Effects of Paraffin Wax Therapy and Dry Cupping on Pain and Wrist Function in Patients With Rheumatoid Arthritis

Rheumatic Arthritis

Rheumatoid Arthritis, Paraffin Wax Therapy, Dry Cupping, Pain Intensity, Wrist Joint Function, Complementary Therapy, Wrist Functional Performance

Rheumatoid arthritis is a chronic inflammatory disease that can cause pain, stiffness, and reduced functional performance in the wrist and hand joints. These problems may make daily activities, such as gripping objects and performing self-care tasks, more difficult. The purpose of this study is to evaluate the effects of paraffin wax therapy and dry cupping on pain intensity and wrist joint functional performance among patients with rheumatoid arthritis. The study will compare two groups: one receiving paraffin wax therapy and the other receiving dry cupping therapy Pain intensity and wrist joint functional performance will be assessed before and after the interventions using standardized assessment tools. The findings may help determine whether these complementary therapies can reduce pain and improve wrist function in patients with rheumatoid arthritis.

Background Rheumatoid arthritis (RA) is a prevalent systemic chronic inflammatory disorder that impacts roughly 1% of the global population, frequently resulting in disability and imposing significant social and economic consequences. Rheumatoid arthritis is characterized by polyarthritis, immune system abnormalities, autoimmune reactions, a high prevalence of comorbidities, and early mortality. A fundamental characteristic of rheumatoid arthritis is the deterioration of the extracellular matrix, resulting in the disintegration of cartilage, tendons, bones, and ligaments. Furthermore, the constitutional manifestations of rheumatoid arthritis (RA) encompass fever, weariness, weight reduction, malaise, and diminished appetite (1). Rheumatoid arthritis (RA) is a prevalent immune-mediated inflammatory disorder mostly impacting synovial joints, frequently commencing in the hands and feet. The diagnosis relies on clinical patterns of joint involvement and may be corroborated by the presence of autoantibodies (Rheumatoid factor or ACPAs) and systemic inflammatory markers. Rheumatoid arthritis imposes a considerable burden, encompassing joint pain, stiffness, fatigue, diminished physical function, and frequent healthcare requirements, all of which adversely affect quality of life. Extra-articular problems, including pulmonary disease, nodules, and pericarditis, are infrequent nevertheless contribute to morbidity. Comorbidities such as cardiovascular disease, infections, depression, and cancer exacerbate risks. Mortality continues to exceed that of the general population, primarily because to cardiovascular, pulmonary, and oncological factors, although recent advancements (2). The joints most frequently impacted by rheumatoid arthritis are the ankle, foot, knee, hip, spine, shoulder, elbow, wrist, and hand. Approximately 80-90% of patients with rheumatoid arthritis are believed to experience involvement of the hands and wrists. The joints that experience the most pain are the wrist, hand, ankle, and foot. The wrist and hand joints necessitate enhanced functional movements for daily activities, particularly in gripping tasks that demand optimal coordination, muscle strength, joint flexibility, spatial orientation, and awareness, while being devoid of contractures and abnormalities (3). Conventional treatment using disease-modifying antirheumatic medications (DMARDs) and glucocorticoids can diminish disease activity; nevertheless, they frequently fail to completely relieve pain or restore hand function and may entail considerable side effects and financial burden (4,5). Consequently, there is increasing interest in adjunctive therapies such as paraffin wax therapy and dry cupping, utilized to alleviate pain and enhance hands joint function in rheumatoid arthritis and other inflammatory arthritis (6,7). Important of study Rheumatoid arthritis (RA) is a chronic systemic autoimmune disorder that predominantly impacts the joints, resulting in pain, swelling, stiffness, and progressive functional decline. In 2019, around 18 million individuals worldwide were diagnosed with rheumatoid arthritis (RA), with women representing around 70% of the patient population and over half of the cases occurring in adults aged over 55 years (8). Approximately 13 million individuals experience moderate to severe rheumatoid arthritis that could gain from organized rehabilitation programs(9). Rheumatoid arthritis predominantly impacts the tiny joints of the hands, wrists, and feet; however, larger joints, including the knees, shoulders, and elbows, are also typically affected (10). Recent evidence underscores the global impact of rheumatoid arthritis (RA), revealing a 23.8% reduction in age-standardized mortality rates from 1990 to 2020, while prevalence persists in its upward trajectory. Projections indicate that by 2050, the prevalence of individuals with rheumatoid arthritis (RA) would rise by 80.2%, totaling roughly 31.7 million cases globally (4). The global prevalence of rheumatoid arthritis exhibits regional inequalities, typically being more pronounced in industrialized nations. This is ascribed to both modifiable factors, like smoking, food, and environmental exposures, and non-modifiable factors, such as genetic predisposition and sex. The "mucosal origin hypothesis" posits that environmental stimuli at mucosal locations, such as the oral cavity, lungs, and intestines, engage with genetic predisposition to commence the autoimmune process. Notwithstanding the increasing prevalence, the severity of the disease and related comorbidities have diminished over the past thirty years, primarily attributable to enhanced treatment protocols and multimodal management approaches (11). Rheumatoid arthritis and associated rheumatic and musculoskeletal illnesses are primary contributors to pain, disability, and diminished life expectancy globally. The World Health Organization (WHO) states that musculoskeletal diseases impact almost 2 billion individuals worldwide, making them the primary cause of disability (12). Rehabilitation is pivotal in the care of rheumatoid arthritis, aiming for pain alleviation, joint preservation, maintenance of mobility, and increased engagement in everyday activities. Multidisciplinary rehabilitation strategies that incorporate physicians, nurses, physiotherapists, psychologists, and occupational therapists have demonstrated efficacy in enabling patients to control symptoms, sustain functional independence, and enhance psychosocial well-being (13). This signifies an increasing desire for efficacious therapeutic and rehabilitative strategies to alleviate disability and enhance quality of life. Consequently, non-pharmacological therapies are crucial in addressing chronic pain and functional impairments in rheumatoid arthritis. Recent guidelines from the European Alliance of Associations for Rheumatology (EULAR) for challenging cases of rheumatoid arthritis (RA) encompass modalities such as cognitive behavioral therapy, mindfulness, Tai Chi, acupuncture, and physiotherapy (14). Moreover, there is increasing interest in adjunctive therapies such as paraffin wax therapy and dry cupping, utilized to alleviate pain and enhance joint mobility in rheumatoid arthritis and other inflammatory arthritis (6,7). Paraffin wax bath therapy is extensively utilized to enhance circulation, alleviate discomfort, and foster relaxation in the hands and feet. This technique entails the application of molten paraffin wax (often at 40-45°C) to the hands through immersion or the "drip-wrap" approach (15-17). The continuous heat transfer causes vasodilation, enhances local blood circulation and tissue perfusion, alleviates muscle spasms, and fosters tissue flexibility (16,18-20). Evidence indicates that paraffin wax, especially when used in conjunction with hand exercises, markedly alleviates pain, boosts hand functionality, diminishes stiffness, and improves performance in everyday tasks for individuals with rheumatoid arthritis and hand osteoarthritis (15-17,19,21,22). Proposed mechanisms for paraffin wax bath therapy encompass enhanced circulation, lymphatic drainage, edema resorption, and regulation of nociceptive pathways (17,18). The safety profile is good, with minimal documented adverse effects (19). Paraffin wax therapy may serve as a helpful adjunct to rehabilitation programs for rheumatoid arthritis, specifically in enhancing hand function and mobility. Numerous studies have demonstrated that paraffin wax therapy alleviates pain and enhances range of motion. Paraffin wax therapy, when combined with regular medical care, markedly alleviates pain intensity and morning stiffness, thereby enhancing the quality of life for people with rheumatoid arthritis. Paraffin wax therapy offers enhanced improvements in inflammatory indicators and joint symptoms when used in conjunction with drugs (such as methotrexate) rather than with medications alone. Moreover, paraffin wax therapy enhances function, particularly when integrated with strengthening exercises, hence enhancing joint mobility, muscle strength, and the ability to perform daily activities (23,24,25). Cupping therapy, an ancient practice rooted in Middle Eastern and Asian traditions, has demonstrated potential advantages in alleviating pain and inflammation by mechanisms including improved circulation, immunological modulation, and decreased oxidative stress. This treatment is categorized into two primary types: dry cupping, which is the direct application of suction to the skin, and wet cupping, which involves superficial incisions to extract blood from the dermal microcirculation (1). Dry Cupping Therapy is an ancient therapeutic technique originating from traditional medicine systems, particularly Unani. This method entails generating localized suction on the skin using cups, which may be traditionally heated glass or contemporary vacuum-pumped acrylic or silicone, applied at specific points or over affected areas(26-33) Negative pressure, generally ranging from -100mmHg to -500mmHg, elevates the skin and underlying tissues into the cup, resulting in localized hyperemia and petechiae. Clinical trials demonstrate effectiveness in alleviating pain and enhancing functional impairment in illnesses such as chronic low back pain, neck pain, and knee osteoarthritis (27-30,33). The vessels Frequently utilized acupoints for systemic disorders in rheumatoid arthritis (RA) encompass BL13 (Feishu - Lung), BL21 (Pishu - Spleen), BL22 (Shenshu - Kidney), and regions above impacted joints or muscles (26,28,33,34). Previous research investigating the efficacy of paraffin wax therapy and cupping in patients with rheumatoid arthritis have validated the usefulness of these interventions in alleviating pain and enhancing joint mobility. Nevertheless, research has predominantly focused on assessing the benefits of paraffin wax and dry cupping in isolation, with minimal studies directly comparing their efficacy in alleviating pain intensity and enhancing joint mobility in individuals with rheumatoid arthritis. Moreover, research has concentrated on non-pharmacological and herbal interventions via traditional herbal medicine or nutritional strategies, with few studies directly addressing physical therapies such as paraffin wax and cupping (23,26,35). Consequently, further study is essential to uncover therapeutic approaches that provide superior benefits as a complimentary choice. Addressing this gap is crucial for facilitating evidence-based decisions for rehabilitation techniques, improving functional independence, and alleviating pain associated with rheumatoid arthritis. This study is the inaugural investigation comparing the efficacy of paraffin wax therapy and dry cupping on pain intensity and wrist joint functional performance for patients with rheumatoid arthritis, hence enhancing its significance and scientific merit. Objectives of the study 1. To evaluate the effect of paraffin wax therapy on pain intensity and wrist joint functional performance for patients with rheumatoid arthritis. 2. To evaluate the effect of dry cupping therapy on pain intensity and wrist joint functional performance for patients with rheumatoid arthritis. 3. To compare the effectiveness of paraffin wax therapy and dry cupping therapy in reducing pain intensity and improving wrist joint functional performance for patients with rheumatoid arthritis. Hypothesis 1. Null Hypothesis (H0): Neither paraffin wax therapy nor dry cupping therapy has a significant effect on reducing pain intensity or wrist joint functional performance for patients with rheumatoid arthritis, and there is no significant difference between the two therapies. 2. Alternative Hypothesis (H1): Both paraffin wax therapy and dry cupping therapy have a significant effect on reducing pain intensity and wrist joint functional performance for patients with rheumatoid arthritis, with a significant difference in effectiveness between the two therapies. Methodology Research design: A true experimental Randomized Controlled Trial (RCT) will employ a parallel design involving two groups: one receiving paraffin wax treatment and the other undergoing dry cupping treatment. This study aims to randomly select participants to compare the effects of paraffin wax treatment against dry cupping treatment on pain intensity and wrist joint functional performance for patients with rheumatoid arthritis. The selected research design incorporates an intervention involving two specific treatments (Paraffin wax therapy and Dry cupping therapy) administered to participants, randomization (where participants are allocated randomly into two groups) to mitigate bias and control extraneous variables, and the inclusion of a comparison group (where each group receives one of the two treatments, facilitating a direct comparison of outcomes). The variables will be assessed prior to and following the intervention (Pre- and Post-Test Measures) to determine the capacity to infer causality. The random control and structured intervention allow for the conclusion that any variation in the findings is ascribed to the treatment type rather than extraneous influences. Setting The research will take conducted at Rheumatology Clinic at Baghdad Teaching Hospital in Baghdad city This center focuses on the treatment of arthropathies and musculoskeletal conditions. A paraffin wax therapy apparatus and a dry cupping apparatus will be utilized. Sample and sampling Participants will consist of persons diagnosed with Rheumatoid Arthritis (RA) based on established criteria Inclusion criteria 1. Age 20-60 years. 2. Diagnosis of RA fulfilling the 2010 ACR/EULAR classification criteria (14). 3. Seropositive for Rheumatoid Factor (RF). 4. Stable dose of conventional RA medications Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as Ibuprofen and Naproxen, csDMARDs (Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs) such as Methotrexate and Hydroxychloroquine, bDMARDs (Biologic Disease-Modifying Anti-Rheumatic Drugs) such as Infliximab and Adalimumab for ≥ 3 months prior to enrollment and agreement to maintain stable regimen during the study period. Exclusion Criteria: 1. Acute joint inflammation or infection in hands/upper back at the time of screening. 2. Severe deformities or recent surgery (past 6 months) in hands/upper back. 3. Skin lesions, open wounds, infections, fragility, or severe vascular disease (e.g., DVT, severe varicose veins) at proposed treatment sites. 4. Significant comorbidities: uncontrolled diabetes mellitus, renal failure, polycythemia vera, active malignancy, severe cardiovascular or respiratory disease, coagulopathies, or use of anticoagulants. 5. Pregnancy or lactation. 6. Prior experience with paraffin wax or cupping therapy within the last 6 months. 7. Known hypersensitivity to paraffin or materials used in cupping (e.g., acrylic, silicone). Minimum sample size According to the principal outcomes reported in previous studies on paraffin (16,17) and dry cupping (1,27,33), the required sample size for this study was calculated using G\*Power (version 3.1). An a priori power analysis for two independent groups (two-tailed t-test) was conducted with the following parameters: significance level (α) = 0.05, statistical power (1-β) = 0.80, and a large effect size (Cohen's d = 0.8), based on previous studies using the Patient-Rated Wrist/Hand Evaluation (PRWHE) in musculoskeletal disorders. The analysis indicated that a minimum of 42 participants (21 per group) would be required. To account for an anticipated dropout rate of approximately 10%, the final sample size will be increased to 48 participants (24 per group). Instrumentation To achieve the objectives of the study, questionnaire format is designed and constructed after reviewing related literature and previous studies by the researcher. The questionnaire consists of including: Part I: Socio-demographic data: This part contains (5 items) including (age, gender, educational level, occupation and marital status). Part II: Clinical information : This part contains (4 items) including (Disease Duration (years), Medication, Laboratory Tests (CRP, ESR, RH factor) , body mass index) Part III: The Visual Analogue Scale (VAS): was used in this study as a standardized instrument to assess pain intensity. The VAS was originally developed by Huskisson (1974) and has since been widely applied and validated in various clinical, musculoskeletal, and rheumatologic pain studies. Recent evidence supports its high sensitivity and clinical applicability in assessing pain among patients with chronic and postoperative conditions, confirming its continued relevance in contemporary research (36,37,38) The VAS is a single-item, unidimensional measure designed to evaluate pain as a single construct. It consists of a horizontal line with numerical anchors ranging from 0 to 10, where 0 represents "no pain" and 10 represents "severe pain." Participants are asked to indicate their pain intensity by marking a point on the line that best reflects their perceived level of pain, and the score is obtained by measuring the distance from the left anchor point to the participant's mark (36) Pain intensity measured using the VAS is commonly classified into categories to facilitate clinical interpretation, with scores of 1-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain. This classification system has been widely adopted in musculoskeletal and rheumatologic research and enhances the interpretability of pain outcomes(39) The Visual Analogue Scale has demonstrated excellent validity, including strong content and construct validity, with correlation coefficients exceeding 0.90 in studies involving chronic pain and inflammatory musculoskeletal conditions. These findings confirm the instrument's effectiveness in accurately capturing pain intensity (40) In terms of reliability, the VAS has consistently shown high test-retest reliability, with reported coefficients greater than 0.90, indicating strong stability and reproducibility of measurements over time. This level of reliability supports its use in both clinical practice and interventional research designs(37) Part IV: The Health Assessment Questionnaire-Disability Index (HAQ-DI): is a widely used, standardized instrument designed to assess functional disability in patients with rheumatoid arthritis and other rheumatologic conditions. It evaluates an individual's ability to perform activities of daily living and is internationally recognized as a gold standard outcome measure in rheumatoid arthritis research due to its strong psychometric properties and clinical relevance(41,42,43). (The HAQ-DI was originally developed by James F. Fries and colleagues at Stanford University and has since become one of the most frequently used tools for assessing functional status in patients with chronic rheumatic diseases. Its extensive use in clinical trials and outcome evaluations reflects its effectiveness in monitoring disease impact and treatment response (41,42) The questionnaire consists of 20 items distributed across eight functional domains, including dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain contains two to three items, allowing comprehensive assessment of functional ability across multiple aspects of daily living Each item in the HAQ-DI is scored using a 4-point Likert scale ranging from 0 (no difficulty) to 3 (unable to do). For each domain, the highest item score is selected, and the final HAQ-DI score is calculated as the mean of the eight domain scores, yielding a total score between 0 and 3, with higher scores indicating greater functional disability. The HAQ-DI has demonstrated strong validity, including content, construct, and criterion validity. Significant correlations have been reported between HAQ-DI scores and disease activity, physical function, radiographic damage, and quality-of-life measures, confirming its effectiveness in evaluating functional status among patients with rheumatoid arthritis . In terms of reliability, the HAQ-DI has shown excellent internal consistency, with Cronbach's alpha values ranging from 0.90 to 0.97, as well as high test-retest reliability, with intraclass correlation coefficients exceeding 0.85. These findings indicate a high degree of stability and consistency of the instrument over time (44). The HAQ-DI is a copyrighted instrument, and formal permission is required for its use in research, clinical trials, or publication. Licensing and authorization are managed by Stanford University and Mapi Research Trust, particularly for translated versions of the questionnaire. The original HAQ-DI was developed in English, and an official Arabic version (Saudi Arabia) was translated and culturally adapted following standardized linguistic validation procedures. This version was approved by Mapi Research Trust in collaboration with Stanford University in May 2006 and retains the psychometric properties of the original instrument, supporting its suitability for use in Arabic-speaking populations. (45). In the present study, formal permission to use the Arabic version of the HAQ-DI was obtained prior to data collection, and a copy of the approval is attached at the end of the document. Data Collection: The researcher will obtain consent from all people included in the study to conduct the research. The investigator will initiate contact with the study participants recruited at Rheumatology Clinic at Baghdad Teaching Hospital in Baghdad city to secure their consent for participation and to clarify the study's objectives. Upon obtaining the participants' consent, either through verbal agreement or written signing, the researcher will ensure that this information remains confidential. The investigator will assign randomly. Qualified individuals will be randomly assigned (1:1) to either the Paraffin Wax Group (PW) or the Dry Cupping Group (DC) by computer-generated block randomization. Allocation concealment will be guaranteed through the utilization of sealed, opaque envelopes, which will be opened by a research assistant following the baseline assessment. The Paraffin Wax therapy Group (PW) will receive the intervention via the standardized "drip-wrap" technique as outlined in the literature (15,17). At the commencement of each session, participants will be directed to cleanse and dry their hands meticulously and to remove all jewelry. Medical-grade paraffin wax will be liquefied in a thermostatically regulated bath and sustained at a consistent temperature of 45 ± 1°C, with the temperature confirmed by a thermometer. Each participant will submerge one hand completely into the wax bath for 2-3 seconds and then remove it, permitting the wax to set for 5-10 seconds. This procedure will be executed eight consecutive times to create a consistent, glove-like coating. Subsequent to coating, the wax-encased hand will be positioned in a disposable plastic bag and then enveloped with a terrycloth glove or insulated wrap to preserve warmth. The hand will maintain this posture for 15 minutes. Upon conclusion of the treatment period, the wax "glove" will be meticulously removed in its entirety, and the identical procedure will be performed on the opposite hand (Fig. 1). Treatment sessions will occur biweekly for four consecutive weeks, resulting in a total of eight sessions. All sessions will be overseen by an investigator to ensure compliance with the therapy regimen. The participants in the Dry Cupping Group (DC) would undergo interventions targeting established acupuncture locations utilized for systemic diseases and rheumatoid arthritis. Each participant will be seated comfortably to facilitate optimal access to the application sites. The epidermis at these locations will be meticulously sanitized before cupping. Acrylic cups with diameters ranging from 5 to 6.5 cm will be linked to an electromechanical suction pump featuring a pressure gauge. The DF-750 Portable Suction from Doctor's Friend Medical Instrument Co., Taiwan, will be utilized to generate accurate negative pressures (Fig. 2). Cups will be utilized on designated painful areas frequently employed in studies concerning rheumatoid arthritis (RA) and hand joint discomfort. The chosen points comprise: LI4 (Hegu) (Fig.3): Situated between the first and second metacarpal bones on the dorsal aspect of the hand, between the thumb and index finger. This point is commonly utilized to relieve hand joint pain and rheumatoid arthritis, while LI5 (Yangxi) is situated on the radial aspect of the dorsal wrist crease and is employed for alleviating wrist and hand joint discomfort(Fig.4). TE4 (Yangchi): Situated near the midpoint of the dorsal wrist crease between the extensor tendons (Fig.5), utilized to alleviate stiffness and pain in the wrist and to directly target inflamed or uncomfortable metacarpophalangeal joints, aiming to diminish pain and enhance mobility in rheumatoid arthritis(46,47) . Negative pressure will be incrementally administered, attaining levels of -300 to -400 mmHg, with modifications of ±25 mmHg contingent upon participant tolerance and dermal reaction, meticulously circumventing undue pain or blister development. The cups will be retained for 10 minutes, after which they will be delicately extracted (48,27). Minor petechial or ecchymosis may manifest at the locations of application. The skin will thereafter be cleansed; no dressing will be necessary unless minor abrasions arise, which is uncommon. The intervention will occur biweekly for four successive weeks, resulting in eight sessions overall. All sessions will be overseen by an investigator. Ethical consideration The study will adhere to ethical principles, beginning with approval from the Ethical Committee of the College of Nursing at the University of Baghdad and the Iraqi Ministry of Health. Clinical interventions will be recorded in databases of international clinical trial to take acceptance before start collecting sample. Informed consent will be obtained from all participants to ensure their voluntary participation. Participants' data will be strictly confidential, and data will be stored securely to prevent any potential harm. Data Analysis Data will be entered into the IBM Statistical Package for the Social Sciences (SPSS) version 21 software program and will be analyzed using descriptive and inferential statistical procedures. The statistical approaches to be utilized will include, but will not be limited to, percentages, frequencies, and Analysis Within-group changes (pre- vs post-intervention) will be assessed using paired t-test for normally distributed data. Between-group comparisons will be based on the difference between post- and pre-intervention values (Δ) for each participant, using independent t-test for normally distributed data. Additionally, Repeated Measures ANOVA may be conducted to evaluate the interaction effect between time (pre vs post) and group (Paraffin Wax vs Dry Cupping).

No related papers found yet.

Iraq