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Comparison of the Effectiveness Heavy Slow Resistance and Eccentric Training in Rotator Cuff Tendinopathy

Primary Purpose

Rotator Cuff Tendinopathy, Subacromial Impingement Syndrome, Bicep Tendinitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Heavy slow resistance training
Eccentric exercise training
Sponsored by
Mustafa Kemal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tendinopathy focused on measuring Exercise therapy, Rehabilitation, Resistance training, Shoulder pain, Subacromial impingement syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Describing subacromial pain Rotator cuff tendinopathy (subacromial impingement syndrome, biceps tendinitis and rotator cuff I. and II. stage diagnosis) Continuation of diagnostic symptoms for at least 30 days Exclusion Criteria: Prior shoulder surgery Sign of cervical radiculopathy Shoulder instability or history of upper extremity fracture Full-thickness rotator cuff tear Adhesive capsulitis Humeroscapular periarthritis (osteoarthritis, inflammatory arthropathies, etc.) Neoplasm/malignant status Other independent from shoulder problem being on regular analgesic therapy for ongoing painful conditions Subacromial corticosteroids in the last 2 months having received an injection or participating in a shoulder rehabilitation program

Sites / Locations

  • Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Heavy slow resistance group (HSR group)

Eccentric exercise training group (EE group)

Arm Description

The investigators are planning a 6-week rehabilitation program, 2 days a week. The same physiotherapy and home exercise program will be applied to both groups. The physiotherapy and home exercise program will include patient education, stretching, range of motion and posture exercises. Resistance training will consist of different exercise principles but the same types of exercises. Resistance training: Dumball will be used as exercise equipment. Exercise intensity determined using the Numerical Pain Rating Scale (NPRS). Individual loading will be made according to the amount of weight. The maximum amount of pain producing pain less than 4 on the Numerical Pain Assessment Scale will be determined as exercise intensity. It will include 3 different exercises: 1) Full can. 2) External rotation in side lying. 3) Internal rotation in side lying.

The investigators are planning a 6-week rehabilitation program, 2 days a week. The same physiotherapy and home exercise program will be applied to both groups. The physiotherapy and home exercise program will include patient education, stretching, range of motion and posture exercises. Resistance training will consist of different exercise principles but the same types of exercises. Resistance training: Dumball will be used as exercise equipment. Exercise intensity determined using the Numerical Pain Rating Scale (NPRS). Individual loading will be made according to the amount of weight. The maximum amount of pain producing pain less than 4 on the Numerical Pain Assessment Scale will be determined as exercise intensity. It will include 3 different exercises: 1) Full can. 2) External rotation in side lying. 3) Internal rotation in side lying.

Outcomes

Primary Outcome Measures

The supraspinatus tendon thickness and elasticity
Affected party the supraspinatus tendon thickness and elasticity value will be evaluated by shear-wave elastography by a specialist radiologist.

Secondary Outcome Measures

Isometric muscle strength
Isometric muscle strength of the external and internal rotators of the shoulder and the supraspinatus muscle will be evaluated by manual muscle testing. For manual muscle testing a digital hand-held dynamometer will be used.
Shoulder range of motion
A digital inclinometer will be used to evaluate the range of motion of the shoulder joint. Reviews shoulder flexion, abduction, internal and external rotation movements will be done. Active movement without pain (painless NEH) will be measured. All measurements will be repeated three times and averaged and recorded in degrees.
The level of pain and disability associated with the shoulder
The Shoulder Pain And Disability Index (SPADI), to assess the level of shoulder-related pain and disability will be used.
Shoulder pain severity
The Numerical Pain Rating Scale will be used to assess the severity of shoulder pain.

Full Information

First Posted
July 23, 2023
Last Updated
July 31, 2023
Sponsor
Mustafa Kemal University
Collaborators
The Scientific and Technological Research Council of Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT05969652
Brief Title
Comparison of the Effectiveness Heavy Slow Resistance and Eccentric Training in Rotator Cuff Tendinopathy
Official Title
Comparison of the Effectiveness of Supervised Heavy Slow Resistance Training and Eccentric Exercise Training in Patients With Rotator Cuff Tendinopathy: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 31, 2023 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mustafa Kemal University
Collaborators
The Scientific and Technological Research Council of Turkey

4. Oversight

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

5. Study Description

Brief Summary
Rotator cuff tendinopathy, also called subbracromial impingement syndrome, is one of the most important causes of anterior shoulder pain. Although exercise training is known as an effective intervention method in the treatment of rotator cuff/subacromial impingement problems, there is no definite consensus on which type of exercise is more effective. The aim of this study is to analyze and compare the effects of the Heavy Slow Resistance (HSR) training and eccentric exercise training on pain, function, supraspinatus tendon structure, muscle strength, range of motion, subjective perception of improvement and treatment satisfaction in individuals with subacromial shoulder pain associated with rotator cuff tendinopathy.
Detailed Description
Rotator cuff tendinopathy, also called subbracromial impingement syndrome, is one of the most important causes of anterior shoulder pain. The most frequently affected structure in rotator cuff tendinopathies is the supraspinatus tendon due to its position in the subacromial space. Histological examinations of rotator cuff tendinopathy revealed that the structural changes in supraspinatus tendon injuries are similar to those of the patella and Achilles tendon injuries. In the treatment of Achilles and patellar tendinopathy, it has been shown that eccentric exercise training has positive effects on pain and function, and supports the improvement in the structural and mechanical properties of the tendon. This success of eccentric training in managing lower extremity tendinopathies has encouraged researchers to conduct more scientific studies to develop evidence-based eccentric training guidelines for the conservative treatment of tendinopathies in the shoulder region. Studies showing that eccentric exercise training has positive effects on pain and function in rotator cuff pathologies have begun to take their place in the literature. In some studies, it has been stated that eccentric exercises are a safe and tolerable approach even in patients with rotator cuff tendinopathy who are candidates for arthroscopic subacromial decompression surgery and reduce the number of patients who are candidates for surgery. Again, in a systematic review-meta-analysis study involving individuals with rotator cuff tendinopathy, it was once again summarized that eccentric training has positive effects on pain and function, but it was stated that more studies are needed on this subject. The HSR training is the repetitive gradual and slow contraction of the muscle against the heaviest possible load that the person can tolerate. In this training, the focus is more on the concentric and eccentric phases of the movement, and these phases are requested to be completed slowly in 3 seconds. As a result, the concentric/eccentric phase of an exercise repetition is performed with maximum weight in 6 seconds in total. There is scientific evidence in the current literature that slow resistance training has positive effects on symptoms and tendon structure in patella and Achilles tendinopathy. Beyer et al. compared eccentric exercise training and HSR training in Achilles tendinopathy and reported that both trainings had equally positive effects. However, scientific studies investigating the effects of slow resistance training in rotator cuff pathologies are mostly new and few in number. In a recent single-blind randomized controlled feasibility study conducted on 22 individuals with rotator cuff-related subacromial shoulder pain, the effects of slow resistance training in addition to traditional physical therapy program and traditional physical therapy program were compared. Schydlowsky et al. In their study comparing the effects of a supervised and home-based physiotherapy program in subacromial impingement syndrome, they did not directly examine the effects of slow resistance training, but used the slow resistance training procedure for the rotator cuff muscles. Although exercise training is known as an effective intervention method in the treatment of rotator cuff/subacromial impingement problems, there is no definite consensus on which type of exercise is more effective. However, when previous literature studies from 2022 were examined, a single pilot study was found that examined the effect of specific slow resistance training on symptoms in rotator cuff tendinopathy; No studies could be found comparing specific slow slow resistance training with other exercise interventions. The aim of this thesis, which the investigators planned in the light of this information, is to analyze and compare the effects of heavy slow resistance training and eccentric exercise training on pain, function, supraspinatus tendon structure, muscle strength, range of motion, subjective perception of improvement and treatment satisfaction in individuals with subacromial shoulder pain associated with rotator cuff tendinopathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tendinopathy, Subacromial Impingement Syndrome, Bicep Tendinitis
Keywords
Exercise therapy, Rehabilitation, Resistance training, Shoulder pain, Subacromial impingement syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups will be treated. The first group (experimental group) will be called the heavy slow resistance (HSR) group. The second group (control group) will be called the eccentric exercise (EE) group.
Masking
ParticipantOutcomes Assessor
Masking Description
Patients will not know which group they belong to. Doctors examining patients will also be blinded to group information. Which group the patients are included in will be the primary investigator who only performs the exercises.
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heavy slow resistance group (HSR group)
Arm Type
Experimental
Arm Description
The investigators are planning a 6-week rehabilitation program, 2 days a week. The same physiotherapy and home exercise program will be applied to both groups. The physiotherapy and home exercise program will include patient education, stretching, range of motion and posture exercises. Resistance training will consist of different exercise principles but the same types of exercises. Resistance training: Dumball will be used as exercise equipment. Exercise intensity determined using the Numerical Pain Rating Scale (NPRS). Individual loading will be made according to the amount of weight. The maximum amount of pain producing pain less than 4 on the Numerical Pain Assessment Scale will be determined as exercise intensity. It will include 3 different exercises: 1) Full can. 2) External rotation in side lying. 3) Internal rotation in side lying.
Arm Title
Eccentric exercise training group (EE group)
Arm Type
Active Comparator
Arm Description
The investigators are planning a 6-week rehabilitation program, 2 days a week. The same physiotherapy and home exercise program will be applied to both groups. The physiotherapy and home exercise program will include patient education, stretching, range of motion and posture exercises. Resistance training will consist of different exercise principles but the same types of exercises. Resistance training: Dumball will be used as exercise equipment. Exercise intensity determined using the Numerical Pain Rating Scale (NPRS). Individual loading will be made according to the amount of weight. The maximum amount of pain producing pain less than 4 on the Numerical Pain Assessment Scale will be determined as exercise intensity. It will include 3 different exercises: 1) Full can. 2) External rotation in side lying. 3) Internal rotation in side lying.
Intervention Type
Other
Intervention Name(s)
Heavy slow resistance training
Intervention Description
Patients will perform the exercises in the concentric and eccentric phases with the maximum amount of weight tolerated at a rate of 3 seconds/repetition. The number of sets*repetitions is given below. 2-3 minutes rest between sets will be given. 1st week 3*15 2-3.week 3*12 4th-5th week 3*10 6th week 3*8
Intervention Type
Other
Intervention Name(s)
Eccentric exercise training
Intervention Description
Among the patients in the eccentric exercise group, only the eccentric phase of the exercises in the HSR group, will be asked to actively engage with the affected party. The eccentric contraction rate will be set to 6 seconds. Each exercise will be done 3 sets of 15 repetitions. In the next week, progress will be made in exercise intensity according to tolerance and 500 g will be added to the previous weight. will be continued. If patients cannot tolerate the new weight or there is an increase in pain, the same weight will be continued for another week.
Primary Outcome Measure Information:
Title
The supraspinatus tendon thickness and elasticity
Description
Affected party the supraspinatus tendon thickness and elasticity value will be evaluated by shear-wave elastography by a specialist radiologist.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Isometric muscle strength
Description
Isometric muscle strength of the external and internal rotators of the shoulder and the supraspinatus muscle will be evaluated by manual muscle testing. For manual muscle testing a digital hand-held dynamometer will be used.
Time Frame
6 weeks
Title
Shoulder range of motion
Description
A digital inclinometer will be used to evaluate the range of motion of the shoulder joint. Reviews shoulder flexion, abduction, internal and external rotation movements will be done. Active movement without pain (painless NEH) will be measured. All measurements will be repeated three times and averaged and recorded in degrees.
Time Frame
6 weeks
Title
The level of pain and disability associated with the shoulder
Description
The Shoulder Pain And Disability Index (SPADI), to assess the level of shoulder-related pain and disability will be used.
Time Frame
6 weeks
Title
Shoulder pain severity
Description
The Numerical Pain Rating Scale will be used to assess the severity of shoulder pain.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Describing subacromial pain Rotator cuff tendinopathy (subacromial impingement syndrome, biceps tendinitis and rotator cuff I. and II. stage diagnosis) Continuation of diagnostic symptoms for at least 30 days Exclusion Criteria: Prior shoulder surgery Sign of cervical radiculopathy Shoulder instability or history of upper extremity fracture Full-thickness rotator cuff tear Adhesive capsulitis Humeroscapular periarthritis (osteoarthritis, inflammatory arthropathies, etc.) Neoplasm/malignant status Other independent from shoulder problem being on regular analgesic therapy for ongoing painful conditions Subacromial corticosteroids in the last 2 months having received an injection or participating in a shoulder rehabilitation program
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dilek Ha Esen, PhD. c
Phone
+90533 815 23 71
Email
dilekhandeesen@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nihan Kafa, Prof.
Email
fztnihankafa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Ha Esen, PhD. c
Organizational Affiliation
Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation
City
Ankara
State/Province
Çankaya
ZIP/Postal Code
06540
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dilek Ha Esen, PhD. c.
Phone
+90533 815 23 71
Email
dilekhandeesen@gmail.com
First Name & Middle Initial & Last Name & Degree
Nihan Kafa, Prof.
Email
fztnihankafa@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26018970
Citation
Beyer R, Kongsgaard M, Hougs Kjaer B, Ohlenschlaeger T, Kjaer M, Magnusson SP. Heavy Slow Resistance Versus Eccentric Training as Treatment for Achilles Tendinopathy: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1704-11. doi: 10.1177/0363546515584760. Epub 2015 May 27.
Results Reference
background
PubMed Identifier
26770702
Citation
Bateman M, Adams N. A randomised controlled feasibility study investigating the use of eccentric and concentric strengthening exercises in the treatment of rotator cuff tendinopathy. SAGE Open Med. 2014 Jan 28;2:2050312113520151. doi: 10.1177/2050312113520151. eCollection 2014.
Results Reference
background
PubMed Identifier
33680816
Citation
Macias-Hernandez SI, Garcia-Morales JR, Hernandez-Diaz C, Tapia-Ferrusco I, Velez-Gutierrez OB, Nava-Bringas TI. Tolerance and effectiveness of eccentric vs. concentric muscle strengthening in rotator cuff partial tears and moderate to severe shoulder pain. A randomized pilot study. J Clin Orthop Trauma. 2020 Aug 3;14:106-112. doi: 10.1016/j.jcot.2020.07.031. eCollection 2021 Mar.
Results Reference
background
PubMed Identifier
35033043
Citation
Schydlowsky P, Szkudlarek M, Madsen OR. Comprehensive supervised heavy training program versus home training regimen in patients with subacromial impingement syndrome: a randomized trial. BMC Musculoskelet Disord. 2022 Jan 15;23(1):52. doi: 10.1186/s12891-021-04969-0.
Results Reference
background

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Comparison of the Effectiveness Heavy Slow Resistance and Eccentric Training in Rotator Cuff Tendinopathy

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