Painful arc and cuff impingement The most typical feature presented by patients with shoulder disorders (SD) is pain in their shoulder when they move their arm. In a very large majority of patients this pain takes the form of a painful arc: pain during a specific range (usually between 90° and 150°) of shoulder abduction, which prevents them to raise their hand above shoulder level. Such a painful arc is believed to originate from cuff impingement. The painful arc is supposed to be caused by a
Conditions
Interventions
Patients are randomized into three groups:
A. Patients receive a subacromial injection with a mixture of lidocaine (8 ml) and 2 ml hyaluronic acid (Ostenil) by a specially trained physician
B. The same with a mixture of 8 ml lidocaine with Triamcinoloni acetonidum 10 mg/ml (2 ml)
C. Patients receiving 8 ml lidocaine with 2 ml saline (control group)
Injections can be repeated after 3 and 6 weeks. No co interventions are allowed up to 12 weeks. Self-pain medication with paracet
Sponsors
Academisch ziekenhuis Maastricht
The Research Institute Caphri of the University Maastricht
Eligibility
Inclusion criteria
Inclusion criteria: Eligible are patients of 18 years of age and older, who consult a physician for pain in the shoulder either at rest or elicited or provoked during movement of the shoulder. They must have a painful arc, with or without a disturbed scapulohumeral movement. The diagnosis is subacromial impingement syndrome.
Exclusion criteria
Exclusion criteria: Pain lasting less than 6 weeks; prior injection with corticosteroids last 3 months, less than 100 degrees range of ante flexion; more than 50% restriction of external glenohumeral rotation (compared to the non-affected side); steroid or lidocaine allergy; pregnancy or supposed pregnancy; dementia; (prior) purulent infection of the shoulder joints; tumor, osteoporosis, rheumatoid arthritis (ACR criteria), referred pain from internal organs, or a cervical radicular syndrome as suspected or definite cause for SD; stroke, polyneuropathy, multiple sclerosis, polymyalgia, ankylosing spondylitis (modified NY criteria) as suspected or definite cause for SD; Whiplash, prior fractures or surgery of the shoulder, upper limb, neck or thorax; currently receiving (or needing) treatment for serious behavioral, cognitive or psychiatric disorders. Finally, patients who are not able to complete Dutch questionnaires independently and those who are reluctant to adhere to (allocated) treatments or to complete follow-up will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 3 - 6 - 12 - 26 weeks after the inclusion. The primary clinical outcome measure will be patient perceived recovery measured with a Visual Analogue Scale (VAS) expressed as the proportion of patients indicating very large improvement (including full recovery). The Visual Analogue Scale is a line of 10 cm in length, which is taken to represent the continuum of experienced pain. It has been proved to be a simple, sensitive and reproducible instrument that enables the patient to express the pain in such a way that it can be given a numerical value. (Huskisson, 1983) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Presence of painful arc; 2. Range of motion; 3. The Constant shoulder Score; 4. Patient Specific Disability; 5. Shoulder Disability Questionnaire; 6. Shoulder Pain Score; and 7. Functional Mobility Test. The Constant Shoulder Score is a validated assessment system in which subjective as well as objective assessment takes place in a ratio of 35:65 %. The system is divided into subjective measures for pain and daily activities and objective measures for range of motion and power. The assessment system is designed to provide a full functional assessment applicable to different shoulder conditions. The score is calculated by adding the maximum scores of the individual parameters with a maximum of 100 points. (Constant 1987, 1991, MacDonald 1993) The Patient Specific Disability instrument measures the functional status of the individual patient. For this measurement the patient has to select 3 – 5 complaints in the field of physical activity. The complaints have to be relevant for the individual patient limit the patient in daily or weekly activities. For assessment of these activities a VAS is used. The score is calculated by adding the distance as measured in millimeters of the 3 Visual Analogue Scales (Beurskens, Köke, de Vet 1996) The Shoulder Disability Questionnaire is a functional status questionnaire for pain and / or limitation of movement in the shoulder area. The past 24 hours are assessed through 16 questions that can be answered with either, yes, no or not applicable. Score is calculated by multiplying the ratio yes : no by 100%. (van der Heijden GJ, Leffers P, Bouter LM 2000) The Shoulder Pain Score consists of 6 pain symptom questions and an 101 Numerical Rating Scale (NRS 101) in order tot assess pain experienced by patients with shoulder pain. The score has been proved tot be useful for following the course of the disorder over time and giving an indication when the patient is cured. The score is calculated by adding the score of the | — |
Contacts
Public ContactLudo I.F. Penning
University Hospital Maastricht, Department Orthopedic Surgery, P.O. Box 5800
Outcome results
None listed