Effects of Maitland’s Mobilization on modulating biomarkers in knee osteoarthritis
| ISRCTN | ISRCTN17691569 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17691569 |
| Secondary identifying numbers | isra/phd/maryam |
- Submission date
- 29/04/2018
- Registration date
- 16/09/2019
- Last edited
- 07/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoarthritis is a common joint condition associated with changes in bone and synovial (joint) fluid and destruction of cartilage. However, the involvement of these processes in causing osteoarthritis is still not clear. Measurement of joint space width on plain x-rays is the most valid method of assessing osteoarthritis-related joint damage. The disadvantage of this method is the long gap required between two assessments to see whether the osteoarthritis has improved or deteriorated. Other methods include Magnetic Resonance Imaging (MRI), which is more sophisticated than plain x-ray yet not enough to measure changes in progression or cure of disease. Biochemical markers are another way to measure potential changes in the process of turnover. Biochemical markers are connective tissue molecules which release into the synovial fluid during cartilage or bone turnover. Some studies in animals and humans with osteoarthritis suggest that biochemical markers might be useful in detecting, identifying or measuring high-risk patients. The aims of this study are to compare the effects of Maitland’s Mobilization with conventional treatment on pain, joint function, quality of life, and cartilage, bone and synovial biomarkers in knee osteoarthritis.
Who can participate?
Patients aged 50 to 70 with osteoarthritis
What does the study involve?
Participants are randomly allocated into two groups to be treated with either Maitland’s Mobilization or conventional treatment. Maitland’s Mobilization may vary slightly patient to patient; however, in general the treatment involves exercises three days a week on alternate days. Conventional treatment includes Electrical Heating Pads and Pulse Shortwave Diathermy applied for 15 minutes each, followed by exercises including knee isometrics, knee pressing, knee squeezing and mid-range straining leg raises. Participants are assessed at the end of every sixth week of treatment.
What are the possible benefits and risks of participating?
If successful, the treatment could decrease the severity of osteoarthritis and could be used as a preventative method for potential patients with degenerative joint disease. The study will provide information about changes in biochemical markers that occur with manual therapy manoeuvres. If the findings suggest manual therapy manoeuvres can change biochemical markers, health care support such as drugs and nutrition could be used to change those biochemical markers. This could provide a new approach for a degenerative joint disease that is otherwise irreversible in nature. Degenerative joint disease is so far considered manageable but not curable.
Where is the study run from?
1. Riphah Rehabilitation Center (Pakistan)
2. Lahore General Hospital (Pakistan)
3. Ali Hospital (Pakistan)
When is the study starting and how long is it expected to run for?
July 2018 to December 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Maryam Shabbir
Contact information
Public
Riphah International University
Lahore
54000
Pakistan
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effects of Maitland’s Mobilization on modulating biomarkers in knee osteoarthritis |
| Study objectives | NULL HYPOTHESIS (H0) H0: There will be no significant outcomes of Maitland’s Mobilization on modulating cartilage biomarkers (urine II collagen C-telopeptide, serum cartilage oligomeric matrix protein and serum YKL-40) in knee osteoarthritis H0: There will be no significant outcomes Maitland’s Mobilization on modulating bone biomarkers (Serum Total osteocalcin, urine types I and II collagen C-telopeptide, serum urine types I and II collagen C-telopeptide) in knee osteoarthritis H0: There will be no significant outcomes Maitland’s Mobilization on modulating synovial biomarkers (human cartilage glycoprotein, glucosyl-galactosyl pyridinoline, type III collagen N-propeptide, hyaluronic acid and C reactive protein) in knee osteoarthritis H0: There will be no significant outcomes Maitland’s Mobilization in reducing pain in knee osteoarthritis H0: There will be no significant outcomes Maitland’s Mobilization in improving joint function in knee osteoarthritis H0: There will be no significant outcomes Maitland’s Mobilization on quality of life in knee osteoarthritis ALTERNATIVE HYPOTHESIS (H1) H1: There will be significant outcomes of Maitland’s Mobilization on modulating cartilage biomarkers (urine II collagen C-telopeptide, serum cartilage oligomeric matrix protein and serum YKL-40) in knee osteoarthritis H1: There will be significant outcomes of Maitland’s Mobilization on modulating bone biomarkers (Serum Total osteocalcin, urine types I and II collagen C-telopeptide, serum urine types I and II collagen C-telopeptide) in knee osteoarthritis H1: There will be significant outcomes of Maitland’s Mobilization on modulating synovial biomarkers (human cartilage glycoprotein, glucosyl-galactosyl pyridinoline, type III collagen N-propeptide, hyaluronic acid and C reactive protein) in knee osteoarthritis H1: There will be significant outcomes of Maitland’s Mobilization in reducing pain in knee osteoarthritis H1: There will be significant outcomes of Maitland’s Mobilization in improving joint function in knee osteoarthritis H1: There will be significant outcomes of Maitland’s Mobilization on quality of life in knee osteoarthritis |
| Ethics approval(s) | Research Ethical Committee, Institutional Review Board and Board of Advanced Studies and Research in Isra University, 26/03/2018 |
| Health condition(s) or problem(s) studied | Knee osteoarthritis |
| Intervention | Patients will be randomly allocated into two groups by coin tossing method i.e. Maitland’s Mobilization and Conventional Group. Maitland’s Mobilization Protocol may vary slightly patient to patient; however, general treatment protocol is being applied as follows: 1. Frequency of exercise is three days a week on alternative day basis 2. Intensity is Grade I and II based on Maitland concept 3. Intensity is progressed to Grade III of Maitland’s Grading System, in case, in order to achieve restore, compensate or prevent stiffness and flexibility issues 4. Time of oscillations are 2 or 3 oscillations in a second for 1 to 2 minutes Patient Position Patient lies supine on treatment table with affected knee towards clinician standing side. The knee should be in a resting position of 250. A wedge roll sometimes is used to maintain position or support below knee. Patient Education Patient is educated regarding the procedure. Precautions of pain provocation are briefed to the patient. Therapist/Clinician Position The therapist is in a standing position, facing towards patient on side of patient’s leg under treatment. The therapist holding to fix femur at its distal end while the tibia being oscillated with other hand as per protocol mentioned above. Conventional Treatment This includes Ottawa Panel Evidence-Based Clinical Practice Guidelines for Therapeutic Exercises, after essential modifications to fit in Pakistan’s framework of practice. The hallmark of treatment is covering pain and daily function. Electrophysiological agents and muscle stabilization are used. Electrical Heating Pads and Pulse Shortwave Diathermy is applied for 15 minutes each, followed by exercises including knee isometrics, knee pressing, knee squeezing and mid-range straining leg raises. Transcutaneous electrical nerve stimulator should be given for 10-15 additional minutes. A range of assays/kits will be used for identifying and measurement of various types of biomarkers. The ELISA method will be used in the lab of Riphah College of Rehabilitation Sciences. Lahore Campus. Personnel from the biochemistry department will assist with this procedure and process. After completing the initial screening process, every requited patient will be assessed by an independent assessor expert using primary and secondary outcome measurement tools. This will be included in the baseline assessment. Onwards at end of every sixth week of treatment, every patient will undergo the assessment process. Follow-up examination to be done while patients are advised for Home Plan Exercises after 18 weeks. Follow up to be at 24th week. |
| Intervention type | Other |
| Primary outcome measure | Measured at baseline and every sixth week of treatment: 1. Biomarkers of osteoarthritis measured using ELISA 2. Function, range and pain experienced due to osteoarthritis measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
| Secondary outcome measures | Measured at baseline and every sixth week of treatment: 1. Pain intensity measured using the Numeric Rating Pain Scale 2. Quality of life and problems specific to knee region measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) 3. General quality of life measured using the SF 36 Short Form |
| Overall study start date | 02/07/2018 |
| Completion date | 02/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 68 |
| Key inclusion criteria | 1. Patients of either gender 2. Age 50 to 70 years 3. Patients falling in American College of Rheumatology criteria for primary osteoarthritis 4. Patients with chronic pain from last three months 5. Kellgren-Lawrence Classification System for knee osteoarthritis 6. Patients with body mass index not below than 19 kg/m2 and more than 28 kg/m2 7. Patients who have signed informed consent to be willing to participate in study |
| Key exclusion criteria | 1. Patients with trauma in last 6 months 2. Patients with uncontrolled diabetes mellitus and hypertensive disease 3. Associated inflammatory joint disease such as septic arthritis and R.A 4. Patients taking cover of oral or intra-articular Hyaluronic acid 5. Patient on cover of alendronate and/ or sulfonate compounds of sodium 6. Women receiving any treatment that can interfere with bone metabolism such as hormonal replacement therapy after menopause 7. Patients with undiagnosed pathology or impairment, recent surgery, mixed arthritis condition, patients with spinal problems |
| Date of first enrolment | 02/07/2018 |
| Date of final enrolment | 01/04/2019 |
Locations
Countries of recruitment
- Pakistan
Study participating centres
Lahore
54000
Pakistan
Lahore
54000
Pakistan
Lahore
54000
Pakistan
Sponsor information
Government
Sector H-9, East Service Road، Service Rd E، H 9/4 H-9
Islamabad, Islamabad Capital Territory
Lahore
54000
Pakistan
| Phone | (009251) 90400000 |
|---|---|
| info.ana@hec.gov.pk |
University/education
14 Civic Center, Township
Lahore
54000
Pakistan
| Phone | (009242) 35321871 |
|---|---|
| info@riphah.edu.pk |
Government
| Website | http://www.hec.gov.pk/ |
|---|---|
"ROR" |
https://ror.org/038y3sz68 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. A systematic review in process regarding its previous literature 2. Cross cultural adaptation and translation of outcome measures in also in process that will be published and disseminated during this study Email: physiomalik1@gmail.com; maryambutt85@hotmail.com The measures will be taken into account regarding maintaining confidentiality and privacy of patients in study. The data will be placed in secure and locked place. Data will be discarded after 3 years or before after dissemination and publication of all components of study. |
| IPD sharing plan |
