Osteoarthritis, KneeNCT06181955
Extracorporeal Shock Wave Therapy in Osteoarthritis
A study testing Extracorporeal Shock Wave Therapy and conventional physical therapy in people with Osteoarthritis, Knee, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
The present study has examined the effectiveness of extracorporeal shock wave therapy along with conventional physical therapy on functional ability in grade IV knee osteoarthritis. Intervention program was performed for four weeks. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Extracorporeal Shock Wave Therapy and conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 6 Dec 2021to 27 Apr 2022
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Grade IV primary knee Osteoarthritis (OA) diagnosed by an orthopaedic surgeon based on the Kellgren-Lawrence score
Who cannot join
- Secondary knee OA,
- rheumatoid arthritis,
- psoriatic arthritis,
- the presence of any red flags (metastatic growth, thrombophlebitis),
- neurologic or psychiatric impairments,
- tissue injuries of the knee joint,
Show all 10Show fewer
- previous knee joint replacement or other surgeries in the knee joint,
- already received ESWT,
- Intra articular injection
- unable to walk independently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Extracorporeal Shock Wave Therapy on Improving Functional Ability in Knee Osteoarthritis (Grade iv)
The present study has examined the effectiveness of extracorporeal shock wave therapy along with conventional physical therapy on functional ability in grade IV knee osteoarthritis. Intervention program was performed for four weeks. Conventional physical therapy included ultrasound therapy, isometric quadriceps, straight leg raising (SLR) and isometric hip adductor strengthening exercises. Functional ability was assessed using the Lower Extremity Functional Scale (LEFS) score.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Extracorporeal Shock Wave Therapy, conventional physical therapy
- Keywords
- Physical therapy, Lower Extremity Functional Scale score, Ultrasound therapy, Exercises, Quadriceps
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave TherapyOther
The ESWT was performed by an ESWT instrument (Chattanooga) once a week for four consecutive weeks (a total of four sessions).
conventional physical therapyOther
Conventional physical therapy consisted of ultrasound therapy and three types of knee-strengthening exercises.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The participants in this group received Extracorporeal Shock Wave Therapy (ESWT) in addition to conventional physical therapy. Receives: Other: Extracorporeal Shock Wave Therapy; Other: conventional physical therapy |
| Control group | Active comparator | The participants in this group received conventional physical therapy only. Receives: Other: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Functional Scale (LEFS) score
It is a measurement tool used to assess the functional status and ability of individuals with lower extremity musculoskeletal conditions or injuries. The LEFS consists of 20 items and each item is rated on a scale from 0 to 4, with 0 indicating extreme difficulty to perform the activity and 4 indicating no difficulty at all. The scores for all items are summed to obtain a total score ranging from 0 to 80.
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 posted26 Dec 2023
- Study start6 Dec 2021
- Primary completion2 Feb 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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 group experimental-control design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masood Khan, King Saud University
- Investigators
- Masood Khan, MPTh, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181955
- Sponsor's protocol ID
- AWH/EC/03/2021/2
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 26 Dec 2023
- 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 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Extracorporeal Shock Wave Therapy on Improving Functional Ability in Knee Osteoarthritis (Grade iv)
- ClinicalTrials.gov ID
- NCT06181955
- Acronym / sponsor ID
- AWH/EC/03/2021/2
- Conditions
- Osteoarthritis, Knee
- Keywords
- Physical therapy, Lower Extremity Functional Scale score, Ultrasound therapy, Exercises, Quadriceps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 26 Dec 2023 (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.
The present study has examined the effectiveness of extracorporeal shock wave therapy along with conventional physical therapy on functional ability in grade IV knee osteoarthritis. Intervention program was performed for four weeks. Conventional physical therapy included ultrasound therapy, isometric quadriceps, straight leg raising (SLR) and isometric hip adductor strengthening exercises. Functional ability was assessed using the Lower Extremity Functional Scale (LEFS) score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two group experimental-control design
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Extracorporeal Shock Wave Therapy, Other: conventional physical therapyThe participants in this group received Extracorporeal Shock Wave Therapy (ESWT) in addition to conventional physical therapy. |
| Control group | Active comparator | Other: conventional physical therapyThe participants in this group received conventional physical therapy only. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Grade IV primary knee Osteoarthritis (OA) diagnosed by an orthopaedic surgeon based on the Kellgren-Lawrence score
Key exclusion criteria (10 listed)
- Secondary knee OA,
- rheumatoid arthritis,
- psoriatic arthritis,
- the presence of any red flags (metastatic growth, thrombophlebitis),
- neurologic or psychiatric impairments,
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 |
|---|---|---|
| Extracorporeal Shock Wave TherapyThe ESWT was performed by an ESWT instrument (Chattanooga) once a week for four consecutive weeks (a total of four sessions). | Other | Experimental |
| conventional physical therapyConventional physical therapy consisted of ultrasound therapy and three types of knee-strengthening exercises. | Other | Control group, Experimental |
Primary outcome
Lower Extremity Functional Scale (LEFS) score
Time frame: 4 weeks
It is a measurement tool used to assess the functional status and ability of individuals with lower extremity musculoskeletal conditions or injuries. The LEFS consists of 20 items and each item is rated on a scale from 0 to 4, with 0 indicating extreme difficulty to perform the activity and 4 indicating no difficulty at all. The scores for all items are summed to obtain a total score ranging from 0 to 80.
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 26 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Masood Khan, MPTh principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy and conventional physical therapy in people with Osteoarthritis, Knee, 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 1 inclusion and 10 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 26 Dec 2023. 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?
Lower Extremity Functional Scale (LEFS) score (time frame: 4 weeks). 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 26 Dec 2023.