Effectiveness of Low-level Laser Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

During rotator cuff tear healing stages, there are complex interactions between a variety of tissue growth factors and cells, ultimately resulting in tissue that is markedly different from that of normal, uninjured tendon. Hence, there is a strong drive to investigate the role of potential therapies in the form of biological augments that may restore the pathologic tissue to a near normal physiological state. In this context, low-level laser therapy (LLLT) may be an effective choice in the treatment of nonoperative small and medium-sized rotator cuff tears (RCT). To the best of our knowledge, there is no randomized controlled study investigating the effects of the LLLT in patients with a arthroscopic rotator cuff repair (ARCR). Therefore, the aim of the current study is to investigate all the possible effects of the LLLT in terms of functional status, pain-free mobility, and quality-of-life.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of High Intensity Lazer Therapy in Partial Supraspinatus Tear

NCT05335785

Supraspinatus Tear

UNKNOWN NA

Effectiveness of Video-Based Rehabilitation Program on Pain, Functionality and Quality of Life in the Treatment of Rotator Cuff Tears

NCT03373799

Rotator Cuff Tear Pain, Shoulder

COMPLETED NA

Telerehabilitation in Individuals With Rotator Cuff Tear

NCT05904249

Rotator Cuff Tears Physiotherapy and Rehabilitation Shoulder Pain +1 more

COMPLETED NA

Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair?

NCT05670080

Rotator Cuff Tears Motor Imagery Muscle Activity +4 more

SUSPENDED NA

The Effect of Laser Therapy in the Management of Adhesive Capsulitis: a Randomized Clinical Trial

NCT05469672

Pain Disorder Low Level Laser Therapy

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Recently, there is a increasing evidence that the addition of low-level laser therapy (LLLT) to treatment program of shoulder problems plays an important role in stimulation of healing, augmenting tissue repair, relief of pain and inflammation, and restoration of function. LLLT, phototherapy or photobiomodulation refers to the use of photons at a non-thermal irradiance to alter biological activity. The basic biological mechanism behind the effects of LLLT is thought to be through absorption of red and near infrared light by mitochondrial chromophores, in particular cytochrome c oxidase (CCO) which is contained in the respiratory chain located within the mitochondria, and perhaps also by photoacceptors in the plasma membrane of cells. It is hypothesized that this absorption of light energy may cause photodissociation of inhibitory nitric oxide from CCO9 leading to enhancement of enzyme activity, electron transport, mitochondrial respiration and adenosine triphosphate (ATP) production. In turn, LLLT alters the cellular redox state which induces the activation of numerous intracellular signaling pathways, and alters the affinity of transcription factors concerned with cell proliferation, survival, tissue repair and regeneration.

During rotator cuff tear healing stages, there are complex interactions between a variety of tissue growth factors and cells, ultimately resulting in tissue that is markedly different from that of normal, uninjured tendon. Hence, there is a strong drive to investigate the role of potential therapies in the form of biological augments that may restore the pathologic tissue to a near normal physiological state. In this context, LLLT may be an effective choice in the treatment of nonoperative small and medium-sized rotator cuff tears (RCT). o the best of our knowledge, there is no randomized controlled study investigating the effects of the LLLT in patients with a arthroscopic rotator cuff repair (ARCR). Therefore, the aim of the current study is to investigate all the possible effects of the LLLT in terms of functional status, pain-free mobility, and quality-of-life.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rotator Cuff Tears Rehabilitation Rotator Cuff Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Double-blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo Group

In addition to the conservative treatment of the control group, low-level laser therapy (turned off) will be applied for 6 weeks. In the placebo group, laser instrument will be applied in the same way but the device will be turned off during treatment sessions.

Group Type PLACEBO_COMPARATOR

In addition to the conservative treatment, Low-level laser therapy (turned off)

Intervention Type OTHER

For Placebo Group In the placebo group, laser instrument will be applied in the same way but the device will be turned off during treatment sessions. Patients and physiotherapist will be asked to use protective eyeglasses during therapy for safety.

Experimental Group

In addition to the conservative treatment of the control group, low-level laser therapy will be applied for 6 weeks.

Group Type EXPERIMENTAL

In addition to the conservative treatment, Low-level laser therapy

Intervention Type OTHER

For Experimental Group A Gallium-aluminum-arsenide (Ga-Al-As) diode laser instrument (Roland Serie, Elettronica Pagani, Paderno, Italy, Mod IR 27/1) will be used (wavelength 904 nm, 5500 Hz frequency, 27 W maximum power output per pulse, 13.2 mW average power, 0.8-cm2 spot size, 1.6 J of total energy will be delivered per point at each session at a power density of 16.5 mW/cm2, and the cumulative energy per point for all sessions was 16 J).

Ga-Al-As laser therapy will be applied to experimental group patients two times per week for 6 weeks in 10-min sessions. LLLT will be applied over the tuberculum majus and minus, the anterior and posterior faces of the capsule, and the subacromial regions. Each point will be treated for 120 sec. The head of the instrument will be held perpendicular to the body surface and in skin contact without pressure.

Control Group

For 6 weeks, all three groups will receive five sessions per week of a protocolised treatment based on therapeutic exercises, analgesic electrotherapy and cryotherapy.

Group Type ACTIVE_COMPARATOR

Conservative treatment solely

Intervention Type OTHER

For Control Group All patients using an immobilization bandage up to post-operative 6th week will receive the standardized 6-week supervised rehabilitation program advocated by the same physiotherapist (CK), 7 years of experience in the clinical treatment of rotator cuff tear, after the baseline assessment. Composed of 30 treatment sessions (five days/week) of 45 to 60 minutes, the rehabilitation program will be provided individually to all participants. Physiotherapy sessions will be devoted to strength, mobilizations, stretching, perturbation, and sensorimotor training using motor control exercises, hence, to restore adequate shoulder neuromuscular control. The treatment program will also be included patient education.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

In addition to the conservative treatment, Low-level laser therapy

For Experimental Group A Gallium-aluminum-arsenide (Ga-Al-As) diode laser instrument (Roland Serie, Elettronica Pagani, Paderno, Italy, Mod IR 27/1) will be used (wavelength 904 nm, 5500 Hz frequency, 27 W maximum power output per pulse, 13.2 mW average power, 0.8-cm2 spot size, 1.6 J of total energy will be delivered per point at each session at a power density of 16.5 mW/cm2, and the cumulative energy per point for all sessions was 16 J).

Ga-Al-As laser therapy will be applied to experimental group patients two times per week for 6 weeks in 10-min sessions. LLLT will be applied over the tuberculum majus and minus, the anterior and posterior faces of the capsule, and the subacromial regions. Each point will be treated for 120 sec. The head of the instrument will be held perpendicular to the body surface and in skin contact without pressure.

Intervention Type OTHER

In addition to the conservative treatment, Low-level laser therapy (turned off)

For Placebo Group In the placebo group, laser instrument will be applied in the same way but the device will be turned off during treatment sessions. Patients and physiotherapist will be asked to use protective eyeglasses during therapy for safety.

Intervention Type OTHER

Conservative treatment solely

For Control Group All patients using an immobilization bandage up to post-operative 6th week will receive the standardized 6-week supervised rehabilitation program advocated by the same physiotherapist (CK), 7 years of experience in the clinical treatment of rotator cuff tear, after the baseline assessment. Composed of 30 treatment sessions (five days/week) of 45 to 60 minutes, the rehabilitation program will be provided individually to all participants. Physiotherapy sessions will be devoted to strength, mobilizations, stretching, perturbation, and sensorimotor training using motor control exercises, hence, to restore adequate shoulder neuromuscular control. The treatment program will also be included patient education.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* being 18-65 years old
* being diagnosed with a rotator cuff tear not exceeding 3 cm based on magnetic resonance imaging and clinical continuity tests
* history of arthroscopic rotator cuff tear
* using a velpeau bandage up to post-operative 6th week
* compliance to range of motion (ROM) exercises including pendulum exercises, passive flexion and abduction stretching, and active cervical movements
* volunteering to participate in the study.

Exclusion Criteria

* Patients with diabetes mellitus
* neurological problems
* cervical disc herniation
* visual, verbal, and/or cognitive defects
* systemic inflammatory problems
* trauma
* contraindications for mobilization
* former shoulder fractures and surgery
* a history of adhesive capsulitis
* traumatic shoulder instability
* patients who were in ≥stage 3 on the Goutallier system
* those who received a corticosteroid injection on the affected side within 6 weeks prior to diagnosis

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No