NCT Number: NCT06903936
Knee arthritis is a chronic joint disease that causes pain, disability and impaired quality of life, leading to significant social and health problems worldwide. Moreover, these public and economic impacts related to osteoarthritis of the knee are expected to increase in the future. With the global increase in the proportion of the elderly population, overall obesity rates and the associated incidence of osteoarthritis of the knee, clinicians are now focusing on new treatment strategies. The diagnosis is usually made by history, physical examination and radiography (X-ray) and there is no need for additional examination.
Today, both non-surgical and surgical interventions are used in the treatment of knee arthritis. Non-surgical options include patient education, weight loss, physical therapy (PT), support or foot orthosis, oral painkillers, non-cortisol anti-inflammatory drugs, cortisols, hyaluronic acid, plasma injections rich in platelets, prolotherapy, stem cell therapy and genicular nerve blocks.
The aim of the study was to compare the benefits of genicular nerve block and physical therapy in volunteers with knee pain for more than 3 months like you and to determine the most appropriate method.
In this study, Genicular nerve block and Physical therapy in patients with knee arthritis;
* Effects on knee pain, mobility and functional ability * It is aimed to examine the effects on equilibrium parameters.
A total of 66 participants will be included in the study. Participants will be randomly assigned to three groups by envelope selection method. Your treatment method will be determined according to the treatment method in the envelope you choose.
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Notify Me40 year–70 year
All sexes
Interventional
Not applicable
Kirsehir Ahi Evran University Physical Medicine and Rehabilitation Hospital, Kirşehi̇r, Turkey (Türkiye)
Knee osteoarthritis (KOA) is a chronic joint disease that causes pain, disability and impaired quality of life, leading to significant social and health problems worldwide. Moreover, these public and economic impacts related to KOA are expected to increase in the future. With the global increase in the proportion of the elderly population, overall obesity rates and the associated incidence of KOA, clinicians are now focusing on new treatment strategies.
Currently, both non-surgical and surgical interventions are used to treat KOA. Non-surgical options include patient education, self-management strategies, weight loss, physical therapy (PT), brace or foot orthosis, oral analgesics, non-steroidal anti-inflammatory drugs, steroids, hyaluronic acid, platelet-rich plasma injections, prolotherapy stem cell therapy and genicular nerve blocks, all aimed at relieving pain, improving function and delaying the need for surgery. PT is an established and evidence-based treatment option for reducing pain and improving function in KOA.
Through the use of PT modalities such as thermal therapies, therapeutic ultrasound, electrical stimulation and laser therapy, which are known to modulate inflammation, are known to have an impact on pain, function and quality of life. On the other hand, genicular nerve block (GNB) is a recently developed treatment option for KOA that targets the three sensory nerves of the knee (superior lateral, superior medial and inferior medial genicular nerve) to block pain transmission to the central nervous system. Only a few studies have been conducted using GNB in patients with chronic KOA, demonstrating a reduction in pain and improvement in knee function. Eventually, GNB gained popularity in rheumatology to modulate inflammation in patients with rheumatoid arthritis. Studies investigating different methods of application of GNB in chronic KOA, namely ultrasound-guided and fluoroscopy-guided GNB, reported no difference in treatment efficacy between the two methods. However, Kim et al. reported that ultrasound is more suitable for imaging because it does not require radiation exposure.
The aim of this study was to compare the effects of genicular nerve block and physical therapy on knee pain, mobility, functional ability and balance parameters in patients with knee osteoarthritis (KOA) and to investigate whether they are superior to the control group.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
6 ml of solution consisting of 5 ml 2% lidocaine hydrochloride and 1 ml 40 mg triamcinolone acetonide will be injected equally into the superomedial, inferomedial and superolateral genicular nerve branches using a 23G (0.6*60mm) needle under ultrasound guidance.
Group 2: PT (PHYSICAL THERAPY) group: In the PT group, all interventions will be performed with the patient supine and knees in extension. First, superficial heating will be applied using a hotpack for 20 minutes, followed by therapeutic ultrasound in continuous mode at a frequency of 1 MHz and 1.5 Watt/cm2 for 5 minutes to achieve deep thermal effects. Then traditional transcutaneous electrical nerve stimulation (TENS) will be applied for 15 minutes for a total of 15 sessions.
Group 3: Control group: For 3 weeks, exercise therapy will be applied by the patient. Knee range of motion exercises, quadriceps strengthening exercises, hamstring stretching exercises will be taught to the patients by the doctor and they will be asked to do them every day, 2 times a day, 10 repetitions for a total of 3 weeks. The use of NSAIDs will be restricted during the treatment period.
Time frame: before treatment (week 0)
Visual analog scale (VAS), pain intensity is usually graded as "no pain" 0 points and "the most severe pain imagined" 10 points (10 cm scale). Scoring intervals in pain intensity; <3 mild pain, 3-6 moderate pain, >6 severe pain. VAS is a practical scale widely used in chronic pain worldwide.As the VAS score increases, the severity of pain increases.
Time frame: at the end of treatment (week 3)
Visual analog scale (VAS), pain intensity is usually graded as "no pain" 0 points and "the most severe pain imagined" 10 points (10 cm scale). Scoring intervals in pain intensity; <3 mild pain, 3-6 moderate pain, >6 severe pain. VAS is a practical scale widely used in chronic pain worldwide.As the VAS score increases, the severity of pain increases.
Time frame: 9 weeks after treatment (week 12)
Visual analog scale (VAS), pain intensity is usually graded as "no pain" 0 points and "the most severe pain imagined" 10 points (10 cm scale). Scoring intervals in pain intensity; <3 mild pain, 3-6 moderate pain, >6 severe pain. VAS is a practical scale widely used in chronic pain worldwide.As the VAS score increases, the severity of pain increases.
Time frame: before treatment (week 0)
WOMAC index (Western Ontario and McMaster Universities to assess knee functionality): It consists of three subscales: Pain (5 questions), stiffness (2 questions) and function (17 questions). Total scores range from 0 to 96, with higher scores indicating poor functioning. The validity and reliability of the WOMAC index has been demonstrated in Turkish DOA patients.
Time frame: at the end of treatment (week 3)
WOMAC index (Western Ontario and McMaster Universities to assess knee functionality): It consists of three subscales: Pain (5 questions), stiffness (2 questions) and function (17 questions). Total scores range from 0 to 96, with higher scores indicating poor functioning. The validity and reliability of the WOMAC index has been demonstrated in Turkish DOA patients.
Time frame: 9 weeks after treatment (week 12)
WOMAC index (Western Ontario and McMaster Universities to assess knee functionality): It consists of three subscales: Pain (5 questions), stiffness (2 questions) and function (17 questions). Total scores range from 0 to 96, with higher scores indicating poor functioning. The validity and reliability of the WOMAC index has been demonstrated in Turkish DOA patients.
Time frame: before treatment (week 0)
6-minute walk test (6MWT): Patients would be asked to walk at their preferred pace for 6 minutes along a 30m corridor marked at 3m intervals; rest or change in walking speed would be allowed if necessary. The maximum distance covered in 6 minutes along the 30m corridor will be measured.The purpose of the 6-minute walking test is to evaluate whether patients respond to the given treatment.
Time frame: at the end of treatment (week 3)
6-minute walk test (6MWT): Patients would be asked to walk at their preferred pace for 6 minutes along a 30m corridor marked at 3m intervals; rest or change in walking speed would be allowed if necessary. The maximum distance covered in 6 minutes along the 30m corridor will be measured.The purpose of the 6-minute walking test is to evaluate whether patients respond to the given treatment.
Time frame: 9 weeks after treatment (week 12)
6-minute walk test (6MWT): Patients would be asked to walk at their preferred pace for 6 minutes along a 30m corridor marked at 3m intervals; rest or change in walking speed would be allowed if necessary. The maximum distance covered in 6 minutes along the 30m corridor will be measured.The purpose of the 6-minute walking test is to evaluate whether patients respond to the given treatment.
Time frame: before treatment (week 0)
Notthingam activities of daily living scale: It consists of 4 subsections; mobility (6 items), kitchen (5 items), household (5 items) and leisure activities (6 items). Responses to all questions are evaluated.
not done, 0 points; with help, 1 point; done on own with difficulty, 2 points; done easily on own, 3 points. The total scores for each subsection and the sum of the scores for all subsections give the final total Notthingam activities of daily living scale scores ranging from 0 to 66 points.High scores indicate good performance in daily life activities.
Time frame: at the end of treatment (week 3)
Notthingam activities of daily living scale: It consists of 4 subsections; mobility (6 items), kitchen (5 items), household (5 items) and leisure activities (6 items). Responses to all questions are evaluated.
not done, 0 points; with help, 1 point; done on own with difficulty, 2 points; done easily on own, 3 points. The total scores for each subsection and the sum of the scores for all subsections give the final total Notthingam activities of daily living scale scores, ranging from 0 to 66 points.High scores indicate good performance in daily life activities.
Time frame: 9 weeks after treatment (week 12)
Notthingam activities of daily living scale: It consists of 4 subsections; mobility (6 items), kitchen (5 items), household (5 items) and leisure activities (6 items). Responses to all questions are evaluated.
not done, 0 points; with help, 1 point; done on own with difficulty, 2 points; done easily on own, 3 points. The total scores for each subsection and the sum of the scores for all subsections give the final total Notthingam activities of daily living scale scores, ranging from 0 to 66 points.High scores indicate good performance in daily life activities.
Time frame: before treatment (week 0)
Measurement of Balance Parameters on the Biodex Balance Device: In this study, postural stability and fall risk (total score, anteroposterior, mediolateral and overall stability) will be assessed on the Bioedex balance device before treatment (week 0), at the end of treatment (week 3) and 9 weeks after treatment (week 12).
To avoid bias during measurements and surveys, the measurer will be blinded to the participants.
A high score on overall balance indicates poor balance. The overall stability index is believed to be the best indicator of a patient's overall ability to balance the platform. In this study, we evaluated static balance on the Biodex balance device.
Medio-lateral stability index (MLSI), anterior-posterior stability index (APSI), overall stability index (OSI) are standard deviations assessing fluctuations around the zero point from the horizontal rather than around the group mean. Higher values indicate more deviations and poor balance control.
Time frame: at the end of treatment (week 3)
Measurement of Balance Parameters on the Biodex Balance Device: In this study, postural stability and fall risk (total score, anteroposterior, mediolateral and overall stability) will be assessed on the Bioedex balance device before treatment (week 0), at the end of treatment (week 3) and 9 weeks after treatment (week 12).
To avoid bias during measurements and surveys, the measurer will be blinded to the participants.
A high score on overall balance indicates poor balance. The overall stability index is believed to be the best indicator of a patient's overall ability to balance the platform. In this study, we evaluated static balance on the Biodex balance device.
Medio-lateral stability index (MLSI), anterior-posterior stability index (APSI), overall stability index (OSI) are standard deviations assessing fluctuations around the zero point from the horizontal rather than around the group mean. Higher values indicate more deviations and poor balance control.
Time frame: 9 weeks after treatment (week 12)
Measurement of Balance Parameters on the Biodex Balance Device: In this study, postural stability and fall risk (total score, anteroposterior, mediolateral and overall stability) will be assessed on the Bioedex balance device before treatment (week 0), at the end of treatment (week 3) and 9 weeks after treatment (week 12).
To avoid bias during measurements and surveys, the measurer will be blinded to the participants.
A high score on overall balance indicates poor balance. The overall stability index is believed to be the best indicator of a patient's overall ability to balance the platform. In this study, we evaluated static balance on the Biodex balance device.
Medio-lateral stability index (MLSI), anterior-posterior stability index (APSI), overall stability index (OSI) are standard deviations assessing fluctuations around the zero point from the horizontal rather than around the group mean. Higher values indicate more deviations and poor balance control.
Ahi Evran University Education and Research Hospital
Other
Comparison of the Effects of Ultrasound-guided Genicular Nerve Block and Conventional Physical Therapy on Pain, Functionality and Balance in Patients With Knee Osteoarthritis
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