Skip to main content
OpenTrials
Completed

NCT Number: NCT04784377

High and Low Laser for Subacromial Impingement Syndrome

Shoulder pain is the third most common musculoskeletal problem after lumbar and neck diseases in clinical practice, and the most common cause of shoulder pain is subacromial impingement syndrome. The main goal of treatment is to reduce pain and to solve the mechanical problem that causes functional impairment. Low-level laser treatment is an increasingly used treatment modality in the treatment of subacromial impingement syndrome as in many musculoskeletal diseases, as it promotes cell proliferation and tissue regeneration by its anti-inflammatory and photobiostimulation properties. Also, High-intensity laser therapy is a treatment method that is gaining popularity in the recent years. These ultra-short impulses effect a deep action in the biological tissue (3-4 cm), with a homogeneous distribution of the light source in the irradiated soft tissue, but without excessive thermal enhancements. It reduces pain and edema with photomechanic effects in deep tissues. As far as the investigators know, there are no studies comparing these two treatment modalities in subacromial impingement syndrome yet. This study was planned to compare the efficacy of High-intensity laser therapy and low-intensity laser therapy in treatment of patients with subacromial impingement syndrome.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Cairo University

Giza, 12613, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • shoulder pain for at least one month
  • male and female patients with age range from 25-45 years old
  • positive impingement test results
  • stage I or II disease according to the Neer classification, confirmed by MRI
  • visual analog scale score greater than 40 mm.

Exclusion criteria

patients will be excluded if they have:

  • major trauma to the shoulder
  • stage III subacromial impingement syndrome
  • diabetes mellitus
  • hypothyroidism
  • calcific tendinitis
  • adhesive capsulitis (forward flexion less than 160, horizontal abduction less than 160
  • installation of cardiac pacemaker
  • history of a physical therapy program for the same shoulder in the last 6 months.

Treatment and study plan

high intensity laser in addition to traditional physical therapy exercises

Other

high intensity laser will be used with 1064 nm wavelength and maximum of 25 W power. Analgesic and biostimulant modes were used in the present study.

Also the patients will receive traditional physical therapy exercises in the form of flexibility and strengthening exercises for shoulder muscles.

low level laser in addition to traditional physical therapy exercises

Other

patients will receive low level Laser Therapy in addition to traditional physical therapy exercises.

diode laser device with a wavelength of 850nm, power output of 100mV, continuous wave and 0.07cm2 spot area laser will be used. The laser will be applied with a dosage of 5 joule/cm2 (totally 15-20 joule) at the most 5 painful points for 1 minute at each point over subacromial region of the shoulder.

Also the patients will receive traditional physical therapy exercises in the form of flexibility and strengthening exercises for shoulder muscles.

traditional physical therapy exercises

Other

Also the patients will receive traditional physical therapy exercises in the form of flexibility and strengthening exercises for shoulder muscles.

Primary outcomes

  1. pain intensity

    Time frame: change from base line at three weeks

    Pain will be evaluated by a visual analogue scale (VAS). The patient will be asked to mark the severity of pain on a 100-mm line with "no pain" on one end and "most unbearable pain" on the other end

Secondary outcomes

  1. shoulder range of motion

    Time frame: change from baseline at three weeks

    Flexion, abduction, and external rotation will be measured by using goniometer in a supine position and the active movements will be recorded. The goniometer will be centered at the acromion for abduction, greater tubercle for flexion, and olecranon for external rotation at 90° shoulder and elbow flexion

  2. pain pressure threshold

    Time frame: change from baseline at three weeks

    Pressure Pain Threshold will be determined with an analogue algometer at the most painful point of the subacromial area. This point will be determined by a previous examination based on the point that the patient determined as 'his or her point of maximum pain'.

  3. Shoulder Pain and Disability Index

    Time frame: change from baseline at three weeks

    this scale will be used to assess functional status of the shoulder. The SPADI includes shoulder questions and consists of two subscales: pain and disability. Pain subscale consists of 5 items, and disability subscale consists of 8 items, and the total score is 0-100

  4. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: change from baseline at three weeks

    This scale assesses sleep quality and disorder and consists of seven subcomponents (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, drug use, and daytime functions) and 19 items. Each component is evaluated on a score of 0-3 and is evaluated with a total sleep score ranging from 0 to 21, and high scores represent low sleep quality. A PSQI total score < 5 points is considered "good" sleep quality and > 5 points is "bad" sleep quality.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

High Intensity Versus Low Level Laser Therapy in Treatment of Patients With Subacromial Impingement Syndrome: A Randomized, Double-blind, Controlled Trial.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2021
Registry last updated
Jan 25, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.