Comparison of the Effectiveness Heavy Slow Resistance and Eccentric Training in Rotator Cuff Tendinopathy
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| ClinicalTrials.gov Identifier: NCT05969652 |
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Recruitment Status :
Not yet recruiting
First Posted : August 1, 2023
Last Update Posted : March 5, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rotator Cuff Tendinopathy Subacromial Impingement Syndrome Bicep Tendinitis | Other: Heavy slow resistance training Other: Eccentric exercise training | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 22 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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 (Participant, Outcomes 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. |
| Primary Purpose: | Treatment |
| 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 |
| Estimated Study Start Date : | March 31, 2024 |
| Estimated Primary Completion Date : | March 31, 2025 |
| Estimated Study Completion Date : | December 31, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Heavy slow resistance group (HSR group)
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. |
Other: Heavy slow resistance training
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 |
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Active Comparator: Eccentric exercise training group (EE group)
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. |
Other: Eccentric exercise training
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. |
- The supraspinatus tendon thickness and elasticity [ Time Frame: 6 weeks ]Affected party the supraspinatus tendon thickness and elasticity value will be evaluated by shear-wave elastography by a specialist radiologist.
- Isometric muscle strength [ Time Frame: 6 weeks ]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 [ Time Frame: 6 weeks ]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 [ Time Frame: 6 weeks ]The Shoulder Pain And Disability Index (SPADI), to assess the level of shoulder-related pain and disability will be used.
- Shoulder pain severity [ Time Frame: 6 weeks ]The Numerical Pain Rating Scale will be used to assess the severity of shoulder pain.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05969652
| Contact: Dilek Ha Esen, PhD. c | +90533 815 23 71 | dilekhandeesen@gmail.com | |
| Contact: Nihan Kafa, Prof. | fztnihankafa@gmail.com |
| Turkey | |
| Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation | |
| Ankara, Çankaya, Turkey, 06540 | |
| Contact: Dilek Ha Esen, PhD. c. +90533 815 23 71 dilekhandeesen@gmail.com | |
| Contact: Nihan Kafa, Prof. fztnihankafa@gmail.com | |
| Principal Investigator: | Dilek Ha Esen, PhD. c | Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation |
| Responsible Party: | Dilek Hande Esen, MSc, PT, Principal Investigator, Mustafa Kemal University |
| ClinicalTrials.gov Identifier: | NCT05969652 |
| Other Study ID Numbers: |
E-77082166-302.08.01-547254 |
| First Posted: | August 1, 2023 Key Record Dates |
| Last Update Posted: | March 5, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Exercise therapy Rehabilitation Resistance training Shoulder pain Subacromial impingement syndrome |
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Tendinopathy Shoulder Impingement Syndrome Muscular Diseases Musculoskeletal Diseases |
Tendon Injuries Wounds and Injuries Shoulder Injuries Joint Diseases |