Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05210036 |
| Other study ID # |
Physical Medicine |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 15, 2015 |
| Est. completion date |
December 30, 2016 |
Study information
| Verified date |
January 2022 |
| Source |
Balikesir University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
