Effectiveness of Cervicothoracic Manipulative Treatment in Unilateral Shoulder Impingement Syndrome: A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Universidad de Almeria
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Disability Questionnaire Arm, Shoulder and Hand (DASHe)
Study Overview
Brief Summary
The objective of this protocol is to compare degree of improvement can be achieved in patients with shoulder pain by treatment with Manipulative Techniques for the cervicothoracic spine versus home exercises.
Detailed Description
Design: Randomized Clinical Trial. Objective: to determine the effects of manipulative techniques for the ervicothoracic spine versus home exercises on pain, disability, and range of movement in patients with unilateral shoulder inmingement syndrome.
Methods and Measures: ninety-two subjects will be randomly assigned to one of two groups.
Intervention: For 5-weeks, the groups 1 will undergo tratment comprising manipulative protocol techniques for the cervicothoracic spine (2/week) and the group 2 will develop a home exercise (2/week).
Main Outcome Measures: Intensity of pain, disability, and range of motion data will be collected at baseline, and 24hr after the last therapy application. Mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome measure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Report of pain or dysfunction with overhead activities
- •Demonstration of pain during active shoulder movements
- •Demonstration of a positive Neer/Hawkins-Kennedy test
- •Recent onset within the last 12 months
- •Report of non-traumatic onset
- •Demonstration of a painful arc of the arm from 60° to 120° of flexion
- •Report of a baseline pain level of ≥2/10 on an 11 point numeric scale
Exclusion Criteria
- •The presence of any red flags
- •A history of frozen shoulder
- •Disorders of the acromioclavicular joint
- •Degenerative arthritis of the glenohumeral joint
- •Known calcifying tendonitis (if identified by radiograph)
- •Shoulder instability
- •Posttraumatic disorders
- •Shoulder surgery and/or elbow, hand, wrist and blatantly misdiagnosed cervical spine disorders
Arms & Interventions
Exercise Therapy
Home exercises for 30 minutes (2/weeks) with muscle stretching and strengthening the shoulder girdle.
Intervention: Home Exercises (Other)
Manipulative Therapy Techniques
Lift Technique for mid-thoracic spine. Mobilization by low cervical spine on the upper lateral thoracic translation. Technical Dog flexion for high thoracic spine (T1-T4). Technical Dog flexion for mid-thoracic spine (T5-T8). Technical Dog flexed to low thoracic spine (T9-T12). Direct drive technology prone to mid-thoracic spine.
Intervention: Manipulative Therapy Techniques (Other)
Outcomes
Primary Outcomes
Disability Questionnaire Arm, Shoulder and Hand (DASHe)
Time Frame: At baseline and 5 weeks
This questionnaire asks about the symptoms as well as your ability to perform certain activities. This questionnaire has 30 items, and the results are clasified in: no difficulty, mild difficulty, moderate dificulty, severe dificulty and unable
Secondary Outcomes
- Range of Motion(At baseline and 5 weeks)
- Visual Analogue Scale(At baseline and 5 weeks)
- Shoulder Disability Questionnaire(At baseline and 5 weeks)
- Hawkins-Kennedy Test(At baseline and 5 weeks)
- Neer Test.(At baseline and 5 weeks)
Investigators
Adelaida María Castro-Sánchez
PhD (Lecturer)
Universidad de Almeria