Knee OsteoarthritisNCT05606354
Taping Versus Conventional Physiotherapy in Knee Osteoarthritis
A study testing Intervention group in people with Knee Osteoarthritis, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The purpose of this study is to determine the effects of kinesio taping versus conventional physiotherapy in women with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Oct 2022to 10 Mar 2024
- 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 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with knee Osteoarthritis who are being referred to Physiotherapy OPD of Dow University Ojha Campus.
- Having grade-2 Osteoarthritis (mild).)
- Aged between 50 to 60 years.
- BMI (25-29.9) -Category Overweight .
- In case of bilateral knee pain, the most painful side will be identified for intervention to see the outcome.
Who cannot join
- Total knee replacement done or any other knee surgeries.
- Rheumatoid arthritis.
- Intra articular injections received within a month.
- Knee OA -grade1(doubtful), grade3 (moderate)and grade 4 (severe).
- Altered skin sensation around the knee area.
- Having known sensitivity to tape materials.
- Underlying skin disorders.
- Recent knee trauma or fracture.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dow institute of physical medicine and rehabilitation
Karachi, Sindh
About this study
Official title: Effects of Kinesio Taping Versus Conventional Physiotherapy in Women With Knee Osteoarthritis- A Single-Center RCT
The purpose of this study is to determine the effects of kinesio taping versus conventional physiotherapy in women with knee osteoarthritis.
Read the detailed description
- This study will be a Randomized control trial. The calculated sample size for this study was 68 (34 in each group). To compensate the expected dropouts the sample size was increased by 15 %. Hence the final sample size will be 80 (40 in each group).
- The participants of this study will be female patients having Grade.2 knee osteoarthritis aged in between 50 to 60 years having BODY MASS INDEX (BMI) range 25-29.9(Overweight), who are being referred to Dow Ojha Physiotherapy OUT PATIENT DEPARTMENT. The subjects will be divided into 2 equal groups through Randomization Technique (Coin toss).
- Intervention group will receive regular physiotherapy exercises with Kinesio tape application, Whereas Control group will be given the same exercises without Kinesio taping.
- First assessment will be done at the baseline and second(final) will be conducted at the end of 3rd week (after 9 sessions).
- Data will be analyzed through SPSS (Statistical Package for the Social Sciences) Version-26. For mean comparison of dependent variables among Experimental and Control group Repeated Measure two-way Analysis of covariance will be performed. P-value less than 0.05 will be considered significant.
- Conditions
- Knee Osteoarthritis
- Being tested
- Intervention group
- Keywords
- knee osteoarthritis, Kinesio Taping, exercises, overweight, Female patients, degenerative disease
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
Experimental
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Group A) | Experimental | STRECHING EXERCISES:
A. HAMSTRING MUSCLE STRECHING.
B. CALF MUSCLE STRECHING:
2. STRENGTHENING EXCERCISES: 2 exercises will be performed on targeted muscle group Quadriceps. A. QUADRICEP MUSCLE (with ankle weight). B. QUADRICEP MUSCLE (straight leg raise).
3. KNEE RANGE OF MOTION EXERCISES: (FLEXION AND EXTENSION)
4. FUNCTIONAL EXERCISES:
A. SIT TO STAND:
B. CLIMBING STAIRS:
KINESIO TAPING The following KT application techniques will be used for intervention group after identifying the goal. Goal - A: Proprioception Stimulation and Mechanical Correction Tape Technique-A: (Strip Cutting Shape: One Y-shaped + two I-shaped strips).
Goal B: Lymphatic Correction and Muscle Correction Tape Technique-B: (Strip Cutting Shape: Two Y-shaped + two I-shaped strips). Receives: Other: Intervention group |
| control group (Group.B) | Other | GROUP.B - (CONTROL) - EXERCISES ONLY WITHOUT KINESIO TAPE The exercise types and dosage will be exactly the same for control group (as in experimental group (as mentioned above) But no kinesio tape will be given to this group. Receives: Other: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISUAL ANALOGUE SCALE
USED FOR PAIN - (0CM to 10CM) 0=no pain, 10=worst pain.
Measured: 3 WEEKS
THE WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX
USED FOR PAIN ,STIFFNESS AND PHYSICAL FUNCTION (SCORE 0-96) 0=GOOD OUTCOME, 96=WORSE OUTCOME
Measured: 3 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start7 Oct 2022
- Primary completion10 Mar 2024
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- There are two groups: interventional and Control. Both groups will receive one standard treatment which is exercises. interventional group will receive kinesio tape and control group will not receive any kinesio tape.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aqsa Bhutto, Dow University of Health Sciences
- Investigators
- aqsa bhutto, DPT, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606354
- Sponsor's protocol ID
- 2644
- Status last verified
- Jul 2024
- First submitted
- 24 Oct 2022
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Upadhaya S, Ram CS, Kumar M, Katiyar N. EFFECT OF KINESIO TAPING AND CONVENTIONAL PHYSIOTHERAPY ON DISABILITY AND PAIN IN KNEE OSTEOARTHRITIS. Turkish Journal of Physiotherapy and Rehabilitation.;32:2.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesio Taping Versus Conventional Physiotherapy in Women With Knee Osteoarthritis- A Single-Center RCT
- ClinicalTrials.gov ID
- NCT05606354
- Acronym / sponsor ID
- 2644
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, Kinesio Taping, exercises, overweight, Female patients, degenerative disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 4 Nov 2022 (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 purpose of this study is to determine the effects of kinesio taping versus conventional physiotherapy in women with knee osteoarthritis.
Detailed description
- This study will be a Randomized control trial. The calculated sample size for this study was 68 (34 in each group). To compensate the expected dropouts the sample size was increased by 15 %. Hence the final sample size will be 80 (40 in each group).
- The participants of this study will be female patients having Grade.2 knee osteoarthritis aged in between 50 to 60 years having BODY MASS INDEX (BMI) range 25-29.9(Overweight), who are being referred to Dow Ojha Physiotherapy OUT PATIENT DEPARTMENT. The subjects will be divided into 2 equal groups through Randomization Technique (Coin toss).
- Intervention group will receive regular physiotherapy exercises with Kinesio tape application, Whereas Control group will be given the same exercises without Kinesio taping.
- First assessment will be done at the baseline and second(final) will be conducted at the end of 3rd week (after 9 sessions).
- Data will be analyzed through SPSS (Statistical Package for the Social Sciences) Version-26. For mean comparison of dependent variables among Experimental and Control group Repeated Measure two-way Analysis of covariance will be performed. P-value less than 0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two groups: interventional and Control. Both groups will receive one standard treatment which is exercises. interventional group will receive kinesio tape and control group will not receive any kinesio tape.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Group A) | Experimental | Other: Intervention groupSTRECHING EXERCISES: A. HAMSTRING MUSCLE STRECHING. B. CALF MUSCLE STRECHING: 2. STRENGTHENING EXCERCISES: 2 exercises will be performed on targeted muscle group Quadriceps. A. QUADRICEP MUSCLE (with ankle weight). B. QUADRICEP MUSCLE (straight leg raise). 3. KNEE RANGE OF MOTION EXERCISES: (FLEXION AND EXTENSION) 4. FUNCTIONAL EXERCISES: A. SIT TO STAND: B. CLIMBING STAIRS: KINESIO TAPING The following KT application techniques will be used for intervention group after identifying the goal. Goal - A: Proprioception Stimulation and Mechanical Correction Tape Technique-A: (Strip Cutting Shape: One Y-shaped + two I-shaped strips). Goal B: Lymphatic Correction and Muscle Correction Tape Technique-B: (Strip Cutting Shape: Two Y-shaped + two I-shaped strips). |
| control group (Group.B) | Other | Other: Intervention groupGROUP.B - (CONTROL) - EXERCISES ONLY WITHOUT KINESIO TAPE The exercise types and dosage will be exactly the same for control group (as in experimental group (as mentioned above) But no kinesio tape will be given to this group. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women diagnosed with knee Osteoarthritis who are being referred to Physiotherapy OPD of Dow University Ojha Campus.
- Having grade-2 Osteoarthritis (mild).)
- Aged between 50 to 60 years.
- BMI (25-29.9) -Category Overweight .
- In case of bilateral knee pain, the most painful side will be identified for intervention to see the outcome.
Key exclusion criteria (8 listed)
- Total knee replacement done or any other knee surgeries.
- Rheumatoid arthritis.
- Intra articular injections received within a month.
- Knee OA -grade1(doubtful), grade3 (moderate)and grade 4 (severe).
- Altered skin sensation around the knee area.
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 |
|---|---|---|
| Intervention groupExperimental | Other | Intervention group (Group A), control group (Group.B) |
Primary outcome
VISUAL ANALOGUE SCALE
Time frame: 3 WEEKS
USED FOR PAIN - (0CM to 10CM) 0=no pain, 10=worst pain.
THE WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX
Time frame: 3 WEEKS
USED FOR PAIN ,STIFFNESS AND PHYSICAL FUNCTION (SCORE 0-96) 0=GOOD OUTCOME, 96=WORSE OUTCOME
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 Jul 2024.
- BackgroundUpadhaya S, Ram CS, Kumar M, Katiyar N. EFFECT OF KINESIO TAPING AND CONVENTIONAL PHYSIOTHERAPY ON DISABILITY AND PAIN IN KNEE OSTEOARTHRITIS. Turkish Journal of Physiotherapy and Rehabilitation.;32:2.
Related trials for Knee Osteoarthritis
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A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
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Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
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RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
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SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
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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.
aqsa bhutto, DPT principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Knee Osteoarthritis, run by Dow University of Health Sciences at 1 site in Pakistan.
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 5 inclusion and 8 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 Jul 2024. 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 Pakistan. 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?
VISUAL ANALOGUE SCALE (time frame: 3 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?
On the ClinicalTrials.gov record for NCT05606354, which also lists 1 linked publication.
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 Jul 2024.