Knee OsteoarthritisNCT05058235
Comparison of Active Release Technique and Bent Leg Raise In Osteoarthritis.
A study testing Active Release Technique and Bent leg raise in people with Knee Osteoarthritis, run by Riphah International University at 2 sites in Pakistan.
Trial summary
The objective of the study was to compare the effects of active release technique and bent leg raise on hamstring flexibility, functional outcomes, and pain in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Active Release Technique and Bent leg raise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesPakistan
- Study dates
- 14 Nov 2020to 30 Apr 2021
- 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
- Diagnosed patients of Knee Osteoarthritis
- Hamstring length less than 160 degrees
- Minimum history of 3 months
- Willing to participate
Who cannot join
- Patients who have passive knee extension more than 160 degrees
- Patients with less than 3 months history
- Patients who have osteoarthritis of other than the knee joint
- Patients with history of fracture
- Patients with post surgical history
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Noor Physio and Sports Injury Clinic, G-8 Markaz
Islamabad, Federal, 44000
Riphah Rehabilitation Center, Westridge campus, Potohar Tower, Peshawar Road
Rawalpindi, Punjab Province, 46000
About this study
Official title: Comparison Of Effects Of Active Release Technique And Bent Leg Raise On Hamstring Flexibility In Patients With Knee Osteoarthritis
The objective of the study was to compare the effects of active release technique and bent leg raise on hamstring flexibility, functional outcomes, and pain in patients with knee osteoarthritis.
Read the detailed description
Knee Osteoarthritis is a common progressive degenerative joint disease. Muscular weakness and other structural abnormalities can cause low back pain. Hamstring muscle being a postural muscle has an increased tendency to become tight. In this study, participants with knee osteoarthritis having hamstring tightness were included. Active Release Technique and Bent Leg Raise technique have been used to increase flexibility in hamstrings in these patients with knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Active Release Technique, Bent leg raise
- Keywords
- Active Release Technique, Bent leg raise, Hamstring flexibility
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Release TechniqueOther
Moist Hot pack 10 mins/1 set/ (6 days/ week), TENS 20 mins/1 set/ (6 days/ week), Quadriceps Isometric Strengthening 5 sec hold, 10 reps/ 1 set/(6 days/ week), Active release Technique 5 reps/ 1 set/ (6 days/ week)
A total of 2 weeks (12 sessions, 6 sessions/ week) were given each consisting of 40 mins.
Bent leg raiseOther
Moist Hot pack 10 mins/1 set/ (6 days/ week), TENS 20 mins/1 set/ (6 days/ week), Quadriceps Isometric Strengthening 5 sec hold, 10 reps/ 1 set/(6 days/ week), Bent leg raise 5 sec hold/ 5 sec stretch/ 3 reps/ 1 min rest interval/ 1 set/ (6 days/ week).
A total of 2 weeks (12 sessions, 6 sessions/ week) were given each consisting of 40 mins.
| Study group | Role | What they receive |
|---|---|---|
| Active Release Technique | Experimental | Hot pack, TENS, Quadriceps Isometric strengthening, Active Release Technique Receives: Other: Active Release Technique |
| Bent leg raise | Active comparator | Hot pack, TENS, Quadriceps Isometric strengthening, Bent leg raise Receives: Other: Bent leg raise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamstring flexibility
Changes from baseline, Hamstring flexibility was measured through passive knee extension test with the help of Goniometer. Normal value of knee extension angle is 180 degrees. Values decreased than 160 degree represents hamstring tightness.
Measured: 12 days
Secondary outcomes (2)
Functional outcome
Changes from baseline, Functional outcome was taken through western Ontario McMaster Universities Osteoarthritis Index tool. It comprises three sections containing 24 items. Score ranges from 0 to 96. 0 representing a healthy state and higher scores indicating worst health.
Measured: 12 days
Pain on Visual analogue Scale
Changes from baseline, Pain was measured through Visual Analogue Scale. It comprises of a continuous scale of 10cm line. 0 to 4mm represents "no pain", 5mm to 44mm indicates "mild pain", whereas 45mm to 74mm indicates "moderate pain" and continues to the range of "worst pain" between 75mm to 100 mm.
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start14 Nov 2020
- Primary completion20 Apr 2021
- Study completion30 Apr 2021
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.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asghar Khan, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058235
- Sponsor's protocol ID
- REC/00853 Syeda Nayab Sheeraz
- Status last verified
- Sep 2021
- First submitted
- 23 Aug 2021
- Last updated
- 27 Sep 2021
- 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 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Effects Of Active Release Technique And Bent Leg Raise On Hamstring Flexibility In Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05058235
- Acronym / sponsor ID
- REC/00853 Syeda Nayab Sheeraz
- Conditions
- Knee Osteoarthritis
- Keywords
- Active Release Technique, Bent leg raise, Hamstring flexibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 14 Nov 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 27 Sep 2021 (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 objective of the study was to compare the effects of active release technique and bent leg raise on hamstring flexibility, functional outcomes, and pain in patients with knee osteoarthritis.
Detailed description
Knee Osteoarthritis is a common progressive degenerative joint disease. Muscular weakness and other structural abnormalities can cause low back pain. Hamstring muscle being a postural muscle has an increased tendency to become tight. In this study, participants with knee osteoarthritis having hamstring tightness were included. Active Release Technique and Bent Leg Raise technique have been used to increase flexibility in hamstrings in these patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Release Technique | Experimental | Other: Active Release TechniqueHot pack, TENS, Quadriceps Isometric strengthening, Active Release Technique |
| Bent leg raise | Active comparator | Other: Bent leg raiseHot pack, TENS, Quadriceps Isometric strengthening, Bent leg raise |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed patients of Knee Osteoarthritis
- Hamstring length less than 160 degrees
- Minimum history of 3 months
- Willing to participate
Key exclusion criteria (5 listed)
- Patients who have passive knee extension more than 160 degrees
- Patients with less than 3 months history
- Patients who have osteoarthritis of other than the knee joint
- Patients with history of fracture
- Patients with post surgical history
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 |
|---|---|---|
| Active Release TechniqueMoist Hot pack 10 mins/1 set/ (6 days/ week), TENS 20 mins/1 set/ (6 days/ week), Quadriceps Isometric Strengthening 5 sec hold, 10 reps/ 1 set/(6 days/ week), Active release Technique 5 reps/ 1 set/ (6 days/ week) A total of 2 weeks (12 sessions, 6 sessions/ week) were given each consisting of 40 mins. | Other | Active Release Technique |
| Bent leg raiseMoist Hot pack 10 mins/1 set/ (6 days/ week), TENS 20 mins/1 set/ (6 days/ week), Quadriceps Isometric Strengthening 5 sec hold, 10 reps/ 1 set/(6 days/ week), Bent leg raise 5 sec hold/ 5 sec stretch/ 3 reps/ 1 min rest interval/ 1 set/ (6 days/ week). A total of 2 weeks (12 sessions, 6 sessions/ week) were given each consisting of 40 mins. | Other | Bent leg raise |
Primary outcome
Hamstring flexibility
Time frame: 12 days
Changes from baseline, Hamstring flexibility was measured through passive knee extension test with the help of Goniometer. Normal value of knee extension angle is 180 degrees. Values decreased than 160 degree represents hamstring tightness.
2 secondary outcomes
Functional outcome
Time frame: 12 days
Pain on Visual analogue Scale
Time frame: 12 days
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 27 Sep 2021.
- 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.
Asghar Khan, Phd principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Release Technique and Bent leg raise in people with Knee Osteoarthritis, run by Riphah International University 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 4 inclusion and 5 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 27 Sep 2021. 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?
Hamstring flexibility (time frame: 12 days). 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 27 Sep 2021.