TendinosisNCT05030402
Efficacy of Maitland Mobilization in Shoulder Pathology
A study testing Maitland, Tens, exercise, SW and Conventional physiotherapy in people with Tendinosis, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tendinosis
- What is being tested?
- Maitland, Tens, exercise, SW and Conventional physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSpain
- Study dates
- 3 Sep 2020to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a shoulder pathology.
- Have a restriction at least of two ranges of movement of the shoulder.
- Sign the consent before starting the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
GRUPO ICOT Policlínico Las Palmas.
Las Palmas de Gran Canaria, Las Palmas, 35006
About this study
Official title: 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.
Read the 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.
- Conditions
- Tendinosis
- Being tested
- Maitland, Tens, exercise, SW, Conventional physiotherapy
- Keywords
- Shoulder, Maitland, Tendinosis
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaitlandProcedure or surgery
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, SWProcedure or surgery
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 physiotherapyProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Maitland; Procedure: 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. Receives: Procedure: Tens, exercise, SW; Procedure: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Baseline and 1, 5, and 7 weeks after treatment
Secondary outcomes (2)
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
Measured: Baseline and 1, 5, and 7 weeks after treatment
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
Measured: Baseline and 1, 5, and 7 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start3 Sep 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TendinosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Las Palmas de Gran Canaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karishma Chuhermal Lalwani Mangtani, University of Las Palmas de Gran Canaria
- Investigators
- Karishma LALWANI MANGTAN, Principal investigator, University of Las Palmas de Gran Canaria (ULPGC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030402
- Sponsor's protocol ID
- ULPGC02
- Status last verified
- Nov 2022
- First submitted
- 29 Jun 2021
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29540872Hauswirth 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.
PubMed 28035910Cook 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.
PubMed 23791561Carlson 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.
PubMed 17244697Noten 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.
PubMed 26284892
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effec of Maitland in Shoulder Pathology
- ClinicalTrials.gov ID
- NCT05030402
- Acronym / sponsor ID
- ULPGC02
- Conditions
- Tendinosis
- Keywords
- Shoulder, Maitland, Tendinosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of Las Palmas de Gran CanariaUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maitland group | Experimental | Procedure: Maitland, Procedure: Tens, exercise, SW31 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. |
| Control group | Active comparator | Procedure: Tens, exercise, SW, Procedure: Conventional physiotherapy32 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Have a shoulder pathology.
- Have a restriction at least of two ranges of movement of the shoulder.
- Sign the consent before starting the study.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaitlandAn 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 or surgery | Maitland group |
| Tens, exercise, SWAn 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 or surgery | Control group, Maitland group |
| Conventional physiotherapyAn 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 or surgery | Control group |
Primary outcome
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.
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.
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
2 secondary outcomes
Change of American shoulder and elbow Surgeons" (ASES)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Background: PubMed 29540872Haider 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.
- Background: PubMed 28035910Hauswirth 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.
- Background: PubMed 23791561Cook 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.
- Background: PubMed 17244697Carlson 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.
- Background: PubMed 26284892Noten 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karishma LALWANI MANGTAN principal investigator
University of Las Palmas de Gran Canaria (ULPGC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maitland, Tens, exercise, SW and Conventional physiotherapy in people with Tendinosis, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Range of Motion (ROM) (time frame: Baseline and 1, 5, and 7 weeks after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05030402, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.