Knee ArthroscopyNCT04308772
Web-Based Physiotherapy Following Knee Arthroscopy
A study testing Web-based Physiotherapy in people with Knee Arthroscopy and Physical Therapy, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial summary
Web-based physiotherapy might improve care following knee arthroscopy. For this study half of the participants will receive usual care (printed leaflet) and half will receive 6 weeks of web-based physiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroscopy, Physical Therapy
- What is being tested?
- Web-based Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jun 2018to 31 Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone Knee Arthroscopy surgery.
- Access to a personal computer/tablet or smart phone with an email address and internet connection
- Be able to understand English.
Who cannot join
- Infection or other post-operative complications
- Other significant co-morbidities for which exercise is contra-indicated
- Unwilling to be randomised to intervention/control group
- Taking part in another research project
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth University Hospital
Glasgow, G51 4TF
About this study
Web-based physiotherapy might improve care following knee arthroscopy. For this study half of the participants will receive usual care (printed leaflet) and half will receive 6 weeks of web-based physiotherapy.
Read the detailed description
Despite its minimally invasive nature, studies have shown that patients undergoing arthroscopic meniscectomy have pain, effusion, loss of range of motion, functional, neuromuscular and biomechanical changes, loss of quadriceps muscle strength, and a reduced quality of life (Durand et al.,1993;Goodwin and Morrissey,2003; Glatthorn et al.,2010). With changes in service delivery patients following arthroscopy only receive a printed leaflet. Web-based physiotherapy may offer offer cost effective support to patients. Therefore, the aim of this study is to undertake a single blind, randomised controlled pilot study examining the effectiveness of a six week web-based physiotherapy programme compared to usual care alone, for people following knee arthroscopy and to gather essential information for the planning of a definitive trial.
- Conditions
- Knee Arthroscopy, Physical Therapy
- Being tested
- Web-based Physiotherapy
- Keywords
- knee, arthroscopy, physiotherapy, web-based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based PhysiotherapyBehavioural
Participants will receive an exercise programme, based on those patients usually get in the form of an exercise leaflet, delivered via a web-based physio website (www.giraffehealth.com). Participants will be asked to complete their exercise programme as prescribed (at least once each day) and to fill out an online exercise diary which the physiotherapist can see remotely from the clinical site.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Those randomised to the usual care arm will receive a leaflet which contains a standard programme of exercises Participants will be asked to complete their exercise programme as prescribed (at least once per day). |
| Web-based physiotherapy | Experimental | Participants will receive a six week exercise programme, based on those in the usual care exercise sheet delivered via the web-based physio website (www.giraffehealth.com). Receives: Behavioral: Web-based Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS).
The KOOS is a patient reported outcome measure, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It consists of 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).The KOOS is self-administered and takes approximately 10 minutes to complete. The KOOS is reliable, responsive to surgery and physical therapy and can be used to evaluate the course of knee injury and treatment outcomes (Roos et al.,1998).
Measured: Baseline to 6 weeks.
Secondary outcomes (3)
Change in Cincinnati Sports Activity Scale (CSAS)
CSAS is a patient reported outcome measure, developed to assess the patients' sports participation and identify patients who experience symptoms during athletic activities. It consists of 16 items in 5 separately scored subscales; the frequency of participation, the knee functions that occur during various sports activities and activities of daily living, the change that occurs in activity levels between treatment periods and the problems patients encounter with individual sports that place varying loads on the knee joint. The CSAS is self-reported and takes approximately 6 minutes to complete. The CSAS is reliable, valid and responsive and can be used to evaluate the sports activity levels and participation (Noyes et al., 1989).
Measured: Baseline to 6 weeks.
Adherence to exercise programme
Participants are advised to undertake their exercise programme at least once per day for six weeks and adherence will be based on the mean number of completed entries in exercise diaries over the 6 weeks of the programme and the total adherence to the programme will be calculated as a percentage.
Measured: Weekly for 6 weeks
Health Resource Form
a form detailing the number of interactions with health care professionals, such as physiotherapy and GP visits and medication use during the study.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start25 Jun 2018
- Primary completion29 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroscopyStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Responsible party
- Sponsor
- Investigators
- Spiros Nikologiannis, Principal investigator, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308772
- Sponsor's protocol ID
- 18/WS/0077
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 16 Mar 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 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Based Physiotherapy Following Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT04308772
- Acronym / sponsor ID
- 18/WS/0077
- Conditions
- Knee Arthroscopy, Physical Therapy
- Keywords
- knee, arthroscopy, physiotherapy, web-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 16 Mar 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.
Web-based physiotherapy might improve care following knee arthroscopy. For this study half of the participants will receive usual care (printed leaflet) and half will receive 6 weeks of web-based physiotherapy.
Detailed description
Despite its minimally invasive nature, studies have shown that patients undergoing arthroscopic meniscectomy have pain, effusion, loss of range of motion, functional, neuromuscular and biomechanical changes, loss of quadriceps muscle strength, and a reduced quality of life (Durand et al.,1993;Goodwin and Morrissey,2003; Glatthorn et al.,2010). With changes in service delivery patients following arthroscopy only receive a printed leaflet. Web-based physiotherapy may offer offer cost effective support to patients. Therefore, the aim of this study is to undertake a single blind, randomised controlled pilot study examining the effectiveness of a six week web-based physiotherapy programme compared to usual care alone, for people following knee arthroscopy and to gather essential information for the planning of a definitive trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Those randomised to the usual care arm will receive a leaflet which contains a standard programme of exercises Participants will be asked to complete their exercise programme as prescribed (at least once per day). |
| Web-based physiotherapy | Experimental | Behavioral: Web-based PhysiotherapyParticipants will receive a six week exercise programme, based on those in the usual care exercise sheet delivered via the web-based physio website (www.giraffehealth.com). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have undergone Knee Arthroscopy surgery.
- Access to a personal computer/tablet or smart phone with an email address and internet connection
- Be able to understand English.
Key exclusion criteria (4 listed)
- Infection or other post-operative complications
- Other significant co-morbidities for which exercise is contra-indicated
- Unwilling to be randomised to intervention/control group
- Taking part in another research project
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 |
|---|---|---|
| Web-based PhysiotherapyParticipants will receive an exercise programme, based on those patients usually get in the form of an exercise leaflet, delivered via a web-based physio website (www.giraffehealth.com). Participants will be asked to complete their exercise programme as prescribed (at least once each day) and to fill out an online exercise diary which the physiotherapist can see remotely from the clinical site. | Behavioural | Web-based physiotherapy |
Primary outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS).
Time frame: Baseline to 6 weeks.
The KOOS is a patient reported outcome measure, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It consists of 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).The KOOS is self-administered and takes approximately 10 minutes to complete. The KOOS is reliable, responsive to surgery and physical therapy and can be used to evaluate the course of knee injury and treatment outcomes (Roos et al.,1998).
3 secondary outcomes
Change in Cincinnati Sports Activity Scale (CSAS)
Time frame: Baseline to 6 weeks.
Adherence to exercise programme
Time frame: Weekly for 6 weeks
Health Resource Form
Time frame: Week 6
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 16 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Knee Arthroscopy
Recruiting
Anterior Nerves of the Knee Block Versus Femoral Nerve Block for Knee Arthroscopy
Postoperative Pain, Knee Arthroscopy
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 4
Geko™ Device in Prevention of Pain and Swelling Following Knee Arthroscopy
Post Operative Swelling
Active, not recruitingPhase 3
Dronabinol After Arthroscopic Surgery
Knee Osteoarthritis, Knee Injuries
Not yet recruiting
Needle Arthroscopy vs Conventional Arthroscopy in Knees
Meniscectomy, Meniscal Tears
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.
Spiros Nikologiannis principal investigator
Glasgow Caledonian 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 Web-based Physiotherapy in people with Knee Arthroscopy and Physical Therapy, run by Glasgow Caledonian University at 1 site in United Kingdom.
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 3 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 16 Mar 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 United Kingdom. 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?
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS). (time frame: Baseline to 6 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 16 Mar 2020.