Efficacy of Oral Hyaluronic Acid and Collagen Supplementation Compared With Hyaluronic Acid Infiltration Treatment in Rotator Cuff Tendinopathies: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Numeric rating scale (NRS)
研究概览
简要总结
The present study aims to investigate the effectiveness of oral supplementation with a nutraceutical containing Collagen, Hyaluronic Acid, Vitamin C, and Manganese in functional outcome and pain reduction in cases of shoulder rotator cuff tendinopathy compared to a cycle of intra-articular hyaluronic acid injections.
The project involves the recruitment of 50 adult individuals presenting with shoulder pain and instrumental evidence of rotator cuff tendinopathy. All participants will receive one intra-articular injection of 1 ml of triamcinolone acetonide 40 mg. After the injection, participants will be divided into two groups according to Good Clinical Practice guidelines. One group will begin taking one vial per day for 56 days of an oral supplement containing Hyaluronic Acid, Collagen, Vitamin C, and Manganese (HA-COL) (Tendogenial®, B2Pharma) starting from the day following enrollment (Group 1). The other group will undergo a cycle of 3 intra-articular injections with hyaluronic acid (HA) (Hyalotend®, Fidia) (Group 2).
The hypothesis is that oral supplementation with HA-COL may have the same efficacy as intra-articular hyaluronic acid treatment in reducing pain and improving shoulder functionality.
Functional assessments will be conducted by a clinician unaware of the participants' group assignment. The following assessment scales will be used:
Numeric Rating Scale (NRS) for pain (from 0 to 10), evaluating 3 aspects of pain: 1) pain at rest, 2) nocturnal pain, 3) pain during movement.
Shoulder Disability Questionnaire (SDQ) for functionality.
Assessments will be conducted at the following time points:
T0) Before the administration of corticosteroid intra-articular injection (baseline).
T1) Seven days after the start of HA-COL intake for Group 1 and before the first intra-articular HA injection for Group 2 (T1, seven days from T0).
T2) At mid-cycle of oral HA-COL supplementation for Group 1 (28 days of intake) and seven days after the last HA injection for Group 2 (T2, 21 days from T1).
T3) Follow-up at 28 days from T2, at the end of the 56-day oral treatment cycle for Group 1, and 28 days after the last injection for Group 2 (T3, 56 days from T0).
详细描述
Background Shoulder pain is a prevalent symptom primarily affecting the adult population, with an incidence of approximately 19 per 1000 and a prevalence ranging from 7 to 26%, particularly affecting women. The primary cause of shoulder pain is rotator cuff pathology, characterized by nocturnal pain and weakness, especially during external rotation and elevation movements of the shoulder, attributable to excessive loading on the cuff tissues. These symptoms often result in disability and functional impairment.
The etiology of rotator cuff pathology appears multifactorial, often associated with chronic age-related degeneration characterized by a reduced ability to synthesize collagen, increased levels of free radicals, and heightened catabolic activity (5). Tendinopathies exhibit widespread structural changes, including increased apoptosis of tenocytes, collagen fiber disintegration leading to a decrease in collagen type I, an increase in collagen type III resulting in a reversal of the collagen I/III ratio, and ineffective neoangiogenesis.
As tendinopathy primarily represents a degenerative condition where the inflammatory component plays a minor role, current therapeutic strategies mainly focus on regenerative approaches. While intra-articular cortisone therapy has historically been utilized to alleviate pain from rotator cuff injuries, its potential detrimental effect on tendon collagen limits its long-term efficacy, rendering cortisone therapy beneficial only in the short term.
Conversely, intra-articular treatment with hyaluronic acid (HA) for rotator cuff injuries appears promising in reducing pain and improving shoulder function. A recent review analyzed 11 studies encompassing a total of 1102 patients. Low to medium molecular weight hyaluronic acids were utilized in these studies, with infiltration performed either via anatomical landmarks or ultrasound guidance, targeting either intra-articular or subacromial sites. Moreover, rare minor side effects (such as pain at the injection site or slight vagal effects) were reported, with no instances of allergic reactions.
Hyaluronic acid (HA) is a carbohydrate, specifically a mucopolysaccharide, naturally present in all living organisms. When unbound to other molecules, it binds to water, imparting a rigid viscous 'jelly-like' quality. HA serves as an integral component of synovial fluid, crucial for joint chondroprotection, and constitutes a significant portion of the tendon extracellular matrix.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Both study groups will undergo assessment using pain and functional scales by a clinician who is blinded to the treatment group
入排标准
- 年龄范围
- 30 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent shoulder pain lasting for at least 2 months unresponsive to conservative treatment (nonsteroidal anti-inflammatory drugs [NSAIDs] and rehabilitation)
- •Ultrasound or MRI evidence of a rotator cuff lesion without complete tendon rupture
- •Limited active range of motion (ROM) in the shoulder
排除标准
- •Traumatic shoulder injury as the cause of pain
- •History of shoulder dislocation, fracture, or previous shoulder surgery
- •Presence of signs indicating ligamentous instability
- •Severe shoulder arthrosis, adhesive capsulitis, or calcific tendinitis
- •Previous infiltrative treatment with corticosteroids, hyaluronic acid, or collagen within the past 6 months
- •Diagnosis of rheumatic or neoplastic diseases
- •Ongoing therapy with anticoagulants
- •Cervical radiculopathy
- •Pregnancy
- •History of heart, kidney, or liver failure
- •Cognitive impairment
研究组 & 干预措施
Oral supplemention
Assumption of 1 vial/day starting from the day after enrollment for 56 days. This supplement contains Collagen, Hyaluronic Acid, Vitamin C, and Manganese.
干预措施: Collagen, Hyaluronic Acid, Vitamin C, and Manganese (Dietary Supplement)
Intra-articolar infiltration
Intra-articular injections of a viscous solution of sodium salt hyaluronic acid (500-730 kDa) in pre-filled 20 mg/2 ml syringes, 1/week for 3 weeks.
干预措施: Intra-articular infiltration (Drug)
结局指标
主要结局
Numeric rating scale (NRS)
时间窗: 1) (T0 - baseline). 2) Before the first administration of intra-articular HA for Group 2 and at seven days from the initiation of HA-COL for Group 1 (T1, seven days from T0). 3) At seven days fo
Change from baseline NRS at 1 weeks and at 4 weeks and at 8 weeks. NRS is a 10-point scale grading the pain at rest, during movement and during night-time
次要结局
- Shoulder Disability Questionnaire (SDQ) for shoulder functionality(1) (T0 - baseline). 2) Before the first administration of intra-articular HA for Group 2 and at seven days from the initiation of HA-COL for Group 1 (T1, seven days from T0). 3) At seven days fo)
研究者
Stefano Brunelli
Principal Investigator, MD
I.R.C.C.S. Fondazione Santa Lucia
