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Rotator Cuff TendinopathyNCT05969652

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

A study testing Heavy slow resistance training and Eccentric exercise training in people with Rotator Cuff Tendinopathy and Subacromial Impingement Syndrome, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Heavy slow resistance training and Eccentric exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
31 Jan 2026to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.)
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dilek Ha Esen, PhD. c contact

+90533 815 23 71

dilekhandeesen@gmail.com

Nihan Kafa, Prof. contact

fztnihankafa@gmail.com

Turkey (Türkiye)1 site
  • Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation

    Ankara, Çankaya, 06540

    Dilek Ha Esen, PhD. c., +90533 815 23 71, dilekhandeesen@gmail.com

    Nihan Kafa, Prof., fztnihankafa@gmail.com

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Heavy slow resistance training, Eccentric exercise training
Keywords
Exercise therapy, Rehabilitation, Resistance training, Shoulder pain, Subacromial impingement syndrome
Medical subject headings
Shoulder Impingement Syndrome, Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heavy slow resistance trainingOther

    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

  • Eccentric exercise trainingOther

    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.

Study groups in NCT05969652
Study groupRoleWhat they receive
Heavy slow resistance group (HSR group)ExperimentalThe 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.
Receives: Other: Heavy slow resistance training
Eccentric exercise training group (EE group)Active comparatorThe 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.
Receives: Other: Eccentric exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks

Secondary outcomes (4)
  1. 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.

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

  3. 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.

    Measured: 6 weeks

  4. Shoulder pain severity

    The Numerical Pain Rating Scale will be used to assess the severity of shoulder pain.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start31 Jan 2026 (estimated)
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05969652
Sponsor's protocol ID
E-77082166-302.08.01-547254
Status last verified
Jun 2024
First submitted
23 Jul 2023
Last updated
27 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26018970
  • 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.

    PubMed 26770702
  • 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.

    PubMed 33680816
  • 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.

    PubMed 35033043

Questions about this trial

What is this clinical trial studying?

A study testing Heavy slow resistance training and Eccentric exercise training in people with Rotator Cuff Tendinopathy and Subacromial Impingement Syndrome, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).

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 9 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: opening soon, as of the sponsor's last update on 27 Jun 2024. 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 Turkey (Türkiye). 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dilek Ha Esen, PhD. c (+90533 815 23 71, dilekhandeesen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The supraspinatus tendon thickness and elasticity (time frame: 6 weeks). 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 NCT05969652, which also lists 4 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 27 Jun 2024.

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