Pain DisorderNCT05469672
The Effect of Laser Therapy in the Management of Adhesive Capsulitis: a Randomized Clinical Trial
A study testing Low-level laser therapy and High-intensity laser therapy in people with Pain Disorder and Low Level Laser Therapy, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to compare the effects of low-level laser therapy (LLLT) and high-intensity laser therapy (HILT) on shoulder joint range of motion, level of pain and functional status in patients with adhesive capsulitis Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Pain Disorder, Low Level Laser Therapy
- What is being tested?
- Low-level laser therapy and High-intensity laser therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2020to 27 Nov 2021
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients aged between 25-65 years
- patients clinically diagnosed with adhesive capsulitis, characterized by limitation of passive external rotation of the affected shoulder to less than 50% of the contralateral shoulder and normal radiographic finding of the affected shoulder
- patients with severe pain and shoulder limitation for at least 3 months
- patients who are literate and able to understand verbal instructions in our language.
Who cannot join
- Calcific tendinopathy, glenohumeral osteoarthritis, fracture, shoulder surgery, shoulder trauma, history of malignancy and infection, history of inflammatory rheumatic diseases
- History of bilateral simultaneous adhesive capsulitis
- Recent history of lung, breast, or bypass surgery/radiotherapy
- History of corticosteroid injection to the same shoulder in the last 1 year
- History of cervical radiculopathy/brachial plexus lesion
- Neuromuscular disease history
- History of physical therapy program for the same shoulder in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Low-level Laser Versus High-intensity Laser Therapy in the Management of Adhesive Capsulitis: a Randomized Clinical Trial
In this study, it was aimed to compare the effects of low-level laser therapy (LLLT) and high-intensity laser therapy (HILT) on shoulder joint range of motion, level of pain and functional status in patients with adhesive capsulitis
Read the detailed description
This study will be designed as a randomized, prospective, single-blind clinical trial with a 3-week follow-up. A total of 50 patients who applied to our hospital with the complaint of shoulder pain will be evaluated for inclusion in the study. Patients will be randomized into two groups as high-intensity laser (HILT) + stretching exercise group and low-level laser (LLLT) + stretching exercise group.
- Conditions
- Pain Disorder, Low Level Laser Therapy
- Being tested
- Low-level laser therapy, High-intensity laser therapy
- Keywords
- Adhesive capsulitis Pain, High-intensity laser therapy, Low-level laser therapy, Pain
- Medical subject headings
- Somatoform Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapyOther
For LLLT, laser treatment will be applied using gallium-aluminum-arsenide (GaAIAs, infrared laser) diode laser (Chattanooga, Mexico, USA) at a wavelength of 904 nm, output power of 240 Mw and a frequency of 5000 Hz. The spot area is about 0.5 cm2. A total of 9 points will irradiated along the glenohumeral joint, with a power density of 3 j/cm2 at each point. The application time was 50 seconds to each point. The total dose per shoulder was 27 J per treatment. Three sessions of LILT therapy per week will administered over a three-week period.
High-intensity laser therapyOther
HILT: A hot laser derived from a Nd: YAG laser has 12 W (watt) and 1064 nm characteristics. The device will administered to the shoulder area in two steps in the HILT group: phase I and phase II. The application will made utilizing continuous circular movements in both phases I and II. The first three sessions consisted of a 75-second intermittent phase analgesic effect at 8 W and 10 J/cm2 for a total energy of 100 J. The following six sessions consisted of a continuous 30-second bio stimulating effect with a dosage of 12 W 120 J/cm2. Over the course of three weeks, nine treatment sessions of HILT will be given.
| Study group | Role | What they receive |
|---|---|---|
| low-level laser therapy | Active comparator | LLLT will be performed 3 times a week for a period of 3 weeks Receives: Other: Low-level laser therapy; Other: High-intensity laser therapy |
| high-intensity laser therapy | Active comparator | HILT will be performed 3 times a week for a period of 3 weeks Receives: Other: Low-level laser therapy; Other: High-intensity laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain. Change from baseline in pain on the VAS at week 3
This is a 10 cm ruler that describes painlessness at one end and the most severe pain at the other. A patient scores his/her pain from 0 to 10.
Measured: Baseline-Week 3
Secondary outcomes (2)
Shoulder Pain and Disability Index
The severity of pain and limitation experienced by individuals during certain activities will be evaluated with the Shoulder Pain and Disability Index (SPADI). SPADI is an evaluation method filled by the individual, lasting approximately 5-10 minutes, which questions the state of pain and disability in the shoulder. [11] SPADI consists of 2 sections and 13 sub-headings, namely pain and disability. The first part consists of 5 questions which evaluate the worst pain level being experienced in the last 14 days, lying on the affected side, and level of pain during reaching up, reaching behind the neck, and pushing activity. The second part evaluates the disability level by questioning the level of limitation experienced by the individual during personal care, dressing and carrying activities. The total score range in the scale ranges from 0 to 130.
Change from baseline in pain and disability on the Shoulder Pain and Disability Index at week 3
Measured: Baseline and week 3
Measuring the range of motion at shoulder joint
Shoulder active range of motion (flexion, abduction, internal and external rotation) will be measured with a universal goniometry.
Change from baseline in shoulder joint on the measuring the range of motion at shoulder joint at week 3
Measured: Baseline and week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start25 Dec 2020
- Primary completion25 Nov 2021
- Study completion27 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain DisorderStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banu Ordahan, Necmettin Erbakan University
- Investigators
- BANU ORDAHAN, Principal investigator, Meram Medical School, Necmettin Erbakan University, Konya, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469672
- Sponsor's protocol ID
- BOrdahan
- Status last verified
- Apr 2026
- First submitted
- 18 Jul 2022
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ordahan B, Yigit F, Mulkoglu C. Efficacy of Low-level Laser Versus High-intensity Laser Therapy in the Management of Adhesive Capsulitis: A Randomized Clinical Trial. Saudi J Med Med Sci. 2023 Jul-Sep;11(3):201-207. doi: 10.4103/sjmms.sjmms_626_22. Epub 2023 Jul 15.
PubMed 37533657
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-level Laser Versus High-intensity Laser Therapy in the Management of Adhesive Capsulitis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05469672
- Acronym / sponsor ID
- BOrdahan
- Conditions
- Pain Disorder, Low Level Laser Therapy
- Keywords
- Adhesive capsulitis Pain, High-intensity laser therapy, Low-level laser therapy, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 25 Dec 2020 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 27 Nov 2021 (actual)
- First posted
- 22 Jul 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.
In this study, it was aimed to compare the effects of low-level laser therapy (LLLT) and high-intensity laser therapy (HILT) on shoulder joint range of motion, level of pain and functional status in patients with adhesive capsulitis
Detailed description
This study will be designed as a randomized, prospective, single-blind clinical trial with a 3-week follow-up. A total of 50 patients who applied to our hospital with the complaint of shoulder pain will be evaluated for inclusion in the study. Patients will be randomized into two groups as high-intensity laser (HILT) + stretching exercise group and low-level laser (LLLT) + stretching exercise group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-level laser therapy | Active comparator | Other: Low-level laser therapy, Other: High-intensity laser therapyLLLT will be performed 3 times a week for a period of 3 weeks |
| high-intensity laser therapy | Active comparator | Other: Low-level laser therapy, Other: High-intensity laser therapyHILT will be performed 3 times a week for a period of 3 weeks |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients aged between 25-65 years
- patients clinically diagnosed with adhesive capsulitis, characterized by limitation of passive external rotation of the affected shoulder to less than 50% of the contralateral shoulder and normal radiographic finding of the affected shoulder
- patients with severe pain and shoulder limitation for at least 3 months
- patients who are literate and able to understand verbal instructions in our language.
Key exclusion criteria (7 listed)
- Calcific tendinopathy, glenohumeral osteoarthritis, fracture, shoulder surgery, shoulder trauma, history of malignancy and infection, history of inflammatory rheumatic diseases
- History of bilateral simultaneous adhesive capsulitis
- Recent history of lung, breast, or bypass surgery/radiotherapy
- History of corticosteroid injection to the same shoulder in the last 1 year
- History of cervical radiculopathy/brachial plexus lesion
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 |
|---|---|---|
| Low-level laser therapyFor LLLT, laser treatment will be applied using gallium-aluminum-arsenide (GaAIAs, infrared laser) diode laser (Chattanooga, Mexico, USA) at a wavelength of 904 nm, output power of 240 Mw and a frequency of 5000 Hz. The spot area is about 0.5 cm2. A total of 9 points will irradiated along the glenohumeral joint, with a power density of 3 j/cm2 at each point. The application time was 50 seconds to each point. The total dose per shoulder was 27 J per treatment. Three sessions of LILT therapy per week will administered over a three-week period. | Other | high-intensity laser therapy, low-level laser therapy |
| High-intensity laser therapyHILT: A hot laser derived from a Nd: YAG laser has 12 W (watt) and 1064 nm characteristics. The device will administered to the shoulder area in two steps in the HILT group: phase I and phase II. The application will made utilizing continuous circular movements in both phases I and II. The first three sessions consisted of a 75-second intermittent phase analgesic effect at 8 W and 10 J/cm2 for a total energy of 100 J. The following six sessions consisted of a continuous 30-second bio stimulating effect with a dosage of 12 W 120 J/cm2. Over the course of three weeks, nine treatment sessions of HILT will be given. | Other | high-intensity laser therapy, low-level laser therapy |
Primary outcome
Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain. Change from baseline in pain on the VAS at week 3
Time frame: Baseline-Week 3
This is a 10 cm ruler that describes painlessness at one end and the most severe pain at the other. A patient scores his/her pain from 0 to 10.
2 secondary outcomes
Shoulder Pain and Disability Index
Time frame: Baseline and week 3
Measuring the range of motion at shoulder joint
Time frame: Baseline and week 3
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 14 Apr 2026.
- Derived from this study: PubMed 37533657Ordahan B, Yigit F, Mulkoglu C. Efficacy of Low-level Laser Versus High-intensity Laser Therapy in the Management of Adhesive Capsulitis: A Randomized Clinical Trial. Saudi J Med Med Sci. 2023 Jul-Sep;11(3):201-207. doi: 10.4103/sjmms.sjmms_626_22. Epub 2023 Jul 15.
- 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.
BANU ORDAHAN principal investigator
Meram Medical School, Necmettin Erbakan University, Konya, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level laser therapy and High-intensity laser therapy in people with Pain Disorder and Low Level Laser Therapy, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
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 7 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 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Analog Scale (VAS) is used to measure and monitor the intensity of pain. Change from baseline in pain on the VAS at week 3 (time frame: Baseline-Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05469672, which also lists 1 linked publication.
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 14 Apr 2026.