The Effect of Laser Therapy in the Management of Adhesive Capsulitis: a Randomized Clinical Trial

NCT ID: NCT05469672

Last Updated: 2022-09-28

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-25

Study Completion Date

2022-10-25

Brief Summary

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In this study, it was aimed to compare the effects of low-level laser therapy (LLLT) and high-intensity laser therapy (HILT) on shoulder joint range of motion, level of pain and functional status in patients with adhesive capsulitis

Detailed Description

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This study will be designed as a randomized, prospective, single-blind clinical trial with a 3-week follow-up. A total of 50 patients who applied to our hospital with the complaint of shoulder pain will be evaluated for inclusion in the study. Patients will be randomized into two groups as high-intensity laser (HILT) + stretching exercise group and low-level laser (LLLT) + stretching exercise group.

Conditions

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Pain Disorder Low Level Laser Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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low-level laser therapy

LLLT will be performed 3 times a week for a period of 3 weeks

Group Type ACTIVE_COMPARATOR

Low-level laser therapy

Intervention Type OTHER

For LLLT, laser treatment will be applied using gallium-aluminum-arsenide (GaAIAs, infrared laser) diode laser (Chattanooga, Mexico, USA) at a wavelength of 904 nm, output power of 240 Mw and a frequency of 5000 Hz. The spot area is about 0.5 cm2. A total of 9 points will irradiated along the glenohumeral joint, with a power density of 3 j/cm2 at each point. The application time was 50 seconds to each point. The total dose per shoulder was 27 J per treatment. Three sessions of LILT therapy per week will administered over a three-week period.

High-intensity laser therapy

Intervention Type OTHER

HILT: A hot laser derived from a Nd: YAG laser has 12 W (watt) and 1064 nm characteristics. The device will administered to the shoulder area in two steps in the HILT group: phase I and phase II. The application will made utilizing continuous circular movements in both phases I and II. The first three sessions consisted of a 75-second intermittent phase analgesic effect at 8 W and 10 J/cm2 for a total energy of 100 J. The following six sessions consisted of a continuous 30-second bio stimulating effect with a dosage of 12 W 120 J/cm2. Over the course of three weeks, nine treatment sessions of HILT will be given.

high-intensity laser therapy

HILT will be performed 3 times a week for a period of 3 weeks

Group Type ACTIVE_COMPARATOR

Low-level laser therapy

Intervention Type OTHER

For LLLT, laser treatment will be applied using gallium-aluminum-arsenide (GaAIAs, infrared laser) diode laser (Chattanooga, Mexico, USA) at a wavelength of 904 nm, output power of 240 Mw and a frequency of 5000 Hz. The spot area is about 0.5 cm2. A total of 9 points will irradiated along the glenohumeral joint, with a power density of 3 j/cm2 at each point. The application time was 50 seconds to each point. The total dose per shoulder was 27 J per treatment. Three sessions of LILT therapy per week will administered over a three-week period.

High-intensity laser therapy

Intervention Type OTHER

HILT: A hot laser derived from a Nd: YAG laser has 12 W (watt) and 1064 nm characteristics. The device will administered to the shoulder area in two steps in the HILT group: phase I and phase II. The application will made utilizing continuous circular movements in both phases I and II. The first three sessions consisted of a 75-second intermittent phase analgesic effect at 8 W and 10 J/cm2 for a total energy of 100 J. The following six sessions consisted of a continuous 30-second bio stimulating effect with a dosage of 12 W 120 J/cm2. Over the course of three weeks, nine treatment sessions of HILT will be given.

Interventions

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Low-level laser therapy

For LLLT, laser treatment will be applied using gallium-aluminum-arsenide (GaAIAs, infrared laser) diode laser (Chattanooga, Mexico, USA) at a wavelength of 904 nm, output power of 240 Mw and a frequency of 5000 Hz. The spot area is about 0.5 cm2. A total of 9 points will irradiated along the glenohumeral joint, with a power density of 3 j/cm2 at each point. The application time was 50 seconds to each point. The total dose per shoulder was 27 J per treatment. Three sessions of LILT therapy per week will administered over a three-week period.

Intervention Type OTHER

High-intensity laser therapy

HILT: A hot laser derived from a Nd: YAG laser has 12 W (watt) and 1064 nm characteristics. The device will administered to the shoulder area in two steps in the HILT group: phase I and phase II. The application will made utilizing continuous circular movements in both phases I and II. The first three sessions consisted of a 75-second intermittent phase analgesic effect at 8 W and 10 J/cm2 for a total energy of 100 J. The following six sessions consisted of a continuous 30-second bio stimulating effect with a dosage of 12 W 120 J/cm2. Over the course of three weeks, nine treatment sessions of HILT will be given.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. patients aged between 25-65 years
2. patients clinically diagnosed with adhesive capsulitis, characterized by limitation of passive external rotation of the affected shoulder to less than 50% of the contralateral shoulder and normal radiographic finding of the affected shoulder
3. patients with severe pain and shoulder limitation for at least 3 months
4. patients who are literate and able to understand verbal instructions in our language.

Exclusion Criteria

1. Calcific tendinopathy, glenohumeral osteoarthritis, fracture, shoulder surgery, shoulder trauma, history of malignancy and infection, history of inflammatory rheumatic diseases
2. History of bilateral simultaneous adhesive capsulitis
3. Recent history of lung, breast, or bypass surgery/radiotherapy
4. History of corticosteroid injection to the same shoulder in the last 1 year
5. History of cervical radiculopathy/brachial plexus lesion
6. Neuromuscular disease history
7. History of physical therapy program for the same shoulder in the last 6 months.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Necmettin Erbakan University

OTHER

Sponsor Role lead

Responsible Party

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Banu Ordahan

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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BANU ORDAHAN

Role: PRINCIPAL_INVESTIGATOR

Meram Medical School, Necmettin Erbakan University, Konya, Turkey

Central Contacts

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BANU ORDAHAN

Role: CONTACT

5058741256

References

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Ordahan B, Yigit F, Mulkoglu C. Efficacy of Low-level Laser Versus High-intensity Laser Therapy in the Management of Adhesive Capsulitis: A Randomized Clinical Trial. Saudi J Med Med Sci. 2023 Jul-Sep;11(3):201-207. doi: 10.4103/sjmms.sjmms_626_22. Epub 2023 Jul 15.

Reference Type DERIVED
PMID: 37533657 (View on PubMed)

Other Identifiers

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BOrdahan

Identifier Type: -

Identifier Source: org_study_id

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