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HILT and US Therapies in Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis of Shoulder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound Therapy (US)
High-Intensity Laser Therapy (HILT)
Sponsored by
Balikesir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis of Shoulder focused on measuring Frozen Shoulder, Ultrasound, High-Intensity Laser Therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically diagnosed with primary (idiopathic) AC,
  • Pain and movement restriction in his or her shoulder for at least 3 months,
  • Restriction of passive external rotation in the involved shoulder restricted with less than 50% of the contralateral shoulder,
  • Normal radiography findings

Exclusion Criteria:

  • Both shoulders were involved,
  • Other shoulder pathologies (glenohumeral osteoarthritis, calcific tendinitis, rotator cuff tear, etc.),
  • Cervical radiculopathy,
  • Brachial plexus lesion,
  • Neuromuscular disorders,
  • Inflammatory rheumatic disorders,
  • Malignancy,
  • Acute trauma,
  • Patients who had fracture affecting the involved shoulder joint, patients who underwent a surgical intervention, patients who underwent intraarticular injection for the involved shoulder within the last 6 months,
  • Patients who received physical therapy for the glenohumeral joint within the last 1 year, and
  • Photoallergy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Ultrasound Therapy

    High-Intensity Laser Therapy

    Arm Description

    The patients in group 1 received therapeutic US with BTL-4710 ultrasound device. The therapeutic US was administered at the frequency of 3 megahertz, intensity of 1.5 w/cm2 and an area of 25 cm2 for 5 minutes in the continue mode. The procedure of therapeutic US was performed by a physiotherapist experienced in using the device for 15 sessions in total 5 times a week for 3 weeks.

    The patients in group 2 received HILT with BTL-6000 high-intensity laser device. The therapy consisted of 2 stages in each session. The first stage was performed in analgesic mode for analgesic effect at the frequency of 25 Hz, in the wavelength of 1064 nm, the power of 8 watt, the dose of 12 j/cm2, the area of 25 cm2, and 300 j in total for 2 minutes and 30 seconds. The second stage was performed in bio-stimulating mode for biostimulation effect in the wavelength of 1064 nm, the power of 7 watt, the dose of 100 j/cm2, the area of 25 cm2, and 2500 j in total for 5 minutes and 57 seconds. The total length of administration was approximately 8.5 minutes for each stage. The procedure of the therapy was performed by a physiotherapist experienced in using the device for 9 sessions in total 3 times a week for 3 weeks.

    Outcomes

    Primary Outcome Measures

    Visual analogue scale (VAS)-pain,
    Detection of improvements in VAS-pain,
    Shoulder Pain and Disability Index (SPADI)
    Detection of improvements in SPADI
    Joint range of motion (ROM)
    Detection of improvements in joint range of motion (ROM) with goniometer

    Secondary Outcome Measures

    Full Information

    First Posted
    December 30, 2021
    Last Updated
    January 13, 2022
    Sponsor
    Balikesir University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05210036
    Brief Title
    HILT and US Therapies in Adhesive Capsulitis
    Official Title
    Comparison of The Effectiveness of High-intensity Laser and Ultrasound Therapies in Adhesive Capsulitis: A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 15, 2015 (Actual)
    Primary Completion Date
    May 15, 2016 (Actual)
    Study Completion Date
    December 30, 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background: Adhesive capsulitis (AC) is a common musculoskeletal disease characterized by pain and limitation of movement in the shoulders of patients. Purpose: This study aimed to assess the effectiveness of short- and long-term therapeutic ultrasound (US) and high-intensity laser therapy (HILT) in the treatment of AC. Methods: A total of 60 patients with AC were randomized into two groups. Group I received US (15 sessions in total) and Group II received HILT (9 sessions in total) for 3 weeks. In addition, all the patients received 15 sessions of physical therapy programs (hot pack, TENS and therapeutic exercises). Assessments were made using VAS-Pain, Shoulder Pain and Disability Index (SPADI) and range of motion (ROM) with goniometer before and at the end of the treatment and in the posttreatment 1st and 6th months.
    Detailed Description
    INTRODUCTION AC is a common musculoskeletal disease characterized with pain on the patients' shoulder, movement restriction and insufficiency in daily life activities [1]. The prevalence of AC is between 2-5% in general population and higher between the ages of 40 and 60 and among women [2]. The aim in the treatment of AC is to relieve pain and increase the joint range of motion (ROM) and functioning [5]. The treatment of AC remains controversial because the level of evidence for various treatments is limited [6]. Controlled prospective studies are difficult to design and perform because of controversies in the definition, classification, diagnosis and stages of AC [6]. Many different treatment methods such as medical treatment, physical therapy, exercises, intraarticular steroid injections, suprascapular nerve block, manipulation under anesthesia, and surgical interventions are used in the treatment of AC [7]. Although many different treatment methods are used in the treatment of AC there is no consensus on the standard treatment method. Positive effects of physical therapy practices on AC in the short and long term have been revealed [8]. Among physical therapy practices, superficial and deep heating agents (infrared radiation, hot pack, shortwave diathermy, low-density laser therapy, HILT and US, etc.), electrotherapy modalities (Transcutaneous Electrical Nerve Stimulation (TENS), diadinamic current, galvanic current, etc.) and exercises are used alone or in combination in the treatment of AC [9]. Therapeutic US is often used in physical therapy practices in the treatment of AC and the interest in HILT has recently been increasing as well [10]. This study aimed to investigate whether there was a difference between therapeutic US and HILT in terms of the short-term and long-term effects on pain, ROM and functional condition in the treatment of AC. METHODS The study was designed as a prospective, randomized, controlled, and single-blind study. A total of 60 patients who were admitted to the physical therapy and rehabilitation outpatient clinic with pain and movement restriction in their shoulder and who signed the patient information consent form were included in the study. A total of 60 patients who met the inclusion criteria of the study were divided into 2 groups (30 patients in each group) with simple randomization method by using a table of random numbers created on the computer. The researchers who made the assessment measurements were unaware of which patient was in which group. Statistical analysis of the results was performed by a biostatistician who had no information about the therapies the patient groups received. All the patients included in the study received a total of 15 sessions of physical therapy program 5 times a week for 3 weeks. All the patients received hot pack at 60oC for 20 minutes and conventional TENS at 80 Hz for 20 minutes for their involved shoulder. In addition to these therapies, the patients in group 1 received US and those in group 2 received HILT. After physical therapy, all the participants received therapeutic exercise program (3 sets of 10 reps with 3-minute intervals between the sets) consisting of active-assisted ROM, passive stretching and Codman exercises for their shoulder joint for 30 minutes in accompany with a physiotherapist. Interventions for groups; Grup 1 (US) = US + Hot Pack + TENS + Therapeutic Exercise Program Grup 2 (HILT) = HILT + Hot Pack + TENS + Therapeutic Exercise Program The patients were assessed with the measurements of visual analogue scale (VAS)-pain, Shoulder Pain and Disability Index (SPADI) and ROM with goniometer before and at the end of the treatment and in the posttreatment 1st and 6th months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adhesive Capsulitis of Shoulder
    Keywords
    Frozen Shoulder, Ultrasound, High-Intensity Laser Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasound Therapy
    Arm Type
    Active Comparator
    Arm Description
    The patients in group 1 received therapeutic US with BTL-4710 ultrasound device. The therapeutic US was administered at the frequency of 3 megahertz, intensity of 1.5 w/cm2 and an area of 25 cm2 for 5 minutes in the continue mode. The procedure of therapeutic US was performed by a physiotherapist experienced in using the device for 15 sessions in total 5 times a week for 3 weeks.
    Arm Title
    High-Intensity Laser Therapy
    Arm Type
    Active Comparator
    Arm Description
    The patients in group 2 received HILT with BTL-6000 high-intensity laser device. The therapy consisted of 2 stages in each session. The first stage was performed in analgesic mode for analgesic effect at the frequency of 25 Hz, in the wavelength of 1064 nm, the power of 8 watt, the dose of 12 j/cm2, the area of 25 cm2, and 300 j in total for 2 minutes and 30 seconds. The second stage was performed in bio-stimulating mode for biostimulation effect in the wavelength of 1064 nm, the power of 7 watt, the dose of 100 j/cm2, the area of 25 cm2, and 2500 j in total for 5 minutes and 57 seconds. The total length of administration was approximately 8.5 minutes for each stage. The procedure of the therapy was performed by a physiotherapist experienced in using the device for 9 sessions in total 3 times a week for 3 weeks.
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasound Therapy (US)
    Other Intervention Name(s)
    Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Therapeutic Exercise Program
    Intervention Description
    All the patients included in the study received a total of 15 sessions of physical therapy program 5 times a week for 3 weeks. Physical Therapy Program; Hot Pack at 60 degrees Celsius for 20 minutes TENS at 80 Hz for 20 minutes Therapeutic exercise program (3 sets of 10 reps with 3-minute intervals between the sets) consisting of active-assisted ROM, passive stretching and Codman exercises for their shoulder joint for 30 minutes in accompany with a physiotherapist.
    Intervention Type
    Device
    Intervention Name(s)
    High-Intensity Laser Therapy (HILT)
    Other Intervention Name(s)
    Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Therapeutic Exercise Program
    Intervention Description
    All the patients included in the study received a total of 15 sessions of physical therapy program 5 times a week for 3 weeks. Physical Therapy Program; Hot Pack at 60 degrees Celsius for 20 minutes TENS at 80 Hz for 20 minutes Therapeutic exercise program (3 sets of 10 reps with 3-minute intervals between the sets) consisting of active-assisted ROM, passive stretching and Codman exercises for their shoulder joint for 30 minutes in accompany with a physiotherapist.
    Primary Outcome Measure Information:
    Title
    Visual analogue scale (VAS)-pain,
    Description
    Detection of improvements in VAS-pain,
    Time Frame
    "at the end of the treatment, week 3", "at the end of the treatment, month 1" "at the end of the treatment, month 6"
    Title
    Shoulder Pain and Disability Index (SPADI)
    Description
    Detection of improvements in SPADI
    Time Frame
    "at the end of the treatment, week 3", "at the end of the treatment, month 1" "at the end of the treatment, month 6"
    Title
    Joint range of motion (ROM)
    Description
    Detection of improvements in joint range of motion (ROM) with goniometer
    Time Frame
    "at the end of the treatment, week 3", "at the end of the treatment, month 1" "at the end of the treatment, month 6"

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinically diagnosed with primary (idiopathic) AC, Pain and movement restriction in his or her shoulder for at least 3 months, Restriction of passive external rotation in the involved shoulder restricted with less than 50% of the contralateral shoulder, Normal radiography findings Exclusion Criteria: Both shoulders were involved, Other shoulder pathologies (glenohumeral osteoarthritis, calcific tendinitis, rotator cuff tear, etc.), Cervical radiculopathy, Brachial plexus lesion, Neuromuscular disorders, Inflammatory rheumatic disorders, Malignancy, Acute trauma, Patients who had fracture affecting the involved shoulder joint, patients who underwent a surgical intervention, patients who underwent intraarticular injection for the involved shoulder within the last 6 months, Patients who received physical therapy for the glenohumeral joint within the last 1 year, and Photoallergy

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    HILT and US Therapies in Adhesive Capsulitis

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