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The aim of this study is to evaluate the effects of low-level laser therapy (LLLT) and therapeutic ultrasound combined with home-based exercise in comparison with home-based exercise alone in patients with subacromial impingement syndrome (SIS). Participants are going to evaluate before training, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, and the Shoulder Pain and Disability Index (SPADI).
SIS is an important cause of pain and disability and affects activities of daily living. Therefore, a major goal of SIS treatment is to reduce pain and improve upper extremity function. In this prospective, randomized controlled, single-blind, interventional trial, a total of 60 patients with SIS who met the eligibility criteria are going to enrolled in the study. Eligible participants are going to randomly assign to one of the three groups by an independent blinded researcher, using a computer-generated random numbers and allocation ratio of 1:1:1: the LLLT group (LG, n = 20), the ultrasound therapy group (UG, n = 20), and the control group (CG, n = 20). Participants are going to evaluate before training, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, and the Shoulder Pain and Disability Index (SPADI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-level laser therapy | Experimental | In the low-level laser therapy group, each patient are going to receive low-level laser therapy and cold-pack therapy and perform a home-based exercise program 5 times a week, once a day for 15 sessions. |
|
| Therapeutic ultrasound | Experimental | In the therapeutic ultrasound group, each patient are going to receive therapeutic ultrasound and cold-pack therapy and perform a home-based exercise program 5 times a week, once a day for 15 sessions. |
|
| Control | Active Comparator | Participants are going to perform a home-based exercise program and receive cold-pack therapy 5 times a week, once a day for 15 sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-level laser therapy | Device | Gallium-aluminum-arsenide diode laser device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline activity pain score at 1-months and 3-months | Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome | Baseline, 1-month, 3-month |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline rest pain score at 1-months and 3-months | Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome | Baseline, 1-month, 3-month |
| Change from baseline Shoulder Pain and Disability Index at 1-months and 3-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nalan Capan | Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D019534 | Shoulder Impingement Syndrome |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D014464 | Ultrasonic Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
| D003972 | Diathermy |
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| Therapeutic ultrasound |
| Device |
Therapeutic pulsed ultrasound with a frequency of 1 MHz |
|
| Home-based exercise | Other | Home-based exercises 3 days a week; each exercise comprises one set with 5 repetitions over 4 weeks. |
|
Shoulder Pain and Disability Index (SPADI) measures shoulder pain and shoulder disability. Total score ranges from 0 to 130, where a higher score indicates a worsening status. Each item is scored with the VAS, which ranges from 0 (no pain or no difficulty) to 10 (worst pain imaginable or very difficult, help required) |
| Baseline, 1-month, 3-month |
| Change from baseline night pain score at 1-months and 3-months | Visual Analogue Scale- Night pain (0-10 point). Higher scores mean a worse outcome | Baseline, 1-month, 3-month |
| D006979 |
| Hyperthermia, Induced |