Effectiveness of Low-level Laser Therapy

Hacettepe University

Status: Completed

Conditions: Rehabilitation; Rotator Cuff Injuries; Rotator Cuff Tears

Treatments: Other: In addition to the conservative treatment, Low-level laser therapy; Other: In addition to the conservative treatment, Low-level laser therapy (turned off); Other: Conservative treatment solely

Study type: Interventional

Funder types: Other

Identifiers

NCT04836000

2021100

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

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

Experimental Group

Experimental group

Description:

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

Treatment:

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

Control Group

Active Comparator group

Description:

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

Treatment:

Other: Conservative treatment solely