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NCT Number: NCT07800559

The Combined Effect of Thoracic Manipulation and Instrument-assisted Soft Tissue Mobilization in Patients With Shoulder Impingement Syndrome

This study will be conducted to investigate the combined effect of thoracic manipulation and instrument-assisted soft tissue mobilization in patients with shoulder impingement syndrome

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Shoulder impingement syndrome (SIS) represents one of the most prevalent musculoskeletal disorders affecting the upper extremity, accounting for 44-65% of all shoulder complaints in clinical practice. The condition is characterized by mechanical compression of the rotator cuff tendons and subacromial bursa beneath the coracoacromial arch during arm elevation, resulting in pain, inflammation, and reduced quality of life. Thoracic spinal manipulation aims to restore mobility and optimize scapular positioning. Studies have shown that adding Maitland thoracic manipulation or Mulligan SNAGs to exercise leads to superior improvements in pain and range of motion.Thoracic spine manipulation (TSM) is one of the techniques that can be used to gain thoracic mobility in peoples with shoulder dysfunction Instrument-assisted soft tissue mobilization (IASTM) uses specialized tools to treat myofascial restrictions. It triggers a localized inflammatory response that initiates healing and remodeling. While promising in tendinopathy cases, there is a significant evidence gap regarding its efficacy when combined with joint-based manual therapy for SIS. Investigating the synergistic effects of combining these regional and local interventions with foundational scapular stabilization exercises will provide a comprehensive, evidence-based framework that is currently lacking in the literature.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with shoulder impingement syndrome from both genders their age from 18-55 years.
  • History of shoulder pain for one month.
  • Positive Neer's impingement test and Hawkin's Kennedy test.
  • Painful arc sign.

Exclusion criteria

  • History of Shoulder girdle fracture, dislocation and surgery
  • Diagnosed with frozen shoulder or rotator cuff tear
  • History of cervicobrachial pain
  • Any neuromuscular pain in upper limb and use of corticosteroids or pain subsiding medication.
  • Inflammatory arthropathies (e.g., rheumatoid arthritis, ankylosing spondylitis).
  • Fracture or malignancy in the shoulder region
  • Contraindications to manual therapy or thoracic manipulation (e.g., osteoporosis, spinal cord compression, vertebral artery insufficiency).
  • Contraindications to IASTM (e.g., open wounds, skin infections, bleeding disorders, anticoagulant therapy).

Treatment and study plan

Conventional physical therapy

Other

the patients will receive conventional physical therapy in the form of transcutaneous electrical nerve stimulation, ultrasound, and therapeutic exercise. The exercise includes range of motion exercises, stretching, scapular stabilization exercises, and rotator cuff strengthening.

thoracic manibulation

Other

With the participant in a prone position, the therapist will apply a high-velocity, short-lever, posterior-to-anterior (P-A) thrust. The thrust will be directed toward the spinous or transverse processes of the hypomobile thoracic vertebrae. Thoracic thrust manipulation demonstrated to manipulate specific thoracic segment mainly the mid-thoracic, plus conventional physical therapy.

Instrument assisted soft tissue mobilization

Other

The IASTM technique will be performed for 20 seconds parallel to the muscle fibers, followed by 20 seconds perpendicular to the muscle fibers, with the instrument held at a 45° angle to the skin. The beveled side of the M2T blade will be in contact with the skin. Stroke pressure and speed will be modified according to the participant's tolerance to avoid causing pain and according to the depth of the treated muscle plus conventional physical therapy.The technique will be applied to the pectoral muscles, shoulder rotator cuff musculature, and periscapular musculature, including the upper, middle, and lower fibers of the trapezius, rhomboids major and minor, teres major, and latissimus dorsi

thoracic manipulation and instrument-assisted soft tissue mobilization

Other

the patients will receive The IASTM technique will be performed for 20 seconds parallel to the muscle fibers followed by 20 seconds perpendicular to the muscle fibers, with the instrument held at a 45° angle to the skin plus thoracic manibulation in which the therapist will apply a high-velocity, short-lever, posterior-to-anterior (P-A) thrust. The thrust will be directed toward the spinous or transverse processes of the hypomobile thoracic vertebrae. Thoracic thrust manipulation demonstrated to manipulate specific thoracic segments, mainly the mid-thoracic, plus conventional physical therapy. finally, the pateitns will recieve conventional physical therapy

Primary outcomes

  1. upper limb disability

    Time frame: up to six weeks

    Disabilities of the arm, shoulder and hand (Quick DASH) questionnaire will be used toassess upper limb diability.the QuickDASH only contains 11 items .It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms.The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level.The QuickDASH outcome measure is designed to be used on patients presenting with one or more disabilities of the arm, shoulder, and hand. Scoring with 100 is more severe disability, and zero mean no disability.

Secondary outcomes

  1. pain intensity

    Time frame: up to 6 weeks

    neumerical pain rating scale will be used to assess pain. It consists of a line, often 10 cm long (100mm); its ends are generally labelled with verbal pain anchors (e.g., "no pain" and "pain as bad as it could be"). Patients are asked to indicate the point along the line from 0-10 cm marked in 1 cm increments where 0 cm represents no pain and 10 cm the most severe pain imaginable

  2. shoulder range of motion

    Time frame: up to six weeks

    The Digital goniometer will be used to assess shoulder range of motion.

  3. shoulder proprioception (joint position error)

    Time frame: up to six weeks

    shoulder joint position error will be assessed by a smartphone clinometer application. Proprioception test was done by moving the participant's arms from the starting position (0 degrees) to the target angles. The arm remained at each target angle for 5 seconds, allowing the subjects to memorize the position before returning to the starting position. Subsequently, the subjects were instructed to independently move their arms towards each target angle.

  4. life disability

    Time frame: up to six weeks

    World Health Organization Quality of Life BREF will be used to assess life disability. The WHOQOL-BREF is a 26-item instrument that assesses quality of life across four domains: physical health (items 3, 4, 10, 15, 16, 17, and 18), psychological health (items 5, 6, 7, 11, 19, and 26), social relationships (items 20, 21, and 22), and environment (items 8, 9, 12, 13, 14, 23, 24, and 25). Items 1 and 2 assess overall quality of life and general health, respectively. Each item is rated on a 5-point Likert scale from 1 to 5. Items 3 and 4 are reverse-scored. For each domain, the item scores are averaged and multiplied by 4, producing a domain score ranging from 4 to 20, with higher scores indicating better quality of life.

  5. pressure pain threshold

    Time frame: up to six weeks

    pressure pain threshold wil be assessed by algometer.During the assessment, the patient is instructed to indicate the exact moment the sensation transitions from comfortable pressure to the onset of pain, effectively translating a subjective experience into an objective, measurable value (typically recorded in kg/cm² or Newtons).

Study contacts

Contact information is provided by the study sponsor or research team.

Nabil mahmoud, professor

CONTACT

[email protected]

+20 12 00133613

mahmoud kashef, phd

CONTACT

[email protected]

+20 10 94523424

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: SIS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

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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