Knee Osteoarthritis (Knee OA)NCT06737783
Thoracic Mobility Exercises Impact in Tibio Femoral Arthritis Patients
A study testing Thoracic mobility exercises + Conventional therapy and Self myofascial release with foam roller, T6- T7 Maitland mobilization + Conventional therapy in people with Knee Osteoarthritis (Knee OA), run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this randomized clinical trial is to find the effect of thoracic mobility exercises on thoracic hyper kyphosis and hamstring flexibility with tibiofemoral arthritis patients on reducing hyper kyphotic posture, knee pain and improving flexibility of hamstring muscles. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- Thoracic mobility exercises + Conventional therapy and Self myofascial release with foam roller, T6- T7 Maitland mobilization + Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Dec 2024to 10 Jun 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thoracic Kyphotic angle > 40
- Asymptomatic (no pain symptoms in) thoracic spine
- Able to stand independently
- Less than 70 degree Hip Flexion Angle on active SLR, with limited knee extension range more than 20 degree restriction on AKE test
- Bilateral Hamstring tightness
- Visual Analogue Scale in targeted Joint Tibiofemoral arthritis \>3 cm
- Having Osteoarthritis in Tibio femoral Joint, according to KL (Grade 2 and 3)
- X-rays showing evidence of reduced knee spaced/osteoarthritis symptoms B/L( >2 year)
Who cannot join
- Muscle/tendon injuries of hamstring
- Spinal Injuries, scoliosis, tumors and malignancies
- Any surgery, infection, skin sensitivity, trauma, fracture and fall
- Involvement in regular flexibility yoga program
- Patient with intra articular steroidal therapy with in last 6 months
- Patient unwilling to comply follow up schedule
- Patient involvement in another interventional study
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
National Institue of Rehabilitation Medicine (Nirm)
Islamabad, Punjab Province, 46000
About this study
Official title: Effects of Thoracic Mobility Exercises on Thoracic Hyper Kyphosis and Impact on Hamstring Flexibility in Patients With Tibio Femoral Arthritis
The aim of this randomized clinical trial is to find the effect of thoracic mobility exercises on thoracic hyper kyphosis and hamstring flexibility with tibiofemoral arthritis patients on reducing hyper kyphotic posture, knee pain and improving flexibility of hamstring muscles.
Read the detailed description
Tibio Femoral Arthritis is a painful heterogeneous musculoskeletal condition that comprises of articular cartilage degradation, distortion of joint tissues, depletion in synovial fluid and progression over time. Decline in joint ROM usually began in fourth decade, more common in women in the age of menopause mostly the age of 45 years or elder. In Pakistan prevalence of Tibio femoral arthritis is 28.0% in urban population and 25.0% in the rural population, estimated o outstretch 35% by 2030. Hamstring muscle are part of superficial posterior anatomical chain in body that form meridians or myofascial chains connected to thoracolumbar fascia via sacro tuberous ligament.
Knee joint movements are primarily facilitated by the quadriceps and hamstrings, which play a crucial role in ensuring smooth and accurate ambulation. Tightness in hamstring put stress on Tibio-femoral joint which further reduce its range of motion especially knee extension, joint loading problems, induce compensatory movements, gait limitations, disturbs overall spinal postural alignment, increase thoracic kyphosis, decrease lumbar lordosis, and inducing posterior pelvic tilt. Until now most existing studies focus on the impact of thoracic mobility on thoracic spine issues or general posture, with limited research on its secondary effects on lower limb flexibility in 45 to 65 years old Tibio femoral arthritic patients. There is still research gap present to identify comprehensive effects of thoracic mobility exercises, on hyper kyphotic postures with tightened hamstrings, complementing Tibio femoral arthritis with aging.
- Conditions
- Knee Osteoarthritis (Knee OA)
- Being tested
- Thoracic mobility exercises + Conventional therapy, Self myofascial release with foam roller, T6- T7 Maitland mobilization + Conventional therapy
- Keywords
- Thoracic hyperkyphosis, Hamstring flexibility, thoracic mobility exercises
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic mobility exercises + Conventional therapyOther
mobility exercises comprises of Cat and camel stretch (On hands and knees (supported with knee braces), alternating between arching the back up and dropping it down to stretch thoracic spine), Thoracic rotations in side lying (side lying on the side with knees bent, rotating the upper body to increase thoracic mobility alternatively), Thoracic extension at wall using body weight (Standing with back to wall, gently pushing the upper back into extension while keeping the lower back stable), half kneeling chop thrust (Kneeling on one knee (supported with knee braces), rotating the torso while keeping the pelvis stable to mobilize the thoracic spine) , Thoracic extension with a foam roller (Lying on the back with foam roller along thoracic spine, rolling gently to extend the thoracic spine in supine position). Adopt these positions with 5 secs hold and 15-20 reps will be performed for 2 sets and 10 reps per set.
Self myofascial release with foam roller, T6- T7 Maitland mobilization + Conventional therapyOther
Hamstring Self myofascial release with foam roller (Sitting with one leg extended, roll the foam roller along the hamstring while applying pressure to tender spots) 3 sets with 30 to 120 secs rolling duration per second for 5 mins T6-T7 grade 3 Maitland mobilization (Lying on the back, the therapist applies a sustained, posterior-to-anterior force on T6-T7 in prone position) 30 repetitions, with 1 min rest between 4 sets for 15 mins. Conventional therapy includes Hot pack/Cold pack + tens = 15 mins, Frequency 80 Hz, Pulse duration: 100 microseconds, Static quads (10 reps, 10 second hold, 2 sets), Active knee flexion and extension ROMs (10 reps, 5 secs hold, 2 sets), Long Axis Knee traction (5 reps, 30 secs hold, 10sec rest in b/w 2 sets), Kaltenborn Knee Glides Ant and Post direction ( 5 reps, 30 secs hold,10 sec rest interval in b/w 2 sets), Calf stretches (10 reps, 5 secs hold , 2 sets).
| Study group | Role | What they receive |
|---|---|---|
| Thoracic mobility exercises + Conventional therapy | Experimental | mobility exercises comprises of Cat and camel stretch (On hands and knees (supported with knee braces), alternating between arching the back up and dropping it down to stretch thoracic spine), Thoracic rotations in side lying (side lying on the side with knees bent, rotating the upper body to increase thoracic mobility alternatively), Thoracic extension at wall using body weight (Standing with back to wall, gently pushing the upper back into extension while keeping the lower back stable), half kneeling chop thrust (Kneeling on one knee (supported with knee braces), rotating the torso while keeping the pelvis stable to mobilize the thoracic spine) ,Thoracic extension with a foam roller (Lying on the back with foam roller along thoracic spine, rolling gently to extend the thoracic spine in supine position). Adopt these positions with 5 secs hold and 15-20 reps will be performed for 2 sets and 10 reps per set.
hold and 15-20 reps will be performed for 2 sets and 10 reps per set. Receives: Other: Thoracic mobility exercises + Conventional therapy |
| Self myofascial release with foam roller, T6- T7 Maitland mobilization and conventional therapy | Active comparator | Hamstring Self myofascial release with foam roller (Sitting with one leg extended, roll the foam roller along the hamstring while applying pressure to tender spots) 3 sets with 30 to 120 secs rolling duration per second for 5 mins T6-T7 grade 3 Maitland mobilization (Lying on the back, the therapist applies a sustained, posterior-to-anterior force on T6-T7 in prone position) 30 repetitions, with 1 min rest between 4 sets for 15 mins.
Conventional therapy includes Hot pack/Cold pack + tens = 15 mins, Frequency 80 Hz, Pulse duration: 100 microseconds, Static quads (10 reps, 10 second hold, 2 sets), Active knee flexion and extension ROMs (10 reps, 5 secs hold, 2 sets), Long Axis Knee traction (5 reps, 30 secs hold, 10sec rest in b/w 2 sets), Kaltenborn Knee Glides Ant and Post direction ( 5 reps, 30 secs hold,10 sec rest interval in b/w 2 sets), Calf stretches (10 reps, 5 secs hold , 2 sets). Receives: Other: Self myofascial release with foam roller, T6- T7 Maitland mobilization + Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active knee extension test (Goniometer)
Active knee extension (AKE) test was to measure hamstring flexibility. The participants lay in the supine/prone position with the tested hip flexed 90°, knee flexed 90° and were asked to extend the knee as much as possible until they felt strong resistance. Ensure Lumbar spine should be in neutral position. Axis of Goniometer will be placed on Lateral femoral condyle of femur. While moving and stationary arm on lateral aspect of midline of femur and fibula. Complete knee extension was 0° shows optimal flexibility and any lack of knee extension was measured with a universal goniometer with higher angle 20 degrees indicates poorer flexibility of hamstring muscles.
Measured: 4 weeks
Visual Analogue scale VAS
The VAS is a simple bidirectional graphic tool with a 10-cm horizontal line for assessing musculoskeletal pain intensity. Left side of scale represent 0 digit indicates "no pain" and the right end marked with 10 indicates "worst imaginable pain". The participants were asked to draw a vertical mark on the line to represent their level of pain intensity when patient asked to extend knee from flexion and from flexion position to extension. The length from the left end to the vertical mark, made by the participant shown her/his pain intensity
Measured: 4 weeks
Baseline bubble Inclinometer
Thoracic kyphosis angle was calculated using a baseline bubble inclinometer, a device used to measure curvature of spine. Inclinometer can measure angles b/w 20 to 60 degrees for thoracic region on wider arc of 180 degree. Participant should be in neutral position. Firstly, an inclinometer was placed over the spinous process of T1 and T2 for measurement (first inclinometer angle). Secondly, another inclinometer was placed over the spinous process of T12 and L1 for angle measurement (second inclinometer angle). The kyphosis angle was taken by taking difference between two measurements. Threshold for hyperkyphotic is greater 40 degrees.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start3 Dec 2024
- Primary completion2 Jun 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737783
- Sponsor's protocol ID
- REC/02007 Sameen Fatima
- Status last verified
- Aug 2025
- First submitted
- 12 Dec 2024
- Last updated
- 19 Aug 2025
- 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 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thoracic Mobility Exercises on Thoracic Hyper Kyphosis and Impact on Hamstring Flexibility in Patients With Tibio Femoral Arthritis
- ClinicalTrials.gov ID
- NCT06737783
- Acronym / sponsor ID
- REC/02007 Sameen Fatima
- Conditions
- Knee Osteoarthritis (Knee OA)
- Keywords
- Thoracic hyperkyphosis, Hamstring flexibility, thoracic mobility exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 17 Dec 2024 (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 aim of this randomized clinical trial is to find the effect of thoracic mobility exercises on thoracic hyper kyphosis and hamstring flexibility with tibiofemoral arthritis patients on reducing hyper kyphotic posture, knee pain and improving flexibility of hamstring muscles.
Detailed description
Tibio Femoral Arthritis is a painful heterogeneous musculoskeletal condition that comprises of articular cartilage degradation, distortion of joint tissues, depletion in synovial fluid and progression over time. Decline in joint ROM usually began in fourth decade, more common in women in the age of menopause mostly the age of 45 years or elder. In Pakistan prevalence of Tibio femoral arthritis is 28.0% in urban population and 25.0% in the rural population, estimated o outstretch 35% by 2030. Hamstring muscle are part of superficial posterior anatomical chain in body that form meridians or myofascial chains connected to thoracolumbar fascia via sacro tuberous ligament.
Knee joint movements are primarily facilitated by the quadriceps and hamstrings, which play a crucial role in ensuring smooth and accurate ambulation. Tightness in hamstring put stress on Tibio-femoral joint which further reduce its range of motion especially knee extension, joint loading problems, induce compensatory movements, gait limitations, disturbs overall spinal postural alignment, increase thoracic kyphosis, decrease lumbar lordosis, and inducing posterior pelvic tilt. Until now most existing studies focus on the impact of thoracic mobility on thoracic spine issues or general posture, with limited research on its secondary effects on lower limb flexibility in 45 to 65 years old Tibio femoral arthritic patients. There is still research gap present to identify comprehensive effects of thoracic mobility exercises, on hyper kyphotic postures with tightened hamstrings, complementing Tibio femoral arthritis with aging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic mobility exercises + Conventional therapy | Experimental | Other: Thoracic mobility exercises + Conventional therapymobility exercises comprises of Cat and camel stretch (On hands and knees (supported with knee braces), alternating between arching the back up and dropping it down to stretch thoracic spine), Thoracic rotations in side lying (side lying on the side with knees bent, rotating the upper body to increase thoracic mobility alternatively), Thoracic extension at wall using body weight (Standing with back to wall, gently pushing the upper back into extension while keeping the lower back stable), half kneeling chop thrust (Kneeling on one knee (supported with knee braces), rotating the torso while keeping the pelvis stable to mobilize the thoracic spine) ,Thoracic extension with a foam roller (Lying on the back with foam roller along thoracic spine, rolling gently to extend the thoracic spine in supine position). Adopt these positions with 5 secs hold and 15-20 reps will be performed for 2 sets and 10 reps per set. hold and 15-20 reps will be performed for 2 sets and 10 reps per set. |
| Self myofascial release with foam roller, T6- T7 Maitland mobilization and conventional therapy | Active comparator | Other: Self myofascial release with foam roller, T6- T7 Maitland mobilization + Conventional therapyHamstring Self myofascial release with foam roller (Sitting with one leg extended, roll the foam roller along the hamstring while applying pressure to tender spots) 3 sets with 30 to 120 secs rolling duration per second for 5 mins T6-T7 grade 3 Maitland mobilization (Lying on the back, the therapist applies a sustained, posterior-to-anterior force on T6-T7 in prone position) 30 repetitions, with 1 min rest between 4 sets for 15 mins. Conventional therapy includes Hot pack/Cold pack + tens = 15 mins, Frequency 80 Hz, Pulse duration: 100 microseconds, Static quads (10 reps, 10 second hold, 2 sets), Active knee flexion and extension ROMs (10 reps, 5 secs hold, 2 sets), Long Axis Knee traction (5 reps, 30 secs hold, 10sec rest in b/w 2 sets), Kaltenborn Knee Glides Ant and Post direction ( 5 reps, 30 secs hold,10 sec rest interval in b/w 2 sets), Calf stretches (10 reps, 5 secs hold , 2 sets). |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Thoracic Kyphotic angle > 40
- Asymptomatic (no pain symptoms in) thoracic spine
- Able to stand independently
- Less than 70 degree Hip Flexion Angle on active SLR, with limited knee extension range more than 20 degree restriction on AKE test
- Bilateral Hamstring tightness
Key exclusion criteria (7 listed)
- Muscle/tendon injuries of hamstring
- Spinal Injuries, scoliosis, tumors and malignancies
- Any surgery, infection, skin sensitivity, trauma, fracture and fall
- Involvement in regular flexibility yoga program
- Patient with intra articular steroidal therapy with in last 6 months
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 |
|---|---|---|
| Thoracic mobility exercises + Conventional therapymobility exercises comprises of Cat and camel stretch (On hands and knees (supported with knee braces), alternating between arching the back up and dropping it down to stretch thoracic spine), Thoracic rotations in side lying (side lying on the side with knees bent, rotating the upper body to increase thoracic mobility alternatively), Thoracic extension at wall using body weight (Standing with back to wall, gently pushing the upper back into extension while keeping the lower back stable), half kneeling chop thrust (Kneeling on one knee (supported with knee braces), rotating the torso while keeping the pelvis stable to mobilize the thoracic spine) , Thoracic extension with a foam roller (Lying on the back with foam roller along thoracic spine, rolling gently to extend the thoracic spine in supine position). Adopt these positions with 5 secs hold and 15-20 reps will be performed for 2 sets and 10 reps per set. | Other | Thoracic mobility exercises + Conventional therapy |
| Self myofascial release with foam roller, T6- T7 Maitland mobilization + Conventional therapyHamstring Self myofascial release with foam roller (Sitting with one leg extended, roll the foam roller along the hamstring while applying pressure to tender spots) 3 sets with 30 to 120 secs rolling duration per second for 5 mins T6-T7 grade 3 Maitland mobilization (Lying on the back, the therapist applies a sustained, posterior-to-anterior force on T6-T7 in prone position) 30 repetitions, with 1 min rest between 4 sets for 15 mins. Conventional therapy includes Hot pack/Cold pack + tens = 15 mins, Frequency 80 Hz, Pulse duration: 100 microseconds, Static quads (10 reps, 10 second hold, 2 sets), Active knee flexion and extension ROMs (10 reps, 5 secs hold, 2 sets), Long Axis Knee traction (5 reps, 30 secs hold, 10sec rest in b/w 2 sets), Kaltenborn Knee Glides Ant and Post direction ( 5 reps, 30 secs hold,10 sec rest interval in b/w 2 sets), Calf stretches (10 reps, 5 secs hold , 2 sets). | Other | Self myofascial release with foam roller, T6- T7 Maitland mobilization and conventional therapy |
Primary outcome
Active knee extension test (Goniometer)
Time frame: 4 weeks
Active knee extension (AKE) test was to measure hamstring flexibility. The participants lay in the supine/prone position with the tested hip flexed 90°, knee flexed 90° and were asked to extend the knee as much as possible until they felt strong resistance. Ensure Lumbar spine should be in neutral position. Axis of Goniometer will be placed on Lateral femoral condyle of femur. While moving and stationary arm on lateral aspect of midline of femur and fibula. Complete knee extension was 0° shows optimal flexibility and any lack of knee extension was measured with a universal goniometer with higher angle 20 degrees indicates poorer flexibility of hamstring muscles.
Visual Analogue scale VAS
Time frame: 4 weeks
The VAS is a simple bidirectional graphic tool with a 10-cm horizontal line for assessing musculoskeletal pain intensity. Left side of scale represent 0 digit indicates "no pain" and the right end marked with 10 indicates "worst imaginable pain". The participants were asked to draw a vertical mark on the line to represent their level of pain intensity when patient asked to extend knee from flexion and from flexion position to extension. The length from the left end to the vertical mark, made by the participant shown her/his pain intensity
Baseline bubble Inclinometer
Time frame: 4 weeks
Thoracic kyphosis angle was calculated using a baseline bubble inclinometer, a device used to measure curvature of spine. Inclinometer can measure angles b/w 20 to 60 degrees for thoracic region on wider arc of 180 degree. Participant should be in neutral position. Firstly, an inclinometer was placed over the spinous process of T1 and T2 for measurement (first inclinometer angle). Secondly, another inclinometer was placed over the spinous process of T12 and L1 for angle measurement (second inclinometer angle). The kyphosis angle was taken by taking difference between two measurements. Threshold for hyperkyphotic is greater 40 degrees.
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 19 Aug 2025.
- 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.
Maria khalid, MSOMPT principal investigator
Riphah International 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 Thoracic mobility exercises + Conventional therapy and Self myofascial release with foam roller, T6- T7 Maitland mobilization + Conventional therapy in people with Knee Osteoarthritis (Knee OA), run by Riphah International University 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 8 inclusion and 7 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 19 Aug 2025. 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?
Active knee extension test (Goniometer) (time frame: 4 weeks). The study lists 3 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 19 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.