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CompletedNCT05062941Updated Sep 30, 2021

The Effect of High-intensity Laser Therapy in Patients With Chronic Shoulder Pain

An interventional study of Conventional physiotherapy and High-intensity laser therapy (HILT) in Chronic Shoulder Pain, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-30.

Sponsored by Marmara University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Apr 2018, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The aim of this study was to investigate the effects of biostimulating, analgesic and noninvasive high intensity laser therapy on pain, functionality and quality of life in patients with chronic shoulder pain. Participants between the ages of 18-75 and without any cognitive, communication and psychiatric problems were included in the study. Patients were randomized into two groups and both received conventional physiotherapy and rehabilitation program for 3 weeks, 5 sessions a week. The treatment program applied was as followed; the control Group (n = 25): conventional physiotherapy and study Group (n = 25): conventional physiotherapy and High-intensity Laser Therapy (HILT). Upper extremity range of motion was evaluated with 'goniometer', pain threshold with 'algometer, muscle strength with 'myometer'; disability status with 'The Disabilities of the Arm, Shoulder and Hand (DASH)'.

Read the detailed description

The aim of this study was to investigate the effects of biostimulating, analgesic and noninvasive high intensity laser therapy on pain, functionality and quality of life in patients with chronic shoulder pain. Participants between the ages of 18-75 and without any cognitive, communication and psychiatric problems were included in the study. Patients were randomized into two groups and both received conventional physiotherapy and rehabilitation program for 3 weeks, 5 sessions a week. The treatment program applied was as followed; the control Group (n = 25): conventional physiotherapy and study Group (n = 25): conventional physiotherapy and High-intensity Laser Therapy (HILT). Upper extremity range of motion was evaluated with 'goniometer', pain threshold with 'algometer, muscle strength with 'myometer'; disability status with 'The Disabilities of the Arm, Shoulder and Hand (DASH)'.

02

Conditions studied

  • Chronic Shoulder Pain

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03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 56 is close to the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Volunteered to participate in the study,
  • Aged 18-75 years
  • being diagnosed with chronic shoulder pain

Exclusion criteria

Exclusion Criteria:

  • not having sufficient cooperation to follow exercises,
  • having any communication problems or psychiatric problems,
  • having any cardiac or orthopedic discomfort that may prevent the application of evaluation methods.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Active comparator
    Control group

    Conventional therapy (CT) was applied to all participants. CT included application of 15 minutes of hot-pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS) in conventional mode, 5 minutes of ultrasound (1.5 W/cm2, 1 MHz), 20 minutes of interference current with vacuum electrodes (80 Hz pulse frequency, 1/1 rectangular spectrum), and exercises (all exercises were applied as 1 set of 10 repetitions in each direction: Codman exercises (3-directions), wand exercises (4-directions), exercises using the shoulder wheel (2-directions), exercises with exercise band (5-directions), exercises on the finger ladder (1 set of 10 repetitions in both directions); and shoulder capsule stretching exercises performed (1 set of 12 repetitions) by asking the subjects to wait 20 seconds where the tension was felt).

    Other: Conventional physiotherapy

  • Active comparator
    Study group

    Same conventional therapy (CT) that was applied to control group was also applied to all participants in this group. CT included application of 15 minutes of hot-pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS), 5 minutes of ultrasound, 20 minutes of interference current with vacuum electrodes, and the same exercises. In addition to the CT program, only study group has received HILT (BTL 6000, BTL Industries, Inc., USA) application to the shoulder area (analgesic mode, 25 Hz,10 W, 12 j/cm2) for 2 minutes.

    Other: Conventional physiotherapy · Device: High-intensity laser therapy (HILT)

Interventions

  • OtherConventional physiotherapy

    Conventional therapy (CT) included application of 15 minutes of hot-pack, 20 minutes of transcutaneous electrical nerve stimulation, 5 minutes of ultrasound, 20 minutes of interference current with vacuum electrodes, and exercises.

  • DeviceHigh-intensity laser therapy (HILT)

    HILT stimulates oxidation of mitochondria and ATP creation by delivering high energy output inside the tissues and with this photochemistry effect, metabolism and blood circulation is increased resulting HILT to cause quick absorption of edema and removal of exudates. HILT (BTL 6000, BTL Industries, Inc., USA) application was to the shoulder area in the analgesic mode of the device at a frequency of 25 Hz with a power of 10 W and a dosage of 12 j/cm2 for 2 minutes: 5 sessions a week for 3 weeks and 15 sessions in total.

06

What researchers measure

Primary outcomes

  1. Change in range of motion from baseline to week 3

    The range of motion of the joints in the upper extremities will be measured using the universal goniometer before and after the treatment.

    Time frame: 3 weeks

  2. Change in pain threshold from baseline to week 3

    The pain threshold will be measured with a digital algometer device. Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure-pain threshold studies that the rate at which manual force is applied should be consistent to provide the greatest reliability.

    Time frame: 3 weeks

  3. Change in disability of the upper extremity from baseline to week 3

    Disability of the upper extremities will be assessed with 'The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire'. It is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The questionnaire was designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time. The 30-item questionnaire includes 21 physical function items, 6 symptom items, and 3 social/role function items. Each 30 items are marked from 1 (No Difficulty) to 5 (Unable). DASH are added to form the raw, or actual, score. A minimum score is 30; a maximum is 150. The range of the scores, therefore-from 30 to 150-equals 120. The raw score is then transformed to a zero-to-100 scale with zero reflecting no disability (good function) and 100 reflecting maximum disability.

    Time frame: 3 weeks

  4. Change in muscle strength from baseline to week 3

    The muscle strength of shoulder flexion, abduction, adduction, external and internal rotation movements will be evaluated by using the Baseline Push-Pull (New York) dynamometer. Results will be calculated in kg (1 lb = 0.454 kg). The patient's arm will be stabilized and the patient will be asked to show maximum resistance within 2 sec against the dynamometer placed and then hold it for 5 seconds at this position and power. The measurement will be repeated twice and recorded with the average of these two values.

    Time frame: 3 weeks

  5. Change in health status from baseline to week 3

    In the evaluation of the health status of the individuals the Short Form-36 (SF-36) questionnaire was used. SF-36 is a questionnaire developed to self-evaluate the quality of life. It consists of 36 items in total and has eight sub-parameters. Subscales are scored between 0 and 100, and higher scores indicate higher quality of life.

    Time frame: 3 weeks

07

Study locations

1 site
  • Cadde Medical Center
    Istanbul, 48965, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05062941
Lead sponsor
Marmara University
Collaborators
Medipol University
Responsible party
Sponsor
First posted
Sep 30, 2021
Start date
Apr 1, 2018
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Sep 30, 2021

Study contacts

Zubeyir Sari, Prof.
study director · Marmara University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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