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Effectiveness of Cervicothoracic Manipulative Treatment in Unilateral Shoulder Impingement Syndrome: A Randomized Controlled Trial.

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02214199
Enrollment
92
Registered
2014-08-12
Start date
2014-08-31
Completion date
2015-12-31
Last updated
2016-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercises Therapy, Manual Theapy, Shoulder Pain

Keywords

Shoulder Pain, Shoulder Impingement Syndrome, Exercise therapy, Randomized Controlled Trial

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.

Interventions

OTHERHome Exercises

Sponsors

Andaluz Health Service
CollaboratorOTHER_GOV
Universidad de Almeria
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

1. Report of pain or dysfunction with overhead activities 2. Demonstration of pain during active shoulder movements 3. Demonstration of a positive Neer/Hawkins-Kennedy test 4. Recent onset within the last 12 months 5. Report of non-traumatic onset 6. Demonstration of a painful arc of the arm from 60° to 120° of flexion 7. 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

Design outcomes

Primary

MeasureTime frameDescription
Disability Questionnaire Arm, Shoulder and Hand (DASHe)At baseline and 5 weeksThis 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

MeasureTime frameDescription
Shoulder Disability QuestionnaireAt baseline and 5 weeksShoulder Disability Questionnaire is a mesure covering 16 items designed to evaluate functional status limitation in patients with shoulder disorders.
Hawkins-Kennedy TestAt baseline and 5 weeksThe Hawkins and Kennedy test was interpreted as indicative of impingement between the greater tuberosity of the humerus against the coraco- humeral ligament, trapping all those structures which intervene. It has been reported as less reliable than the Neer impingement test.
Neer Test.At baseline and 5 weeksNeer's Test assesses for possible rotator cuff impingement. Stabilize the scapula and with the thumb pointing down and passively flex the arm. Pain is a positive test.
Range of MotionAt baseline and 5 weeksThe range of motion will be evaluated in flexion, extension, rotation, adduction, and abduction.
Visual Analogue ScaleAt baseline and 5 weeksA 10-point numerical pain scale (0:no pain, 10: maximum pain) assesses the intensity of pain.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026