Knee OsteoarthritisNCT04682171
Low Level Laser Therapy in Knee Osteoarthritis
A study testing Low level laser therapy and Conventional Exercise Therapy in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will be Randomized Controlled Trial. It will be conducted in Allied Hospital Faisalabad. The study will be completed in four months duration. Consecutive sampling technique will be used for data collection. A sample size of 40 patients will be taken in this study. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Low level laser therapy and Conventional Exercise Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Dec 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both males and females
- Patients with age 45-65 years
- Patients with knee OA of grade II or III according to Kellgren-Lawrence grade.
- Pain intensity ranging between> 5 measured by Numeric Pain Rating Scale.
- Patients who had minimum score of 25 on the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) total score.
- Patients having knee pain for at least 3 months.
Who cannot join
- Patients with pain in other lower limb joints.
- Patients with symptomatic hip osteoarthritis.
- Patients with knee surgery in last 6 months.
- Patients with complaint of cancer, diabetes, neurological deficit or uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Low Level Laser Therapy on Knee Pain and Function in Patients With Knee Osteoarthritis
The study will be Randomized Controlled Trial. It will be conducted in Allied Hospital Faisalabad. The study will be completed in four months duration. Consecutive sampling technique will be used for data collection. A sample size of 40 patients will be taken in this study. Participants will be divided into two groups. Group A will be treated by LLLT and conventional exercises. Group B will perform conventional exercises only. Numeric Pain Rating Scale will be used to measure pain. Western Ontario McMaster Universities Osteoarthritis Index Score (WOMAC) and Sit to stand test will be used to measure knee function. Goniometry will be used to measure ROM of knee. The participants will fill numeric pain rating scale and WOMAC as subjective measurements. Knee flexion ROM will be measured with universal Goniometer. Total 12 sessions will be given with three sessions per week. Post treatment readings will be taken at the end of 4th week. Data will be analyzed on SPSS 25.
Read the detailed description
One of the most common forms of arthritis is Osteoarthritis. Approximately 15% of the population is affected by the disease. The prevalence of the disease increases with the age, with the peak incidence at fourth decade of life. Study shows that in Southern Pakistan mean age of the patients suffering from Osteoarthritis was 58 years. The disease was more dominant in women with the 3:8 male to female ratio. Study shows that 13.9% of adults aged 25 years and above and 33.6% of older adults aged over 65 years are suffering from osteoarthritis.
According to Johnston County Osteoarthritis Project prevalence of symptomatic knee OA was recorded to be 16% and 28% for radiographic knee OA. Kellgren-Lawrence classified knee osteoarthritis based on the appearance of osteophytes in knee AP radiographs. Grades 0-4 were assigned with >2 indicating radiographic OA. Pain and stiffness are significant clinical features of OA which leads to reduced physical function while articular cartilage degeneration is considered to be important pathological feature of OA. Genetic factors, age-related physiological changes and biomechanical factors are considered risk factors of osteoarthritis. Several studies shows that increased age and BMI increases the risk of knee osteoarthritis. One of the important factors in knee osteoarthritis is being overweight.Physical inactivity is also associated with osteoarthritis. Most notable symptom of osteoarthritis is pain which is also determining factor of disability in patients with osteoarthritis. Pain increases physical inactivity which leads to increased body weight and eventually predispose the person to osteoarthritis.Quadriceps weakness may contribute to prompt clinical finding of knee osteoarthritis. Pain of osteoarthritis may causes reduced quadriceps strength. However some studies reveal that quadriceps weakness plays as a risk factor for knee osteoarthritis especially in females. Reduced muscle strength was reported in 24% of patients with Kellgren-Lawrence grade II knee OA. It is widely accepted that among the patients with knee osteoarthritis quadriceps weakness is caused by muscle atrophy which reduces muscle strength. It is reported that age-related quadriceps weakness is linked with functional limitations and increased rate of falling among elders.
Treatment options for osteoarthritis include pharmacological and non-pharmacological methods. The primary goal of these treatments is to relieve joint pain and improve functional quality of life. Non-steroidal anti inflammatory (NSAIDS) are used widely but their use is now limited due
to high frequency of side effects specially side effects of gastrointestinal tracts.Therefore non-pharmacological treatment is preferred for elderly patients. Non-pharmacological treatment includes weight reduction, manual therapy, strengthening exercises, electrical stimulation, ultrasound, interferential current and laser therapy.
Low level laser therapy (LLLT) is non-invasive and painless modality used for the treatment of knee osteoarthritis. Studies show that it markedly alleviates both acute and chronic conditions such as carpal tunnel syndrome, knee injuries, low back pain, chronic arthritis and rheumatoid arthritis. Due to its stimulatory effect on tissue metabolism and ability to regulate the inflammatory effect after knee injuries, LLLT is considered as a favorable therapeutic modality for OA. It is reported that LLLT was effective for fibroblast and osteoblast proliferation, bone regeneration, collagen synthesis, cellular oxygenation and release of neurotransmitters linked with pain modulation.
Evidence shows that regular physical activity reduces pain and improves physical function among the patients with knee OA. However being inactive and disuse of affected limb may disturbs joint mechanics leading to softening of articular cartilage which leads to rapid degeneration of cartilage. This study will focus on additive effects of LLL therapy on knee OA patients for improving pain and function. This study will provide an insight in traditional methods that are used in OA patients.
- LITERATURE REVIEW: Osteoarthritis is the most common form arthritis which is overall ranked among 50 common sequelae of injuries and diseases. Almost 250 million people or 4% of the world's population is affected by osteoarthritis. It is generally divided into primary OA and secondary OA. Etiology of primary OA is not clear but some factors such as genetic factor, ethnicity, age related changes and biomechanical factors play an important role. Post traumatic, dysplastic, infectious, inflammatory or biomechanical etiologies are common cause of secondary OA.
Females are more affected with hand, feet and knee OA. Women are more subjected to severe knee OA than men especially after menopause due to the role of estrogen. Oestrogen unmasks the symptoms of OA by increasing pain sensitivity(1). According to a study male to female ratio affected by OA in Pakistan is 3:8.
Most significant symptom of knee OA is pain leading to increased physical inactivity which increases body weight and predispose the person to OA. Obesity is also a risk factor for developing knee OA.
Pain in knee OA also reduces strength in quadriceps muscle. Quadriceps weakness in OA may be associated with the action of quadriceps during gait. Shock absorption at the knee is provided by eccentric contraction of quadriceps. The spontaneous loading at the knee resulting from inability to compensate the large compressive forces leads to quadriceps weakness and osteoarthritic changes.
A number of evidence shows that exercise reduces the symptoms of OA and improves the knee joint function. However the most advantageous type or combination of exercises is uncertain. Physical inactivity and disuse of the affected limb result in loss of flexibility around knee joint leading to impaired joint mechanics and increased clinical findings of pain. Participation in physical activity and exercise has been recorded to improve joint function and beneficial for the treatment of knee OA.
Physical therapy interventions for knee OA include electrical stimulation, manual therapy, strengthening exercises, ultrasound, interferential current therapy, laser therapy and orthotic devices. Low level laser therapy (LLLT) has been widely used for relieving pain in many
musculoskeletal disorders. It has been considered as non-invasive and safe treatment for knee OA due its stimulatory effect on tissue metabolism and ability to regulate inflammatory process after injury Osteoarthritis is more common in females as compared to males. Pain, joint stiffness and reduced physical activity are prominent symptoms of knee OA. Genetic factors, reduced BMI, overweight, age related physical changes and quadriceps weakness are considered risk factors for knee OA. Physical inactivity disturbs the knee biomechanics and increases the symptoms of knee OA. Studies show that exercise helps to improve the symptoms of knee OA and enhance physical function. Low level laser therapy is non-invasive and painless therapeutic modality used for treating knee OA. Evidence proves that LLLT helps in relieving pain of OA and improving microcirculation due to its stimulatory effect on tissue metabolism.
- Conditions
- Knee Osteoarthritis
- Being tested
- Low level laser therapy, Conventional Exercise Therapy
- Keywords
- Knee pain, Knee function, Degenerative knee disease
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser therapyOther
- Gallium aluminium arsenide laser device will be used with wavelength of 850nm, power 100 mW, spot size of 1.0 mm and energy of 6J/point for 60seconds. Total 8 points will be irradiated. It will take 20 minutes.
- Patient will receive treatment in supine position with the affected knee(s) slightly flexed supported by the pillow or rolled towel.
- On the affected knee the laser probe will placed with full contact with skin at 8 points. Three points at medial side of the knee, three points at lateral side and two points at the medial edge of the bicep femoris muscle tendon and semitendinosus muscle tendon in the popliteal fossa
Conventional Exercise TherapyOther
- Quadriceps isometric strengthening exercises.
- Range of motion and active stretching exercises applied to hamstring and quadriceps muscle.
- Hamstring muscle isometric exercises
- Active ankle pump.
- Short arc terminal extension exercises for the knee joint.
- Static and dynamic strengthening exercises for the hip abductors, adductors and extensor group of muscles.
- Non-weight bearing progressive resistance exercises with weighted cuffs, with progression to closed chain exercises as patient's pain allows.
- Isometric exercises were applied with 6 second contractions and rest period of 2 seconds. Isotonic exercises were started as 10 repetitions with half of weight of 10 RM, 10 repetitions with three fourth of this weight and 10 repetitions with whole 10 RM
| Study group | Role | What they receive |
|---|---|---|
| Low level Laser Therapy | Experimental | Low Level Laser Therapy and Conventional Exercise therapy Receives: Other: Low level laser therapy; Other: Conventional Exercise Therapy |
| Conventional ExerciseTherapy | Active comparator | Conventional ExerciseTherapy Receives: Other: Conventional Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
NPRS is a segmented version of Visual Analogue Scale (VAS). It consists of number from 0 to 10. Patient selects a number that best reflects his/her pain intensity where 0 is no pain and 10 is maximum pain. For construct validity, NPRS was highly correlated to Visual Analogue Scale (VAS) (0.86-0.95).The test-retest reliability of this scale is recorded to be 0.96
Measured: 4th week
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
WOMAC is a valid and reliable outcome measuring tool for evaluating patients with hip and knee osteoarthritis. It measures degree of pain (5 questions), severity of joint stiffness (2 questions) and physical functions (17 questions). WOMAC score was recorded on five points Likert Scale ranging from 0-4 where 0 shows no pain/limitation and 4 shows extreme pain/limitation. Maximum score for pain, joint stiffness and physical function are 28, 8 and 68 respectively with total of 96 scores indicating severe disease.
Measured: 4th week
Secondary outcomes (1)
Knee Rang of Motion (Flexion and Extension)
Universal goniometer is a valid and reliable tool for measuring knee range of motion
Measured: 4th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start30 Dec 2020
- Primary completion25 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saima Zahid, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682171
- Sponsor's protocol ID
- REC/RCRS/20/1040 Abeel Ashraf
- Status last verified
- Aug 2021
- First submitted
- 21 Dec 2020
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnson VL, Hunter DJ. The epidemiology of osteoarthritis. Best Pract Res Clin Rheumatol. 2014 Feb;28(1):5-15. doi: 10.1016/j.berh.2014.01.004.
PubMed 24792942Alghadir A, Omar MT, Al-Askar AB, Al-Muteri NK. Effect of low-level laser therapy in patients with chronic knee osteoarthritis: a single-blinded randomized clinical study. Lasers Med Sci. 2014 Mar;29(2):749-55. doi: 10.1007/s10103-013-1393-3. Epub 2013 Aug 3.
PubMed 23912778Akhter E, Bilal S, Kiani A, Haque U. Prevalence of arthritis in India and Pakistan: a review. Rheumatol Int. 2011 Jul;31(7):849-55. doi: 10.1007/s00296-011-1820-3. Epub 2011 Feb 18.
PubMed 21331574Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
PubMed 18163497Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80.
PubMed 17216685Kohn MD, Sassoon AA, Fernando ND. Classifications in Brief: Kellgren-Lawrence Classification of Osteoarthritis. Clin Orthop Relat Res. 2016 Aug;474(8):1886-93. doi: 10.1007/s11999-016-4732-4. Epub 2016 Feb 12. No abstract available.
PubMed 26872913Jackson BD, Wluka AE, Teichtahl AJ, Morris ME, Cicuttini FM. Reviewing knee osteoarthritis--a biomechanical perspective. J Sci Med Sport. 2004 Sep;7(3):347-57. doi: 10.1016/s1440-2440(04)80030-6.
PubMed 15518300Jarvholm B, Lewold S, Malchau H, Vingard E. Age, bodyweight, smoking habits and the risk of severe osteoarthritis in the hip and knee in men. Eur J Epidemiol. 2005;20(6):537-42. doi: 10.1007/s10654-005-4263-x.
PubMed 16121763Christensen R, Bartels EM, Astrup A, Bliddal H. Effect of weight reduction in obese patients diagnosed with knee osteoarthritis: a systematic review and meta-analysis. Ann Rheum Dis. 2007 Apr;66(4):433-9. doi: 10.1136/ard.2006.065904. Epub 2007 Jan 4.
PubMed 17204567Rosemann T, Kuehlein T, Laux G, Szecsenyi J. Osteoarthritis of the knee and hip: a comparison of factors associated with physical activity. Clin Rheumatol. 2007 Nov;26(11):1811-7. doi: 10.1007/s10067-007-0579-0. Epub 2007 Mar 2.
PubMed 17332977Huang Z, Chen J, Ma J, Shen B, Pei F, Kraus VB. Effectiveness of low-level laser therapy in patients with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2015 Sep;23(9):1437-1444. doi: 10.1016/j.joca.2015.04.005. Epub 2015 Apr 23.
PubMed 25914044Alqualo-Costa R, Thome GR, Perracini MR, Liebano RE. Low-level laser therapy and interferential current in patients with knee osteoarthritis: a randomized controlled trial protocol. Pain Manag. 2018 May;8(3):157-166. doi: 10.2217/pmt-2017-0057. Epub 2018 May 3.
PubMed 29722602Alfredo PP, Bjordal JM, Dreyer SH, Meneses SR, Zaguetti G, Ovanessian V, Fukuda TY, Junior WS, Lopes Martins RA, Casarotto RA, Marques AP. Efficacy of low level laser therapy associated with exercises in knee osteoarthritis: a randomized double-blind study. Clin Rehabil. 2012 Jun;26(6):523-33. doi: 10.1177/0269215511425962. Epub 2011 Dec 14.
PubMed 22169831Esser S, Bailey A. Effects of exercise and physical activity on knee osteoarthritis. Curr Pain Headache Rep. 2011 Dec;15(6):423-30. doi: 10.1007/s11916-011-0225-z.
PubMed 21956792
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Level Laser Therapy on Knee Pain and Function in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04682171
- Acronym / sponsor ID
- REC/RCRS/20/1040 Abeel Ashraf
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee pain, Knee function, Degenerative knee disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be Randomized Controlled Trial. It will be conducted in Allied Hospital Faisalabad. The study will be completed in four months duration. Consecutive sampling technique will be used for data collection. A sample size of 40 patients will be taken in this study. Participants will be divided into two groups. Group A will be treated by LLLT and conventional exercises. Group B will perform conventional exercises only. Numeric Pain Rating Scale will be used to measure pain. Western Ontario McMaster Universities Osteoarthritis Index Score (WOMAC) and Sit to stand test will be used to measure knee function. Goniometry will be used to measure ROM of knee. The participants will fill numeric pain rating scale and WOMAC as subjective measurements. Knee flexion ROM will be measured with universal Goniometer. Total 12 sessions will be given with three sessions per week. Post treatment readings will be taken at the end of 4th week. Data will be analyzed on SPSS 25.
Detailed description
One of the most common forms of arthritis is Osteoarthritis. Approximately 15% of the population is affected by the disease. The prevalence of the disease increases with the age, with the peak incidence at fourth decade of life. Study shows that in Southern Pakistan mean age of the patients suffering from Osteoarthritis was 58 years. The disease was more dominant in women with the 3:8 male to female ratio. Study shows that 13.9% of adults aged 25 years and above and 33.6% of older adults aged over 65 years are suffering from osteoarthritis.
According to Johnston County Osteoarthritis Project prevalence of symptomatic knee OA was recorded to be 16% and 28% for radiographic knee OA. Kellgren-Lawrence classified knee osteoarthritis based on the appearance of osteophytes in knee AP radiographs. Grades 0-4 were assigned with >2 indicating radiographic OA. Pain and stiffness are significant clinical features of OA which leads to reduced physical function while articular cartilage degeneration is considered to be important pathological feature of OA. Genetic factors, age-related physiological changes and biomechanical factors are considered risk factors of osteoarthritis. Several studies shows that increased age and BMI increases the risk of knee osteoarthritis. One of the important factors in knee osteoarthritis is being overweight.Physical inactivity is also associated with osteoarthritis. Most notable symptom of osteoarthritis is pain which is also determining factor of disability in patients with osteoarthritis. Pain increases physical inactivity which leads to increased body weight and eventually predispose the person to osteoarthritis.Quadriceps weakness may contribute to prompt clinical finding of knee osteoarthritis. Pain of osteoarthritis may causes reduced quadriceps strength. However some studies reveal that quadriceps weakness plays as a risk factor for knee osteoarthritis especially in females. Reduced muscle strength was reported in 24% of patients with Kellgren-Lawrence grade II knee OA. It is widely accepted that among the patients with knee osteoarthritis quadriceps weakness is caused by muscle atrophy which reduces muscle strength. It is reported that age-related quadriceps weakness is linked with functional limitations and increased rate of falling among elders.
Treatment options for osteoarthritis include pharmacological and non-pharmacological methods. The primary goal of these treatments is to relieve joint pain and improve functional quality of life. Non-steroidal anti inflammatory (NSAIDS) are used widely but their use is now limited due
to high frequency of side effects specially side effects of gastrointestinal tracts.Therefore non-pharmacological treatment is preferred for elderly patients. Non-pharmacological treatment includes weight reduction, manual therapy, strengthening exercises, electrical stimulation, ultrasound, interferential current and laser therapy.
Low level laser therapy (LLLT) is non-invasive and painless modality used for the treatment of knee osteoarthritis. Studies show that it markedly alleviates both acute and chronic conditions such as carpal tunnel syndrome, knee injuries, low back pain, chronic arthritis and rheumatoid arthritis. Due to its stimulatory effect on tissue metabolism and ability to regulate the inflammatory effect after knee injuries, LLLT is considered as a favorable therapeutic modality for OA. It is reported that LLLT was effective for fibroblast and osteoblast proliferation, bone regeneration, collagen synthesis, cellular oxygenation and release of neurotransmitters linked with pain modulation.
Evidence shows that regular physical activity reduces pain and improves physical function among the patients with knee OA. However being inactive and disuse of affected limb may disturbs joint mechanics leading to softening of articular cartilage which leads to rapid degeneration of cartilage. This study will focus on additive effects of LLL therapy on knee OA patients for improving pain and function. This study will provide an insight in traditional methods that are used in OA patients.
- LITERATURE REVIEW: Osteoarthritis is the most common form arthritis which is overall ranked among 50 common sequelae of injuries and diseases. Almost 250 million people or 4% of the world's population is affected by osteoarthritis. It is generally divided into primary OA and secondary OA. Etiology of primary OA is not clear but some factors such as genetic factor, ethnicity, age related changes and biomechanical factors play an important role. Post traumatic, dysplastic, infectious, inflammatory or biomechanical etiologies are common cause of secondary OA.
Females are more affected with hand, feet and knee OA. Women are more subjected to severe knee OA than men especially after menopause due to the role of estrogen. Oestrogen unmasks the symptoms of OA by increasing pain sensitivity(1). According to a study male to female ratio affected by OA in Pakistan is 3:8.
Most significant symptom of knee OA is pain leading to increased physical inactivity which increases body weight and predispose the person to OA. Obesity is also a risk factor for developing knee OA.
Pain in knee OA also reduces strength in quadriceps muscle. Quadriceps weakness in OA may be associated with the action of quadriceps during gait. Shock absorption at the knee is provided by eccentric contraction of quadriceps. The spontaneous loading at the knee resulting from inability to compensate the large compressive forces leads to quadriceps weakness and osteoarthritic changes.
A number of evidence shows that exercise reduces the symptoms of OA and improves the knee joint function. However the most advantageous type or combination of exercises is uncertain. Physical inactivity and disuse of the affected limb result in loss of flexibility around knee joint leading to impaired joint mechanics and increased clinical findings of pain. Participation in physical activity and exercise has been recorded to improve joint function and beneficial for the treatment of knee OA.
Physical therapy interventions for knee OA include electrical stimulation, manual therapy, strengthening exercises, ultrasound, interferential current therapy, laser therapy and orthotic devices. Low level laser therapy (LLLT) has been widely used for relieving pain in many
musculoskeletal disorders. It has been considered as non-invasive and safe treatment for knee OA due its stimulatory effect on tissue metabolism and ability to regulate inflammatory process after injury Osteoarthritis is more common in females as compared to males. Pain, joint stiffness and reduced physical activity are prominent symptoms of knee OA. Genetic factors, reduced BMI, overweight, age related physical changes and quadriceps weakness are considered risk factors for knee OA. Physical inactivity disturbs the knee biomechanics and increases the symptoms of knee OA. Studies show that exercise helps to improve the symptoms of knee OA and enhance physical function. Low level laser therapy is non-invasive and painless therapeutic modality used for treating knee OA. Evidence proves that LLLT helps in relieving pain of OA and improving microcirculation due to its stimulatory effect on tissue metabolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low level Laser Therapy | Experimental | Other: Low level laser therapy, Other: Conventional Exercise TherapyLow Level Laser Therapy and Conventional Exercise therapy |
| Conventional ExerciseTherapy | Active comparator | Other: Conventional Exercise TherapyConventional ExerciseTherapy |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Both males and females
- Patients with age 45-65 years
- Patients with knee OA of grade II or III according to Kellgren-Lawrence grade.
- Pain intensity ranging between> 5 measured by Numeric Pain Rating Scale.
- Patients who had minimum score of 25 on the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) total score.
Key exclusion criteria (4 listed)
- Patients with pain in other lower limb joints.
- Patients with symptomatic hip osteoarthritis.
- Patients with knee surgery in last 6 months.
- Patients with complaint of cancer, diabetes, neurological deficit or uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low level laser therapy* Gallium aluminium arsenide laser device will be used with wavelength of 850nm, power 100 mW, spot size of 1.0 mm and energy of 6J/point for 60seconds. Total 8 points will be irradiated. It will take 20 minutes. * Patient will receive treatment in supine position with the affected knee(s) slightly flexed supported by the pillow or rolled towel. * On the affected knee the laser probe will placed with full contact with skin at 8 points. Three points at medial side of the knee, three points at lateral side and two points at the medial edge of the bicep femoris muscle tendon and semitendinosus muscle tendon in the popliteal fossa | Other | Low level Laser Therapy |
| Conventional Exercise Therapy1. Quadriceps isometric strengthening exercises. 2. Range of motion and active stretching exercises applied to hamstring and quadriceps muscle. 3. Hamstring muscle isometric exercises 4. Active ankle pump. 5. Short arc terminal extension exercises for the knee joint. 6. Static and dynamic strengthening exercises for the hip abductors, adductors and extensor group of muscles. 7. Non-weight bearing progressive resistance exercises with weighted cuffs, with progression to closed chain exercises as patient's pain allows. 8. Isometric exercises were applied with 6 second contractions and rest period of 2 seconds. Isotonic exercises were started as 10 repetitions with half of weight of 10 RM, 10 repetitions with three fourth of this weight and 10 repetitions with whole 10 RM | Other | Conventional ExerciseTherapy, Low level Laser Therapy |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 4th week
NPRS is a segmented version of Visual Analogue Scale (VAS). It consists of number from 0 to 10. Patient selects a number that best reflects his/her pain intensity where 0 is no pain and 10 is maximum pain. For construct validity, NPRS was highly correlated to Visual Analogue Scale (VAS) (0.86-0.95).The test-retest reliability of this scale is recorded to be 0.96
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 4th week
WOMAC is a valid and reliable outcome measuring tool for evaluating patients with hip and knee osteoarthritis. It measures degree of pain (5 questions), severity of joint stiffness (2 questions) and physical functions (17 questions). WOMAC score was recorded on five points Likert Scale ranging from 0-4 where 0 shows no pain/limitation and 4 shows extreme pain/limitation. Maximum score for pain, joint stiffness and physical function are 28, 8 and 68 respectively with total of 96 scores indicating severe disease.
1 secondary outcome
Knee Rang of Motion (Flexion and Extension)
Time frame: 4th Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Background: PubMed 24792942Johnson VL, Hunter DJ. The epidemiology of osteoarthritis. Best Pract Res Clin Rheumatol. 2014 Feb;28(1):5-15. doi: 10.1016/j.berh.2014.01.004.
- Background: PubMed 23912778Alghadir A, Omar MT, Al-Askar AB, Al-Muteri NK. Effect of low-level laser therapy in patients with chronic knee osteoarthritis: a single-blinded randomized clinical study. Lasers Med Sci. 2014 Mar;29(2):749-55. doi: 10.1007/s10103-013-1393-3. Epub 2013 Aug 3.
- Background: PubMed 21331574Akhter E, Bilal S, Kiani A, Haque U. Prevalence of arthritis in India and Pakistan: a review. Rheumatol Int. 2011 Jul;31(7):849-55. doi: 10.1007/s00296-011-1820-3. Epub 2011 Feb 18.
- Background: PubMed 18163497Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
- Background: PubMed 17216685Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80.
- Background: PubMed 26872913Kohn MD, Sassoon AA, Fernando ND. Classifications in Brief: Kellgren-Lawrence Classification of Osteoarthritis. Clin Orthop Relat Res. 2016 Aug;474(8):1886-93. doi: 10.1007/s11999-016-4732-4. Epub 2016 Feb 12. No abstract available.
- Background: PubMed 15518300Jackson BD, Wluka AE, Teichtahl AJ, Morris ME, Cicuttini FM. Reviewing knee osteoarthritis--a biomechanical perspective. J Sci Med Sport. 2004 Sep;7(3):347-57. doi: 10.1016/s1440-2440(04)80030-6.
- Background: PubMed 16121763Jarvholm B, Lewold S, Malchau H, Vingard E. Age, bodyweight, smoking habits and the risk of severe osteoarthritis in the hip and knee in men. Eur J Epidemiol. 2005;20(6):537-42. doi: 10.1007/s10654-005-4263-x.
- Background: PubMed 17204567Christensen R, Bartels EM, Astrup A, Bliddal H. Effect of weight reduction in obese patients diagnosed with knee osteoarthritis: a systematic review and meta-analysis. Ann Rheum Dis. 2007 Apr;66(4):433-9. doi: 10.1136/ard.2006.065904. Epub 2007 Jan 4.
- Background: PubMed 17332977Rosemann T, Kuehlein T, Laux G, Szecsenyi J. Osteoarthritis of the knee and hip: a comparison of factors associated with physical activity. Clin Rheumatol. 2007 Nov;26(11):1811-7. doi: 10.1007/s10067-007-0579-0. Epub 2007 Mar 2.
- Background: PubMed 25914044Huang Z, Chen J, Ma J, Shen B, Pei F, Kraus VB. Effectiveness of low-level laser therapy in patients with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2015 Sep;23(9):1437-1444. doi: 10.1016/j.joca.2015.04.005. Epub 2015 Apr 23.
- Background: PubMed 29722602Alqualo-Costa R, Thome GR, Perracini MR, Liebano RE. Low-level laser therapy and interferential current in patients with knee osteoarthritis: a randomized controlled trial protocol. Pain Manag. 2018 May;8(3):157-166. doi: 10.2217/pmt-2017-0057. Epub 2018 May 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saima Zahid, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low level laser therapy and Conventional Exercise Therapy in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: 4th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04682171, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.