- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05030402
Efficacy of Maitland Mobilization in Shoulder Pathology
November 24, 2022 updated by: Karishma Chuhermal Lalwani Mangtani, University of Las Palmas de Gran Canaria
Effec of Maitland in Shoulder Pathology
The shoulder is a mobile structure which generates a lot of pathologies.
One of them is rotator cuff tendinosis.
On the other hand, it has been investigated that Maitland is effective for reducing pain and for mobility in the cervical and lumbar spine and in joints such as the knee and ankle, however, there are few studies that confirm that it is effective in shoulder pathologies.So here the investigatprs want to study the effectiveness of Maitland as an adjunctive treatment for shoulder pathologies, comparing it with conventional physiotherapy treatment, in relation to the reduction of pain and increased mobility.
For that the investigators have a randomized clinical trial with two group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Group 1 receives tens, SW, conventional physiotherapy and exercises as treatment.
Group 2 receives tens, SW, Mailtland, and exercises.
An assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment.
The EVA ASES, DASH and SF-36 scales are included and the biomechanics study is used for the range of mobility.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Las Palmas
-
Las Palmas de Gran Canaria, Las Palmas, Spain, 35006
- GRUPO ICOT Policlínico Las Palmas.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a shoulder pathology.
- Have a restriction at least of two ranges of movement of the shoulder.
- Sign the consent before starting the study.
Exclusion Criteria:
- Patients with a history of shoulder or neck surgery.
- Patients with neurological damage such as stroke or disease of Parkinson's, as well as those with rheumatism, osteoporosis, surgical fixation, or malignant tumors.
- Have a radiating pain in shoulder from a cervical injury.
- Pregnant patients.
- Patients who do not sign the consent before starting the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Maitland group
31 patients receives tens, SW, Maitland, and exercises.
An assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment.
The EVA ASES, DASH and SF-36 scales are included and the biomechanics study is used for the range of mobility.
|
An assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment.
The EVA ASES, DASH and SF-36 scales are included and the biomechanics study is used for the range of mobility.
An assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment.
The EVA ASES, DASH and SF-36 scales are included and the biomechanics study is used for the range of mobility.
|
|
Active Comparator: Control group
32 receives tens, SW, conventional physiotherapy and exercises as treatment.
An assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment.
The EVA ASES, DASH and SF-36 scales are included and the biomechanics study is used for the range of mobility.
|
An assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment.
The EVA ASES, DASH and SF-36 scales are included and the biomechanics study is used for the range of mobility.
An assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment.
The EVA ASES, DASH and SF-36 scales are included and the biomechanics study is used for the range of mobility.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Range of Motion (ROM)
Time Frame: Baseline and 1, 5, and 7 weeks after treatment
|
Active ROM of the affected shoulder is measured using a Mechanic Analysis to assess range of motion.
These measurements included abduction, flexion, internal rotation, and external rotation.
|
Baseline and 1, 5, and 7 weeks after treatment
|
|
Change of Visual Analog Scale (VAS)
Time Frame: Baseline and 1, 5, and 7 weeks after treatment
|
Visual analogue score (VAS) was done at rest and at shoulder movement.
VAS was explained to the patients during assessment as 0 equal no pain and 10 equal worst imaginable pain.
|
Baseline and 1, 5, and 7 weeks after treatment
|
|
Change of Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame: Baseline and 1, 5, and 7 weeks after treatment
|
Disabilities of the Arm, Shoulder and Hand (DASH) was filled by patient during assessment as 0 equal better functionality and 100 equal worst functionality
|
Baseline and 1, 5, and 7 weeks after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of American shoulder and elbow Surgeons" (ASES)
Time Frame: Baseline and 1, 5, and 7 weeks after treatment
|
Disabilities of the Arm, Shoulder and Hand (DASH) was filled by patient during assessment as 0 equal worst functionality and 100 is equal better functionality
|
Baseline and 1, 5, and 7 weeks after treatment
|
|
Change of 36-Item Health Survey (SF-36)
Time Frame: Baseline and 1, 5, and 7 weeks after treatment
|
Health Survey (SF-36) was filled by patient during assessment as 0 equal worst health and 100 is equal better health
|
Baseline and 1, 5, and 7 weeks after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Karishma LALWANI MANGTAN, University of Las Palmas de Gran Canaria (ULPGC)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Noten S, Meeus M, Stassijns G, Van Glabbeek F, Verborgt O, Struyf F. Efficacy of Different Types of Mobilization Techniques in Patients With Primary Adhesive Capsulitis of the Shoulder: A Systematic Review. Arch Phys Med Rehabil. 2016 May;97(5):815-25. doi: 10.1016/j.apmr.2015.07.025. Epub 2015 Aug 15.
- 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.
- Haider R, Bashir MS, Adeel M, Ijaz MJ, Ayub A. Comparison of conservative exercise therapy with and without Maitland Thoracic Manipulative therapy in patients with subacromial pain: Clinical trial. J Pak Med Assoc. 2018 Mar;68(3):381-387.
- Hauswirth J, Ernst MJ, Preusser ML, Meichtry A, Kool J, Crawford RJ. Immediate effects of cervical unilateral anterior-posterior mobilisation on shoulder pain and impairment in post-operative arthroscopy patients. J Back Musculoskelet Rehabil. 2017;30(3):615-623. doi: 10.3233/BMR-160566.
- Carlson M, Hadlock T. Physical therapist management following rotator cuff repair for a patient with postpolio syndrome. Phys Ther. 2007 Feb;87(2):179-92. doi: 10.2522/ptj.20050200. Epub 2007 Jan 23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 3, 2020
Primary Completion (Actual)
October 31, 2021
Study Completion (Actual)
October 31, 2022
Study Registration Dates
First Submitted
June 29, 2021
First Submitted That Met QC Criteria
August 31, 2021
First Posted (Actual)
September 1, 2021
Study Record Updates
Last Update Posted (Actual)
November 30, 2022
Last Update Submitted That Met QC Criteria
November 24, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULPGC02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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