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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05030402
Other study ID # ULPGC02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 3, 2020
Est. completion date October 31, 2022

Study information

Verified date November 2022
Source University of Las Palmas de Gran Canaria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date October 31, 2022
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Maitland
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.
Tens, exercise, SW
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.
Conventional physiotherapy
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.

Locations

Country Name City State
Spain GRUPO ICOT Policlínico Las Palmas. Las Palmas de Gran Canaria Las Palmas

Sponsors (1)

Lead Sponsor Collaborator
University of Las Palmas de Gran Canaria

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Range of Motion (ROM) 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
Primary Change of Visual Analog Scale (VAS) 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
Primary Change of Disabilities of the Arm, Shoulder and Hand (DASH) 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 Change of American shoulder and elbow Surgeons" (ASES) 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
Secondary Change of 36-Item Health Survey (SF-36) 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
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