Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT02982460
Status:
UNKNOWN
Last Update Posted:
2018-10-12
First Post:
2016-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Isoinertial Training on Rotator Cuff Tendinopathy
Sponsor:
University of Malaga
Organization:
Study Overview
Official Title:
The Effects of Isoinertial Training on Rotator Cuff Tendinopathy. A Randomized Controlled Double-blind Follow-up Trail. A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rotator cuff tendinopathy (RCT) is regarded as a common and burdensome source of shoulder pain with prevalence estimated to be as high as 14% in general working-age population. RCT is a broad entity, including a vast variety of diagnosis such as shoulder impingement syndrome, RC tendinitis/tendinosis, as well as subacromial bursitis. The course of RCT is characterised by persistent pain and/or disability and/or recurrent episodes. It often leads to decrease function, lower health-related quality of life, poor sleep quality, work absenteeism, as well as patient's suffering. Previous studies support exercise as an adequate treatment in RCT. Nevertheless, our knowledge, there is no studies evaluating the effects of isoinertial training in RCT. Therefore, the aim of this study will be to pilot the methods proposed to conduct a substantive study to evaluate the efficacy of isoinertial training plus eccentric training versus eccentric training alone on improving pain and function in RCT. The objectives were to evaluate: (i) The process of recruitment and retention rates; (ii) Willingness of participants to be randomised; (iii) The extent of contamination between groups; (iv) Participant adherence with treatment. The secondary aim will be to analyse the effects of isoinertial training plus eccentric training versus eccentric training alone on rotator cuff strength, scapular muscle activity, and scapular muscle endurance in people with RCT.
Detailed Description:
Study design and setting The design of the present study will be a randomized controlled single-blind trial with 2 follow-ups (one week and one month after intervention) that will be performed between January 2017 and March 2017 in one private physiotherapy clinic in Malaga, Spain. The outcomes will be assessed at baseline (t1), one week after intervention (t2), and one month after intervention (t3). Written informed consent will be acquired for all participants prior to their participation. The study will be implemented and reported in line with the CONSORT statement.
Recruitment Eligible participants who will be interested in the study will be asked to provide written informed consent to participate. Subsequently the patient-reported outcome measures will be completed to establish baseline pain, function, rotator cuff strength, scapular muscle activity, scapular muscle endurance and level of self-efficacy. After completion of the baseline measures, the participants will be randomly allocated to the isoinertial training plus eccentric or eccentric training groups. The measures of pain, function, rotator cuff strength, scapular muscle activity, scapular muscle endurance and self-efficacy will be repeated one week and one month after intervention. Anonymized age and gender will be collected for those participants who decline to take part in the study to assess the external validity of the recruited sample of participants. Participant data files will be stored in numerical order and in a secure and accessible place and manner. Participant files will be maintained in storage for a period of 3 years after completion of the study.
Recruitment Eligible participants who will be interested in the study will be asked to provide written informed consent to participate. Subsequently the patient-reported outcome measures will be completed to establish baseline pain, function, rotator cuff strength, scapular muscle activity, scapular muscle endurance and level of self-efficacy. After completion of the baseline measures, the participants will be randomly allocated to the isoinertial training plus eccentric or eccentric training groups. The measures of pain, function, rotator cuff strength, scapular muscle activity, scapular muscle endurance and self-efficacy will be repeated one week and one month after intervention. Anonymized age and gender will be collected for those participants who decline to take part in the study to assess the external validity of the recruited sample of participants. Participant data files will be stored in numerical order and in a secure and accessible place and manner. Participant files will be maintained in storage for a period of 3 years after completion of the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: