Knee OsteoarthritisNCT04830748
Effect of Mechanical Traction and Therapeutic Exercises in Treatment of Primary Knee Osteoarthritis
A study testing Mechanical knee traction and Therapeutic exercises in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare between therapeutic exercises and therapeutic exercises preceded by mechanical traction in treatment of patients with primary knee osteoarthritis attributed to the outcomes of pain, muscle strength, functional disability and functional performance. Hypotheses 1. 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?
- Mechanical knee traction and Therapeutic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Dec 2022
- 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
- Patients will have grade II of primary knee osteoarthritis.
- Patients with bilateral primary knee osteoarthritis, the more painful knee will be selected as the affected knee in this study.
- Age of patients will range from 45 years to 65 years old.
- Duration of illness will range from 3- 12 months.
Who cannot join
- Malignancy
- presence of skin lesions or infections at the treatment sites
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of physical therapy Cairo university
Cairo, Giza Governorate, 12613
About this study
The purpose of this study is to compare between therapeutic exercises and therapeutic exercises preceded by mechanical traction in treatment of patients with primary knee osteoarthritis attributed to the outcomes of pain, muscle strength, functional disability and functional performance.
Hypotheses
- There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on reduction of knee pain severity in patients with primary knee osteoarthritis.
- There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on reduction of functional disability in patients with primary knee osteoarthritis.
- There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on increasing isometric quadriceps muscle strength in patients with primary knee osteoarthritis.
- There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on increasing isometric hamstring muscle strength in patients with primary knee osteoarthritis.
- There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on decreasing walking time in patients with primary knee osteoarthritis.
- There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on decreasing ascending and descending stairs time in patients with primary knee osteoarthritis.
Read the detailed description
Knee osteoarthritis is the most common cause of musculoskeletal pain and disability, resulting in major disability and pain in affected individuals. It is a chronic degenerative disorder of multifactorial aetiology, including acute and/or chronic insults from normal wear and tear, age, obesity and joint injury. It nearly affects about one in each eight adults worldwide, its prevalence rates vary from 7.8 to 9.3% in Egyptian population.
Current clinical guidelines recommend non pharmacological conservative strategies including physical therapy given their ease of application and relatively low cost with minimal adverse effects (e.g.: strengthening exercises, aerobic exercises, stretching exercises, hydrotherapy, manual therapy, massage therapy, thermotherapy, electrotherapy, ultrasound therapy, external support braces and taping).
It was reported that therapeutic exercise is beneficial for patients with knee osteoarthritis in terms of outcomes of pain, function, performance and quality of life. In addition, it was reported that strengthening, flexibility and neuromotor skill exercises have a large efficacy over aerobic and mind body exercise.
Unloading strategies should be proposed as a first line of therapy for the patient with knee osteoarthritis before any attempts are made at tissue regeneration, repair or replacement.
Manual or mechanical knee joint distraction is a conservative technique that provides transient joint separation and unloading that aids in improving clinical symptoms of patients.
Addition of mechanical knee distraction to therapeutic exercises helps in gaining the positive effects of both exercise and unloading techniques. Although this approach has not been used extensively or applied pragmatically, several studies were found showing promising results in terms of reducing pain at both rest and movement, improving knee flexion and extension range of motion, reducing disability, increasing functional abilities and improving the quality of life of patients.
Forty male and female patients with the diagnosis of primary knee osteoarthritis will be recruited in this study. All patients will be assessed and treated in the outpatient clinic of the faculty of physical therapy, Cairo University. Patients will be randomly distributed into 2 equal experimental groups: the first experimental group will receive therapeutic exercises (stretching and strengthening exercise) while the second experimental group will receive mechanical traction of the knee followed by therapeutic exercises. All patients will be treated for 12 sessions, 3 times per week each other day for 4 weeks. Clinical assessments will include assessment of pain severity, functional disability, isometric muscle strength, and functional performance.
- Conditions
- Knee Osteoarthritis
- Being tested
- Mechanical knee traction, Therapeutic exercises
- Keywords
- Traction, Distraction, Therapeutic exercises
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical knee tractionOther
Continuous knee joint mechanical traction will be applied to the patients positioned in supine lying position with the affected knee flexed at 25-30 degrees by a wedge placed under the affected knee. The thigh will be secured with a strap for stabilization and the leg will be held by the specially designed greave with the weight of traction hanging throughout a pulley system. The amount of traction will be set to about 10% of body weight. The treatment will be applied for 20 minutes continuously, once a day, 3 times per week for 4 weeks. The traction force will be progressed gradually during the program ( e.g.: weekly increase force by 1% of body weight if the patient can tolerate the duration of 20 min with the preset force).
Therapeutic exercisesOther
Therapeutic exercises will be divided into stretching and strengthening exercises:
Stretching will be done passively for the hamstring, rectus femoris and calf muscles. Each exercise will be done for 3 reps each with a hold period of 30-60 secs with a 30-60 rest period between reps.
Strengthening exercises will be done for the quadriceps and hamstring muscles ( inner range knee extension- knee extension in sitting- straight leg raise in flexion- prone hamstring curl- standing hamstring curl- straight leg raise in extension). Exercise will be done for 3 sets each will consist of 10 reps with a rest period of 2-3 minutes between sets. The starting weight should be 50% of the patient's 1 RM. The end position will be held for 5 seconds. Progression will be achieved by increasing the exercise rep and intensity gradually throughout the program. E.g.: weekly increase force by 5% if patient can tolerate an increased repetition of 20 rep with the preset force.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic exercises group | Active comparator | The first group will receive therapeutic exercises in the form of stretching and strengthening exercises of the knee. Receives: Other: Therapeutic exercises |
| Therapeutic exercises and mechanical traction group | Experimental | The experimental group will receive the same exercise program of the first group preceded by continuous mechanical traction of the knee. Receives: Other: Mechanical knee traction; Other: Therapeutic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of knee pain severity change after 4 weeks of intervention
Knee pain severity will be measured on an 11-point numerical pain rating scale, where 0= no pain and 10= worst possible pain.
Measured: baseline, 4 weeks
Secondary outcomes (4)
Measurement of Functional Disability change after 4 weeks of intervention
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered patient reported measure that is both valid and disease-specific.It has been translated and validated into Arabic language. It is a 24-item questionnaire, grouped into three subscales including pain; stiffness; and physical function. Total score ranges from 0 (best) to 96 (worst) points.
Measured: baseline, 4 weeks
Measurement of Isometric quadriceps and hamstring Muscle Strength change after 4 weeks of intervention
Isometric muscle strength (Nm/kg) will be recorded for quadriceps and hamstring muscle groups. Using a hand held dynamo-meter the torque generated by the muscle is measured in newton-metre (Nm) which is later normalised to body mass in kilograms (kg).
muscle strength = Torque (Nm) / body mass (kg).
Measured: baseline, 4 weeks
Measurement of Functional Performance change after 4 weeks of intervention using the 40 meter fast paced walk test
The 40 meter fast paced walk test is a performance-based test that measures short distance walking activity. Three trials will be done for each test with a 5 min. rest between trials and a 10 min. rest between tests.
Measured: baseline, 4 weeks
Measurement of Functional Performance change after 4 weeks of intervention using the 12 step stair climb test
The 12 step stair climb test is a performance-based test that measures the time required to go up and down 12 stairs (step height, 17 cm; step depth, 30 cm). Three trials will be done for each test with a 5 min. rest between trials and a 10 min. rest between tests.
Measured: baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 May 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- 2 groups The first group will include 20 patients and will receive therapeutic exercises in the form of stretching and strengthening exercises of the knee. The second group will include 20 patients and will receive the same exercise program of the first group preceded by continuous mechanical traction of the knee.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, moaaz ragab riyad amin, Cairo University
- Investigators
- Karima Abdelaty Hassan, lecturer, Study director, Cairo UniversityIbrahim Magdy Elnaggar, Prof, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830748
- Sponsor's protocol ID
- MT & TE & 1ry KOA
- Status last verified
- Dec 2022
- First submitted
- 19 Mar 2021
- Last updated
- 8 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alpayci M, Ozkan Y, Yazmalar L, Hiz O, Ediz L. A randomized controlled trial on the efficacy of intermittent and continuous traction for patients with knee osteoarthritis. Clin Rehabil. 2013 Apr;27(4):347-54. doi: 10.1177/0269215512459062. Epub 2012 Sep 7.
PubMed 22960239Bellamy N, Campbell J, Stevens J, Pilch L, Stewart C, Mahmood Z. Validation study of a computerized version of the Western Ontario and McMaster Universities VA3.0 Osteoarthritis Index. J Rheumatol. 1997 Dec;24(12):2413-5.
PubMed 9415651Bohannon RW. Measuring knee extensor muscle strength. Am J Phys Med Rehabil. 2001 Jan;80(1):13-8. doi: 10.1097/00002060-200101000-00004.
PubMed 11138949Brosseau L, Taki J, Desjardins B, Thevenot O, Fransen M, Wells GA, Mizusaki Imoto A, Toupin-April K, Westby M, Alvarez Gallardo IC, Gifford W, Laferriere L, Rahman P, Loew L, De Angelis G, Cavallo S, Shallwani SM, Aburub A, Bennell KL, Van der Esch M, Simic M, McConnell S, Harmer A, Kenny GP, Paterson G, Regnaux JP, Lefevre-Colau MM, McLean L. The Ottawa panel clinical practice guidelines for the management of knee osteoarthritis. Part two: strengthening exercise programs. Clin Rehabil. 2017 May;31(5):596-611. doi: 10.1177/0269215517691084. Epub 2017 Feb 1.
PubMed 28183213Chopra A, Abdel-Nasser A. Epidemiology of rheumatic musculoskeletal disorders in the developing world. Best Pract Res Clin Rheumatol. 2008 Aug;22(4):583-604. doi: 10.1016/j.berh.2008.07.001.
PubMed 18783739Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24.
PubMed 26405113Guermazi A, Hunter DJ, Roemer FW. Plain radiography and magnetic resonance imaging diagnostics in osteoarthritis: validated staging and scoring. J Bone Joint Surg Am. 2009 Feb;91 Suppl 1:54-62. doi: 10.2106/JBJS.H.01385.
PubMed 19182026Guermazi M, Poiraudeau S, Yahia M, Mezganni M, Fermanian J, Habib Elleuch M, Revel M. Translation, adaptation and validation of the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) for an Arab population: the Sfax modified WOMAC. Osteoarthritis Cartilage. 2004 Jun;12(6):459-68. doi: 10.1016/j.joca.2004.02.006.
PubMed 15135142Kennedy DM, Stratford PW, Wessel J, Gollish JD, Penney D. Assessing stability and change of four performance measures: a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskelet Disord. 2005 Jan 28;6:3. doi: 10.1186/1471-2474-6-3.
PubMed 15679884Khademi-Kalantari K, Mahmoodi Aghdam S, Akbarzadeh Baghban A, Rezayi M, Rahimi A, Naimee S. Effects of non-surgical joint distraction in the treatment of severe knee osteoarthritis. J Bodyw Mov Ther. 2014 Oct;18(4):533-9. doi: 10.1016/j.jbmt.2013.12.001. Epub 2013 Dec 11.
PubMed 25440203Lee DK, Lee NY. Case study of continuous knee joint traction treatment on the pain and quality of life of patients with degenerative gonarthritis. J Phys Ther Sci. 2018 Jun;30(6):848-849. doi: 10.1589/jpts.30.852. Epub 2018 Jun 12.
PubMed 29950778Maher S, Creighton D, Kondratek M, Krauss J, Qu X. The effect of tibio-femoral traction mobilization on passive knee flexion motion impairment and pain: a case series. J Man Manip Ther. 2010 Mar;18(1):29-36. doi: 10.1179/106698110X12595770849560.
PubMed 21655421McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
PubMed 24462672Palhais NS, Guntern D, Kagel A, Wettstein M, Mouhsine E, Theumann N. Direct magnetic resonance arthrography of the knee: utility of axial traction. Eur Radiol. 2009 Sep;19(9):2225-31. doi: 10.1007/s00330-009-1389-3. Epub 2009 Apr 7.
PubMed 19350249Rausch Osthoff AK, Niedermann K, Braun J, Adams J, Brodin N, Dagfinrud H, Duruoz T, Esbensen BA, Gunther KP, Hurkmans E, Juhl CB, Kennedy N, Kiltz U, Knittle K, Nurmohamed M, Pais S, Severijns G, Swinnen TW, Pitsillidou IA, Warburton L, Yankov Z, Vliet Vlieland TPM. 2018 EULAR recommendations for physical activity in people with inflammatory arthritis and osteoarthritis. Ann Rheum Dis. 2018 Sep;77(9):1251-1260. doi: 10.1136/annrheumdis-2018-213585. Epub 2018 Jul 11.
PubMed 29997112
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mechanical Traction and Therapeutic Exercises in Treatment of Primary Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04830748
- Acronym / sponsor ID
- MT & TE & 1ry KOA
- Conditions
- Knee Osteoarthritis
- Keywords
- Traction, Distraction, Therapeutic exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 5 Apr 2021 (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 purpose of this study is to compare between therapeutic exercises and therapeutic exercises preceded by mechanical traction in treatment of patients with primary knee osteoarthritis attributed to the outcomes of pain, muscle strength, functional disability and functional performance.
Hypotheses
- There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on reduction of knee pain severity in patients with primary knee osteoarthritis.
- There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on reduction of functional disability in patients with primary knee osteoarthritis.
- There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on increasing isometric quadriceps muscle strength in patients with primary knee osteoarthritis.
- There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on increasing isometric hamstring muscle strength in patients with primary knee osteoarthritis.
- There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on decreasing walking time in patients with primary knee osteoarthritis.
- There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on decreasing ascending and descending stairs time in patients with primary knee osteoarthritis.
Detailed description
Knee osteoarthritis is the most common cause of musculoskeletal pain and disability, resulting in major disability and pain in affected individuals. It is a chronic degenerative disorder of multifactorial aetiology, including acute and/or chronic insults from normal wear and tear, age, obesity and joint injury. It nearly affects about one in each eight adults worldwide, its prevalence rates vary from 7.8 to 9.3% in Egyptian population.
Current clinical guidelines recommend non pharmacological conservative strategies including physical therapy given their ease of application and relatively low cost with minimal adverse effects (e.g.: strengthening exercises, aerobic exercises, stretching exercises, hydrotherapy, manual therapy, massage therapy, thermotherapy, electrotherapy, ultrasound therapy, external support braces and taping).
It was reported that therapeutic exercise is beneficial for patients with knee osteoarthritis in terms of outcomes of pain, function, performance and quality of life. In addition, it was reported that strengthening, flexibility and neuromotor skill exercises have a large efficacy over aerobic and mind body exercise.
Unloading strategies should be proposed as a first line of therapy for the patient with knee osteoarthritis before any attempts are made at tissue regeneration, repair or replacement.
Manual or mechanical knee joint distraction is a conservative technique that provides transient joint separation and unloading that aids in improving clinical symptoms of patients.
Addition of mechanical knee distraction to therapeutic exercises helps in gaining the positive effects of both exercise and unloading techniques. Although this approach has not been used extensively or applied pragmatically, several studies were found showing promising results in terms of reducing pain at both rest and movement, improving knee flexion and extension range of motion, reducing disability, increasing functional abilities and improving the quality of life of patients.
Forty male and female patients with the diagnosis of primary knee osteoarthritis will be recruited in this study. All patients will be assessed and treated in the outpatient clinic of the faculty of physical therapy, Cairo University. Patients will be randomly distributed into 2 equal experimental groups: the first experimental group will receive therapeutic exercises (stretching and strengthening exercise) while the second experimental group will receive mechanical traction of the knee followed by therapeutic exercises. All patients will be treated for 12 sessions, 3 times per week each other day for 4 weeks. Clinical assessments will include assessment of pain severity, functional disability, isometric muscle strength, and functional performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups The first group will include 20 patients and will receive therapeutic exercises in the form of stretching and strengthening exercises of the knee. The second group will include 20 patients and will receive the same exercise program of the first group preceded by continuous mechanical traction of the knee.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercises group | Active comparator | Other: Therapeutic exercisesThe first group will receive therapeutic exercises in the form of stretching and strengthening exercises of the knee. |
| Therapeutic exercises and mechanical traction group | Experimental | Other: Mechanical knee traction, Other: Therapeutic exercisesThe experimental group will receive the same exercise program of the first group preceded by continuous mechanical traction of the knee. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients will have grade II of primary knee osteoarthritis.
- Patients with bilateral primary knee osteoarthritis, the more painful knee will be selected as the affected knee in this study.
- Age of patients will range from 45 years to 65 years old.
- Duration of illness will range from 3- 12 months.
Key exclusion criteria (2 listed)
- Malignancy
- presence of skin lesions or infections at the treatment sites
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 |
|---|---|---|
| Mechanical knee tractionContinuous knee joint mechanical traction will be applied to the patients positioned in supine lying position with the affected knee flexed at 25-30 degrees by a wedge placed under the affected knee. The thigh will be secured with a strap for stabilization and the leg will be held by the specially designed greave with the weight of traction hanging throughout a pulley system. The amount of traction will be set to about 10% of body weight. The treatment will be applied for 20 minutes continuously, once a day, 3 times per week for 4 weeks. The traction force will be progressed gradually during the program ( e.g.: weekly increase force by 1% of body weight if the patient can tolerate the duration of 20 min with the preset force). | Other | Therapeutic exercises and mechanical traction group |
| Therapeutic exercisesTherapeutic exercises will be divided into stretching and strengthening exercises: Stretching will be done passively for the hamstring, rectus femoris and calf muscles. Each exercise will be done for 3 reps each with a hold period of 30-60 secs with a 30-60 rest period between reps. Strengthening exercises will be done for the quadriceps and hamstring muscles ( inner range knee extension- knee extension in sitting- straight leg raise in flexion- prone hamstring curl- standing hamstring curl- straight leg raise in extension). Exercise will be done for 3 sets each will consist of 10 reps with a rest period of 2-3 minutes between sets. The starting weight should be 50% of the patient's 1 RM. The end position will be held for 5 seconds. Progression will be achieved by increasing the exercise rep and intensity gradually throughout the program. E.g.: weekly increase force by 5% if patient can tolerate an increased repetition of 20 rep with the preset force. | Other | Therapeutic exercises and mechanical traction group, Therapeutic exercises group |
Primary outcome
Measurement of knee pain severity change after 4 weeks of intervention
Time frame: baseline, 4 weeks
Knee pain severity will be measured on an 11-point numerical pain rating scale, where 0= no pain and 10= worst possible pain.
4 secondary outcomes
Measurement of Functional Disability change after 4 weeks of intervention
Time frame: baseline, 4 weeks
Measurement of Isometric quadriceps and hamstring Muscle Strength change after 4 weeks of intervention
Time frame: baseline, 4 weeks
Measurement of Functional Performance change after 4 weeks of intervention using the 40 meter fast paced walk test
Time frame: baseline, 4 weeks
Measurement of Functional Performance change after 4 weeks of intervention using the 12 step stair climb test
Time frame: baseline, 4 weeks
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 8 Dec 2022.
- Background: PubMed 22960239Alpayci M, Ozkan Y, Yazmalar L, Hiz O, Ediz L. A randomized controlled trial on the efficacy of intermittent and continuous traction for patients with knee osteoarthritis. Clin Rehabil. 2013 Apr;27(4):347-54. doi: 10.1177/0269215512459062. Epub 2012 Sep 7.
- Background: PubMed 9415651Bellamy N, Campbell J, Stevens J, Pilch L, Stewart C, Mahmood Z. Validation study of a computerized version of the Western Ontario and McMaster Universities VA3.0 Osteoarthritis Index. J Rheumatol. 1997 Dec;24(12):2413-5.
- Background: PubMed 11138949Bohannon RW. Measuring knee extensor muscle strength. Am J Phys Med Rehabil. 2001 Jan;80(1):13-8. doi: 10.1097/00002060-200101000-00004.
- Background: PubMed 28183213Brosseau L, Taki J, Desjardins B, Thevenot O, Fransen M, Wells GA, Mizusaki Imoto A, Toupin-April K, Westby M, Alvarez Gallardo IC, Gifford W, Laferriere L, Rahman P, Loew L, De Angelis G, Cavallo S, Shallwani SM, Aburub A, Bennell KL, Van der Esch M, Simic M, McConnell S, Harmer A, Kenny GP, Paterson G, Regnaux JP, Lefevre-Colau MM, McLean L. The Ottawa panel clinical practice guidelines for the management of knee osteoarthritis. Part two: strengthening exercise programs. Clin Rehabil. 2017 May;31(5):596-611. doi: 10.1177/0269215517691084. Epub 2017 Feb 1.
- Background: PubMed 18783739Chopra A, Abdel-Nasser A. Epidemiology of rheumatic musculoskeletal disorders in the developing world. Best Pract Res Clin Rheumatol. 2008 Aug;22(4):583-604. doi: 10.1016/j.berh.2008.07.001.
- Background: PubMed 26405113Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24.
- Background: PubMed 19182026Guermazi A, Hunter DJ, Roemer FW. Plain radiography and magnetic resonance imaging diagnostics in osteoarthritis: validated staging and scoring. J Bone Joint Surg Am. 2009 Feb;91 Suppl 1:54-62. doi: 10.2106/JBJS.H.01385.
- Background: PubMed 15135142Guermazi M, Poiraudeau S, Yahia M, Mezganni M, Fermanian J, Habib Elleuch M, Revel M. Translation, adaptation and validation of the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) for an Arab population: the Sfax modified WOMAC. Osteoarthritis Cartilage. 2004 Jun;12(6):459-68. doi: 10.1016/j.joca.2004.02.006.
- Background: PubMed 15679884Kennedy DM, Stratford PW, Wessel J, Gollish JD, Penney D. Assessing stability and change of four performance measures: a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskelet Disord. 2005 Jan 28;6:3. doi: 10.1186/1471-2474-6-3.
- Background: PubMed 25440203Khademi-Kalantari K, Mahmoodi Aghdam S, Akbarzadeh Baghban A, Rezayi M, Rahimi A, Naimee S. Effects of non-surgical joint distraction in the treatment of severe knee osteoarthritis. J Bodyw Mov Ther. 2014 Oct;18(4):533-9. doi: 10.1016/j.jbmt.2013.12.001. Epub 2013 Dec 11.
- Background: PubMed 29950778Lee DK, Lee NY. Case study of continuous knee joint traction treatment on the pain and quality of life of patients with degenerative gonarthritis. J Phys Ther Sci. 2018 Jun;30(6):848-849. doi: 10.1589/jpts.30.852. Epub 2018 Jun 12.
- Background: PubMed 21655421Maher S, Creighton D, Kondratek M, Krauss J, Qu X. The effect of tibio-femoral traction mobilization on passive knee flexion motion impairment and pain: a case series. J Man Manip Ther. 2010 Mar;18(1):29-36. doi: 10.1179/106698110X12595770849560.
- 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.
Karima Abdelaty Hassan, lecturer study director
Cairo University
Ibrahim Magdy Elnaggar, Prof study director
Cairo 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 Mechanical knee traction and Therapeutic exercises in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 2 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 8 Dec 2022. 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 Egypt. 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?
Measurement of knee pain severity change after 4 weeks of intervention (time frame: baseline, 4 weeks). 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 NCT04830748, which also lists 17 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 8 Dec 2022.