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

NCT05969652 | Not Yet Recruiting

• 1 other identifier: E-77082166-302.08.01-547254
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tendinopathy; Subacromial Impingement Syndrome; Bicep Tendinitis

Keywords

Exercise therapy; Rehabilitation; Resistance training; Shoulder pain; Subacromial impingement syndrome

Outcome Measures

Primary Outcomes (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.

  6 weeks

Secondary Outcomes (4)

• Isometric muscle strength

  6 weeks

• Shoulder range of motion

  6 weeks

• The level of pain and disability associated with the shoulder

  6 weeks

• Shoulder pain severity

  6 weeks

Study Arms (2)

Heavy slow resistance group (HSR group)

EXPERIMENTAL

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

Eccentric exercise training group (EE group)

ACTIVE COMPARATOR

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

Interventions

Heavy slow resistance training OTHER

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

Heavy slow resistance group (HSR group)

Eccentric exercise training OTHER

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.

Eccentric exercise training group (EE group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mustafa Kemal University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

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

Ankara, Çankaya, 06540, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 26018970 BACKGROUND

• 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.

  PMID: 26770702 BACKGROUND

• 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.

  PMID: 33680816 BACKGROUND

• 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.

  PMID: 35033043 BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dilek Ha Esen, PhD. c

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Ha Esen, PhD. c

CONTACT

+90533 815 23 71; dilekhandeesen@gmail.com

Nihan Kafa, Prof.

CONTACT

fztnihankafa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, PT, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 23, 2023
• First Posted: August 1, 2023
• Study Start: January 31, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)