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NCT Number: NCT04676919

The Effect of Phonophoresis in Subacromial Impingement Syndrome.

Subacromial impingement syndrome (SIS) is a dysfunction caused by an impingement of the rotator cuff tendon between the head of the humerus and the acromion as a result of changes in the subacromial space. The patients' symptoms, such as pain, limited joint mobility and reduced strength, may lead to a diagnosis of SIS. The conservative treatment of individuals with SIS is includes analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), steroid injections and physiotherapy. Ultrasound therapy is one of the common physiotherapy applications for SIS, but its effectiveness is controversial. Phonophoresis is a combination of ultrasound therapy and medical therapy. In phonophoresis, a medicine in gel form is used as a transmitter with ultrasound instead of the aquatic conductor gel. It was hypothesized that ultrasound waves favoring the penetration of an anti-inflammatory drug would lead to an improved response to the treatment of SIS. However, the effectiveness of ultrasound modes (pulsed or continuous) can be used in phonophoresis is debatable. The purpose of this study is to determine the effect of ultrasound therapy, pulsed mode ultrasound and continuous mode ultrasound phonophoresis in patients with SIS.

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Key information

Conditions

Subacromial Impingement Syndrome Joint Diseases Musculoskeletal Diseases Shoulder Impingement Syndrome Shoulder Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Volkan deniz

Ankara, 06560, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • to be diagnosed as shoulder impingement syndrome,
  • shoulder pain for at least one month,
  • VAS score over 40mm.

Exclusion criteria

  • grade III supraspinatus tendon injury,
  • major shoulder trauma,
  • diabetes mellitus,
  • hipotiroidizm,
  • adhesive capsulitis,
  • cardiac pacemaker
  • physical therapy or local injection to the shoulder at last six month
  • serious cervical pathologies.

Treatment and study plan

phonophoresis therapy with pulsed mode ultrasound

Device

phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks

phonophoresis therapy with continuous mode ultrasound

Device

phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks

Sham Ultrasound

Device

sham ultrasound therapy, five days a week for three weeks

Primary outcomes

  1. Visual Analog Scale

    Time frame: Baseline, Change from baseline pain scores at three weeks, Change from baseline pain scores at three months

    The visual analog scale (VAS) is a pain rating scale first used by Hayes and Patterson in 1921. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

  2. The Shortened version of Disability of the Arm, Shoulder, and Hand

    Time frame: Baseline, Change from baseline shoulder pain and function scores at three weeks, Change from baseline shoulder pain and function at three months

    Disability of the Arm, Shoulder, and Hand (DASH) was designed to describe disability experienced by patients with any musculoskeletal condition of the upper extremity and to monitor change in symptoms and upper limb function over time. The DASH questionnaire has been validated in patients with upper extremity musculoskeletal disorders such as rheumatoid arthritis and shoulder impingement syndrome. The Quick-DASH is a shortened version of the DASH

Secondary outcomes

  1. Nottingham Health Profile

    Time frame: Baseline, Change from baseline quality of life scores at three weeks, Change from baseline quality of life scores at three months

    Nottingham Health Profile (NHP) evaluates emotional, social, and physical health problems perceived by the patient. It consists of six parts: pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), physical mobility (8 items), and energy level (3 items). Higher scores correspond to poorer perceived health status.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Phonophoresis Therapy in Subacromial Impingement Syndrome: Comparing of Pulsed Mode Ultrasound Phonophoresis and Continuous Mode Ultrasound Phonophoresis.

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2020
Registry last updated
Jul 28, 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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