Clinical trial NCT04321655: Reduce Pain and Improve Quality of Life in Patient With Knee Osteoarthritis by Light, Sound and Brain Stimulation
Official title: Reduce Pain and Improve Quality of Life in Patient With Knee Osteoarthritis by Light, Sound and Brain Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
uphill
incline walking
degeneration
laser therapy
ultrasound
tDCS
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
Collaborators: name: Maharishi Markendeswar University (Deemed to be University)
First posted: 2020-03-25
Enrollment: 160
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients affected with osteoarthritis knee have associated with pain and inflammation of the joint capsule, impaired muscular stabilization, decrease range of motion and functional disability. Laser therapy, phonophoresis, transcranial direct current stimulation (tDCS) and conventional physiotherapy exercises has innumerable benefits to the patients with knee osteoarthritis (KOA).However, it is still not clear which treatment is effective among them in rehabilitating the patients with chronic knee osteoarthritis (KOA). Aim is to establish the benefits of High intensity Laser therapy, phonophoresis, tDCS and conventional physiotherapy in the treatment of patient with chronic KOA living in the hilly terrain. A total of 160 patients with chronic KOA will be recruited by the simple random sampling (random number generator) to participate in randomized, double blind randomized controlled, study. Recruited patients with chronic KOA will be randomly divided into four groups, high intensity-laser therapy (HILT) group, ibuprofen gel phonophoresis (IGP) group, transcranial direct current stimulation (tDCS) group and conventional physiotherapy (CPT) group. Duration of the treatment will be 8 minutes in one session/knee joint for HILT and IGP and 30 minutes in one session for tDCS each day for 3 days/week for 8 weeks. Thus, each patient with chronic KOA will receive 24 sessions in total. The Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC), Digitalized pain pressure algometer (ALGO-DS-01) and 36-Item Short Form Health Survey (SF-36) questionnaire are the outcome measures will be recorded at baseline, end of 8-week post-intervention period.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with clinical chronic knee OA according to the diagnostic criteria of American College of Rheumatology (ACR) were included in the study
* Age between 45-70
* Both sex male and female

Exclusion Criteria:

* Unwillingness to participate in the study,
* Recent history (within the last 3 months) of physical therapy to the same joint,
* Recent history (within the last 3 months) of intra-articular procedure (injection and/or lavage) to the knee,
* History of knee surgery/fracture,
* Acute synovitis/arthritis including the infectious conditions,
* Presence of malignancy,
* Pregnancy
* Taking pain relief medications
* Any metal implants near the site of stimulation

Primary outcomes:
measure: Digitalized pain pressure algometer
timeFrame: Changes will be measured at baseline and end of 8 week intervention
measure: Western Ontario and Mc Master Universities Osteoarthritis Index
timeFrame: Changes will be measured at baseline and end of 8 week intervention
Secondary outcomes:
measure: 36-Item Short Form Health Survey
timeFrame: Changes will be measured at baseline and end of 8 week intervention
Other outcomes:
Locations:
Study officials:
affiliation: Maharishi Markandeshwar Medical College and Hospital
name: Adarsh K Srivastav, MPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Maharishi Markandeshwar Medical College and Hospital
name: Asir J Samuel, MPT, Ph.D
role: STUDY_CHAIR
affiliation: Maharishi Markandeshwar Medical College and Hospital
name: Vipin Saini, Ph.D
role: STUDY_DIRECTOR
References:
citation: Chang WJ, Bennell KL, Hodges PW, Hinman RS, Young CL, Buscemi V, Liston MB, Schabrun SM. Addition of transcranial direct current stimulation to quadriceps strengthening exercise in knee osteoarthritis: A pilot randomised controlled trial. PLoS One. 2017 Jun 30;12(6):e0180328. doi: 10.1371/journal.pone.0180328. eCollection 2017.
citation: Stiglic-Rogoznica N, Stamenkovic D, Frlan-Vrgoc L, Avancini-Dobrovic V, Vrbanic TS. Analgesic effect of high intensity laser therapy in knee osteoarthritis. Coll Antropol. 2011 Sep;35 Suppl 2:183-5.
citation: Coskun Benlidayi I, Gokcen N, Basaran S. Comparative short-term effectiveness of ibuprofen gel and cream phonophoresis in patients with knee osteoarthritis. Rheumatol Int. 2018 Oct;38(10):1927-1932. doi: 10.1007/s00296-018-4099-9. Epub 2018 Jul 12.
citation: Srivastav AK, Sharma N, Samuel AJ. tDCS combined with cognitive training in a patient with chronic traumatic head injury. Neurophysiol Clin. 2020 Apr;50(2):133-134. doi: 10.1016/j.neucli.2020.02.004. Epub 2020 Mar 5. No abstract available.