Knee OsteoarthritisNCT04589858
Effect of Manual Therapies With Supervised Exercise Protocol on Pain and Functional Disability in Patients With Knee OA
A study testing Supervised exercise protocol and Specified Manual Therapies in people with Knee Osteoarthritis, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Osteoarthritis (OA) is referred to a group of conditions that involve mostly the larger weight-bearing joints such as the hip, knee, and ankle. It is the result of an intricate, multifaceted, progressive softening and break-down of articular cartilage along with capsular fibrosis and re-growth of new cartilages and… Read more about this study
- Who is it for?
- Ages 47 to 60 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Supervised exercise protocol and Specified Manual Therapies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 24 Sep 2019to 5 Mar 2020
- Phase
- Interventional
- 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 47 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged between 47 to 60 years;
- mild to moderate pain in one/both knees for 3-months;
- the pain intensity score between 2 to 6 on NPRS;
- morning stiffness <30-minutes;
- Self-reported crepitus on knee motion;
- grade 1 to 3 on Kellgren-Lawrence radiographic grading scale for Knee OA
Who cannot join
- diagnosed case of post-traumatic knee stiffness;
- history of bone infection and malignancy (osteomyelitis and tumour); neurological disorder (sciatica);
- history of joint replacement/meniscal surgery/mechanical knee pain/infection to the knee joint; suffering from severe cardiopulmonary disease (chronic obstructive pulmonary disease);
- Patient showed non-cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Specified Manual Therapies in Combination With a Supervised Exercise Protocol on Managing Pain Intensity and Functional Disability in Patients With Knee Osteoarthritis
Osteoarthritis (OA) is referred to a group of conditions that involve mostly the larger weight-bearing joints such as the hip, knee, and ankle. It is the result of an intricate, multifaceted, progressive softening and break-down of articular cartilage along with capsular fibrosis and re-growth of new cartilages and bones called osteophytes at the margin of the articular surfaces to increase the surface area of them.
The current study aimed to find out the efficacy of specified manual therapies in combination with a supervised exercise protocol on managing pain intensity and functional disability in patients with knee osteoarthritis.
Read the detailed description
Out of 70-millions older adults in the America, the majority of females have been suffering from osteoarthritis (OA) that progressively lead to chronic pain, joint stiffness, reduced mobility, muscle atrophy, poor balance, and ultimately, physical disability. Other physiological changes such as reduction in quadriceps' muscle strength and range of motion (ROM) in sagittal plane, and shortening of soft tissues around the joints collectively yield the distinctive clinical features such as articular pain; worsening on weight -bearing activities, resting/morning joint stiffness, progressive decline in physical activities and increasing to deformities/disabilities.Researchers observed the effectiveness of a structured exercise programs including an aerobic exercise program, a resistance exercise program, and a health education program in improving functional outcomes (self-reported disability) and decreasing the knee pain among older adults with knee OA at short-term and long term.the manual therapy along with supervised exercise protocol revealed a significant reduction in joint stiffness and knee pain and improvement in functional status of the patients with knee OA for short-term and long-term (1-year follow-up) than the placebo therapy (sub-therapeutic dose of ultrasound).
The study based on a randomized, pretest-posttest experimental group design, included a total of 32-participants with knee osteoarthritis randomly divided into groups A and B. Group A received a supervised exercise protocol, however group B received specified manual therapies in a combination of a supervised exercise protocol. Pain and functional disability measured with NPRS and WOMAC index respectively. Data collected on day-1st pre-intervention (baseline), day-14th posttest, and day-28th follow-up and analyzed using t-test and one-way ANOVA by keeping the level of significance at p<0.05.
- Conditions
- Knee Osteoarthritis
- Being tested
- Supervised exercise protocol, Specified Manual Therapies
- Keywords
- Specified manual therapy, Strengthening exercise, Stretching exercise, Knee OA, NPRS, WOMAC
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise protocolOther
Strengthening exercises:It included a sets/group of exercises such as a static quad set in knee extension, standing terminal knee extension, seated leg-press, partial squats weight-lessened with arm support as needed, and step-ups Stretching Exercises:A slow, sustained stretching was performed in different positions for different group of muscles with holding time 30-seconds, a gap of 1-minute between two repetitions, and repeated 3-times per session on alternate day for 2-weeks. The stretching performed for the calf muscle, hamstring muscle, and quadriceps femoris muscle in standing, supine, and prone positions respectively.
Specified Manual TherapiesOther
Myofascial Mobilization: Patellar glide performed in all available ROM and direction such as superior-inferior and lateral-medial translation/glides of patella over patellar fossa.
Myofascial manipulation technique: Manipulation of knee joint. An impulse type thrust was delivered, directed in the caudal direction to mobilize the joint in a near-full extension position.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Received a supervised exercise protocol including both strengthening and stretching exercises for specific muscle groups. Receives: Other: Supervised exercise protocol |
| Group B | Experimental | Received manual therapies including both myofascial mobilization and manipulation technique in addition to a supervised exercise protocol. Receives: Other: Supervised exercise protocol; Other: Specified Manual Therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Assessed by Numeric Pain Rating Scale (NPRS)
Measured: 4-weeks
Functional disability
Assessed by WOMAC index
Measured: 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start24 Sep 2019
- Primary completion27 Nov 2019
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel groups randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMIR IQBAL, King Saud University
- Investigators
- AMIR IQBAL, MPT-Ortho, Principal investigator, Rehabilitation Research Chair, CAMS, King Saud University, Riyadh, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589858
- Sponsor's protocol ID
- RRC-2019-20
- Status last verified
- Oct 2020
- First submitted
- 11 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Specified Manual Therapies in Combination With a Supervised Exercise Protocol on Managing Pain Intensity and Functional Disability in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04589858
- Acronym / sponsor ID
- RRC-2019-20
- Conditions
- Knee Osteoarthritis
- Keywords
- Specified manual therapy, Strengthening exercise, Stretching exercise, Knee OA, NPRS, WOMAC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 19 Oct 2020 (actual)
- 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 referred to a group of conditions that involve mostly the larger weight-bearing joints such as the hip, knee, and ankle. It is the result of an intricate, multifaceted, progressive softening and break-down of articular cartilage along with capsular fibrosis and re-growth of new cartilages and bones called osteophytes at the margin of the articular surfaces to increase the surface area of them.
The current study aimed to find out the efficacy of specified manual therapies in combination with a supervised exercise protocol on managing pain intensity and functional disability in patients with knee osteoarthritis.
Detailed description
Out of 70-millions older adults in the America, the majority of females have been suffering from osteoarthritis (OA) that progressively lead to chronic pain, joint stiffness, reduced mobility, muscle atrophy, poor balance, and ultimately, physical disability. Other physiological changes such as reduction in quadriceps' muscle strength and range of motion (ROM) in sagittal plane, and shortening of soft tissues around the joints collectively yield the distinctive clinical features such as articular pain; worsening on weight -bearing activities, resting/morning joint stiffness, progressive decline in physical activities and increasing to deformities/disabilities.Researchers observed the effectiveness of a structured exercise programs including an aerobic exercise program, a resistance exercise program, and a health education program in improving functional outcomes (self-reported disability) and decreasing the knee pain among older adults with knee OA at short-term and long term.the manual therapy along with supervised exercise protocol revealed a significant reduction in joint stiffness and knee pain and improvement in functional status of the patients with knee OA for short-term and long-term (1-year follow-up) than the placebo therapy (sub-therapeutic dose of ultrasound).
The study based on a randomized, pretest-posttest experimental group design, included a total of 32-participants with knee osteoarthritis randomly divided into groups A and B. Group A received a supervised exercise protocol, however group B received specified manual therapies in a combination of a supervised exercise protocol. Pain and functional disability measured with NPRS and WOMAC index respectively. Data collected on day-1st pre-intervention (baseline), day-14th posttest, and day-28th follow-up and analyzed using t-test and one-way ANOVA by keeping the level of significance at p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel groups randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Supervised exercise protocolReceived a supervised exercise protocol including both strengthening and stretching exercises for specific muscle groups. |
| Group B | Experimental | Other: Supervised exercise protocol, Other: Specified Manual TherapiesReceived manual therapies including both myofascial mobilization and manipulation technique in addition to a supervised exercise protocol. |
Who may qualify
- Ages
- 47 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- aged between 47 to 60 years;
- mild to moderate pain in one/both knees for 3-months;
- the pain intensity score between 2 to 6 on NPRS;
- morning stiffness <30-minutes;
- Self-reported crepitus on knee motion;
Key exclusion criteria (4 listed)
- diagnosed case of post-traumatic knee stiffness;
- history of bone infection and malignancy (osteomyelitis and tumour); neurological disorder (sciatica);
- history of joint replacement/meniscal surgery/mechanical knee pain/infection to the knee joint; suffering from severe cardiopulmonary disease (chronic obstructive pulmonary disease);
- Patient showed non-cooperation
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 |
|---|---|---|
| Supervised exercise protocolStrengthening exercises:It included a sets/group of exercises such as a static quad set in knee extension, standing terminal knee extension, seated leg-press, partial squats weight-lessened with arm support as needed, and step-ups Stretching Exercises:A slow, sustained stretching was performed in different positions for different group of muscles with holding time 30-seconds, a gap of 1-minute between two repetitions, and repeated 3-times per session on alternate day for 2-weeks. The stretching performed for the calf muscle, hamstring muscle, and quadriceps femoris muscle in standing, supine, and prone positions respectively. | Other | Group A, Group B |
| Specified Manual TherapiesMyofascial Mobilization: Patellar glide performed in all available ROM and direction such as superior-inferior and lateral-medial translation/glides of patella over patellar fossa. Myofascial manipulation technique: Manipulation of knee joint. An impulse type thrust was delivered, directed in the caudal direction to mobilize the joint in a near-full extension position. | Other | Group B |
Primary outcome
Pain Intensity
Time frame: 4-weeks
Assessed by Numeric Pain Rating Scale (NPRS)
Functional disability
Time frame: 4-weeks
Assessed by WOMAC index
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 22 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
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.
AMIR IQBAL, MPT-Ortho principal investigator
Rehabilitation Research Chair, CAMS, King Saud University, Riyadh, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise protocol and Specified Manual Therapies in people with Knee Osteoarthritis, run by King Saud University at 1 site in Saudi Arabia.
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 6 inclusion and 4 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Pain Intensity (time frame: 4-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2020.