Effectiveness of Low-level Laser Therapy

NCT04836000 | Completed

• 1 other identifier: 2021100
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Tears; Rehabilitation; Rotator Cuff Injuries

Keywords

Laser Therapy; Low-Level; Biostimulation; Phototherapy; Rotator Cuff Injuries; Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• Constant-Murley score (Functional Outcome)

  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 Outcomes (5)

• Western Ontario Rotator Cuff index (Functional Outcome and Quality of life)

  6 weeks

• Pain-free mobility of the shoulder

  6 weeks

• EQ-5D-5L (quality-of-life)

  6 weeks

• Visual Analog Scale (Pain)

  6 weeks

• Hospital Anxiety and Depression Scale (HADS, Anxiety and depression)

  6 weeks

Study Arms (3)

Placebo Group

PLACEBO COMPARATOR

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)

Experimental Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

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

Experimental Group

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

Placebo Group

Conservative treatment solely 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.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Caner KARARTI

Kırşehir, 40100, Turkey (Türkiye)

Location

Related Publications (5)

• Kuhn JE, Dunn WR, Sanders R, An Q, Baumgarten KM, Bishop JY, Brophy RH, Carey JL, Holloway BG, Jones GL, Ma CB, Marx RG, McCarty EC, Poddar SK, Smith MV, Spencer EE, Vidal AF, Wolf BR, Wright RW; MOON Shoulder Group. Effectiveness of physical therapy in treating atraumatic full-thickness rotator cuff tears: a multicenter prospective cohort study. J Shoulder Elbow Surg. 2013 Oct;22(10):1371-9. doi: 10.1016/j.jse.2013.01.026. Epub 2013 Mar 27.

  PMID: 23540577 BACKGROUND

• Ranebo MC, Bjornsson Hallgren HC, Holmgren T, Adolfsson LE. Surgery and physiotherapy were both successful in the treatment of small, acute, traumatic rotator cuff tears: a prospective randomized trial. J Shoulder Elbow Surg. 2020 Mar;29(3):459-470. doi: 10.1016/j.jse.2019.10.013. Epub 2020 Jan 7.

  PMID: 31924516 BACKGROUND

• Kukkonen J, Joukainen A, Lehtinen J, Mattila KT, Tuominen EK, Kauko T, Aarimaa V. Treatment of Nontraumatic Rotator Cuff Tears: A Randomized Controlled Trial with Two Years of Clinical and Imaging Follow-up. J Bone Joint Surg Am. 2015 Nov 4;97(21):1729-37. doi: 10.2106/JBJS.N.01051.

  PMID: 26537160 BACKGROUND

• Awotidebe AW, Inglis-Jassiem G, Young T. Low-level laser therapy and exercise for patients with shoulder disorders in physiotherapy practice (a systematic review protocol). Syst Rev. 2015 Apr 30;4:60. doi: 10.1186/s13643-015-0050-2.

  PMID: 25925768 BACKGROUND

• Haslerud S, Magnussen LH, Joensen J, Lopes-Martins RA, Bjordal JM. The efficacy of low-level laser therapy for shoulder tendinopathy: a systematic review and meta-analysis of randomized controlled trials. Physiother Res Int. 2015 Jun;20(2):108-25. doi: 10.1002/pri.1606. Epub 2014 Dec 2.

  PMID: 25450903 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Caner Karartı, Hacettepe University

Model Details: Randomized

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: April 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: October 30, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)