HILT and US Therapies in Adhesive Capsulitis

NCT05210036 | Completed

• 1 other identifier: Physical Medicine
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adhesive Capsulitis of Shoulder

Keywords

Frozen Shoulder, Ultrasound, High-Intensity Laser Therapy

Outcome Measures

Primary Outcomes (3)

• Visual analogue scale (VAS)-pain,

  Detection of improvements in VAS-pain,

  "at the end of the treatment, week 3", "at the end of the treatment, month 1" "at the end of the treatment, month 6"

• Shoulder Pain and Disability Index (SPADI)

  Detection of improvements in SPADI

  "at the end of the treatment, week 3", "at the end of the treatment, month 1" "at the end of the treatment, month 6"

• Joint range of motion (ROM)

  Detection of improvements in joint range of motion (ROM) with goniometer

  "at the end of the treatment, week 3", "at the end of the treatment, month 1" "at the end of the treatment, month 6"

Study Arms (2)

Ultrasound Therapy

ACTIVE COMPARATOR

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.

Device: Ultrasound Therapy (US)

High-Intensity Laser Therapy

ACTIVE COMPARATOR

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.

Device: High-Intensity Laser Therapy (HILT)

Interventions

Ultrasound Therapy (US) DEVICE

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.

Also known as: Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Therapeutic Exercise Program

Ultrasound Therapy

High-Intensity Laser Therapy (HILT) DEVICE

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.

Also known as: Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Therapeutic Exercise Program

High-Intensity Laser Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Balikesir University: lead

MeSH Terms

Conditions

Bursitis

Interventions

Ultrasonic Therapy; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 27, 2022
• Study Start: November 15, 2015
• Primary Completion: May 15, 2016
• Study Completion: December 30, 2016
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share