Knee OsteoarthritisNCT05529914
Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis
A study testing Myofascial release, Neuromuscular exercises and Cold pack in people with Knee Osteoarthritis and Pes Anserine Bursitis, run by Dow University of Health Sciences at 2 sites in Pakistan.
Trial summary
A randomized control trial will be conducted at the outpatient department of Dow Institute of Physical Medicine and Rehabilitation. A sample size of 80 is calculated using PASS version 11 software. The subjects will be first screened and those who fulfill the inclusion criteria, will be asked to fill the consent form. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Knee Osteoarthritis, Pes Anserine Bursitis
- What is being tested?
- Myofascial release, Neuromuscular exercises and Cold pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesPakistan
- Study dates
- 27 Sep 2022to 30 Apr 2023
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and Females both with the age between 40-60 years.
- Patients with unilateral or bilateral knee osteoarthritis with pes anserine syndrome.
- Patients with knee pain more than 3.4 cm on visual analogue scale as minimum cut of value.
- Kellgren and Lawrence grade II and III on radiological findings.
- Duration of knee osteoarthritis more than 3 months (chronic).
Who cannot join
- Patients with any neurological disorder.
- Knee deformities such as contractures, genu valgum and genu varum.
- Septic knee arthritis.
- History of ligamentous injury or meniscal tear.
- Cancer or any other malignancy or bone tumor.
- Any history of previous lower limb arthroplasty or other knee surgery.
- Comorbid like diabetes mellitus.
- Inflammatory rheumatic disease (R.A).
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Dow Institute of Physical Medicine and Rehabilitation
Karachi, Sindh, 74200
Sindh Institute of Physical Medicine and Rehabilitation
Karachi, Sindh, 74200
About this study
Official title: Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis: A Randomized Control Trial
A randomized control trial will be conducted at the outpatient department of Dow Institute of Physical Medicine and Rehabilitation. A sample size of 80 is calculated using PASS version 11 software. The subjects will be first screened and those who fulfill the inclusion criteria, will be asked to fill the consent form. After selection, the participants will be randomly allocated by the help of computer generated randomization sheet, into two groups i.e. experimental and the control group. The group A will be provided with the myofascial release along with the neuromuscular training whereas the group B will only receive the neuromuscular training. Cold pack will be applied to both the groups. The neuromuscular training consists of warm-up phase, lunges, sideways exercises, wall squats, weight transfer exercises, step up and down and the cool down phase. Total 12 sessions of 35 minutes each will be given to all the participants for about 4 weeks on alternate days. Outcome measures will be analyzed by visual analogue scale (VAS) for pain assessment, goniometry for range of motion and the Knee injury and Osteoarthritis Outcome Score (KOOS) to evaluate the functional assessment of the patients at the baseline and the post intervention.
- Conditions
- Knee Osteoarthritis, Pes Anserine Bursitis
- Being tested
- Myofascial release, Neuromuscular exercises, Cold pack
- Medical subject headings
- Osteoarthritis, Knee, Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial releaseOther
It is a type of physical therapy often used to treat myofascial pain syndrome with pressure.
Neuromuscular exercisesOther
Exercises commonly utilized in neuromuscular training programs to improve strength, balance , speed and agility. It will comprised of Warm-up, Lunges, Sideways exercises, Wall squats, Weight transfer exercise, Step up \& down, Cool-down
Cold packOther
Also called Cold pack therapy
Application of cold pack around the patient's body, and covered with dry towel
| Study group | Role | What they receive |
|---|---|---|
| Myofascial release + Neuromuscular exercises + Cold pack | Experimental | Not described Receives: Other: Myofascial release; Other: Neuromuscular exercises; Other: Cold pack |
| Neuromuscular exercises + Cold pack | Active comparator | Not described Receives: Other: Neuromuscular exercises; Other: Cold pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity on visual analogue scale after four weeks
The Visual Analogue Scale is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between pains with similar conditions.. It is 0 to 10 cm scale. Patients rate their pain on that scale. Higher the score in centimeter, severe will be the pain experienced.
Measured: Baseline and 4 weeks
Change in range of motion assessed with universal goniometer after four weeks
The Goniometer is an instrument for the precise measurement of range of movement angles in degree , especially one used to measure the angles before and after range of motion.. Increase in the degree of angle suggests increase in range of movement.
Measured: Baseline and 4 weeks
Secondary outcomes (1)
Change in functional disability assessed with Knee injury and osteoarthritis outcome score after four weeks.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems regarding functional disability. In consists of total 100 scores. Increase in scores suggests decreased functional disability and decrease in scores suggests increased functional disability.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start27 Sep 2022
- Primary completion30 Mar 2023
- Study completion30 Apr 2023
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Hassan, Dow University of Health Sciences
- Investigators
- Farhan I Khan, PhD, Study director, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529914
- Sponsor's protocol ID
- RHassan
- Status last verified
- Jan 2024
- First submitted
- 3 Sep 2022
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05529914
- Acronym / sponsor ID
- RHassan
- Conditions
- Knee Osteoarthritis, Pes Anserine Bursitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 7 Sep 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.
A randomized control trial will be conducted at the outpatient department of Dow Institute of Physical Medicine and Rehabilitation. A sample size of 80 is calculated using PASS version 11 software. The subjects will be first screened and those who fulfill the inclusion criteria, will be asked to fill the consent form. After selection, the participants will be randomly allocated by the help of computer generated randomization sheet, into two groups i.e. experimental and the control group. The group A will be provided with the myofascial release along with the neuromuscular training whereas the group B will only receive the neuromuscular training. Cold pack will be applied to both the groups. The neuromuscular training consists of warm-up phase, lunges, sideways exercises, wall squats, weight transfer exercises, step up and down and the cool down phase. Total 12 sessions of 35 minutes each will be given to all the participants for about 4 weeks on alternate days. Outcome measures will be analyzed by visual analogue scale (VAS) for pain assessment, goniometry for range of motion and the Knee injury and Osteoarthritis Outcome Score (KOOS) to evaluate the functional assessment of the patients at the baseline and the post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofascial release + Neuromuscular exercises + Cold pack | Experimental | Other: Myofascial release, Other: Neuromuscular exercises, Other: Cold pack |
| Neuromuscular exercises + Cold pack | Active comparator | Other: Neuromuscular exercises, Other: Cold pack |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and Females both with the age between 40-60 years.
- Patients with unilateral or bilateral knee osteoarthritis with pes anserine syndrome.
- Patients with knee pain more than 3.4 cm on visual analogue scale as minimum cut of value.
- Kellgren and Lawrence grade II and III on radiological findings.
- Duration of knee osteoarthritis more than 3 months (chronic).
Key exclusion criteria (8 listed)
- Patients with any neurological disorder.
- Knee deformities such as contractures, genu valgum and genu varum.
- Septic knee arthritis.
- History of ligamentous injury or meniscal tear.
- Cancer or any other malignancy or bone tumor.
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 |
|---|---|---|
| Myofascial releaseIt is a type of physical therapy often used to treat myofascial pain syndrome with pressure. | Other | Myofascial release + Neuromuscular exercises + Cold pack |
| Neuromuscular exercisesExercises commonly utilized in neuromuscular training programs to improve strength, balance , speed and agility. It will comprised of Warm-up, Lunges, Sideways exercises, Wall squats, Weight transfer exercise, Step up \& down, Cool-down | Other | Myofascial release + Neuromuscular exercises + Cold pack, Neuromuscular exercises + Cold pack |
| Cold packAlso: Cold pack therapyApplication of cold pack around the patient's body, and covered with dry towel | Other | Myofascial release + Neuromuscular exercises + Cold pack, Neuromuscular exercises + Cold pack |
Primary outcome
Change in pain intensity on visual analogue scale after four weeks
Time frame: Baseline and 4 weeks
The Visual Analogue Scale is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between pains with similar conditions.. It is 0 to 10 cm scale. Patients rate their pain on that scale. Higher the score in centimeter, severe will be the pain experienced.
Change in range of motion assessed with universal goniometer after four weeks
Time frame: Baseline and 4 weeks
The Goniometer is an instrument for the precise measurement of range of movement angles in degree , especially one used to measure the angles before and after range of motion.. Increase in the degree of angle suggests increase in range of movement.
1 secondary outcome
Change in functional disability assessed with Knee injury and osteoarthritis outcome score after four weeks.
Time frame: Baseline and 4 weeks
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 9 Jan 2024.
- 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.
Farhan I Khan, PhD study director
Dow University of Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial release, Neuromuscular exercises and Cold pack in people with Knee Osteoarthritis and Pes Anserine Bursitis, run by Dow University of Health Sciences at 2 sites 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 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in pain intensity on visual analogue scale after four weeks (time frame: Baseline and 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 9 Jan 2024.