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Efficacy of Maitland Mobilization in Shoulder Pathology

Primary Purpose

Tendinosis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Maitland
Tens, exercise, SW
Conventional physiotherapy
Sponsored by
University of Las Palmas de Gran Canaria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinosis focused on measuring Shoulder, Maitland, Tendinosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GRUPO ICOT Policlínico Las Palmas.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Maitland group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

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
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

Full Information

First Posted
June 29, 2021
Last Updated
November 24, 2022
Sponsor
University of Las Palmas de Gran Canaria
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1. Study Identification

Unique Protocol Identification Number
NCT05030402
Brief Title
Efficacy of Maitland Mobilization in Shoulder Pathology
Official Title
Effec of Maitland in Shoulder Pathology
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Las Palmas de Gran Canaria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinosis
Keywords
Shoulder, Maitland, Tendinosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maitland group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Maitland
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Tens, exercise, SW
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Range of Motion (ROM)
Description
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.
Time Frame
Baseline and 1, 5, and 7 weeks after treatment
Title
Change of Visual Analog Scale (VAS)
Description
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.
Time Frame
Baseline and 1, 5, and 7 weeks after treatment
Title
Change of Disabilities of the Arm, Shoulder and Hand (DASH)
Description
Disabilities of the Arm, Shoulder and Hand (DASH) was filled by patient during assessment as 0 equal better functionality and 100 equal worst functionality
Time Frame
Baseline and 1, 5, and 7 weeks after treatment
Secondary Outcome Measure Information:
Title
Change of American shoulder and elbow Surgeons" (ASES)
Description
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
Time Frame
Baseline and 1, 5, and 7 weeks after treatment
Title
Change of 36-Item Health Survey (SF-36)
Description
Health Survey (SF-36) was filled by patient during assessment as 0 equal worst health and 100 is equal better health
Time Frame
Baseline and 1, 5, and 7 weeks after treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karishma LALWANI MANGTAN
Organizational Affiliation
University of Las Palmas de Gran Canaria (ULPGC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
GRUPO ICOT Policlínico Las Palmas.
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35006
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
29540872
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.
Results Reference
background
PubMed Identifier
28035910
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.
Results Reference
background
PubMed Identifier
23791561
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.
Results Reference
background
PubMed Identifier
17244697
Citation
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.
Results Reference
background
PubMed Identifier
26284892
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.
Results Reference
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Efficacy of Maitland Mobilization in Shoulder Pathology

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