The Effects of the Inclusion of Mobilisation With Movement to an Exercise Programme in Patients With Rotator Cuff Related Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Shoulder Pain Disability Index (SPADI).
研究概览
简要总结
Rotator cuff related pain is considered the main source of musculoskeletal shoulder pain that affects function and produces pain on movement. Amongst the existing physiotherapeutic management approaches, exercise therapy has been recognized as the first line approach. The use of manual therapy in the management of this condition has been debated and studies have shown contradictory results. A specific manual therapy approach, mobilisation with movement (MWM), seems promising in this population as it aims to improve pain-free range of motion and includes active engagement of the participant.
详细描述
Rotator cuff related pain is a term that includes a diversity of shoulder conditions known as: subacromial impingement syndrome, rotator cuff tendinitis/tendinopathy, rotator cuff tear, bursitis. The use of a broader term is useful as the diagnostic accuracy of special orthopaedic tests have been widely criticised and are unable to identify pathognomonic sources of symptoms in people presenting with shoulder pain. Additionally, even though diagnostic imaging is capable of identifying pathology in patients with rotator cuff related pain, studies demonstrate that their correlation with clinical presentation is questionable.
Shoulder pain is one of the most common sources of musculoskeletal pain that might affect up to 20% of the population. Additional important epidemiological data concerning shoulder pain is the fact that approximately 40% of people complaining of shoulder pain will still be symptomatic after six months. Physiotherapy has an important role in the management of rotator cuff related pain and exercise is the main therapeutic approach when considering pain and functional restriction,
Mobilisation with movement (MWM) is one alternative musculoskeletal approach that focuses on improving active pain-free range of motion. This concept of treatment incorporates a passive accessory glide produced by the clinician, followed by an active movement executed by the patient. Different studies have suggested positive effects of MWM in patients complaining of shoulder pain. On the other hand, other studies reported no superior effects when using MWM in their studies. Several methodological aspects might have influenced this discrepancy in results, such as population, dosage and type of MWM utilized, follow-up period and outcome measures. Due to this uncertainty, the current research aims to further explore the inclusion of MWM to an exercise programme in patients with rotator cuff related pain.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Blinding of participants: participants will be unaware about the specificities of the group allocation. The inclusion of a sham mobilisation with movement (MWM) procedure has the aim to mask the manual therapy procedure. For a naive participant, it is unlikely that he/she might be able to discern the real MWM from the sham MWM. In addition, participants will be requested to avoid discussing the interventions received with the outcome assessor.
A scale ranging from "treatment under investigation" to "I don´t know" will be used to assess blinding of participants.
Blinding of outcome assessor: this research assistant will only be responsible for conducting the outcome assessments. He/she will be unaware of group allocation and will also be requested not to discuss any specifics about the treatment programmes with the participants
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral shoulder pain of atraumatic origin.
- •Complaining of shoulder pain for at least six weeks.
- •Scoring at least 3 out 10 on a numeric pain rating scale (0- no pain; 10- worst pain imaginable).
- •Pain on active shoulder movement
- •Pain provoked by at least three of the following tests: Hawkins-Kennedy, Neer, painful arc, resisted external rotation, empty or full can.
- •Participants referred by a specialist under the diagnosis of subacromial impingement syndrome, rotator cuff tendinopathy, partial rotator cuff tears, subacromial pain, bursitis.
排除标准
- •Shoulder pain following a traumatic event.
- •History compatible with complete rotator cuff and biceps rupture.
- •Adhesive capsulitis.
- •History of dislocation.
- •Glenohumeral osteoarthritis.
- •Systemic, local or self-immune inflammatory conditions.
- •Previous shoulder or neck surgery.
- •Familiar pain provoked by neck movements.
- •Presence of radicular signs.
- •Use of corticosteroids over the past six months.
- •Diagnosis of fibromyalgia.
- •Participants with clinical depression
- •Participants under treatment for her/his shoulder condition.
结局指标
主要结局
Shoulder Pain Disability Index (SPADI).
时间窗: Changes from baseline and study completion (5 weeks) and 4 weeks follow-up.
SPADI is a self-reported questionnaire that contains thirteen different items. There are two domains: pain (5 items) and functional activity (8 items). Each item ranges from 0 (no pain / no difficulty) to 10 (worst imaginable pain / so difficult that requires help).
Visual Analogue Scale (VAS) for pain.
时间窗: Changes from baseline and study completion (5 weeks) and 4 weeks follow-up.
VAS for pain, is a scale that measures pain level. The scale ranges from 0 (no pain) to 10 (worst imaginable pain).
次要结局
- Pain pressure threshold(Changes from baseline and study completion (5 weeks).)
- Global rating scale of change (GROC)(Through study completion and 4 weeks follow-up.)
- Active pain-free range of motion.(Changes from baseline and study completion (5 weeks).)
- Expectations of physiotherapy(Change at 3 weeks of treatment from baseline)
研究者
Rafael Baeske
Principal investigator
Federal University of Health Science of Porto Alegre