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Completed

NCT Number: NCT04319250

The Effectiveness Of Ischemic Compression And IASTM In Trigger Point Treatment In Patients With Rotator Cuff Tear

The aim of this study is to determine the effects of ischemic compression and IASTM techniques on pain, EHA, functionality, anxiety and depression in patients with the diagnosis of RM tear and presence of ATN. In addition, ischemic compression and EDYDM methods were aimed to compare and to reveal which application would be more useful.

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Key information

Conditions

Rotator Cuff Tears Arthralgia Joint Diseases Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Myofascial Trigger Point Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rotator Cuff Injuries Rupture Shoulder Injuries Shoulder Pain Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Aydin University

Istanbul, Turkey (Türkiye)

About this study

In this study participants were randomly divided into two groups. While ischemic compression was applied to one group for the determined active trigger points, instrument assisted soft tissue mobilization (IASTM) was applied to the other group for active trigger points. In addition to the treatment, both groups were subjected to a joint rehabilitation program.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being between 40-65 years old
  • Having been diagnosed with partial RM rupture
  • RM rupture in MRI image
  • At least 3 ATNs in the shoulder complex
  • Hawkins-Kennedy and Empty Can tests positive Symptoms for at least 3 months

Exclusion criteria

  • Sensory problems in the back and shoulders,
  • Shoulder instability
  • Osteoarthritis in the shoulder joint area
  • Glenoid or bone fracture
  • Frozen shoulder pathology
  • Massive RM rupture
  • Rheumatological joint problems
  • Shoulder surgery history

Treatment and study plan

Ischemic compression

Other

ATNs detected in a total of 13 muscles around the shoulder were applied constant pressure at the level of pain tolerated with the thumb (discomfort severity level 7 to 8 out of 10) and for 90 seconds. This method was applied twice a week for 6 weeks.

IASTM

Other

In order to apply EDYDM in the treatment of ATN, titanium plated stainless steel was divided into two parts, front and back, with two tools. The sweep was applied to the anterior muscle fibers at an angle of 45 ° for 40 seconds.

For each TN, continuous pressure was applied with swivel movement at tolerable pain level (discomfort severity level 7 to 8 out of 10) for 1 minute. The back group muscles were applied in the same way.

Rehabilitation program

Other

A rehabilitation program consisting of exercises and manual therapy used in the conservative treatment of rotator cuff tear for both groups was applied twice a week for 6 weeks.

Primary outcomes

  1. Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)

    Time frame: Change from Baseline at 6 weeks

    This is a questionnaire that identifies both functionality and symptoms that can be used in arm, elbow and hand problems. High scores of individuals mean that functional dysfunction is high. Ratings are made between 0 and 100.

Secondary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: Change from Baseline at 6 weeks

    The levels of pain felt at rest / activity / night were measured using Visual Analogue Scale (VAS).

  2. Shoulder Range of Motion (ROM)

    Time frame: Change from Baseline at 6 weeks

    EHA evaluations of flexion, abduction, internal rotation and external rotation of the shoulder joint were performed in the supine position using the universal goniometer.

  3. Active trigger points

    Time frame: Change from Baseline at 6 weeks

    Active trigger points were evaluated by palpation method according to Travell and Simons criteria. Scalene, upper trapezius, levator scapula, supraspinatus, infraspinatus, subskapularis, teres minor, teres major, deltoid anterior and posterior group fibers, pectoralis major, pectoralis minor, biceps brachii muscles were evaluated with palpation method in terms of trigger point presence.

  4. Pain Pressure Threshold (PPT)

    Time frame: Change from Baseline at 6 weeks

    Wagner Force One ™ FDIX" digital algometer was used to evaluate the pain threshold. Measurements were recorded in kg / cm².

  5. The American Shoulder and Elbow Surgeons Standardized Shoulder Assesment Form (ASES)

    Time frame: Change from Baseline at 6 weeks

    This score consists of 1 questioning pain and 10 questions questioning daily life activities.The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function.

  6. Emotional state

    Time frame: Change from Baseline at 6 weeks

    The emotional states of the cases were evaluated using the Hospital Anxiety and Depression Scale (HAD), which consists of 14 questions. (HAD). This scale has a 7-question anxiety (HAD-A) subscale that evaluates the anxiety state, and a 7-question depression (HAD-D) subscale that evaluates the state of depression, and a four-point likert scale is used to answer the questions. For the total score of each sub-score, 0-7 points are normal, 8-10 points are at the border, and 11 points are defined as abnormal

  7. Global Rating of Change (GRC) scale

    Time frame: After 6 weeks treatment

    Patient Satisfaction was assessed Global Rating of Change (GRC) scale. The scale used included 5 points (-2: I am much worse. -1: I am worse, 0: I am the same, +1: I am better, +2: I am much better).

Sponsors and collaborators

Lead sponsor

Istanbul Aydın University

Other

Registry information

Official study title

The Effectiveness Of Ischemic Compression And Instrument Assisted Soft Tissue Mobilization In Trigger Point Treatment In Patients With Rotator Cuff Tear

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 24, 2020
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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