Adhesive Capsulitis of ShoulderNCT05210036
HILT and US Therapies in Adhesive Capsulitis
A study testing Ultrasound Therapy (US) and High-Intensity Laser Therapy (HILT) in people with Adhesive Capsulitis of Shoulder and Pain, run by Balikesir University.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Adhesive Capsulitis of Shoulder, Pain, Disability Physical
- What is being tested?
- Ultrasound Therapy (US) and High-Intensity Laser Therapy (HILT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2015to 30 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 11Show fewer
- 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
About this study
Official title: Comparison of The Effectiveness of High-intensity Laser and Ultrasound Therapies in Adhesive Capsulitis: A Randomized Controlled Study
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.
Read the detailed description
INTRODUCTION AC is a common musculoskeletal disease characterized with pain on the patients' shoulder, movement restriction and insufficiency in daily life activities. The prevalence of AC is between 2-5% in general population and higher between the ages of 40 and 60 and among women.
The aim in the treatment of AC is to relieve pain and increase the joint range of motion (ROM) and functioning. The treatment of AC remains controversial because the level of evidence for various treatments is limited. Controlled prospective studies are difficult to design and perform because of controversies in the definition, classification, diagnosis and stages of AC. 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. 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.
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. 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.
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.
- Conditions
- Adhesive Capsulitis of Shoulder, Pain, Disability Physical
- Being tested
- Ultrasound Therapy (US), High-Intensity Laser Therapy (HILT)
- Keywords
- physical therapy modalities, Adhesive capsulitis, high-intensity laser therapy, ultrasound therapy, frozen shoulder
- Medical subject headings
- Bursitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Therapy (US)Device
Also called Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Therapeutic Exercise Program
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.
High-Intensity Laser Therapy (HILT)Device
Also called Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Therapeutic Exercise Program
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: High-Intensity Laser Therapy (HILT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)-pain,
VAS-pain has proven to be reliable and valid method in determining the degree of pain. It is a 100 mm straight line in horizontal axis. Distance from the lowest VAS level to point that the patient marked was measured in mm (0-100) and numerical values of patient's pain severity were determined.
Measured: Pain intensity was assessed using the Visual Analog Scale (VAS) at baseline, immediately after treatment, and at 1 and 6 months post-treatment.
Shoulder Pain and Disability Index (SPADI)
SPADI developed to assess the shoulder pain and disability consists of two parts. In part 1, a total of 5 questions in pain subgroup assess pain of the patient within the last week (VAS, 0: no pain and 10: worst possible pain) and in part 2, a total of 8 questions in disability subgroup assess the degree of difficulty in movement of the patient within the last 1 week (VAS; 0: no difficulty and 10: needs help). A total score of 0 means maximum well-being while the score of 130 means maximum sickness in SPADI consisting of 13 questions in total. In our study, SPADI was assessed separately as Shoulder Pain Index (SPI), Shoulder Disability Index (SDI) and total SPADI.
Measured: Shoulder pain and disability were assessed using the Shoulder Pain and Disability Index (SPADI) at baseline, immediately after treatment, and at 1 and 6 months post-treatment.
Joint range of motion (ROM)
Detection of improvements in joint range of motion (ROM) with goniometer
Measured: Patients were assessed with measurements of ROM with goniometer before and at the end of the treatment and in the post-treatment 1 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start15 Nov 2015
- Primary completion15 May 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis of ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilal Uysal, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210036
- Sponsor's protocol ID
- Physical Medicine
- Status last verified
- Nov 2026
- First submitted
- 30 Dec 2021
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effectiveness of High-intensity Laser and Ultrasound Therapies in Adhesive Capsulitis: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05210036
- Acronym / sponsor ID
- Physical Medicine
- Conditions
- Adhesive Capsulitis of Shoulder, Pain, Disability Physical
- Keywords
- physical therapy modalities, Adhesive capsulitis, high-intensity laser therapy, ultrasound therapy, frozen shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 15 Nov 2015 (actual)
- Primary completion
- 15 May 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The prevalence of AC is between 2-5% in general population and higher between the ages of 40 and 60 and among women.
The aim in the treatment of AC is to relieve pain and increase the joint range of motion (ROM) and functioning. The treatment of AC remains controversial because the level of evidence for various treatments is limited. Controlled prospective studies are difficult to design and perform because of controversies in the definition, classification, diagnosis and stages of AC. 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. 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.
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. 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Therapy | Active comparator | Device: Ultrasound Therapy (US)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. |
| High-Intensity Laser Therapy | Active comparator | Device: High-Intensity Laser Therapy (HILT)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Both shoulders were involved,
- Other shoulder pathologies (glenohumeral osteoarthritis, calcific tendinitis, rotator cuff tear, etc.),
- Cervical radiculopathy,
- Brachial plexus lesion,
- Neuromuscular disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Therapy (US)Also: Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Therapeutic Exercise ProgramAll 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. | Device | Ultrasound Therapy |
| High-Intensity Laser Therapy (HILT)Also: Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Therapeutic Exercise ProgramAll 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. | Device | High-Intensity Laser Therapy |
Primary outcome
Visual analogue scale (VAS)-pain,
Time frame: Pain intensity was assessed using the Visual Analog Scale (VAS) at baseline, immediately after treatment, and at 1 and 6 months post-treatment.
VAS-pain has proven to be reliable and valid method in determining the degree of pain. It is a 100 mm straight line in horizontal axis. Distance from the lowest VAS level to point that the patient marked was measured in mm (0-100) and numerical values of patient's pain severity were determined.
Shoulder Pain and Disability Index (SPADI)
Time frame: Shoulder pain and disability were assessed using the Shoulder Pain and Disability Index (SPADI) at baseline, immediately after treatment, and at 1 and 6 months post-treatment.
SPADI developed to assess the shoulder pain and disability consists of two parts. In part 1, a total of 5 questions in pain subgroup assess pain of the patient within the last week (VAS, 0: no pain and 10: worst possible pain) and in part 2, a total of 8 questions in disability subgroup assess the degree of difficulty in movement of the patient within the last 1 week (VAS; 0: no difficulty and 10: needs help). A total score of 0 means maximum well-being while the score of 130 means maximum sickness in SPADI consisting of 13 questions in total. In our study, SPADI was assessed separately as Shoulder Pain Index (SPI), Shoulder Disability Index (SDI) and total SPADI.
Joint range of motion (ROM)
Time frame: Patients were assessed with measurements of ROM with goniometer before and at the end of the treatment and in the post-treatment 1 and 6 months.
Detection of improvements in joint range of motion (ROM) with goniometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Therapy (US) and High-Intensity Laser Therapy (HILT) in people with Adhesive Capsulitis of Shoulder and Pain, run by Balikesir University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS)-pain, (time frame: Pain intensity was assessed using the Visual Analog Scale (VAS) at baseline, immediately after treatment, and at 1 and 6 months post-treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.