Is knee-cap taping feasible and acceptable as part of a treatment package for painful knee-cap arthritis?
| ISRCTN | ISRCTN30017763 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30017763 |
| IRAS number | 322953 |
| Secondary identifying numbers | CPMS 54632, NIHR Central Commissioning Facility (CCF) Grant Codes: NIHR204993 |
- Submission date
- 14/11/2024
- Registration date
- 20/11/2024
- Last edited
- 19/12/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Knee-cap arthritis (wear and tear) causes pain and disability for millions of adults in the UK. There are few effective treatments. Knee braces can help but they can be expensive and two-thirds of patients stop wearing them because either their leg is the wrong shape or it slips down. Therefore, this study will test the feasibility of a long-term simpler, cheaper intervention - knee-cap taping. If this study shows that taping is feasible and acceptable to patients, the ultimate goal is to carry out a large Health Technology Assessment-funded trial to test the extended effectiveness of self-managed knee-cap taping in painful knee-cap arthritis. This study aims to see if knee-cap taping is feasible and acceptable as part of a treatment package for painful knee-cap arthritis.
Who can participate?
People with painful knee-cap arthritis
What does the study involve?
Participants will receive the treatment package of best practice care and taping for 3 months. The number of participants willing to enrol will be recorded, their adherence to the intervention, how precisely they applied the tape, if taping had any side effects, and how many people did not complete the trial. Then, 15 participants will participate in one-to-one semi-structured interviews about their experiences of using the tape. Participants will provide advice regarding the treatment package and give insights to inform the development of a large, long-term trial of the effectiveness of taping.
What are the possible benefits and risks of participating?
Participants will benefit from improvement in their knee pain over the 12-week trial period, the aesthetics of using the tape over wearing a bulky knee brace, the comfort of wearing tape over the knee brace, and taping method training (for future use). The clinical follow-up appointments at 2, 6 and 12 weeks, mean being seen more frequently than routine clinic visits.
There are no foreseen ethical, legal or management issues arising from this study.
There may be minimal risk to the participants in Work Package 2 (WP2) and Work Package 3 (WP3), these have been fully disclosed in the Patient Information Sheet.
WP2 risks:
1. Reaction to tape - will have an exclusion criterion that removes people with known allergies to tape, psoriasis, broken skin or lesions in the area. If they have an unknown allergy and react to the tape they will be withdrawn and referred to their GP for treatment.
2. No improvement/worsening of pain - participants will be referred back to their GP or referring clinician at the end of the study for the next step of treatment.
3. Incorrect self-application of tape - this would just lead to inefficacy. The week two visit is in place to check the participants are using the correct method.
WP3 risks:
Participants may find discussing their experiences of taping or knee pain upsetting, and they are asked to let the team know if they wish to take a break or end the interview. If during the interview the participant reveals that their safety or the safety of others may be at risk, this information will be discussed with individuals outside the study team. Lastly, there may be a risk of a breach of confidentiality. Extensive systems are in place to try to prevent this and are detailed this in the PIS. Two PPIE workshops were held in Work Package 1. The purpose of these workshops was to co-design and refine the treatment package using patellar taping for kneecap arthritis, for use in a subsequent clinical trial feasibility study (WP2). It is believed that risks have been minimised from these workshops.
Where is the study run from?
The University of Manchester, Manchester Metropolitan University and the Sponsor is Manchester University NHS Foundation Trust (MFT).
When is the study starting and how long is it expected to run for?
December 2023 to February 2026
Who is funding the study?
NIHR Research for Patient Benefit (RfPB) programme
Who is the main contact?
Prof Michael Callaghan (Chief Investigator), Michael.callaghan@mmu.ac.uk
Deborah Maskell (Project Manager), Deborah.Maskell@manchester.ac.uk
Contact information
Scientific, Principal Investigator
Brooks Building Manchester Metropolitan University, Birley Campus
Manchester
M15 6GX
United Kingdom
 ORCID ID |
0000-0003-3540-2838 |
|---|---|
| Phone | +44 (0)1613060542 |
| Michael.callaghan@mmu.ac.uk |
Public
TAPE-it Project Manager
Division of Musculoskeletal and Dermatological Sciences
The University of Manchester, Room 2.805 Stopford Building, Oxford Road
Manchester
M13 9PT
United Kingdom
| Deborah.Maskell@manchester.ac.uk |
Study information
| Study design | Non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home, Hospital, Internet/virtual |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The feasibility of knee taping in painful patellofemoral joint osteoarthritis (PFJOA): TAPE-it |
| Study acronym | TAPE-it |
| Study objectives | The hypothesis is that medical sports taping of the knee will be both feasible and acceptable to participants as part of a treatment package for painful patellofemoral osteoarthritis. |
| Ethics approval(s) |
Approved 07/11/2024, Cambridge South (Equinox House, City Link, Nottingham, NG2 4LA, United Kingdom; +44 (0)207 1048 154 ; cambridgesouth.rec@hra.nhs.uk), ref: 24/EE/0248 |
| Health condition(s) or problem(s) studied | Medical sports taping of the knee for painful patellofemoral osteoarthritis |
| Intervention | Before the original application: Five patients were invited to be introduced to the project concept and design. Their feedback helped inform the Work Package 1 (WP1) part of the study. WP1: Before this protocol, two workshops were held in January and February 2024. This involved 11 participants being taken through the study concept, and then shown the taping methods and planned training materials for the actual intervention study. This was a PPIE exercise to ensure the right questions were being asked and, the best methods used and were meaningful. The findings from WP1 fully informed the WP2 methods described below. WP2 1. Screening: Manchester Local Care Organisation (MLCO) and Salford Royal Hospital: Clinicians refer potentially eligible patients with PFJOA to the study team either directly to CI or Study Team via secure NHS or NHS.net email address or online Trust system. Participants are given a Participant Information Sheet (PIS) for at least 24 hours to digest the information and ask questions. A member of the research team calls the participant to book a baseline visit. 2. Baseline Visit (30 - 60 minutes): face-to-face in a private room in the NIHR Manchester Clinical Research Facility. 2.1. Aims explained and any questions from PIS answered. 2.2. Provide written informed consent for trial. 2.3. Clinical examination and eligibility questions asked to diagnose PFJOA and confirm eligibility (ineligible patients will be screened fail and referred back to GP or referring clinician). 2.4. Determine aggravating activity, assess the best taping method, show the participant how to apply tape, and provide a Patient Treatment Package. 2.5. Supply two weeks pre-cut tape. 2.6. Baseline Assessments: electronic or paper copy knee pain (VASNA) and knee function (KOOS-PF) questionnaires 2.7. Two-week assessment (20 minutes): Check taping treatment accuracy and correct if required. Supply 10 weeks pre cut tape. Knee pain (VASNA) and knee function (KOOS-PF) questionnaires and adverse events recording 2.8. Six-week assessment (15 minutes): Telephone assessment - knee pain (VASNA), function (KOOS-PF) questionnaires and adverse event recording. 2.9. Twelve-week assessment (15 minutes): Telephone assessment - knee pain (VASNA), function (KOOS-PF) questionnaires and adverse event recording End of WP2: all completing participants will be given a PIS for WP3 and asked if they might want to take part. Then a sample of fifteen consenting participants will be purposefully selected (to show a range of age, sex, and ethnicity) to participate in the one-to-one interviews in WP3 below: WP3: 1. Participants were given a PIS and 24 hours to consider the study and whether they would like to take part. 2. Full Informed Consent was taken and demographic information was collected. A semi-structured interview (approx 60 minutes) will be conducted to gain an in-depth understanding of the participant's experience of WP2. 3. Interviews will be conducted by a trained Research Associate (RA) either in person, online via Teams or over the phone depending on participants' preference. In-person interviews will be held in a private room at the Brooks Building, Birley Campus, Manchester Metropolitan University. 4. Discussions will be from an interview question list but also guided by each patient's response to allow exploration of unanticipated issues/feedback. Emerging findings from each interview will iteratively feed into subsequent interviews. 5. Interviews will be digitally recorded, professionally transcribed and then analysed by the Research Associate. |
| Intervention type | Other |
| Primary outcome measure | Participant uptake is assessed as follows: 1. Recruitment numbers measured using study data at baseline 2. % dropout/withdrawal numbers measured using study data at 2, 6 and 12 weeks |
| Secondary outcome measures | 1. Correct tape application measured using study observation by the CI at the 2-week visit. Advice and adjustments to the taping method if required by the CI. 2. Adherence measured using a count of the remaining tape strips at weeks 2,6,12: Approximate amount of time of tape wearing measured using patient self-reported hours per day and days per week of tape wearing at weeks 2, 6 and 12. 3. Reduction in knee pain measured using the 11-point (0-10) Visual Analogue Scale during a Nominated Activity (VASNA) and knee pain and function measured using the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) at baseline, 2, 6 and 12 weeks |
| Overall study start date | 01/12/2023 |
| Completion date | 28/02/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 40 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 30; UK Sample Size: 30 |
| Key inclusion criteria | 1. Adults over 40 years of age 2. Pain predominantly over the patella (anterior knee pain) and greater than medial or lateral knee pain 3. Clinically significant patellofemoral pain/anterior knee pain on weight-bearing activity such as stair ascent/descent, sit-stand scored at 4 or above on an 11-point (0-10) visual analogue scale (VAS) 4. Already on a stable/regular dose of analgesia 5. Able to understand English (or English speaking) and give full informed consent 6. Willing to participate |
| Key exclusion criteria | 1. Symptoms not attributable to predominant patellofemoral OA or attributable only to medial or lateral knee compartment OA 2. Previous major surgery in the knee to be treated (partial/total knee replacement, knee fracture or knee realignment surgery, high tibial osteotomy) 3. Diagnosis of rheumatoid arthritis, gout or other forms of inflammatory arthritis 4. Cancer within the last 5 years (except non-melanoma skin cancers) 4. Planned knee replacement surgery or other knee surgery in the next 6 months 5. Responded to a steroid or viscosupplementation injection to the painful knee in the last 3 months 6. Those with a known allergy to elasticated tape, with fragile or very sensitive skin, psoriasis, or with lesions/rash/open wound in the are where the tape will be applied 7. Significant neurological disorder (e.g. stroke, dementia, MS, Parkinson's) affecting cognitive ability |
| Date of first enrolment | 16/12/2024 |
| Date of final enrolment | 28/02/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Grosvenor Square
Manchester
M15 6BH
United Kingdom
Manchester
M13 9WL
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Sponsor information
Hospital/treatment centre
Cobbett House, Oxford Road
Manchester
M13 9WL
England
United Kingdom
| Phone | +44 (0)161 2763565 |
|---|---|
| research.sponsor@mft.nhs.uk | |
| Website | https://mft.nhs.uk/ |
"ROR" |
https://ror.org/00he80998 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 02/10/2024 | 19/12/2024 | No | No |
Additional files
Editorial Notes
19/12/2024: Protocol uploaded. The recruitment start date was changed from 01/12/2024 to 16/12/2024.
14/11/2024: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).
