Clinical trial NCT04830748: Effect of Mechanical Traction and Therapeutic Exercises in Treatment of Primary Knee Osteoarthritis
Official title: Effect of Mechanical Traction and Therapeutic Exercises in Treatment of Primary Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Traction
Distraction
Therapeutic exercises
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Malignancy
* presence of skin lesions or infections at the treatment sites

Primary outcomes:
measure: Measurement of knee pain severity change after 4 weeks of intervention
timeFrame: baseline, 4 weeks
Secondary outcomes:
measure: Measurement of Functional Disability change after 4 weeks of intervention
timeFrame: baseline, 4 weeks
measure: Measurement of Isometric quadriceps and hamstring Muscle Strength change after 4 weeks of intervention
timeFrame: baseline, 4 weeks
measure: Measurement of Functional Performance change after 4 weeks of intervention using the 40 meter fast paced walk test
timeFrame: baseline, 4 weeks
measure: Measurement of Functional Performance change after 4 weeks of intervention using the 12 step stair climb test
timeFrame: baseline, 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of physical therapy Cairo university
state: Giza
Study officials:
affiliation: Cairo University
name: Karima Abdelaty Hassan, lecturer
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Ibrahim Magdy Elnaggar, Prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Bellamy 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.
citation: Bohannon RW. Measuring knee extensor muscle strength. Am J Phys Med Rehabil. 2001 Jan;80(1):13-8. doi: 10.1097/00002060-200101000-00004.
citation: Brosseau 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.
citation: Chopra 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.
citation: Fransen 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.
citation: Guermazi 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.
citation: Guermazi 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.
citation: Kennedy 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.
citation: Khademi-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.
citation: Lee 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.
citation: Maher 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.
citation: McAlindon 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.
citation: Palhais 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.
citation: Rausch 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.
citation: Sato T, Sato N, Masui K, Hirano Y. Immediate effects of manual traction on radiographically determined joint space width in the hip joint. J Manipulative Physiol Ther. 2014 Oct;37(8):580-5. doi: 10.1016/j.jmpt.2014.08.002. Epub 2014 Sep 4.
citation: Waller C, Hayes D, Block JE, London NJ. Unload it: the key to the treatment of knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1823-9. doi: 10.1007/s00167-011-1403-6. Epub 2011 Feb 5.