the 2-week intervention, and at 6 and 12 weeks follow-up. Results: The Functional Fascial Taping group demonstrated significantly greater reduction in worst pain compared to placebo group after the 2-week intervention (P = 0.02, effect size = 0.74; 95% confidence interval 0.11-1.34). A higher proportion of participants in Functional Fascial Taping group attained the minimal clinically important difference in worst pain (P = 0.007) and function (P = 0.007) than those in placebo group after the 2-week intervention. There were no significant differences in either group's disability rating or clinically important difference in average pain at any time. Conclusions: Functional Fascial Taping reduced worst pain in patients with non-acute non-specific low back pain during the treatment phase. No medium-term differences in pain or function were observed.     

The Effects of Self-Aromatherapy Massage on Pain and Sleep Quality in Patients with Rheumatoid Arthritis: A Randomized Controlled Trial

BackgroundRheumatoid arthritis is the most common form of inflammatory arthritis and can lead to pain, joint deformity, and disability, resulting in poor sleep quality and lower quality of life. The efficacy of aromatherapy massage on pain levels and sleep quality among rheumatoid arthritis patients remains unclear.AimsTo investigate the effects of aromatherapy on pain and sleep quality among rheumatoid arthritis patients.MethodsThis randomized controlled trial enrolled 102 patients with rheumatoid arthritis from one regional hospital in Taoyuan, Taiwan. Patients were randomly assigned to the intervention (n = 32), placebo (n = 36), or control groups (n = 34). The intervention and placebo groups underwent self-aromatherapy hand massage guided by a self-aromatherapy hand massage manual and video for 10 minutes 3 times a week for 3 weeks. The intervention group used 5% compound essential oils, the placebo group used sweet almond oil, and the control group had no intervention. Pain, sleep quality and sleepiness were measured by using the numerical rating scale for pain, the Pittsburgh Sleep Quality Index and the Epworth Sleepiness Scale at baseline and at 1, 2, and 3 weeks after the intervention.ResultsThe intervention and placebo groups had significantly decreased sleep quality and sleepiness scores from baseline to 3 weeks after aromatherapy massage. Compared with the control group, the intervention group showed statistically significant improvement in the sleep quality scores in the first weeks after aromatherapy massage (B = -1.19, 95% confidence interval [CI]: -2.35, -0.02, P =.046), but no statistically significant differences were found in the changes in pain levels from baseline to the three time points.ConclusionsAromatherapy massage is effective in improving sleep quality in rheumatoid arthritis patients. More studies are needed to evaluate the effects of aromatherapy hand massage on the pain levels of rheumatoid arthritis patients.     

Aquatic physical therapy for hip and knee osteoarthritis: results of a single-blind randomized controlled trial

BACKGROUND AND PURPOSE: Aquatic physical therapy is frequently used in the management of patients with hip and knee osteoarthritis (OA), yet there is little research establishing its efficacy for this population. The purpose of this study was to evaluate the effects of aquatic physical therapy on hip or knee OA. SUBJECTS: A total of 71 volunteers with symptomatic hip OA or knee OA participated in this study. METHODS: The study was designed as a randomized controlled trial in which participants randomly received 6 weeks of aquatic physical therapy or no aquatic physical therapy. Outcome measures included pain, physical function, physical activity levels, quality of life, and muscle strength. RESULTS: The intervention resulted in less pain and joint stiffness and greater physical function, quality of life, and hip muscle strength. Totals of 72% and 75% of participants reported improvements in pain and function, respectively, compared with only 17% (each) of control participants. Benefits were maintained 6 weeks after the completion of physical therapy, with 84% of participants continuing independently. DISCUSSION AND CONCLUSION: Compared with no intervention, a 6-week program of aquatic physical therapy resulted in significantly less pain and improved physical function, strength, and quality of life. It is unclear whether the benefits were attributable to intervention effects or a placebo response.     

A Randomized Controlled Trial on the Effects of Low-Dose Extracorporeal Shockwave Therapy in Patients With Knee Osteoarthritis

ObjectiveTo test the efficacy of low-dose extracorporeal shockwave therapy (ESWT) on osteoarthritis knee pain, lower limb function, and cartilage alteration for patients with knee osteoarthritis.DesignRandomized controlled trial with placebo control.SettingOutpatient physical therapy clinics within a hospital network.ParticipantsEligible volunteers (N=63) with knee osteoarthritis (Kellgren-Lawrence grade II or III) were randomly assigned to 2 groups.InterventionsPatients in the experimental group received low-dose ESWT for 4 weeks while those in the placebo group got sham shockwave therapy. Both groups maintained a usual level of home exercise.Main Outcome MeasuresKnee pain and physical function were measured using a visual analog scale (VAS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Lequesne index at baseline, 5 weeks, and 12 weeks. Cartilage alteration was measured analyzing the transverse relaxation time (T2) mapping.ResultsThe VAS score, WOMAC, and Lequesne index of the ESWT group were significantly better than those of the placebo group at 5 and 12 weeks (P<.05). Both groups showed improvement in pain and disability scores over the 12-week follow-up period (P<.05). In terms of imaging results, there was no significant difference in T2 values between groups during the trial, although T2 values of the ESWT group at 12 weeks significantly increased compared to those at baseline (P=.004). The number and prevalence of adverse effects were similar between the 2 groups, and no serious side effects were found.ConclusionsA 4-week treatment of low-dose ESWT was superior to placebo for pain easement and functional improvement in patients with mild to moderate knee osteoarthritis but had some negative effects on articular cartilage.     

Short-term effects of massage with olive oil on the severity of uremic restless legs syndrome: A double-blind placebo-controlled trial

BackgroundAlthough the efficacy of olive oil massage has been established for different disorders, no studies have yet focused on the effect of olive oil massage on restless legs syndrome (RLS). In this study, we aimed to evaluate the short-term effects of massage with olive oil in reducing the severity of uremic RLS.MethodsThis double-blind placebo-controlled trial was conducted on 60 patients with uremic RLS (mean age: 51.96 ± 10.15), who were randomly divided into olive oil and placebo groups. The olive oil group received massage with olive oil, while the placebo group received massage with liquid paraffin twice a week during hemodialysis sessions for three weeks. For each leg, 10 mL of the olive oil or placebo was applied and then massaged for five min from the plantar surface of the foot to the area below the knee. The severity of RLS was rated on the first day and one week after the final massage therapy session by using the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale.ResultsIn terms of different categories of RLS severity, a significant decline was observed only in the olive oil group from the pre- to post-intervention stages (P = 0.003). After the intervention, the decline in the total RLS severity was more significant in the olive oil group (P < 0.001), compared to the placebo group (P = 0.019). Moreover, a significant difference in the total RLS severity (P < 0.001) and different categories of RLS severity (P = 0.002) was observed after the intervention between the groups in favor of olive oil massage. However, no significant difference was found between groups in pre-intervention stage in this regard (P = 0.363 and P = 0.955, respectively).ConclusionApplication of short-term massage with olive oil as a complementary method seems to be effective in reducing the severity of uremic RLS. Further studies are suggested to identify the sustainability of the findings.     

TENS, electroacupuncture and ice massage: comparison of treatment for osteoarthritis of the knee

The purpose of this study was to compare the effectiveness of transcutaneous nerve stimulation (TENS), electroacupuncture (EA), and ice massage with placebo treatment for the treatment of pain. Subjects (n = 100) diagnosed with osteoarthritis (OA) of the knee were treated with these modalities. The parameters for evaluating the effectiveness of treatment include pain at rest, stiffness, 50 foot walking time, quadriceps muscle strength, and knee flexion degree. The results showed (a) that all three methods could be effective in decreasing not only pain but also the objective parameters in a short period of time; and (b) that the treatment results in TENS, EA and ice massage were superior to placebo.     

Massage treatment in HIV-1 infected Dominican children: a preliminary report on the efficacy of massage therapy to preserve the immune system in children without antiretroviral medication

OBJECTIVES: More than 1.4 million children are living with HIV and global access to antiretrovirals is not yet readily available. Massage therapy, which has been shown to improve immune function in HIV+ adults and adolescents, may provide an important complementary treatment to boost immune status in young children living with HIV disease, especially those without access to antiretroviral medications. No studies have been conducted, however, that specifically target massage therapy to enhance immune function in HIV+ children. DESIGN: Clinical trial with eligible, consented HIV+ children randomized to receive either massage therapy or a friendly visit (controls). SETTINGS/LOCATION: CENISMI/Robert Reid Cabral Hospital, Santo Domingo, Dominican Republic. SUBJECTS: HIV+ children ages 2-8 years. INTERVENTION: Massage therapy sessions (20 minutes, twice weekly, for 12 weeks), conducted by trained nurses, following a structured protocol of moderate pressure stroking and kneading of muscles, using a non-scented oil. The friendly visit control group, (reading, talking, playing quiet games), met with the nurse twice weekly for 12 weeks. OUTCOME MEASURES: At the initial evaluation, and following the 12-week intervention, blood was drawn to determine absolute helper (CD4/T4) and suppressor (CD8/T8) counts. RESULTS: Children in the control arm had a greater relative risk of CD4 count decline (>20%) than massage-treated children (RR = 5.7, p = 0.03). Lymphocyte loss was also more extensive in the controls (p < 0.02), and more of the control group than the massage group lost >50 CD8 lymphocytes (p = 0.03). CONCLUSIONS: The efficacy of massage therapy in maintaining immunocompetence may offer a viable alternative to the thousands of children worldwide without antiretroviral access.     

Fasinumab (REGN475), an antibody against nerve growth factor for the treatment of pain: Results from a double-blind,placebo-controlled exploratory study in osteoarthritis of the knee

The safety, tolerability, and efficacy of fasinumab (REGN475), a fully human monoclonal antibody against nerve growth factor, was evaluated for the treatment of pain in patients with osteoarthritis (OA) of the knee. This was a 24-week, double-blind, placebo-controlled, parallel-group, repeat-dose, exploratory study. Eligible patients 40 to 75 years of age with a diagnosis of OA of the knee and moderate to severe pain were randomized 1:1:1:1 to intravenous fasinumab 0.03, 0.1, or 0.3 mg/kg or placebo and received study drug on day 1 and day 57. Pain intensity was recorded daily using the numeric rating scale. Safety and tolerability, assessed by the incidence of treatment-emergent adverse events (TEAEs), was the primary study endpoint. Secondary study endpoints included the change from baseline in daily walking knee pain and the assessment of pain, function, and stiffness using the Western Ontario and McMaster Osteoarthritis (WOMAC) index. Baseline characteristics were similar among treatment groups (N = 217). After 24 weeks, the incidence of TEAEs ranged from 66.1% to 75.0% in the fasinumab groups vs 63.6% for placebo. The most common TEAEs included arthralgia, hyperesthesia, myalgia, peripheral edema, and joint swelling. Discontinuation for TEAEs occurred in 5.6% of fasinumab patients and 3.7% of placebo patients. All 3 doses of fasinumab were associated with significant (P < .05) improvements compared with placebo in walking knee pain and WOMAC total and subscale scores. Fasinumab was generally well tolerated, and was associated with a significant reduction in walking knee pain and an improvement in function for up to 8 weeks.     

The effect of neuromuscular electrical stimulation on arthritis knee pain in older adults with osteoarthritis of the knee.

The objective of this study was to examine the short- and long-term effects of a home-based, 12-week neuromuscular electrical stimulation (NMES) of the quadriceps femoris to decrease arthritis knee pain in older adults with osteoarthritis of the knee. The study sample (N = 38) was randomly assigned to the NMES treatment plus education group or the arthritis education-only group. Pain was measured in both groups with the McGill Pain Questionnaire (MPQ) at baseline, during the intervention at weeks 4, 8, 12, and at follow-up and with the Arthritis Impact Measurement Scale 2-Pain Subscale (AIMS2-PS) at baseline and week 12. The NMES Pain Diary (PD) was completed 15 minutes before and after each stimulation session. There was a significant 22% decline in pain 15 minutes after as compared with immediately before each NMES treatment (p <.001), as measured by the PD. No significant group differences were found between the 2 groups over the course of the intervention and follow-up. These findings indicate that a home-based NMES intervention reduced arthritis knee pain 15 minutes after a NMES treatment.     

A 2-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, phase III trial comparing the efficacy of oxymorphone extended release and placebo in adults with pain associated with osteoarthritis of the hip or knee

BACKGROUND: Oxymorphone extended release (ER) is a tablet formulation of the mu-opioid agonist oxymorphone designed to achieve a low peak-to-trough fluctuation in plasma concentrations over a 12-hour dosing period. OBJECTIVE: This study compared the analgesic efficacy, dose response, and tolerability of 3 doses of oxymorphone ER given every 12 hours with those of placebo in patients with pain related to osteoarthritis (OA) of the hip or knee. METHODS: This was a 2-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, Phase III trial. Patients with OA of the hip or knee who were receiving an opioid medication for chronic, moderate to severe pain or who were judged by the investigator to have received suboptimal analgesia with nonopioid analgesics entered a 2- to 7-day washout of analgesic medication. When pain in the index joint was >40 mm on a 100-mm visual analog scale (VAS), patients were randomized to receive 1 of 4 regimens: oxymorphone ER 10 mg q12h during weeks 1 and 2; oxymorphone ER 20 mg q12h in week 1 and 40 mg q12h in week 2; oxymorphone ER 20 mg q12h in week 1 and 50 mg q12h in week 2; or placebo q12h during weeks 1 and 2. The primary end point was the change in VAS score for arthritis pain intensity. Other assessments included the Western Ontario and McMaster Universities (WOMAC) OA Index subscales for pain, stiffness, and physical function and the composite index; the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) physical health component summary (PCS) score; the Chronic Pain Sleep Inventory (CPSI) score; vital signs; clinical laboratory parameters; and adverse events (AEs). AEs were recorded at each clinic visit. RESULTS: Three hundred seventy patients were randomized to treatment (95 oxymorphone ER 10 mg, 93 oxymorphone ER 40 mg, 91 oxymorphone ER 50 mg, and 91 placebo), and 198 completed the study. Least squares mean changes from baseline in the VAS arthritis pain intensity score were -21, -28, -29, and -17 mm in the oxymorphone ER 10, 40, and 50 mg and placebo groups, respectively (P = 0.002, modified Tukey linear trend test). Oxymorphone ER 40 and 50 mg produced significant improvements from baseline compared with placebo in the WOMAC subscale scores for pain (least squares mean change: -85.1, -108.0, and -42.5, respectively; P < or = 0.025 for 40 mg, P < or = 0.001 for 50 mg), stiffness (-40.5, -48.1, and -17.0; both, P < or = 0.001), and physical function (-256.8, -310.8, and -116.5; P < or = 0.01 and P < or = 0.001, respectively); the SF-36 PCS score (4.6, 3.6, and -0.1; P < 0.001); and the CPSI score (-21.2, -22.2, and -10.7; P < 0.05). The 10-mg dose also was associated with significant improvements compared with placebo in the WOMAC pain (-83.6; P < or = 0.025) and physical function subscales (-232.9; P < or = 0.025) and the SF-36 PCS score (3.9; P < 0.001). The most frequently reported AEs (> or =5% of patients) in the oxymorphone ER groups were nausea (39.4%), vomiting (23.7%), dizziness (22.6%), constipation (22.2%), somnolence (17.6%), pruritus (16.5%), and headache (15.0%). The majority of AEs with oxymorphone ER were mild or moderate in intensity. Three serious AEs (urinary retention, central nervous system depression, and pancreatitis) were considered possibly or probably related to study medication. CONCLUSION: In these patients with chronic, moderate to severe pain related to OA of the hip or knee, oxymorphone ER administered twice daily for 2 weeks produced dose-related reductions in arthritis pain intensity and improvements in physical function.     

The efficacy and tolerability of glucosamine sulfate in the treatment of knee osteoarthritis: A randomized, double-blind, placebo-controlled trial

Background: Osteoarthritis (OA) is the most common form of arthritis and is often associated with disability and impaired quality of life.Objective: The aim of the study was to assess the efficacy and tolerability of glucosamine sulfate (GS) in the treatment of knee OA.Methods: Consecutive outpatients affected by primary monolateral or bilateral knee OA were enrolled in this double-blind, double-dummy, prospective, randomized, placebo-controlled trial. One group received GS 1500 mg QD for 12 weeks, and the other group received placebo QD for 12 weeks. The treatment period was followed by a 12-week treatment-free observation phase. Each patient was examined at baseline and at weeks 4, 8, 12, 16, 20, and 24. The primary efficacy criteria were pain at rest and during movement, assessed on a visual analog scale (VAS) of 0 to 100 mm. The secondary criteria included the Western Ontario and McMaster Universities (WOMAC) index for total pain score (W-TPS), total stiffness score (W-TSS), and total physical function score (W-TPFS). VAS, W-TPS, W-TSS, and W-TPFS were evaluated at baseline and at weeks 4, 8, 12, 16, 20, and 24. Analgesic drug consumption (ie, acetaminophen or NSAIDs) was also assessed.Results: Patient demographics were similar in the GS and placebo groups. Of 60 randomized patients (30 per group), 56 completed the study (28 treated with GS and 28 who received placebo). Statistically significant improvements in symptomatic knee OA were observed, as measured by differences in resting pain at weeks 8, 12, and 16 (all, P < 0.05 vs placebo) and in pain during movement at weeks 12 and 16 (both, P < 0.05). W-TPS was lower with GS than placebo at weeks 8, 12, and 16 (all, P < 0.01), and at week 20 (P < 0.05). W-TSS was also lower with GS than placebo at weeks 8, 12, 16, and 20 (all, P < 0.05). W-TPFS was lower with GS than placebo at weeks 8 (P < 0.05), 12 (P < 0.01), 16 (P < 0.05), and 20 (P < 0.05). Drug consumption was lower in the GS group than the placebo group at weeks 8, 12, 16, and 20 (all, P < 0.05). The incidence of adverse events was 36.7% with GS and 40.0% with placebo.Conclusions: GS 1500 mg QD PO for 12 weeks was associated with statistically significant reductions in pain and improvements in functioning, with decreased analgesic consumption, compared with baseline and placebo in these patients with knee OA. A carryover effect was detected after treatment ended.     

Efficacy of a self-management group intervention for elderly persons with chronic pain

OBJECTIVES: To assess the efficacy of a self-management group intervention in improving physical functioning, mood, and pain among elderly persons with chronic pain, and to identify factors that may be associated with improvement. MATERIALS AND METHODS: Forty-five residents of three retirement communities (86% women; mean age, 82.0 years) were assigned randomly to a 7-week pain self-management group or an educational booklet control condition. Participants completed self-report measures of pain, functioning, depression, and pain-related beliefs at baseline, 9 weeks later (after treatment), and 3 months after the post-treatment assessment. RESULTS: The self-management group showed significantly greater pre- to post-treatment improvement in physical role function (P = 0.04) and characteristic pain intensity (P = 0.02). No significant differences were found between groups on measures of pain-related activity interference, depression, and pain-related beliefs. Improvement in characteristic pain and physical role function was not associated with baseline depression scores, pretreatment expectations, or changes in pain-related beliefs. DISCUSSION: This study provides preliminary support for the efficacy of a self-management group intervention for older adults with chronic pain and has implications for future studies of such approaches for this and similar populations.     

Impact of a massage therapy clinical trial on immune status in young Dominican children infected with HIV-1

PURPOSE: The effectiveness of massage therapy on immune parameters was evaluated in young Dominican HIV+ children without current access to antiretroviral therapies. METHODS: Eligible children, who were followed at the Robert Reid Cabral Hospital (San Domingo, Dominican Republic), were randomized to receive either massage treatment or a control/friendly visit twice weekly for 12 weeks. Blood was drawn at baseline and following the 3-month intervention for determinations of CD4, CD8, and CD56 cell counts and percentage, along with activation markers (CD25 and CD69). RESULTS: Despite similar immune parameters at baseline in the two groups, significantly more of the control group exhibited a decline in CD4 cell count (>30%, p = 0.03), postintervention. The decrease was particularly evident in older (5-8 years) children in the control arm, who demonstrated a significant reduction in both CD4 and CD8 cell counts compared to massage-treated older children who remained stable or showed immune improvement. Additionally, a significant increase in CD4+CD25+ cells was observed over the 12-week trial in the massage-treated older children (p = 0.04) but not in the control group. In younger massage-treated children, (2-4 years old), a significant increase in natural killer cells was shown. CONCLUSION: Together these findings support the role for massage therapy in immune preservation in HIV+ children.     

Effects of flurbiprofen and tiaprofenic Acid on oxidative stress markers in osteoarthritis: A prospective, randomized, open-label, active- and placebo-controlled trial

Background:

The relationship between oxidative stress and osteoarthritis (OA) has been widely investigated. Serum malondialdehyde (MDA), nitric oxide (NO), and Cu/Zn superoxide dismutase (SOD) levels are useful markers of oxidative stress. Because of the importance of oxidative stress markers in the pathogenesis of OA, treatment might involve modification of these markers to control oxidative stress.

Objective:

The aim of this study was to compare the effects of 2 conventionalNSAIDs on markers of oxidative stress in patients with OA of the knee.

Methods:

This 3-week, prospective, randomized, open-label, active- and placebo-controlled study was conducted at the Cerrahpasa Faculty of Medicine, Istanbul University, Istanbul, Turkey. Adult patients with clinically and radiographically diagnosed moderate OA of the knee who were previously untreated were enrolled. Patients were randomly assigned to 1 of 3 treatment groups: flurbiprofen 100 mg PO (tablets) BID, tiaprofenic acid 300 mg PO (tablets) BID, or placebo tablets BID. Patients were evaluated using clinical assessment and laboratory testing before treatment (week 0; baseline) and at the end of week 3. The primary end points were the differences in serum MDA, NO, and SOD levels versus placebo. Clinical parameters-pain at rest and on motion-were evaluated using a 10-cm visual analog scale (0 = no pain to 10 = worst pain imaginable). The duration (in minutes) of morning stiffness was recorded by patients, using patient diaries. The differences between treatment groups were assessed using multivariate analysis.

Results:

Thirty-nine patients (20 women, 19 men; mean [SD] age, 59.0 [11.3]years) were included in the study. Mean serum MDA and NO levels were significantly decreased at 3 weeks compared with baseline in the 2 active-treatment groups (all, P < 0.001); these values remained statistically similar to baseline in the placebo group. Serum SOD levels were increased significantly from baseline in the 2 active-treatment groups (both, P < 0.001), but not in the placebo group. No significant differences in serum MDA and NO levels were found between the group receiving flurbiprofen and that receiving tiaprofenic acid. Serum SOD levels were significantly higher in the flurbiprofen group compared with the tiaprofenic acid and placebo groups (both, P < 0.01). The mean (SD) score for pain at rest was significantly lower at 3 weeks compared with baseline with flurbiprofen and tiaprofenic acid (both, P < 0.001), but not with placebo. The mean score for pain on motion was significantly reduced from baseline values only with tiaprofenic acid (P < 0.001). The duration of morning stiffness was significantly shorter at 3 weeks compared with baseline in all 3 study groups (all, P < 0.001). The mean scores for pain on motion and duration of morning stiffness were significantly reduced with tiaprofenic acid compared with placebo (both, P < 0.05). The study had some limitations (ie, small sample size, no blinding, the short duration of the study, and the weak correlation between serum and synovial fluid levels of NO).

Conclusions:

In this comparison of the effects of 3 weeks of treatment withflurbiprofen 100 mg BID and tiaprofenic acid 300 mg BID in patients with knee OA, both treatments effectively reduced serum MDA and NO levels compared with placebo. Only tiaprofenic acid significantly improved pain at rest and on motion and duration of morning stiffness compared with placebo.     

Health-related quality-of-life effects of oxaprozin and nabumetone in patients with osteoarthritis of the knee

Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed for the treatment of signs and symptoms of osteoarthritis (OA). Nabumetone and oxaprozin are 2 of the newer NSAIDs and have been shown to have similar safety and efficacy profiles. Nabumetone 1000 mg to 1500 mg once a day (QD) and oxaprozin 1200 mg QD are commonly recommended doses. This study compared the health-related quality of life (HRQOL) of patients receiving oxaprozin 1200 mg QD with that of patients receiving nabumetone 1000 mg QD or nabumetone 1500 mg QD for the treatment of signs and symptoms of OA of the knee. Two similarly designed, independent, randomized, double-masked, placebo-controlled clinical trials were conducted. In trial 1, patients were randomized to receive oxaprozin 1200 mg QD (n = 109), nabumetone 1000 mg QD (n = 110), or placebo (n = 109); in trial 2, patients received oxaprozin 1200 mg QD (n = 116), nabumetone 1500 mg QD (n = 115), or placebo (n = 116). HRQOL was measured by the Medical Outcomes Study Short-Form-36 Health Survey (1-week recall period) at baseline and weeks 2 and 6. Data from the 2 trials were combined to assess differences across the 4 groups in 8 domains and 2 summary scores at baseline, and changes in HRQOL scores at weeks 2 and 6. At week 2, the oxaprozin group showed significantly greater improvement than the placebo group in role physical, vitality, and mental component summary (MCS) scores (P < 0.05), and in physical functioning, bodily pain, social functioning, and physical component summary (PCS) scores (P < 0.01). The nabumetone 1500-mg group showed significantly greater improvement than the placebo group in bodily pain and social functioning (P < 0.05), and in vitality and MCS score (P < 0.01). No significant differences were observed between the nabumetone 1000-mg and placebo groups. At week 2, the oxaprozin group showed a greater change than the nabumetone 1000-mg group in PCS score (P < 0.05). At week 6, oxaprozin treatment resulted in significantly greater improvement than placebo in physical functioning, role physical, and bodily pain (P < 0.05); social functioning, role emotional, and mental health (P < 0.01); and vitality and MCS score (P < 0.001). The nabumetone 1500-mg group showed significantly greater responses than the placebo group in vitality (P < 0.05), mental health (P < 0.01), and MCS score (P < 0.001). The oxaprozin group had significantly better scores than the nabumetone 1500-mg group in the PCS (P < 0.05), and it showed significantly greater improvement than the nabumetone 1000 mg group in role physical and PCS score (P < 0.01) and in role emotional (P < 0.05). No statistically significant differences were found between placebo and nabumetone 1000 mg at week 6. Results of this study suggest that oxaprozin 1200 mg QD has a significant positive impact on the HRQOL of patients with OA of the knee compared with nabumetone 1000 mg QD and placebo.     

Efficacy and safety of extended-release, once-daily tramadol in chronic pain: a randomized 12-week clinical trial in osteoarthritis of the knee

The efficacy and safety of a once-daily extended-release formulation of tramadol hydrochloride (tramadol ER) was evaluated in patients with moderate to severe chronic pain of osteoarthritis (OA). This was a randomized, double-blind, placebo-controlled, parallel-group, 12-week study. Eligible patients with radiographically confirmed OA of the knee meeting the American College of Rheumatology diagnostic criteria, defined by knee pain and presence of osteophytes, plus at least age >50 years, morning stiffness <30 minutes in duration, and/or crepitus, entered a 2-7 day washout period during which all analgesics were discontinued. When pain at the index knee joint reached > or =40 mm (0-100 mm VAS), patients were randomized to tramadol ER or placebo. Tramadol ER was initiated at 100 mg QD and increased to 200 mg QD by the end of 1 week of treatment. After the first week, further increases to tramadol ER 300 mg or 400 mg QD were allowed. Outcome measures included Arthritis Pain Intensity Visual Analogue Scale (VAS), Western Ontario and McMaster Universities Arthritis Scale (WOMAC) Pain, Stiffness, Physical Function VAS subscales, Patient and Physician Global Assessment of Therapy, Sleep, dropouts due to insufficient therapeutic effect, and adverse events. Two hundred forty-six patients were randomized (tramadol ER 124, placebo 122). There were no baseline differences between the two treatments. The mean age was 61 years, mean duration of OA 12.9 years, and the mean tramadol ER dose was 276 mg QD. All efficacy outcome measures favored tramadol ER over placebo. On the primary outcome variable of average change from baseline in Arthritis Pain Intensity VAS over 12 weeks, tramadol ER was superior to placebo (least squares mean change from baseline: 30.4 mm vs. 17.7 mm, P < 0.001). Significant differences from placebo were evident at week 1, the first post-treatment visit. Similarly, outcomes on the WOMAC Pain, Stiffness and Physical Function subscales, the WOMAC Composite Scale, dropouts due to insufficient therapeutic effect, Patient and Physician Global Assessment of Therapy, and Sleep were all significantly better with tramadol ER than placebo (P < 0.001 to < 0.05). Treatment with tramadol ER results in statistically significant and clinically important and sustained improvements in pain, stiffness, physical function, global status, and sleep in patients with chronic pain. A once-a-day formulation of tramadol has the potential to provide patients increased control over the management of their pain, fewer interruptions in sleep and improved compliance.     

穴位按摩辅助缓解膝骨关节炎患者疼痛的护理研究

目的 研究穴位按摩对缓解膝骨关节炎患者疼痛的影响 方法 于2017年1-12月上海市静安区闸北中心医院中医骨伤科收治的膝骨关节炎患者100例,采取随机数字表法分为观察组(n=50)和对照组(n=50),对照组采用常规护理干预,观察组在此基础上采用穴位按摩,比较两组患者在干预前后膝关节疼痛评估、膝关节功能、膝关节日常活动相关指标。结果 干预后观察组患者VAS、WOMAC、ADL评分均高于对照组,差异具有统计学意义(P＜0.05)。结论 膝骨关节炎患者在常规护理的基础下应用穴位按摩能够切实有效的降低患者的膝关节疼痛感,促使膝关节功能更好地恢复,值得在临床上的普及与实施。     

Effects of Aromatherapy Massage on Face-Down Posture-Related Pain After Vitrectomy: A Randomized Controlled Trial

Postoperative face-down posturing (FDP) is recommended to optimize the effects of intraocular gas tamponade after vitrectomy. However, patients undergoing FDP usually experience physical and psychological burdens. This 3-armed, randomized, single-center trial investigated the effects of aromatherapy on FDP-related physical pain. Sixty-three patients under FDP were randomly allocated to one of three treatment groups: aromatherapy massage with essential oil (AT), oil massage without essential oil (OT), and a control group. The AT and OT groups received 10 minutes of massage by ward nurses trained by an aromatherapist, while the control group received usual care. Outcomes were assessed as short-term (pre- to post-intervention) and long-term (first to third postoperative day) changes in physical pain in five body regions using face-scale. The AT and OT groups both revealed similar short-term pain reductions after intervention, compared with the control group. Regarding long-term effects, neither group experienced significant effects until the second day. Significantly more pain reduction compared with usual care occurred on the third day, mainly in the AT group, though there were few significant differences between the AT and OT groups. In conclusion, this study suggests that simple oil massage is an effective strategy for immediate pain reduction in patients undergoing FDP, while aromatherapy may have a long-term effect on pain reduction.