The Effect of Mobilization With Movement on Pain and Function Among Patients With Knee Osteoarthritis

NCT02865252 | Completed Phase 1 DMC

• 1 other identifier: IRB-2014-04-323
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

Osteoarthritis (OA) is the most prevalent form of arthritis and is reported to be the most important reason behind functional disability and musculoskeletal disorders among aged individuals. OA is "a total joint failure; represented by pathological damage to articular cartilage, that affects bone, menisci, synovium, ligaments, and neuromuscular tissue". Knee OA could be responsible for pain and functional disability in 19.2% of individuals aged more than 45 years in the Framingham study and in 27.8% of such individuals in the Johnston County Osteoarthritis Project. However, in the third National Health and Nutrition Examination Survey (NHANES III), nearly 37% of individuals aged 60 years or older had radiographic knee OA. Oliveria et al. (1995) reported that age- and sex-standardized incidence rates of symptomatic hip, knee, and hand OA were 88, 240, and 100/100,000 person-years, respectively. In addition, the incidence rates of symptomatic OA of the knee, hand, or hip increased rapidly at age 50 and then levelled off beyond age 70. There were not enough data to report the prevalence of OA in Arabic countries. However, a cross-sectional study performed in Saudi Arabia demonstrated radiographic knee OA in 53.3% of men and 60.9% of women, while about 18% of women and 10% of men had symptomatic OA. Although it is well established that OA is mainly caused by damage occurring in the joint because of degeneration and inflammation, there is no known cure for OA and our understanding of the pathological aetiology of OA is still deficient and poorly understood. The primary objective of this study is to investigate the immediate and the carry-over effect of MWM on pain and function in patients with knee OA. A secondary objective is to evaluate this effect among those patients who demonstrate features of central sensitization.

Conditions

Osteoarthritis

Keywords

manual therapy; mobilization with movement

Outcome Measures

Primary Outcomes (14)

• The Visual Analog Scale (VAS)

  Current pain intensity will be measured by a 10-cm line

  Change from Baseline in Visual Analog Scale at Immediate post-intervention

• The Visual Analog Scale (VAS)

  Current pain intensity will be measured by a 10-cm line

  Change from Baseline in Visual Analog Scale at 2 days

• Western Ontario and McMaster Universities (WOMAC) Index

  Self-administered questionnaire presented in Likert-scale format

  Change from Baseline in WOMAC at 2 days

• Self-Leeds Assessment of Neuropathic Symptoms and signs (S-LANSS) Scale

  A clinical-based instrument for identifying patients whose pain is dominated by neuropathic mechanisms

  At Baseline

• Pressure Pain Threshold (PPT)

  A digital pressure algometer will be used to quantify pain intensity in Kpa

  Change from Baseline in PPT at Immediate post-intervention

• Pressure Pain Threshold (PPT)

  A digital pressure algometer will be used to quantify pain intensity in Kpa

  Change from Baseline in PPT at 2 days

• Thermal Perception and Pain Thresholds

  A Thermotest System will be used to determine thermal thresholds in degree centigrade

  Change from Baseline in Thermal Perception and Pain Thresholds at Immediate post-intervention

• Thermal Perception and Pain Thresholds

  A Thermotest System will be used to determine thermal thresholds in degree centigrade

  Change from Baseline in Thermal Perception and Pain Thresholds at 2 days

• Hand-Held Dynamometer

  A digital instrument will be used to examine isometric muscle strength of force development in pound

  Change from Baseline in Hand-Held Dynamometer at Immediate post-intervention

• Hand-Held Dynamometer

  A digital instrument will be used to examine isometric muscle strength of force development for knee flexion and extension in pound

  Change from Baseline in Hand-Held Dynamometer at 2 days

• Standard Goniometer

  Active range of motion for knee flexion and extension in degree

  Change from Baseline in Standard Goniometer at Immediate post-intervention

• Standard Goniometer

  Active range of motion for knee flexion and extension in degree

  Change from Baseline in Standard Goniometer at 2 days

• Three-meter Timed "Up and Go"

  A walk test will be used to test a basic functional mobility

  Change from Baseline in Three-meter Timed "Up and Go" at Immediate post-intervention

• Three-meter Timed "Up and Go"

  A walk test will be used to test a basic functional mobility

  Change from Baseline in Three-meter Timed "Up and Go" at 2 days

Study Arms (2)

MWM treatment

ACTIVE COMPARATOR

Mobilization with movement (MWM) is a combination of sustained passive accessory joint mobilization with an active or functional movement. MWM will be applied (three sets of 10 repetitions) during active knee flexion and extension range of motion (ROM). The therapist initially will apply the pain-free manual glide force on the tibia with the knee resting in a mid-range position. The glide force will be sustained while the patient performed 10 repetitions of self-active full range knee flexion and extension; overpressure was included at the end range.

Other: MWM Treatment

MWM sham

SHAM COMPARATOR

The patients will be handled similarly to MWM treatment group, except that they will not receive directional glide; instead, the physiotherapist's hands are just touch the knee skin without pressure; one hand on the tibia while the other hand on the femur. However, available active knee flexion and extension ROM will be performed (three sets of 10 repetitions).

Other: MWM Sham

Interventions

MWM Treatment OTHER

Also known as: Mobilization with Movement, Manual therapy

MWM treatment

MWM Sham OTHER

MWM sham

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Had unilateral or bilateral knee OA
• Knee OA K\&L grade ≥ 2
• VAS = 3 cm over the previous 24 hours
• Able to walk ≥ 6-meter distances with or without an aid

You may not qualify if:

• Had knee or lower limb surgery
• Oral corticosteroid use (current\\ 4 weeks)
• Altered sensation around knee and shoulder
• Exhibited cognitive difficulties
• Intra-articular corticosteroid or hyaluronic acid injection within 6 months
• Had leg sciatica
• Contraindication to manual therapy

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Related Publications (11)

• Creamer P, Hochberg MC. Osteoarthritis. Lancet. 1997 Aug 16;350(9076):503-8. doi: 10.1016/S0140-6736(97)07226-7. No abstract available.

  PMID: 9274595 BACKGROUND

• Kidd BL. Osteoarthritis and joint pain. Pain. 2006 Jul;123(1-2):6-9. doi: 10.1016/j.pain.2006.04.009. Epub 2006 May 22. No abstract available.

  PMID: 16714085 BACKGROUND

• Alghamdi MA, Olney S, Costigan P. Exercise treatment for osteoarthritis disability. Ann Saudi Med. 2004 Sep-Oct;24(5):326-31. doi: 10.5144/0256-4947.2004.326.

  PMID: 15573841 BACKGROUND

• Gwilym SE, Pollard TC, Carr AJ. Understanding pain in osteoarthritis. J Bone Joint Surg Br. 2008 Mar;90(3):280-7. doi: 10.1302/0301-620X.90B3.20167.

  PMID: 18310746 BACKGROUND

• Gross KD, Hillstrom H. Knee osteoarthritis: primary care using noninvasive devices and biomechanical principles. Med Clin North Am. 2009 Jan;93(1):179-200, xii. doi: 10.1016/j.mcna.2008.09.007.

  PMID: 19059028 BACKGROUND

• Felson DT, Naimark A, Anderson J, Kazis L, Castelli W, Meenan RF. The prevalence of knee osteoarthritis in the elderly. The Framingham Osteoarthritis Study. Arthritis Rheum. 1987 Aug;30(8):914-8. doi: 10.1002/art.1780300811.

  PMID: 3632732 RESULT

• Jordan 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.

  PMID: 17216685 RESULT

• Lawrence 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.

  PMID: 18163497 RESULT

• Oliveria SA, Felson DT, Reed JI, Cirillo PA, Walker AM. Incidence of symptomatic hand, hip, and knee osteoarthritis among patients in a health maintenance organization. Arthritis Rheum. 1995 Aug;38(8):1134-41. doi: 10.1002/art.1780380817.

  PMID: 7639811 RESULT

• Al-Arfaj A, Al-Boukai AA. Prevalence of radiographic knee osteoarthritis in Saudi Arabia. Clin Rheumatol. 2002 May;21(2):142-5. doi: 10.1007/s10067-002-8273-8.

  PMID: 12086165 RESULT

• Alkhawajah HA, Alshami AM. The effect of mobilization with movement on pain and function in patients with knee osteoarthritis: a randomized double-blind controlled trial. BMC Musculoskelet Disord. 2019 Oct 18;20(1):452. doi: 10.1186/s12891-019-2841-4.

  PMID: 31627723 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Movement; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Ali M Alshami, Ph.D

  Imam Abdulrahman Bin Faisal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 12, 2016
• Study Start: October 1, 2015
• Primary Completion: June 1, 2016
• Last Updated: August 12, 2016

Record last verified: 2016-08