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This study aims to compare the efficacy of intra-articular injection of Botulinum toxin and hyaluronic acid on pain in knee osteoarthritis.
Osteoarthritis (OA) is a widespread musculoskeletal disease and a leading cause of chronic disability. Conservative estimates state that up to 240 million people worldwide suffer from it. Knee osteoarthritis (KOA) is associated with chronic inflammation that causes persistent oxidative damage, which subsequently leads to joint degeneration.
Therefore, intra-articular (IA) therapies might be an alternative and safe treatment for these patients.
IA injection of hyaluronic acid (HA) is still a controversial treatment for knee osteoarthritis and comparative studies of HA versus more established treatments are warranted.
Botulinum toxin (BTX), produced by the bacterium Clostridium botulinum, acts on both sensory and motor neurons. Irreversible binding of BTX to presynaptic receptors of motor endplates inhibits acetylcholine release.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group HA | Experimental | Patients will be given intra-articular injection of 2 ml of hyaluronic acid into the joint space three times weekly. |
|
| Group BTX | Experimental | Patients will be given intra-articular injection of 100 units of Botulinum toxin type A, diluted with 5 ml of normal saline three times weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid | Drug | Patients will be given intra-articular injection of 2 ml of hyaluronic acid into the joint space three times weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of pain | Each patient will be instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). | 3 months after the interventions |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of quality of life | The Short form (SF)-36 generic quality of life questionnaire, which is composed of eight domains: functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects, and mental health. | 3 months after the interventions |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed S ElSharkawy, MD | Contact | 00201148207870 | mselsharkawy@med.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Recruiting | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D001905 | Botulinum Toxins |
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| Botulinum toxin type A | Drug | Patients will be given intra-articular injection of 100 units of Botulinum toxin type A, diluted with 5 ml of normal saline three times weekly. |
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) which is a specific functional questionnaire that assesses pain (5 subitems), stiffness (2 items), and function (17 items). |
| 3 months after the interventions |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is self-administered and assesses five outcomes, Pain (nine items); Symptoms (seven items); Activities of Daily Living Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. | 3 months after the interventions |
| D012216 |
| Rheumatic Diseases |
| D008666 |
| Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |