Protocol summary
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Study aim
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Comparing the effect of therapeutic exercises and self-management education with and without functional strength exercises on pain-related outcomes, and functional factors in patients with avascular necrosis of the femoral head.
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Design
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Randomised clinical trial with control group, single-blinded, parallel.
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Settings and conduct
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Assessments are done at baseline, 3 months after the intervention, and 4 months follow up will be performed in the Tehran, Rheumatology Research Center of Shariati Hospital. Data evaluators and analyzers will be blind to the participants in each group.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: male and female between ages of 18–50 years, Diagnosis of avascular necrosis of the femoral head. Exclusion criteria: hip or knee replacement, history of neurological disease, Patients on the waiting list for joint replacement surgery.
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Intervention groups
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The intervention group includes mixed therapeutic exercises plus functional strength exercises, and self-management education and the control group includes mixed therapeutic exercises and self-management education. self-management education aims to reduce and management of pain and increase self-care with correct choices in the face of pain. mixed therapeutic exercises aim to reduce pain and increase function by improving muscle strength, joint range of motion, mobility of joints, and decreasing rigidity. mixed therapeutic exercises plus functional strength exercises with the goal to will reduce pain more in functional activities and also will improve factors related to the function.
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Main outcome variables
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Pain; pain in functional activities; factors related to the function.
General information
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Reason for update
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Based on previous research, which shows a 20% dropout rate in exercise intervention studies, we increased the sample size to 53 patients. Also, the duration of the recruitment end date in this study was increased.
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Acronym
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AVN
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IRCT registration information
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IRCT registration number:
IRCT20220510054814N2
Registration date:
2023-05-30, 1402/03/09
Registration timing:
prospective
Last update:
2024-06-03, 1403/03/14
Update count:
1
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Registration date
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2023-05-30, 1402/03/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-06-22, 1402/04/01
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Expected recruitment end date
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2024-07-22, 1403/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of mixed therapeutic exercises and self-management education with and without functional strength exercises on pain and function factors in patients with avascular necrosis of the femoral head
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Public title
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Investigating the effects of exercise and self-management education on pain and function in patients with avascular necrosis of the femoral head
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosis of osteonecrosis of the femoral head according to the diagnostic criteria of AVN from grade I to IV (based on ARCO classification criteria)
Hip pain/ decreased mobility
Ability to read and write and access to a smartphone or tablet
Age over 18 years
Exclusion criteria:
Participation in a physical therapy program, and regular exercise therapy during the last 6 months
Being on the waiting list for joint replacement surgery (in the next 3 months)
Hip/ knee replacement surgery
Patients who cannot complete therapeutic exercises for a period of three months
Severe osteoporosis
Severe medical, neurological, or psychiatric conditions
Failure to fill out the consent form
Severe osteonecrosis of the knee/ severe knee osteoarthritis
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
53
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Following the baseline examination, by using the method shown on the website http://randomizer.org/, participants will be randomly assigned to the mixed therapeutic exercises group, and functional strength exercises plus mixed therapeutic exercises group. Simple randomization will be used (1:1). The computer will generate a sequence of random numbers. Created before the start of data collection by a researcher who is not involved in the recruitment or treatment of patients. Another researcher, blind to the baseline examination, processes treatment according to the group assignment. An independent assessor who does not know about the study’s hypothesis and methods and is blind to the treatment group assesses the outcome measures before the interventions.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, the assessor will be blinded to the study groups. Furthermore, the data obtained from the study will be analyzed by a statistician who is not aware of the patient groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-03-15, 1401/12/24
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Ethics committee reference number
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IR.SSRC.REC.1401.154
Health conditions studied
1
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Description of health condition studied
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Avascular necrosis of the femoral head
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ICD-10 code
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M87
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ICD-10 code description
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Osteonecrosis
Primary outcomes
1
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Description
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Pain and pain in functional activities
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Timepoint
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Will be measured at the baseline, after the end of 3 months intervention, and after the end of 4 months follow up.
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Method of measurement
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Using a 10 cm numeric pain rating scale during walking and sitting to stand, also pain for the last two weeks
Secondary outcomes
1
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Description
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Measure of dysfunction
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Timepoint
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Will be measured at the baseline, after the end of 3 months intervention, and after the end of 4 months follow up.
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Method of measurement
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Harris Hip Score
2
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Description
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Pain, stiffness and physical function
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Timepoint
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Will be measured at the baseline, after the end of 3 months intervention, and after the end of 4 months follow up.
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Method of measurement
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Western Ontario and McMaster Universities Osteoarthritis index in hip osteoarthritis
3
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Description
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Physical function
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Timepoint
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Will be measured at the baseline, after the end of 3 months intervention, and after the end of 4 months follow up.
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Method of measurement
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Timed up and go (TUG); 30-s chair-stand test
4
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Description
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Joints range of motion
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Timepoint
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Will be measured at the baseline, after the end of 3 months intervention, and after the end of 4 months follow up.
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Method of measurement
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Goniometer
5
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Description
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Muscles strength
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Timepoint
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Will be measured at the baseline, after the end of 3 months intervention, and after the end of 4 months follow up.
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Method of measurement
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Hand-held dynamometer
6
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Description
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Walking speed
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Timepoint
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Will be measured at the baseline, after the end of 3 months intervention, and after the end of 4 months follow up.
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Method of measurement
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10-meter walk test
Intervention groups
1
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Description
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Control group: Mixed therapeutic exercises: Both groups present in this research will receive the Mixed therapeutic exercises protocol. In this way, after registering the demographic information of the patients and performing the pre-tests, education videos of therapeutic exercises with explanations will be sent to the patients. The patients will be told to send a short video of the exercises to the researcher after starting the first exercise session, so that if there are any movement problems or errors, they can be corrected by the researcher. Also, patients are required to do exercises twice a week for 24 sessions (12 weeks) and record their exercises in the diaries calendar (which will be given to them in the first session) after each exercise session. The researcher will be in contact with the patients every two weeks and will monitor the progress of the exercises. Patients will be instructed to report to the researcher any pain (according to the NRS scale) greater than 7 during the exercises and the day after the exercises. Exercises will be progressive and adjusted according to the patient's condition. The exercises will include 4 to 10 minutes of warming up, then doing resistance exercises and mobility and stretching exercises. Hip joint self-traction will be recommended to patients once a week, and like exercises protocol, education will be sent to patients through a video file. Self-management education: Both groups will receive this education. In this education, patients will be aware of the importance of performing exercise protocols. This education will be personalized in a targeted manner and according to previous studies based on the type of illness of the patients, which include: 1. Encouraging the implementation of therapeutic exercise protocol, 2. Encouraging weight control, 3. Using heat modality around the involved joint, 4. Wearing shoes with a flat surface or shoes with a low heel height, 5. Healthy food choices and a balanced diet 6. Encouraging sleep regulation 7. Teaching non-pharmacological techniques to reduce pain.
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Category
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Treatment - Other
2
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Description
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Intervention group: In this group, in addition to self-management education and therapeutic exercises of the control group, education based on the principles of daily functional activities (sitting and standing up, going up and down stairs, standing, sleeping) as well as exercises based on functional and modified activities such as: half squats, half lunges, step up and down with a low height (10 to 30 cm), standing on one leg with the support of the other leg or with the support of the wall. Patients will be told to do the exercises once a week in addition to the exercises of the control group.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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46795-2-2-1402
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kharazmi University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Only demographic and outcomes-related data will be shared.
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When the data will become available and for how long
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Access period starts 6 months after the results are published.
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To whom data/document is available
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Personal information is confidential and general results are available to anyone in the article.
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Under which criteria data/document could be used
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Information is not available to anyone. General results are available to anyone in the article.
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From where data/document is obtainable
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Zohreh Gholami
Email: Zzohreh.Ggholami@gmail.com
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What processes are involved for a request to access data/document
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The applicant can request details from the researchers within 7 to 10 days using the message sent by email.
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Comments
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