Clinical trial NCT05210036: 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
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis of Shoulder
Keywords: Frozen Shoulder, Ultrasound, High-Intensity Laser Therapy
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual analogue scale (VAS)-pain,
timeFrame: "at the end of the treatment, week 3", "at the end of the treatment, month 1" "at the end of the treatment, month 6"
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: "at the end of the treatment, week 3", "at the end of the treatment, month 1" "at the end of the treatment, month 6"
measure: Joint range of motion (ROM)
timeFrame: "at the end of the treatment, week 3", "at the end of the treatment, month 1" "at the end of the treatment, month 6"
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: