Clinical trial NCT04836000: Effectiveness of Low-level Laser Therapy
Official title: Effectiveness of Low-level Laser Therapy in Patients With Arthroscopic Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Rehabilitation
Rotator Cuff Injuries
Keywords: Laser Therapy
Low-Level
Biostimulation
Phototherapy
Rotator Cuff Injuries
Rotator Cuff Tears
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Constant-Murley score (Functional Outcome)
timeFrame: 6 weeks
Secondary outcomes:
measure: Western Ontario Rotator Cuff index (Functional Outcome and Quality of life)
timeFrame: 6 weeks
measure: Pain-free mobility of the shoulder
timeFrame: 6 weeks
measure: EQ-5D-5L (quality-of-life)
timeFrame: 6 weeks
measure: Visual Analog Scale (Pain)
timeFrame: 6 weeks
measure: Hospital Anxiety and Depression Scale (HADS, Anxiety and depression)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Caner KARARTI
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.