Effectiveness of Cervicothoracic Manipulative Treatment in Unilateral Shoulder Impingement Syndrome: A Randomized Controlled Trial.
NCT ID: NCT02214199
Last Updated: 2016-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
92 participants
INTERVENTIONAL
2014-08-31
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Manual Therapy and Exercise vs Exercise in Subjects With Chronic Cervical Pain and Upper Cervical Spine Dysfunction
NCT03670719
Comparison of Two Spinal Manipulation Treatments in Patients With Chronic Mechanical Neck Pain
NCT04268667
Immediate Effects of Manipulation Versus Stretching on Upper Trapezius Pressure Pain Thresholds
NCT02081430
Manual Therapy Versus Manual Therapy and Exercise and Education in Chronic Neck Pain
NCT02033460
Effects of a Single Manual Therapy-Exercise Versus Exercise Session in Patients With Chronic Neck Pain
NCT05085600
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exercise Therapy
Home exercises for 30 minutes (2/weeks) with muscle stretching and strengthening the shoulder girdle.
Home Exercises
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.
Manipulative Therapy Techniques
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Manipulative Therapy Techniques
Home Exercises
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
* 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
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Andaluz Health Service
OTHER_GOV
Universidad de Almeria
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Adelaida María Castro-Sánchez
PhD (Lecturer)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universidad de Almeria
Almería, Almería, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rhon DI, Boyles RB, Cleland JA. One-year outcome of subacromial corticosteroid injection compared with manual physical therapy for the management of the unilateral shoulder impingement syndrome: a pragmatic randomized trial. Ann Intern Med. 2014 Aug 5;161(3):161-9. doi: 10.7326/M13-2199.
Cook C, Learman K, Houghton S, Showalter C, O'Halloran B. The addition of cervical unilateral posterior-anterior mobilisation in the treatment of patients with shoulder impingement syndrome: a randomised clinical trial. Man Ther. 2014 Feb;19(1):18-24. doi: 10.1016/j.math.2013.05.007. Epub 2013 Jun 20.
Alburquerque-Sendin F, Camargo PR, Vieira A, Salvini TF. Bilateral myofascial trigger points and pressure pain thresholds in the shoulder muscles in patients with unilateral shoulder impingement syndrome: a blinded, controlled study. Clin J Pain. 2013 Jun;29(6):478-86. doi: 10.1097/AJP.0b013e3182652d65.
Maenhout AG, Mahieu NN, De Muynck M, De Wilde LF, Cools AM. Does adding heavy load eccentric training to rehabilitation of patients with unilateral subacromial impingement result in better outcome? A randomized, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1158-67. doi: 10.1007/s00167-012-2012-8. Epub 2012 May 12.
Camargo PR, Avila MA, Alburquerque-Sendin F, Asso NA, Hashimoto LH, Salvini TF. Eccentric training for shoulder abductors improves pain, function and isokinetic performance in subjects with shoulder impingement syndrome: a case series. Rev Bras Fisioter. 2012 Jan-Feb;16(1):74-83. doi: 10.1590/s1413-35552012000100013.
Hidalgo-Lozano A, Fernandez-de-las-Penas C, Diaz-Rodriguez L, Gonzalez-Iglesias J, Palacios-Cena D, Arroyo-Morales M. Changes in pain and pressure pain sensitivity after manual treatment of active trigger points in patients with unilateral shoulder impingement: a case series. J Bodyw Mov Ther. 2011 Oct;15(4):399-404. doi: 10.1016/j.jbmt.2010.12.003. Epub 2011 Jan 17.
Gwilym SE, Oag HC, Tracey I, Carr AJ. Evidence that central sensitisation is present in patients with shoulder impingement syndrome and influences the outcome after surgery. J Bone Joint Surg Br. 2011 Apr;93(4):498-502. doi: 10.1302/0301-620X.93B4.25054.
Koike Y, Sano H, Kinjyo T, Imamura I, Masahiro O, Goto M, Ooyama M, Kita A, Itoi E. Shoulder surface temperature and bone scintigraphy findings in patients with rotator cuff tears. Ups J Med Sci. 2011 May;116(2):142-7. doi: 10.3109/03009734.2010.545150. Epub 2011 Feb 16.
Hidalgo-Lozano A, Fernandez-de-las-Penas C, Alonso-Blanco C, Ge HY, Arendt-Nielsen L, Arroyo-Morales M. Muscle trigger points and pressure pain hyperalgesia in the shoulder muscles in patients with unilateral shoulder impingement: a blinded, controlled study. Exp Brain Res. 2010 May;202(4):915-25. doi: 10.1007/s00221-010-2196-4. Epub 2010 Feb 26.
Osteras H, Torstensen TA. The dose-response effect of medical exercise therapy on impairment in patients with unilateral longstanding subacromial pain. Open Orthop J. 2010 Jan 5;4:1-6. doi: 10.2174/1874325001004010001.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21/2013
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.