OsteoarthritisPhase 1NCT02865252
The Effect of Mobilization With Movement on Pain and Function Among Patients With Knee Osteoarthritis
A Phase 1 study testing MWM Treatment in people with Osteoarthritis, run by Imam Abdulrahman Bin Faisal University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- MWM Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Jun 2016
- Phase
- Phase 1
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the detailed description
Participants:
A power analysis was performed using G*Power 3.1 (F tests, analysis of variance [ANOVA]: repeated measure, within-between interaction, and a priori: compute required sample size). A result of 16 patients (treatment group = 8 and sham group = 8) was used to calculate an effect size (ES) of 0.27 for the pressure pain threshold of the knee after the intervention between groups. The power estimated for ANOVA for the two groups with a significance of 0.05 revealed that a total sample size of 27 patients was necessary to obtain a power of 0.80. Considering a 20% attrition rate, a minimum of 18 patients needed to be recruited for the first phase in this study.
Patients with knee OA who attended King Fahd Hospital of the University will be recruited for this study. Patients will be diagnosed at the orthopedic clinic and referred to the Department of Physiotherapy. Patients who are willing to participate in the study will be screened for their eligibility
Ethical considerations:
The study was approved by the Institutional Review Board (IRB) at the University of Dammam (IRB Number: IRB-2014-04-323). Eligible individuals for this study will be informed of the risks and benefits and will be asked to read and sign a written consent form.
Participant confidentiality will be maintained by using a code instead of the participant's name on the data collection form. All data collection forms will be saved in a file and secured in a locker. Only the researcher and the supervisor had a key to open this locker.
Statistical Analysis:
Data will be analyzed using International Business Machines (IBM) Statistical Package for Social Sciences (SPSS) for windows (version 20.0), significance level was set at p < 0.05.
In phase 1, patients characteristics between groups at baseline will be analyzed using an independent t-test. One way ANOVA with repeated measures will be used to analyze the differences for other parametric data, Bonferroni adjustment will be used to compare main effects. Post-hoc tests will be performed to reveal differences of within- between groups over time (baseline, immediately post intervention, and after 2 days of intervention). For Likert-scale WOMAC, the Mann-Whitney U test will be used to investigate between-group analysis. Whereas, the Wilcoxon test will be used for within-group analysis. Further analysis to reveal correlations between the outcome measures will be investigated using Pearson Correlation test.
In phase 2, the groups are matched in age, gender, and BMI. The related t-test will be used to investigate differences between the groups.
- Conditions
- Osteoarthritis
- Being tested
- MWM Treatment, MWM Sham
- Keywords
- manual therapy, mobilization with movement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MWM TreatmentOther
Also called Mobilization with Movement, Manual therapy
MWM ShamOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: MWM Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Visual Analog Scale (VAS)
Current pain intensity will be measured by a 10-cm line
Measured: 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
Measured: 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
Measured: 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
Measured: At Baseline
Pressure Pain Threshold (PPT)
A digital pressure algometer will be used to quantify pain intensity in Kpa
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline in Hand-Held Dynamometer at 2 days
Standard Goniometer
Active range of motion for knee flexion and extension in degree
Measured: Change from Baseline in Standard Goniometer at Immediate post-intervention
Standard Goniometer
Active range of motion for knee flexion and extension in degree
Measured: 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
Measured: 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
Measured: Change from Baseline in Three-meter Timed "Up and Go" at 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali M Alshami, Ph.D, Study director, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865252
- Sponsor's protocol ID
- IRB-2014-04-323
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Creamer P, Hochberg MC. Osteoarthritis. Lancet. 1997 Aug 16;350(9076):503-8. doi: 10.1016/S0140-6736(97)07226-7. No abstract available.
PubMed 9274595Kidd 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.
PubMed 16714085Alghamdi 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.
PubMed 15573841Gwilym 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.
PubMed 18310746Gross 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.
PubMed 19059028Felson 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.
PubMed 3632732Jordan 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 17216685Lawrence 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 18163497Oliveria 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.
PubMed 7639811Al-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.
PubMed 12086165Alkhawajah 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.
PubMed 31627723
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobilization With Movement on Pain and Function Among Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02865252
- Acronym / sponsor ID
- IRB-2014-04-323
- Conditions
- Osteoarthritis
- Keywords
- manual therapy, mobilization with movement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- First posted
- 12 Aug 2016 (estimated)
- 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.
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.
Detailed description
Participants:
A power analysis was performed using G*Power 3.1 (F tests, analysis of variance [ANOVA]: repeated measure, within-between interaction, and a priori: compute required sample size). A result of 16 patients (treatment group = 8 and sham group = 8) was used to calculate an effect size (ES) of 0.27 for the pressure pain threshold of the knee after the intervention between groups. The power estimated for ANOVA for the two groups with a significance of 0.05 revealed that a total sample size of 27 patients was necessary to obtain a power of 0.80. Considering a 20% attrition rate, a minimum of 18 patients needed to be recruited for the first phase in this study.
Patients with knee OA who attended King Fahd Hospital of the University will be recruited for this study. Patients will be diagnosed at the orthopedic clinic and referred to the Department of Physiotherapy. Patients who are willing to participate in the study will be screened for their eligibility
Ethical considerations:
The study was approved by the Institutional Review Board (IRB) at the University of Dammam (IRB Number: IRB-2014-04-323). Eligible individuals for this study will be informed of the risks and benefits and will be asked to read and sign a written consent form.
Participant confidentiality will be maintained by using a code instead of the participant's name on the data collection form. All data collection forms will be saved in a file and secured in a locker. Only the researcher and the supervisor had a key to open this locker.
Statistical Analysis:
Data will be analyzed using International Business Machines (IBM) Statistical Package for Social Sciences (SPSS) for windows (version 20.0), significance level was set at p < 0.05.
In phase 1, patients characteristics between groups at baseline will be analyzed using an independent t-test. One way ANOVA with repeated measures will be used to analyze the differences for other parametric data, Bonferroni adjustment will be used to compare main effects. Post-hoc tests will be performed to reveal differences of within- between groups over time (baseline, immediately post intervention, and after 2 days of intervention). For Likert-scale WOMAC, the Mann-Whitney U test will be used to investigate between-group analysis. Whereas, the Wilcoxon test will be used for within-group analysis. Further analysis to reveal correlations between the outcome measures will be investigated using Pearson Correlation test.
In phase 2, the groups are matched in age, gender, and BMI. The related t-test will be used to investigate differences between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MWM treatment | Active comparator | Other: MWM TreatmentMobilization 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. |
| MWM sham | Sham comparator | Other: MWM ShamThe 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). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| MWM TreatmentAlso: Mobilization with Movement, Manual therapy | Other | MWM treatment |
| MWM Sham | Other | MWM sham |
Primary outcome
The Visual Analog Scale (VAS)
Time frame: Change from Baseline in Visual Analog Scale at Immediate post-intervention
Current pain intensity will be measured by a 10-cm line
The Visual Analog Scale (VAS)
Time frame: Change from Baseline in Visual Analog Scale at 2 days
Current pain intensity will be measured by a 10-cm line
Western Ontario and McMaster Universities (WOMAC) Index
Time frame: Change from Baseline in WOMAC at 2 days
Self-administered questionnaire presented in Likert-scale format
Self-Leeds Assessment of Neuropathic Symptoms and signs (S-LANSS) Scale
Time frame: At Baseline
A clinical-based instrument for identifying patients whose pain is dominated by neuropathic mechanisms
Pressure Pain Threshold (PPT)
Time frame: Change from Baseline in PPT at Immediate post-intervention
A digital pressure algometer will be used to quantify pain intensity in Kpa
Pressure Pain Threshold (PPT)
Time frame: Change from Baseline in PPT at 2 days
A digital pressure algometer will be used to quantify pain intensity in Kpa
Thermal Perception and Pain Thresholds
Time frame: Change from Baseline in Thermal Perception and Pain Thresholds at Immediate post-intervention
A Thermotest System will be used to determine thermal thresholds in degree centigrade
Thermal Perception and Pain Thresholds
Time frame: Change from Baseline in Thermal Perception and Pain Thresholds at 2 days
A Thermotest System will be used to determine thermal thresholds in degree centigrade
Hand-Held Dynamometer
Time frame: Change from Baseline in Hand-Held Dynamometer at Immediate post-intervention
A digital instrument will be used to examine isometric muscle strength of force development in pound
Hand-Held Dynamometer
Time frame: Change from Baseline in Hand-Held Dynamometer at 2 days
A digital instrument will be used to examine isometric muscle strength of force development for knee flexion and extension in pound
Standard Goniometer
Time frame: Change from Baseline in Standard Goniometer at Immediate post-intervention
Active range of motion for knee flexion and extension in degree
Standard Goniometer
Time frame: Change from Baseline in Standard Goniometer at 2 days
Active range of motion for knee flexion and extension in degree
Three-meter Timed "Up and Go"
Time frame: Change from Baseline in Three-meter Timed "Up and Go" at Immediate post-intervention
A walk test will be used to test a basic functional mobility
Three-meter Timed "Up and Go"
Time frame: Change from Baseline in Three-meter Timed "Up and Go" at 2 days
A walk test will be used to test a basic functional mobility
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 12 Aug 2016.
- Background: PubMed 9274595Creamer P, Hochberg MC. Osteoarthritis. Lancet. 1997 Aug 16;350(9076):503-8. doi: 10.1016/S0140-6736(97)07226-7. No abstract available.
- Background: PubMed 16714085Kidd 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.
- Background: PubMed 15573841Alghamdi 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.
- Background: PubMed 18310746Gwilym 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.
- Background: PubMed 19059028Gross 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.
- Results publication: PubMed 3632732Felson 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 7639811Oliveria 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.
- Results publication: PubMed 12086165Al-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.
- Derived from this study: PubMed 31627723Alkhawajah 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.
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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.
Ali M Alshami, Ph.D study director
Imam Abdulrahman Bin Faisal University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MWM Treatment in people with Osteoarthritis, run by Imam Abdulrahman Bin Faisal University.
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 7 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 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The Visual Analog Scale (VAS) (time frame: Change from Baseline in Visual Analog Scale at Immediate post-intervention). The study lists 14 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 NCT02865252, which also lists 11 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 12 Aug 2016.