Acupuncture Treatment of Shoulder Impingement Syndrome: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
The main objective of the current study was to assess the analgesic effect achieved to short- and medium-term by the use of acupuncture on individuals with impingement syndrome of the shoulder, in comparison to the use of acupuncture at sham points. Furthermore, secondary objectives were also sought, such as the short- to medium-term functional recovery of the affected joint, knowing the possible influence that this has over the recovery of the laterality of the subject, as well as the development of a protocol to select points to treat pain affecting the shoulder area.
详细描述
A prospective, controlled, randomized study was carried out. Two parallel, randomly separated groups were monitored. The intervention group received treatment with true acupuncture techniques (TA) on a selection of points described as effective in the literature, and the control group received treatment with acupuncture needles on sham points (SA).
The study was carried out with volunteers, who were informed about its rationale and invited to participate provided they met the following inclusion criteria: they had been diagnosed with the impingement syndrome, with compatible clinical symptoms of more than 3 months of progression; they presented with a unilateral injury; and they had signed their informed consent. Furthermore, the following exclusion criteria were also applied: previous surgery of the injured shoulder; previous luxation or fracture; neurological injuries or illnesses with musculoskeletal disorders.
All the participants who met the selection criteria were invited to an initial consultation to receive information about the study and sign consent. Each participant was randomly assigned to one of the two groups to receive a treatment with: 1) acupuncture at true local and distal points (TA) or 2) acupuncture at sham points (SA).
The random assignment of each participant to one of the two groups of the study was completed when the subjects agreed to participate and signed their consent. Each of them received a code that assigned them to one of the two groups.
The distribution of the participants in each group was also known to the main researcher, having been completed according to a random sequence of codes generated by a random generator program (Numbers®) which produced a list of values (0=acupuncture on sham points (SA); 1=true acupuncture (TA)). Each patient who joined the study received an identification number dictated by the order of their recruitment to the sample, which was matched to the list to include them in one or other of the two groups.
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 (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •they had been diagnosed with the impingement syndrome
- •compatible clinical symptoms of more than 3 months of progression
- •they presented with a unilateral injury
- •they had signed their informed consent.
排除标准
- •previous surgery of the injured shoulder
- •previous luxation or fracture
- •neurological injuries
- •illnesses with musculoskeletal disorders
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Change from baseline in Visual Analogue Scale (VAS) at 3 months after the last session of acupuncture (identified like T2).
A 100 mm long horizontal bar Visual Analogue Scale (VAS), indicating a maximum and a minimum level of pain in every endpoint. This was used without any other data that could give information to the patient, so that it was presented as a horizontal masked bar.
次要结局
- The Questionnaire of Functional Assessment of the Shoulder, University California (UCLA)(Change from baseline in Questionnaire of Functional Assessment of the Shoulder (UCLA Scale) at 3 months after the last session of acupuncture (identified like T2).)
研究者
JUAN CARLOS RUEDA GARRIDO
Medical Director
Rueda, Juan Carlos, M.D., Ph.D.