Effectiveness of Low-level Laser Therapy

October 30, 2023 updated by: Caner Karartı, Hacettepe University

Effectiveness of Low-level Laser Therapy in Patients With Arthroscopic Rotator Cuff Repair

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Kırşehir, Turkey, 40100
        • Caner KARARTI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
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.
Experimental: Experimental Group
In addition to the conservative treatment of the control group, low-level laser therapy will be applied for 6 weeks.
Other: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant-Murley score (Functional Outcome)
Time Frame: 6 weeks
It assesses four aspects related to shoulder pathology; two subjective: pain and activities of daily living (ADL) and two objective: range of motion (ROM) and strength. The subjective components can receive up to 35 points and the objective 65, resulting in a possible maximum total score of 100 points (best function). Pain and ADL are answered by the patient; ROM and strength require a physical evaluation and are answered by the orthopaedic surgeon or the physiotherapist
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario Rotator Cuff index (Functional Outcome and Quality of life)
Time Frame: 6 weeks
It is a self-administering health questionnaire. It has 21 items, exploring 5 different domains: Physical symptoms, Sports and recreation, Work, Social function, Emotions. Each question uses a visual analogue scale (VAS) - which is a straight line, representing a 100-point scale, ranging from 0-100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. To make the final score more clinically friendly, some minor math is involved. The score can be reported as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. Total final WORC scores can, therefore, range from 0% ( lowest functional status level) to 100% (the highest functional status).
6 weeks
Pain-free mobility of the shoulder
Time Frame: 6 weeks
Pain-free flexion and abduction will be assessed with universal goniometer.
6 weeks
EQ-5D-5L (quality-of-life)
Time Frame: 6 weeks
The 5-level EQ-5D version (EQ-5D-5L) essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
6 weeks
Visual Analog Scale (Pain)
Time Frame: 6 weeks
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
6 weeks
Hospital Anxiety and Depression Scale (HADS, Anxiety and depression)
Time Frame: 6 weeks

The HADS scale is a questionnaire commonly used to assess patient/client levels of Anxiety and Depression. HADS is a valid and reliable self-rating scale that measures anxiety and depression in both hospital and community settings. HADS gives clinically meaningful results as a psychological screening tool and can assess the symptom severity of anxiety and depression disorders in clients with illness and the general population.The two sub-scales, anxiety and depression, have been found to be independent measures. In its current form the HADS is now divided into four stages:

Scores of:

0-7 (Normal) 8-10 (Mild) 11-15 (Moderate) 16-21 (Severe)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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