NCT05030402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

1.2 years

First QC Date

June 29, 2021

Last Update Submit

November 24, 2022

Conditions

Keywords

ShoulderMaitlandTendinosis

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Change of American shoulder and elbow Surgeons" (ASES)

    Baseline and 1, 5, and 7 weeks after treatment

  • Change of 36-Item Health Survey (SF-36)

    Baseline and 1, 5, and 7 weeks after treatment

Study Arms (2)

Maitland group

EXPERIMENTAL

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.

Procedure: MaitlandProcedure: Tens, exercise, SW

Control group

ACTIVE COMPARATOR

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.

Procedure: Tens, exercise, SWProcedure: Conventional physiotherapy

Interventions

MaitlandPROCEDURE

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.

Maitland group

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.

Control groupMaitland group

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.

Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Have a shoulder pathology.
  • Have a restriction at least of two ranges of movement of the shoulder.
  • Sign the consent before starting the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GRUPO ICOT PoliclĂ­nico Las Palmas.

Las Palmas de Gran Canaria, Las Palmas, 35006, Spain

Location

Related Publications (5)

  • 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.

    PMID: 29540872BACKGROUND
  • 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.

    PMID: 28035910BACKGROUND
  • 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.

    PMID: 23791561BACKGROUND
  • 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.

    PMID: 17244697BACKGROUND
  • 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.

    PMID: 26284892BACKGROUND

MeSH Terms

Conditions

Tendinopathy

Interventions

Transcutaneous Electric Nerve StimulationExercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Karishma LALWANI MANGTAN

    University of Las Palmas de Gran Canaria (ULPGC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2021

First Posted

September 1, 2021

Study Start

September 3, 2020

Primary Completion

October 31, 2021

Study Completion

October 31, 2022

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations