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The Effect of High-intensity Laser Therapy in Patients With Chronic Shoulder Pain

NCT ID: NCT05062941

Last Updated: 2021-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-12-31

Brief Summary

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The aim of this study was to investigate the effects of biostimulating, analgesic and noninvasive high intensity laser therapy on pain, functionality and quality of life in patients with chronic shoulder pain. Participants between the ages of 18-75 and without any cognitive, communication and psychiatric problems were included in the study. Patients were randomized into two groups and both received conventional physiotherapy and rehabilitation program for 3 weeks, 5 sessions a week. The treatment program applied was as followed; the control Group (n = 25): conventional physiotherapy and study Group (n = 25): conventional physiotherapy and High-intensity Laser Therapy (HILT). Upper extremity range of motion was evaluated with 'goniometer', pain threshold with 'algometer, muscle strength with 'myometer'; disability status with 'The Disabilities of the Arm, Shoulder and Hand (DASH)'.

Detailed Description

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The aim of this study was to investigate the effects of biostimulating, analgesic and noninvasive high intensity laser therapy on pain, functionality and quality of life in patients with chronic shoulder pain. Participants between the ages of 18-75 and without any cognitive, communication and psychiatric problems were included in the study. Patients were randomized into two groups and both received conventional physiotherapy and rehabilitation program for 3 weeks, 5 sessions a week. The treatment program applied was as followed; the control Group (n = 25): conventional physiotherapy and study Group (n = 25): conventional physiotherapy and High-intensity Laser Therapy (HILT). Upper extremity range of motion was evaluated with 'goniometer', pain threshold with 'algometer, muscle strength with 'myometer'; disability status with 'The Disabilities of the Arm, Shoulder and Hand (DASH)'.

Conditions

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Chronic Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

Conventional therapy (CT) was applied to all participants. CT included application of 15 minutes of hot-pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS) in conventional mode, 5 minutes of ultrasound (1.5 W/cm2, 1 MHz), 20 minutes of interference current with vacuum electrodes (80 Hz pulse frequency, 1/1 rectangular spectrum), and exercises (all exercises were applied as 1 set of 10 repetitions in each direction: Codman exercises (3-directions), wand exercises (4-directions), exercises using the shoulder wheel (2-directions), exercises with exercise band (5-directions), exercises on the finger ladder (1 set of 10 repetitions in both directions); and shoulder capsule stretching exercises performed (1 set of 12 repetitions) by asking the subjects to wait 20 seconds where the tension was felt).

Group Type ACTIVE_COMPARATOR

Conventional physiotherapy

Intervention Type OTHER

Conventional therapy (CT) included application of 15 minutes of hot-pack, 20 minutes of transcutaneous electrical nerve stimulation, 5 minutes of ultrasound, 20 minutes of interference current with vacuum electrodes, and exercises.

Study group

Same conventional therapy (CT) that was applied to control group was also applied to all participants in this group. CT included application of 15 minutes of hot-pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS), 5 minutes of ultrasound, 20 minutes of interference current with vacuum electrodes, and the same exercises.

In addition to the CT program, only study group has received HILT (BTL 6000, BTL Industries, Inc., USA) application to the shoulder area (analgesic mode, 25 Hz,10 W, 12 j/cm2) for 2 minutes.

Group Type ACTIVE_COMPARATOR

Conventional physiotherapy

Intervention Type OTHER

Conventional therapy (CT) included application of 15 minutes of hot-pack, 20 minutes of transcutaneous electrical nerve stimulation, 5 minutes of ultrasound, 20 minutes of interference current with vacuum electrodes, and exercises.

High-intensity laser therapy (HILT)

Intervention Type DEVICE

HILT stimulates oxidation of mitochondria and ATP creation by delivering high energy output inside the tissues and with this photochemistry effect, metabolism and blood circulation is increased resulting HILT to cause quick absorption of edema and removal of exudates.

HILT (BTL 6000, BTL Industries, Inc., USA) application was to the shoulder area in the analgesic mode of the device at a frequency of 25 Hz with a power of 10 W and a dosage of 12 j/cm2 for 2 minutes: 5 sessions a week for 3 weeks and 15 sessions in total.

Interventions

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Conventional physiotherapy

Conventional therapy (CT) included application of 15 minutes of hot-pack, 20 minutes of transcutaneous electrical nerve stimulation, 5 minutes of ultrasound, 20 minutes of interference current with vacuum electrodes, and exercises.

Intervention Type OTHER

High-intensity laser therapy (HILT)

HILT stimulates oxidation of mitochondria and ATP creation by delivering high energy output inside the tissues and with this photochemistry effect, metabolism and blood circulation is increased resulting HILT to cause quick absorption of edema and removal of exudates.

HILT (BTL 6000, BTL Industries, Inc., USA) application was to the shoulder area in the analgesic mode of the device at a frequency of 25 Hz with a power of 10 W and a dosage of 12 j/cm2 for 2 minutes: 5 sessions a week for 3 weeks and 15 sessions in total.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Volunteered to participate in the study,
* Aged 18-75 years
* being diagnosed with chronic shoulder pain

Exclusion Criteria

* not having sufficient cooperation to follow exercises,
* having any communication problems or psychiatric problems,
* having any cardiac or orthopedic discomfort that may prevent the application of evaluation methods.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medipol University

OTHER

Sponsor Role collaborator

Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zubeyir Sari, Prof.

Role: STUDY_DIRECTOR

Marmara University

Locations

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Cadde Medical Center

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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28.03.2018.217

Identifier Type: -

Identifier Source: org_study_id