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

Primary Purpose

Pain Disorder, Low Level Laser Therapy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low-level laser therapy
High-intensity laser therapy
Sponsored by
Necmettin Erbakan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Disorder focused on measuring Adhesive capsulitis Pain, High-intensity laser therapy, Low-level laser therapy, Pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    low-level laser therapy

    high-intensity laser therapy

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain. Change from baseline in pain on the VAS at week 3
    This is a 10 cm ruler that describes painlessness at one end and the most severe pain at the other. A patient scores his/her pain from 0 to 10.

    Secondary Outcome Measures

    Shoulder Pain and Disability Index
    The severity of pain and limitation experienced by individuals during certain activities will be evaluated with the Shoulder Pain and Disability Index (SPADI). SPADI is an evaluation method filled by the individual, lasting approximately 5-10 minutes, which questions the state of pain and disability in the shoulder. [11] SPADI consists of 2 sections and 13 sub-headings, namely pain and disability. The first part consists of 5 questions which evaluate the worst pain level being experienced in the last 14 days, lying on the affected side, and level of pain during reaching up, reaching behind the neck, and pushing activity. The second part evaluates the disability level by questioning the level of limitation experienced by the individual during personal care, dressing and carrying activities. The total score range in the scale ranges from 0 to 130. Change from baseline in pain and disability on the Shoulder Pain and Disability Index at week 3
    Measuring the range of motion at shoulder joint
    Shoulder active range of motion (flexion, abduction, internal and external rotation) will be measured with a universal goniometry. Change from baseline in shoulder joint on the measuring the range of motion at shoulder joint at week 3

    Full Information

    First Posted
    July 18, 2022
    Last Updated
    September 27, 2022
    Sponsor
    Necmettin Erbakan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05469672
    Brief Title
    The Effect of Laser Therapy in the Management of Adhesive Capsulitis: a Randomized Clinical Trial
    Official Title
    The Effect of Low-level Laser Versus High-intensity Laser Therapy in the Management of Adhesive Capsulitis: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 25, 2022 (Anticipated)
    Primary Completion Date
    September 25, 2022 (Anticipated)
    Study Completion Date
    October 25, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Necmettin Erbakan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain Disorder, Low Level Laser Therapy
    Keywords
    Adhesive capsulitis Pain, High-intensity laser therapy, Low-level laser therapy, Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    low-level laser therapy
    Arm Type
    Active Comparator
    Arm Description
    LLLT will be performed 3 times a week for a period of 3 weeks
    Arm Title
    high-intensity laser therapy
    Arm Type
    Active Comparator
    Arm Description
    HILT will be performed 3 times a week for a period of 3 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Low-level laser therapy
    Intervention Description
    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
    Intervention Name(s)
    High-intensity laser therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain. Change from baseline in pain on the VAS at week 3
    Description
    This is a 10 cm ruler that describes painlessness at one end and the most severe pain at the other. A patient scores his/her pain from 0 to 10.
    Time Frame
    Baseline-Week 3
    Secondary Outcome Measure Information:
    Title
    Shoulder Pain and Disability Index
    Description
    The severity of pain and limitation experienced by individuals during certain activities will be evaluated with the Shoulder Pain and Disability Index (SPADI). SPADI is an evaluation method filled by the individual, lasting approximately 5-10 minutes, which questions the state of pain and disability in the shoulder. [11] SPADI consists of 2 sections and 13 sub-headings, namely pain and disability. The first part consists of 5 questions which evaluate the worst pain level being experienced in the last 14 days, lying on the affected side, and level of pain during reaching up, reaching behind the neck, and pushing activity. The second part evaluates the disability level by questioning the level of limitation experienced by the individual during personal care, dressing and carrying activities. The total score range in the scale ranges from 0 to 130. Change from baseline in pain and disability on the Shoulder Pain and Disability Index at week 3
    Time Frame
    Baseline and week 3
    Title
    Measuring the range of motion at shoulder joint
    Description
    Shoulder active range of motion (flexion, abduction, internal and external rotation) will be measured with a universal goniometry. Change from baseline in shoulder joint on the measuring the range of motion at shoulder joint at week 3
    Time Frame
    Baseline and week 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients aged between 25-65 years 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 patients with severe pain and shoulder limitation for at least 3 months patients who are literate and able to understand verbal instructions in our language. Exclusion Criteria: Calcific tendinopathy, glenohumeral osteoarthritis, fracture, shoulder surgery, shoulder trauma, history of malignancy and infection, history of inflammatory rheumatic diseases History of bilateral simultaneous adhesive capsulitis Recent history of lung, breast, or bypass surgery/radiotherapy History of corticosteroid injection to the same shoulder in the last 1 year History of cervical radiculopathy/brachial plexus lesion Neuromuscular disease history History of physical therapy program for the same shoulder in the last 6 months.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    BANU ORDAHAN
    Phone
    5058741256
    Email
    banuordahan@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    BANU ORDAHAN
    Organizational Affiliation
    Meram Medical School, Necmettin Erbakan University, Konya, Turkey
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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